The ideas, concepts and conclusions set forth in this draft, including the proposed statutory language and any comments or reporter’s notes, have not been reviewed, debated or approved by the National Conference of Commissioners on Uniform State Laws or the Drafting Committee. They do not reflect the views of the Conference and its Commissioners or the Drafting Committee and its Members and Reporter. Proposed statutory language may not be used to ascertain the intent or meaning of any promulgated final statutory proposal made by the National Conference of Commissioners on Uniform State Laws.

DRAFTING COMMITTEE ON PROTECTION OF GENETIC INFORMATION IN EMPLOYMENT AND INSURANCE ACT

The Committee appointed by and representing the National Conference of Commissioners on Uniform State Laws in preparing this Act consists of the following individuals:

SHELDON F. KURTZ, The University of Iowa College of Law, 446 BLB, Iowa City, IA 52242

KEN H. TAKAYAMA, Legislative Reference Bureau, 415 South Beretania St., State Capitol, Room 446, Honolulu, HI 96813

STEPHEN C. TAYLOR, D.C. Department of Insurance, Securities & Banking, 810 1^st St., NE, Suite 701, Washington, DC 20002

JAMES A. WYNN, JR., NC Court of Appeals, One W. Morgan St., P.O. Box 888, Raleigh, NC 27602

JOAN ZELDON, District of Columbia Superior Court, 515 St., N.W., Bldg. A, Room 219, Washington, DC 20001

ELLEN E. DEASON, Ohio State University, Moritz College of Law, 55 W. 12th Ave., Columbus, OH 43210, Reporter

ROBERT A. STEIN, University of Minnesota Law School, 229 19th Avenue South, Minneapolis, MN 55455, President

GAIL H. HAGERTY, South Central Judicial District, P.O. Box 1013, 514 E. Thayer Ave., Bismark, ND 58502-1013, Division Chair

PETER J. GILLESPIE, 1000 Marquette Bldg., 140 S. Dearborn St., Chicago, IL 60603, ABA Advisor

ROBYN S. SHAPIRO, 777 E. Wisconsin Ave., Suite 2000, Milwaukee, WI 53202, ABA Advisor

JOHN A. SEBERT, 111 N. Wabash Ave., Suite 1010, Chicago, IL 60602, Executive Director

INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

The scientific developments in the field of genetics are often characterized as a “revolution.” This revolution is ushering in a new era of greater understanding of human biological processes and the promise of new approaches to medicine that can tailor medical treatments to individuals’ genetic traits. Genetic tests also offer the possibility of identifying individuals who are at risk of developing certain diseases in the future. Unfortunately, while risk information has the potential to improve preventative medicine, it is also subject to misunderstanding and misuse. This Act strikes a balance between making genetic information available for beneficial uses and preventing acquisition of information that creates a risk of misuse.

There are important policy issues concerning the appropriate form and scope of regulation of genetic information. Appropriate goals for regulation include that (1) individuals should not be coerced into having genetic tests; (2) individuals who want to be tested should not be discouraged through fear of how the results will be used; (3) genetic information should not be used for irrational discrimination, that is, where there is no scientific basis for discrimination; and (4) even “rational” discrimination should be prohibited when it violates public policy, including the policy of preventing discrimination on the basis of disability. Cynthia Nance, Paul Miller, & Mark Rothstein, Discrimination in Employment on the Basis of Genetics, 6 Employee Rights & Employment Policy Journal 57, 79 (2002). See also Henry T. Greely, Genotype Discrimination: The Complex Case for Some Legislative Protection, 149 U. Pa. L. Rev. 1483, 1500 (2001).

The Drafting Committee has articulated four concepts that support the goals of protecting privacy and encouraging testing: control, confidentiality, consent, and counseling. The principle of knowing and voluntary consent can allow an individual to control genetic testing by vesting the decision in the individual to be tested. A baseline rule of confidentiality, coupled with the individual’s capability to consent to exceptions, can allow an individual to control how others acquire, use, retain, or disclose the individual’s genetic information. Finally, given the complexities and uncertainties of genetic science, genetic counseling is necessary if these decisions about consent are to be knowing and informed.

The Drafting Committee has identified reasons why it is important to regulate genetic testing and acquisition, use, retention, and disclosure of genetic information by employers and insurers. These include the need to prevent fears of adverse consequences associated with genetic testing; the tendency to overstate the predictive power of genetic information, which can lead to actions that are not justified by that information; and the growing availability of genetic information.

Fear as a deterrent to genetic testing. To encourage individuals to undergo testing that can lead to advances in genetics and improved medical care, it is important to prevent fears that their privacy may be invaded or that testing may lead to detrimental treatment by employers or insurers. Currently, the public is afraid of taking advantage of genetic testing. See, e.g., Amy Harmon, Fear of Insurance Trouble Leads Many to Shun or Hide DNA Tests, N.Y. Times, Feb. 24, 2008, at A1. There is more than anecdotal evidence that these fears are widespread. In a 1997 national survey, 63% of the respondents reported that they would not take genetic tests if employers or insurers could obtain access to the results. Department of Labor, Department of Health & Human Services, Equal Employment Opportunity Commission, & Department of Justice, Genetic Information and the Workplace (Jan. 20, 1998) (available at http://www.genome.gov/10001732). In an actual genetic study of individuals at risk for hereditary colon cancer, only 43% of those eligible participated. Of those who declined, 39% said the primary reason was fear that the test results would affect their medical insurance coverage. D. Hadley, et al, Genetic Counseling and testing in families with hereditary nonpolyposis colorectal cancer, Archives of Internal Medicine 163: 573-582 (2003). These examples illustrate that individuals must have control not only over whether or not to undergo a test, but also over the information that results from genetic testing.

Exaggerated predictive power of genetic information. Because the human genome has been portrayed with images such as “blueprint,” “code,” and “future diary,” public misunderstandings of the role of genetics are common. Employers and insurers cannot be expected to be exempt from such misunderstandings, which may cause them to exaggerate the predictive potential of genetic information.

There are some rare genetic diseases, such as Huntington’s disease, that are caused by a single gene and that can be predicted with certainty from an individual’s genetic sequence. These diseases may arguably justify “rational” discrimination. But such monogenetic diseases are the exception. They have received much attention as the first diseases for which researchers established a genetic link, but they afflict relatively few individuals. And even with such diseases, there is usually variation in the age that symptoms appear and in their severity that lessens predictability.

The genetic causation of most diseases, and hence their predictability is far more complex. It is more common for medical conditions to result from interactions among multiple genes and with the environment. Most of the diseases that are linked to a genetic variation do not appear in all of the individuals with that genotype. This is termed “incomplete penetrance.” For example, certain forms of the BRCA 1 gene are strongly associated with susceptibility to breast cancer. But only 50 to 85 percent of women who have this form of the gene will ever develop the disease. Moreover, the frequency of particular gene variants and their degree of penetrance often differ among ethnic groups, which also complicates the clinical sensitivity of genetic tests and their predictive capabilities.

Another complicating factor for accurate prediction is that often a large number of genetic variations can cause the same disease. More than 180 different sequences of beta-globin genes are associated with the blood disease beta-thalassemia. And the severity of the symptoms of patients with this disease vary dramatically. Similarly, there are more than 300 forms of the gene responsible for cystic fibrosis. Unfortunately, identifying the variant of the gene does not explain the variation in symptoms.

Low penetrance, multiple genetic variations that may cause a single disease, and other sources of complications diminish the predictive value of genetic testing. In addition to the over-inclusiveness of many medical predictions based on genetic tests (in that a person with a predisposing genotype may never have symptoms of the disease), genetic predictions are also often extremely under-inclusive. For example, the predisposing variants of the BRCA 1 and BRCA 2 genes are present in only 5 to 10 percent of breast cancer patients. Thus, genetic data often do not provide an accurate individualized prediction. This is a major justification for the regulation of genetic information.

Increased Availability of Genetic Information. Scientific advances in genetics mean that a very large amount of information can be obtained from one small sample that is easily obtained and analyzed, yielding data that is easily stored and disseminated. This is not unique, but the concentration of information makes genetic information, which combines the power of many other types of medical information, seem particularly threatening.

Recent developments are making genetic information far more available and increasing the risk that it can be misused. One development is in genetic testing offered directly to consumers. Companies such as 23andMe and Navigenics offer a genome scan of a saliva sample for as little as $1,000. There are companies that purport to help clients find DNA-compatible mates based on differences in immune systems or use DNA samples to identify nutritional needs that can be met by purchases of dietary supplements. See generally Rick Weiss, Genetic Testing Gets Personal: Firms Sell Answers on Health, Even Love, Wash. Post, Mar. 25, 2008.

A second development that will vastly increase the amount of readily available genetic information is the ongoing transition within the practice of medicine to electronic medical records. In 2005, the Secretary of Health and Human Services, Michael Leavitt, established the American Health Information Community, a federal advisory committee, to make recommendations on how to accelerate a shift to electronic records with the goal of reducing costs and improving medical care. Genetic information is typically contained in a standard medical record. Such records could be linked to each other and available electronically.

Scope of Regulation. Proposals to regulate genetic information, however, have provoked a major policy debate over the wisdom of “genetic exceptionalism,” that is, the regulation of genetic testing and information as a special category rather than as part of more comprehensive regulation of medical testing and information. See generally T.H. Murray, Genetic Exceptionalism and Future Diaries: Is Genetic Information Different from other Information, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (Mark A. Rothstein ed. 1977); Sonia M. Sutter, The Allure and Peril of Genetics Exceptionalism: Do We Need Special Genetics Legislation?, 79 Wash U. L.Q. 669 (2001).

In the course of this debate, many arguments for singling out genetics for special attention have been raised and rejected. In the early 1990s, the Task Force on Genetic Information and Insurance, a joint working group of the National Institutes of Health and the United States Department of Energy, considered and rejected three justifications for such a policy: (1) They decided that genetic information is not sufficiently distinct from other health information on the basis of its prophetic potential. Genetic predispositions can be affected by many factors and information on non-genetic characteristics, such as lifestyle, may be better health predictors; (2) Genetic information is also not unique in its implications for family members; and (3) Genetic information is not the only type of health information with the ability to stigmatize.

Other arguments for exceptionalism include that genetic information is particularly sensitive in that it identifies normal variations that fuel discrimination despite their lack of clinical significance. Genetic codes are also viewed as immutable, so that one test can follow a person forever, and genetic information is more probabilistic than other types of medical information. These arguments can also be refuted as a basis for exceptionalism on the ground that they apply as well to other types of health information. Laine Friedman Ross, Genetic Exceptionalism vs. Paradigm Shift: Lessons from HIV, 29 J. L. Med. & Ethics 141 (2001).

There are also objections to treating genetic information separately on practical grounds. The distinction between genetic and non-genetic disorders is increasingly difficult to draw; most conditions have both a genetic and non-genetic component. Opponents of exceptionalism also contend that it is unrealistic to separate genetic information in medical records, so that it would be impossible to comply with restrictions on disclosing genetic information to employers or insurers. L.O. Gostin & J.G. Hodge, Genetic Privacy and the Law: An End to Genetics Exceptionalism, 40 Jurimetirics 21 (1999). Also, there is a social argument that it is unwise to enact laws that treat genetic conditions as if there is a stigma attached to them because that reinforces such attitudes and becomes a self-fulfilling prophecy. Moreover, treating genetics as unique only encourages the public view that genetics exert a special control over our lives, a view termed “genetic essentialism.” See, e.g., Rochelle Cooper Dreyfus & Dorothy Nelkin, The Jurisprudence of Genetics, 45 Vand. L. Rev. 313 (1992).

Most of the opponents of genetic exceptionalism do not oppose privacy protections, rather they advocate more holistic approaches to health information and its use in employment and insurance. The larger debate is about how to protect medical data from harmful uses while providing access for uses that individuals, clinicians, and society regard as beneficial. Genetic information is one part of the problem posed by the ease of collecting, storing, and disseminating personal information. Thus it is possible to argue that the exceptionalism debate is a distraction from more important questions about how regulations should be adapted to new scientific developments. Zita Lazzarini, What Lessons Can We Learn from the Exceptionalism Debate (Finally)?, 29 J. L. Med. & Policy 149 (2001). In the context of health insurance, one commentator maintains that “[g]enetic equity should be regarded not as an exceptional goal, but as an aim consistent with a broader movement toward equitable access to health care in a time of scarcity.” John V. Jacobi, Genetic Discrimination in a Time of False Hopes, 30 Fla. St. U. L. Rev. 363, 364 (2003).

The Drafting Committee’s charge, which covers the misuse of genetic information in employment and insurance, responds to the large number of states that have enacted legislation. That legislation is highly inconsistent and often deals only partially with the issues associated with genetic information. The charge does contemplate genetic exceptionalism by focusing on use of genetic information rather than on health information or privacy more generally. Broader measures for all medical information may not be practical at this time. Nonetheless, it is still important to respond to problems with the use of genetic information. Perhaps regulation of the use of genetic information can serve as an example for policies that need to be developed for the treatment of medical information more generally.

The genetic revolution has raised challenges for several different aspects of privacy: informational privacy, physical privacy, decisional privacy, and proprietary privacy. See Anita L. Allen, Genetic Privacy: Emerging Concepts and Values, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 31 (Mark A. Rothstein, ed. 1997).

Informational privacy can be thought of as an individual’s ability to determine what information about that individual should be available to others. “By controlling personal information, individuals can control the extent to which other people can participate in their lives.” David Orentlicher, Genetic Privacy in the Patient-Physician Relationship, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 77 (Mark A. Rothstein, ed. 1997). Informational privacy of any type is challenging given advances in information technology that greatly increase the potential for others to acquire or disclose one’s personal information.

In the genetic context, an individual’s primary informational concern is the confidentiality or anonymity of the results of genetic testing. This privacy interest extends beyond the results of one’s personal genetic testing to genetic testing of blood relatives, which can also provide information about the individual. The desire to maintain the privacy of this genetic information often has a consequential motivation: people are concerned about others using their genetic information to their detriment. It also springs from a sense of the intrinsic value of keeping such personal information private whether or not the release of genetic information could lead to adverse consequences. The understanding that one’s characteristics, and even one’s personality, are strongly linked to one’s genetic composition heightens the sense that this information is a reflection of personal identity, and thus has inherent personal value.

The other forms of privacy are also important in the context of genetics. Physical privacy, the protection of bodily and personal space, is implicated by genetic testing or treatment. The importance of this form of privacy is recognized in concern for informed, voluntary consent for genetic testing. Decisional privacy, the freedom to make choices without interference by others, is implicated by the need to make decisions about using genetic services. Decisional privacy is an important tenet of genetic counseling, which supports autonomous decisionmaking about having genetic testing and learning the results of the testing. Proprietary privacy, control over possessions and economic interests, is implicated by the value of some individuals’ samples or genetic information and by a sense of ownership of one’s own identity. See Anita L. Allen, Genetic Privacy: Emerging Concepts and Values, in Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 31 (Mark A. Rothstein, ed. 1997).

Privacy is valued in society and law, but not absolutely. The important interest in genetic privacy and confidentiality must be balanced against competing values, including facilitating medical research, improving medical care, protecting public health, enforcing the law, and controlling costs.

State legislation on privacy of medical information is set against the background of the 1996 Health Insurance Portability and Accountability Act (HIPAA), which covers health insurers and other health practitioners, and the recently enacted Genetic Information Nondiscrimination Act of 2008 (GINA), Pub. L. 110-233, which covers health insurers and employers.

Title II of HIPAA required the Department of Health and Human Services to promulgate rules that created standards for the use and dissemination of health care information, including what is now called “The Privacy Rule.” The Privacy Rule, which took effect in 2003, regulates those who create and disclose health information – individual practitioners, multi-national health plans, pharmacies, and information clearinghouses – but not many of the key recipients of this information. “Covered entities,” which include most health insurers, may disclose “protected health information,” i.e., “individually-identifiable health information” to facilitate treatment, payment, or health care operations. For other disclosures, with some exceptions, they must first obtain “consent,” “authorization,” or “agreement” from the individual, depending on the circumstances of the disclosure. The Privacy Rule also allows individuals access to their own health information and gives them the right to request a correction of any inaccurate data. Covered entities must notify individuals of uses of their protected health information and keep records of disclosures.

Health insurers who are covered entities must follow these rules when they disclose health information to employers or life, disability-income, or long-term-care insurers, but employers and these insurers are not directly subject to the HIPAA regulations and so do not need to follow these rules in their own treatment of the information.

Although HIPAA does include general preemption provisions, they do not apply to state laws that relate to the privacy of individually-identifiable health information that are contrary to and more stringent than the federal requirements. Thus HIPPA provides a floor, not a ceiling, for privacy protections and would not preempt the privacy provisions of the Act.

Recent federal legislation has established specific privacy requirements for genetic information. GINA supplements privacy regulations for group, individual and medigap health insurers already covered by the HIPAA privacy regulations. It prohibits these health insurers from requesting, requiring or purchasing genetic information before an individual’s enrollment and from using genetic information in underwriting or determining eligibility.

The legislation also limits acquisition, use, and disclosure of genetic information by employers, labor organizations, employment agencies, and joint labor-management committees. Its provisions do not apply to life, disability-income, and long-term-care insurers. Like HIPAA, the GINA employment provisions do not preempt state legislation that provides equal or greater privacy protection to individuals.

Approximately 15 states have statutes that protect the privacy of genetic information in general, without regard to employment or insurance or any other specific context. Most of these statutes are tailored to cover information derived from genetic testing, although some establish a principle of confidentiality for medical information more generally. (Cal, Maine, ND) Many of these statutes declare that genetic testing and test results are confidential. See, e.g., Ariz. (confidential and privileged), Cal, Maine, New York, Oregon. A few states have established a property right in genetic test results. Alaska Stat. § 18.13.010 (exclusive property right in DNA sample and results of analysis performed on sample); Fla. Stat. § 760.40 (results of DNA analysis are the exclusive property of the person tested); OR (repealed)).

Most of these generally-applicable statutes prohibit obtaining, analyzing, retaining, or disclosing genetic test results without the informed consent or specific authorization of the tested individual. All these statutes also define exceptions where genetic information may be obtained or disclosures may be made without authorization. Typical exceptions include law enforcement purposes and paternity determinations. Some states also exempt certain forms of insurance. See, e.g., Mass. (disability-income and long-term-care insurance); NH (life, disability-income, and long-term-care insurance); NMex (life, disability-income, and long-term-care insurance if underwriting based on sound actuarial principles); OK (life, disability-income, and long-term-care insurance). Others make special provisions for research. See, e.g., NY; OR (repealed).

This draft protects privacy through limitations on the ability of employers and insurers to require genetic tests and to acquire, use, retain, and disclose genetic information. These limitations are coupled with authorization requirements for voluntary testing and acquisition of their genetic information. In the section of the draft on employment, the privacy provisions are presented with information on GINA to enable the Committee to make policy decisions about the extent to which the Uniform Act should supplement the federal statute.

The Drafting Committee considered adopting a property right as a means to protect privacy of genetic information, but decided against this approach. While it might make sense to recognize a property right in genetic information in general, it is difficult to do only in the context of employment and insurance. Moreover, a majority of the Committee felt that a system of limitations on testing, acquisition, use, retention, and disclosure would be as effective as a property right in providing control over genetic information.

Many contend that employers’ ability to obtain genetic information should be limited because it has few appropriate uses in the workplace. The concern is that if employers are permitted to consider genetic information in making personnel decisions, individuals may be unfairly barred or dismissed from employment for reasons that are not related to their ability to do the job. This is an especially high risk with predictive genetic information because so many persons tend to exaggerate the role of genes in disease and mistakenly regard an increased risk of an illness as a certainty that it will occur.

Employers arguably have an economic incentive to use genetic information to avoid hiring employees with higher medical insurance claims, higher absenteeism, or lower productivity. They may also wish to avoid the effect of high health care costs incurred by employees’ dependents. Somewhat perversely, because the federal Health Insurance Portability and Accountability Act (HIPAA) protects employees against discrimination in health insurance based on medical conditions, including genetic characteristics, the most effective way for employers to avoid high insurance costs is to screen applicants and avoid hiring high-risk individuals. Nonetheless, there are few well-documented cases of genetic discrimination in employment.

In 1996, the NIH-DOE Joint Working Group on Ethical, Legal, and Social Implications of Human Genome Research (ELSI Working Group) and the National Action Plan of Breast Cancer developed and issued the following recommendations for state and federal policy makers to protect against genetic discrimination in employment. To a large extent, these recommendations mirror the approach of the Americans With Disabilities Act, described below.

• Employment organizations should be prohibited from using genetic information to affect the hiring of an individual or to affect the terms, conditions, privileges, benefits or termination of employment unless the employment organization can prove this information is job related and consistent with business activity.

• Employment organizations should be prohibited from requesting or requiring collection or disclosure of genetic information prior to a conditional offer of employment, and under all circumstances, employment organizations should be prohibited from requesting or requiring collection or disclosure of genetic information unless the employment organization can prove this information is job related and consistent with business necessity, or otherwise mandated by law. Written and informed consent should be required for each request, collection or disclosure.

• Employment organizations should be restricted from access to genetic information contained in medical records released by individuals as a condition of employment, in claims filed for reimbursement of health care costs and other sources.

• Employment organizations should be prohibited from releasing genetic information without prior written authorization of the individual. Written authorization should be required for each disclosure and include to whom the disclosure will be made.

• Violators of these provisions should be subject to strong enforcement mechanisms, including private right of action.

Karen Rothenberg et al., Genetic Information and the Workplace: Legislative Approaches and Policy Challenges, 275 Science 1755 (1996).

The states are legislating in a regulatory environment in which recent federal legislation, the Genetic Information Nondiscrimination Act of 2008 (GINA), has increased the role of the federal government in regulating genetic testing and genetic information in employment. The employment provisions of this act do not, however, preempt state legislation that provides equal or greater protection to individuals. 42 U.S.C. § 2000ff-8(a)(1). In addition, two federal statutes provide modest legal protections against discrimination in employment on a genetic basis: Title VII of the Civil Rights Act of 1964 (Title VII) and the Americans with Disabilities Act (ADA). These statutes are also important because many states have their own version of these statutes which they have modified to incorporate genetic protections.

Recent federal legislation now specifically regulates acquisition of genetic information and its use by employers. 42 U.S.C. §§ 2000ff to 2000ff-11. GINA applies to employers, employment agencies, labor organizations, and training programs. These entities are prohibited from discriminating on the basis of genetic information. They are also prohibited from acquiring genetic information, with exceptions that include offering genetic services as part of an employer wellness program and genetic monitoring that is required by federal or state law. Employees may bring claims for disparate treatment based on genetic information, but not for disparate impact. In six years, a study group will make recommendations regarding whether or not to add a cause of action for disparate treatment. Remedies and enforcement are generally limited to those available under Title VII of the Civil Rights Act of 1964, which requires filing a claim with the Equal Employment Opportunity Commission.

GINA is supplemented by Title VII, which prohibits employer discrimination on the basis of race, sex, color, national origin, and religion. It is applicable to genetic discrimination if an employer tests a group of employees in one of the protected classes. For example, the court in Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), held that testing only black employees for the sickle cell trait violated Title VII by imposing a condition of employment on the basis of race. It is also possible that testing all employees could violate the Act if the test were for a trait closely associated with a protected group, such as sickle cell trait (which is more prevalent among African-Americans) or Tay-Sachs disease (associated with Ashkenazi Jewish ancestry). However, in these circumstances the statute would require the difficult showing that the testing was a pretext for intentional discrimination against the group or that it had a statistically significant disparate impact on employment opportunities of members of the group. Most importantly, the narrow focus on employers’ actions with respect to certain groups means that Title VII would certainly not apply if an employer instituted a screening program for traits that are not strongly associated with a protected group. See Pauline T. Kim, Genetic Discrimination, Genetic Privacy: Rethinking Employee Protections for a Brave New Workplace, 96 NW U. L. Rev. 1497 (2002).

The ADA could provide some protections against genetic discrimination through its regulation of disability discrimination, although this potential is limited by the United States Supreme Court’s narrow interpretation of the statute. See, e.g., Sutton v. United Air Lines, Inc., 527 U.S. 471, 484-85 (1999) (stating ADA is intended to have limited coverage). “Disability” is defined under the ADA as (1) a physical or mental impairment that substantially limits one or more of the major life activities of an individual; (2) a record of such impairment; or (3) being regarded as having such an impairment. 42 U.S.C. § 12112(d)(2). If a genetically-caused disease results in a disability under the first prong of the definition, the ADA’s protections will apply. The genetic connection is irrelevant; the statute protects the person because of the person’s disability, not its cause. Similarly, under the second prong the ADA covers individuals with a prior history of a genetically-related disability, such as a person recovering from a cancer. Of course, if these genetic conditions do not qualify under the definition of “disability” by substantially limiting a major life activity, the individual is not covered by the ADA.

The application of the ADA to discrimination based on a genetic trait that is not manifested in symptomatic disease is a more difficult question. In 1995 the Equal Employment Opportunity Commission (EEOC) issued a policy statement that an individual should be “regarded as” having a disability under the statute’s third prong if the employer discriminates on the basis of “genetic information relating to illness, disease, or other disorders.” EEOC Order No. 915.002 § 902 (1995). This interpretation of the statute has not been considered by the courts, although several United States Supreme Court justices have expressed their disapproval in dicta. See, e.g., Bragdon v. Abbott, 524 U.S. 624, 661 (1998) (Rehnquist, J., joined by Scalia, J. & Thomas, J., concurring in part & dissenting in part). Moreover, the EEOC’s position has been criticized in both conceptual and practical terms. See, e.g., Pauline T. Kim, Genetic Discrimination, Genetic Privacy: Rethinking Employee Protections for a Brave New Workplace, 96 NW U. L. Rev. 1497 (2002).

The ADA protects a disabled job applicant or employee from discrimination in the workplace. This includes a duty to provide reasonable accommodations to a qualified individual with a disability unless the accommodation would impose an undue hardship on the operation of the business. The ADA also regulates testing and acquisition of information by prohibiting medical examinations or testing before a job offer. However, after making a “conditional offer,” an employer may require an applicant to take a medical exam. After making a conditional offer employers also have the right to require that individuals sign a blanket release disclosing all their medical records to the employer. Furthermore, once an individual is hired, an employer may test the employee if it can justify the testing as job-related.

Concern about economic incentives for employers has led 34 states, as of January 2006, to enact statutes that regulate the use of genetic information or genetic testing by employers. One group of states has used an existing state statute as a platform, amending it to apply to genetic testing or information. A second, larger, group has enacted statutes that are specifically tailored for genetic issues. This diversity of approaches has led to much inconsistency in state law.

In the first group, some states have extended their disability statutes to prohibit discrimination by employers based on genetic information under the rubric of disability. See, e.g., Hawaii RS §§ 378-1 to 378-6; Illinois, 410 ILCS 513/5 to 513/30 (tied to federal Americans with Disability Act); Mich Comp Laws Ann §§ 37.1201-37.1202; NY Exec Law §§ 292, 296 (adds genetic conditions to the definition of protected disability).

Other states in the group that has adapted existing statutes have built on their statutes that prohibit discrimination in employment, expanding them from race, sex, national origin, and other protected classes, to include discrimination based on genetic information. See, e.g., Ariz Rev Stat Ann § 41-1463; Cal Govt Code §§ 12926, 12940; Conn Gen Stat Ann § 46a-60; Mass Gen L ch 151B; Nev Stat § 613.345; NJ Stat Ann §§ 10:5-5, 10.5-12. Wisconsin has used its Fair Employment Act as its vehicle, amending it to restrict the ability of employers to conduct genetic testing and use genetic information. Wis Stat § 111.372.

States in the second group have enacted special statutes that regulate genetic testing or the use of genetic information. This is the largest group of states, but the extent to which they concentrate on the context of employment varies to some extent. Most commonly, the provisions are tailored specifically for employment. See, e.g., Ark Code Ann §§ 11-5-401 to 11-5-405; Del Code Ann § 710; Kan Stat Ann §§ 44-1002(m), 44-1009(a)(9); La Rev Stat Ann §§ 23.302, 23.368-369; Iowa Code § 729.6; Me Rev Stat Ann tit 5, § 19301; Md Code Ann art. 49B §§ 15,16; Minn Stat § 181.974; Neb Rev Stat § 48-236; NH Rev Stat Ann §§ 141-H:1 to 141-H:5; NC Gen Stat § 95-28.1A; Okla Stat tit 36, § 3614.2; Or Rev Stat § 659A.300; RI Gen Laws §§ 28-6.7-1 to 28-6.7-4; S.D. codified laws §§ 60-2-20 to 60-2-21; Tex Lab Code Ann § 21.401; Utah Code Ann §§ 26-45-101 to 26-45-106; Vt Stat Ann tit 18, §§ 9331-9335; Va Code Ann § 40.1-28.7:1(A); Wash Rev Code Ann § 49.44.180. Some statutes cover genetic information more broadly, regulating its use in employment along with insurance and other activities. See, e.g., N Mex Stat Ann § 24-21-2. For other statutes, the focus is on broad regulation of genetic testing and information, with coverage that applies to employers along with others who might use the information. See, e.g., Fla Stat § 760.4; NJ Stat Ann § 10:5-44, Or Rev Stat § 192.537.

The states that have special statutes limiting genetic testing or the use of genetic information in the employment setting have obviously embraced exceptionalism. But so, for the most part, have the states that have added discrimination based on genetic information to their employment discrimination statutes. This is the case because genetic characteristics are singled out and treated differently from other medical conditions under these statutes. An exception is California, whose statute prohibits employment discrimination on the basis of medical conditions in addition to the more traditional categories of race, sex, and national origin. Under this statutory scheme, a genetic characteristic is treated as a medical condition and receives the same protection as other health problems. Finally, disability statutes by definition single out certain types of medical conditions for special protection: those that are disabling because they limit a major life activity. When genetic predispositions or conditions are defined as disabilities, they are treated similarly to this class of medical conditions. However, to the extent that a genetic condition does not fit within the rubric of “limiting a major life activity,” it is being treated differently from other non-disabling medical conditions under these statutes.

The draft presents a framework for the Drafting Committee to consider in structuring a state version of GINA, following the example of the state EEO statutes that supplement federal EEO law. It variously incorporates language from GINA, retains provisions from the prior NCCUSL draft, combines provisions, or offers alternative formulations. The goal is to present the Committee with a tool it can use to balance the goal of consistency with GINA with the policy decisions it has previously made to protect employees’ genetic information.

Life, disability-income, and long-term-care insurance can be distinguished from health insurance in that individual underwriting of policies is more common. This is because a larger proportion of the market for these insurance products consists of individual coverage than group coverage. According to the National Conference of State Legislatures, approximately 60 percent of life insurance, 40 percent of disability-income insurance, and almost all of long-term-care insurance is underwritten individually, compared to only about 10 percent of health insurance. Individual underwriting decisions take individual characteristics into account in determining risk and use this risk calculation in determining an individual’s premium rates and the terms and conditions for coverage and benefits. Individual underwriting could be done more accurately with access to genetic information if that genetic information provides an accurate prediction of the likelihood of claims.

The argument for restricting acquisition of genetic information by the insurance industry is that its predictive power is easily exaggerated and insurers may force applicants to take genetic tests and then deny insurance or charge more based on genetic characteristics. This raises the possibility that a large class of people will lack coverage even though they are not sick and never will become sick. There are also privacy concerns with commercial acquisition of sensitive genetic information and predictions that individuals will avoid genetic testing for fear of adverse effects on their insurability. From the industry perspective, as with health insurance, insurers worry about adverse selection. If applicants seek coverage because a genetic characteristic exposes them to risk, but the insurer does not have this information, this puts the insurer at a financial disadvantage. See generally Mark A. Rothstein, ed., Genetics and Life Insurance: Medical Underwriting and Social Policy (2004).

Life, disability-income, and long-term-care insurance are not covered by the recent federal Genetic Information Nondiscrimination Act of 2008.

Obtaining, retaining, and disclosing information. The insurance industry is primarily regulated by the states, but there are federal laws that affect privacy procedures for some aspects of obtaining, retaining, or disclosing medical information. First, HIPAA is the primary source of privacy rules in the medical context. Long-term-care insurers, like health-care insurers, are directly subject to the privacy rules in HIPAA.

Life and disability-income insurers are not directly subject to HIPAA, but their methods of obtaining medical information are affected indirectly because HIPAA controls the way in which health care providers can furnish them with medical information. Under HIPAA, the consumer must first provide an authorization for disclosure by the health care provider. Therefore, in order to obtain medical information from a health care provider to underwrite new coverage or evaluate a claim, an insurer’s forms must meet HIPAA requirements for consumer authorization. HIPAA does not apply, however, to other forms of access, (such as genetic testing by a life or disability-income insurance company) or to the use, retention, or disclosure of genetic information by life or disability-income insurers.

Second, the Fair Credit Reporting Act affects insurers’ ability to disclose as well as obtain medical information (including genetic information). It imposes requirements on obtaining, using, and disclosing “consumer reports.” The term consumer report may include medical information, including genetic information, that is used as a factor in establishing eligibility for insurance. It does not, however, include medical information disclosed to an affiliate in connection with the business of insurance or annuities and hence such disclosures are not regulated by the act.

The Fair Credit Reporting Act was amended in 2003 by the Fair and Accurate Credit Transactions Act (FACT Act) in response to concerns about the use of medical information in determinations of eligibility for credit. Under the FACT Act, consumer reporting agencies may furnish a consumer report containing medical information in connection with an insurance transaction only with consumer consent. In addition, an insurer or other third party who receives medical information from an insurer in connection with the business of insurance may not re-disclose that information except as necessary to carry out the purpose for which the information was initially disclosed or as otherwise permitted by law.

Third, the Gramm-Leach-Bliley Act (GLBA) protects consumers from certain disclosures of their “nonpublic personal information.” In general, this information may not be shared by a financial institution (including insurers) with an unaffiliated third party unless the consumer has been given notice and an opportunity to opt-out of such sharing. However, sharing without an opt-out opportunity is permitted if it is in connection with the performance of business activities or a joint marketing agreement between financial institutions. The GLBA requires state insurance regulators to adopt rules to implement and enforce its provisions. In doing so, many states have gone further in protecting medical information by requiring an authorization from the consumer (opt-in) before medical information may be shared, as described below.

Obtaining, retaining, and disclosing information. Disclosure of genetic information by insurers is covered under state provisions on general information practices in the insurance industry. First, about 18 states have adopted provisions based on the National Association of Insurance Commissioners’ Insurance Information and Privacy Protection Model Act. These provisions require written authorization from a consumer before an insurer may share personal consumer information, except as needed to perform basic insurance functions. See, e.g., Ariz. Rev. Stat. §§ 20-2101 to 20-2102; Cal. Ins. Code §§ 791.01 to 791.23; Conn. Gen. Stat. §§ 38a-975 to 38a-999a; Ga. Code Ann. §§ 33-39-1 to 33-39-23; 215 Ill. Comp. Stat. Ann. 5/1001 to 5/1024; Me. Rev. Stat. Ann. tit. 24-A §§ 2201 to 2220; Mass. Gen. Laws ch 175I §§ 1 to 22; Minn. Stat. Ann. §§ 72A.49 to 72A.505; Mont. Code Ann. §§ 33-19-101 to 33-19-409; Nev. Admin Code §§ 679B.560 to 679B.750; N.J. Stat. Ann. §§ 17:23A-1 to 17:23A-22; N.C. Gen. Stat. §§ 58-39-1 to 58-39-125; Ohio Rev. Code Ann. §§ 3904.1 to 3904.22; Or. Rev. Stat. §§ 746.600 to 740.690; Va. Code Ann. §§ 38.2-600 to 38.2-620.

Second, in implementing the GLBA, 27 states have adopted provisions specifically protecting medical information from disclosure by insurance companies. These provisions are based on the National Association of Insurance Commissioners’ Privacy of Consumer Financial and Health Information Model Regulation. It provides that an insurer may not disclose nonpublic personal health information unless the consumer has provided authorization or unless the disclosure is made in connection with insurance business functions. See Alaska Admin. Code tit. 3 §§ 26.605 to 26.749; Ark. Ins. Rule & Reg. 74; Cal. Fin. Code §§ 4050 to 4060; Colo. Admin. Ins. Reg 6-4-1; Conn. Admin. Code tit. 38a §§ 8-105 to 8-123; Fla. Admin. Code §§ 69O-128.001 to 69O-128.025; Iowa Admin. Code §§ 191-90.1 to 191-90.26; Kan. Admin. Regs. § 40-1-46; 806 Ky Admin. Regs. 3:210-3:220; Md. Admin. Code §§ 31.16.08.01 to 31.16.08.24; Neb. Rev. Stat.§ 44-901 to 44-925; N.H. Admin. Code Ins. §§ 3001.01 to 3006.05; N.Y. Comp. Code R. & Regs. tit 11, §§ 420.0 to 420.24 (Reg. 169); N.D. Admin. Code §§ 45-14-01-01 to 45-14-01-25; Okla. Admin. Code §§ 365:35-1-1 to 365:35-1-54; Or. Admin. R. 836-080-0501 to 836-080-0551 & 836-080-0600 to 836-080-0700; 31 Pa.Code §§ 146a.1 to 146a.44 & 146b.1 to 146b.24; R.I. Code Regulation 100; S.C. Code Ann. Regs. 69-58; S.D. Admin R. 20:06:45:01 to 20:064531; Tex. Admin Code §§ 22.1 to 22.67; Utah Admin Code 590-206; Vt. Code R. IH-2001-1; Wash. Admin Code §§ 284-04-120 to 284-04-260; W. Va. Code St. R. §§ 114-57-1 to 114-57-22; Wis. Admin. Code § § 25.01 to 25.95; Wyo Ins. Regs. ch. 54 §§ 1 to 26.

Use of Information. General limitations on the use of information in insurance underwriting are included in the Unfair Trade Practices Acts in effect in almost every state. These limitations apply to genetic information as well as to other information. Typically, these provisions prohibit “making or permitting any unfair discrimination between individuals of the same class and equal expectation of life in the rates charged for any life insurance policy or annuity . . . or in any other terms and conditions of such policy.” National Association of Insurance Commissioners Model Unfair Trade Practices Act § 4(G)(1). In many states, disability-income and long-term-care insurance are regulated as health insurance. For health insurance, a typical provision prohibits “unfair discrimination between individuals of the same class and of essentially the same hazard in the amount of premium, policy fees or rates charged for any accident or health insurance policy or in the benefits payable thereunder, or in any of the terms and conditions of such policy, or in any other manner.” § 4(G)(2).

In both life and health insurance, practices that constitute “unfair discrimination” between individuals of the same class are identified as “refusing to insure, refusing to continue to insure, or limiting the amount, extent, or kind of coverage available to an individual or charging a different rate for the same coverage solely because of a physical or mental impairment, except where the refusal, limitation or rate differential is based on sound actuarial principles or is related to actual or reasonably anticipated experience.” National Association of Insurance Commissioners Model Regulation on Unfair Discrimination in Life and Health Insurance on the Basis of Physical or Mental Impairment § 3.

Some states also specifically regulate the use of genetic information in life, disability-income, or long-term-care insurance. Many of them reiterate their Unfair Trade Practices Act by requiring an actuarial justification for the use of genetic information in determining eligibility and in underwriting. This does not address, however, the important question of whether there is a sufficient scientific basis for assessing risk and how the sufficiency of that scientific basis should be determined. Moreover, an additional question in the genetic context is whether or not there are conditions that should be excluded from consideration even if there is an actuarial justification for different treatment.

A 1997 study by the Human Genetics Advisory Commission in the United Kingdom concluded that it is unlikely that actuarially-sound genetic predictions of adult death will be validated and available anytime in the near future. Genetic tests need to be connected to medical and epidemiological research to establish what consequences for health and life-span can be inferred from a given genetic test. The Commission concluded that a requirement to disclose genetic tests as a condition of obtaining insurance would be acceptable only after research has established an association between a given pattern of test results and life events that are relevant for the insurance product. They recommended continuing a moratorium on requiring test results. They also predicted that the life insurance industry could withstand the limited adverse selection that might result from non-disclosure. Human Genetics Advisory Commission, The Implications of Genetic Testing for Insurance (1997).

At least twenty-three states have legislation that regulates genetic testing or the use of genetic information in life, disability, or long-term-care insurance. Twenty-two states have statutes that pertain to life insurance, nineteen apply to disability insurance, and fifteen cover long-term-care insurance.

Obtaining and disclosing genetic information. The most common privacy protection in state law is a requirement for informed consent or authorization for genetic testing by the individual to be tested. Several states have general provisions requiring informed consent to obtain genetic information that are applicable to insurers. See, e.g., Alaska Stat. §§ 18.13.010 (informed and written consent needed for DNA collection, analysis, retention, & disclosure); Del. Code Ann. § 1221(a) (same); Fla. Stat. Ann. § 760.40(2)(a) (informed consent necessary to perform DNA analysis). A larger number of states specifically require an individual’s informed consent or authorization for genetic testing for life, disability-income, or long-term-care insurance. See Ariz. Rev. Stat. Ann. § 20-448.02(A) (life, disability-income, long-term-care); Cal. Ins. Code § 10148 (life, disability-income); Colo. Rev. State § 10-3-1104.7(10)(a) (life, individual disability-income); Minn. Stat. Ann. § 72A.139 (life); Nev. Rev. Stat. Ann. § 629.151 (life); N.J. Stat. Ann. § 17B:30-12(f) (life, disability-income); N.Y. Ins. Law § 2615(a) (life, disability-income, long-term-care); Or. Rev. Stat. § 192.535 (life, disability-income, long-term-care); Vt. Stat. Ann. tit. 18, § 9332(d) (life, disability-income, long-term-care). In a couple of states, insurers that require genetic tests must pay the cost of the test. Cal. Ins. Code § 10148 (life and disability-income); Minn. Stat. Ann. § 72A.139 (life).

Other states prohibit insurance companies from requiring genetic testing as a condition of obtaining insurance. For all three types of insurance, insurers may not require applicants in Massachusetts or Vermont to undergo a genetic test as a condition of issuing or renewing a policy. Mass. Gen. Laws Ann. Ch. 175, § 120E (life); Mass. Gen. Laws Ann. Ch. 175, § 108I (disability-income, long-term-care); Vt. Stat. Ann. tit. 18, § 9334(a). In California, there is a special provision for long-term-care insurance that prohibits insurers from requiring genetic testing to determine insurability or for underwriting. Cal. Ins. Code § 10233.1.

A couple of states impose restrictions on asking applicants for genetic information. In Kentucky, disability-income insurers may not request or require an applicant to disclose a genetic test. Ky. Rev. Stat. Ann. § 304.12-085(3). In contrast, in Massachusetts, all three types of insurers may ask if an applicant has taken a genetic test. The application form must indicate, however, that the applicant is not required to answer questions about genetic testing or genetic information, but that failure to answer may result in denial of coverage or an increased rate. Mass. Gen. Laws Ann. Ch. 175, § 120E (life insurance); Mass. Gen. Laws Ann. Ch. 175, § 108I (disability-income and long-term-care insurance).

Finally, some states also regulate disclosure of genetic information, requiring either informed consent or authorization of the individual tested. See, e.g., Alaska Stat. §§ 18.13.010; Cal. Ins. Code § 10149.1. Another approach classifies genetic information with mental health information and HIV status as “sensitive health information” that requires protections against disclosure beyond that required for medical information. See, e.g., Conn. Gen. Stat. § 38a-999. In terms of access to test results by the individual tested, some states require insurers to provide test results to the individual or the individual’s designated physician. See, e.g., Fla. Stat. § 760.40(3) (general); Minn. Stat. Ann. § 72A.139 (life insurance); N.J. Stat. Ann. § 17B:30-12(f) (life & disability-income insurance, with option for genetic counseling); N.Y. Ins. Law § 2615(e) (if adverse decision for life, disability-income, or long-term-care insurance).

Use of genetic information. The broadest restrictions on use of genetic information prohibit insurers from using genetic testing results or genetic information to determine eligibility or for underwriting. See Colo. Rev. Stat. § 10-3-1104.7(3)(b) (group disability-income & long-term-care insurance); Kan. Stat. Ann. § 40-2259(d) (disability-income & long-term-care insurance). Arizona prevents disability-income and long-term-care insurers from using information about a genetic predisposition in underwriting by permitting those insurers to use genetic test results only if there is an actual diagnosis of a genetic condition. Ariz. Rev. Stat. Ann. § 20-448(F). Both Oregon and Vermont prevent all three types of insurers from using any genetic information about a blood relative for either eligibility or underwriting. Or. Rev. Stat. § 746.135; Vt. Stat. Ann. tit. 18, § 9334(a).

Other states restrict use of genetic information by prohibiting insurers from denying coverage or underwriting based on the applicant’s status as a carrier of a genetic disease. California specifies that life and disability-income insurers may not rely on information about an applicant’s genetic characteristic that causes no adverse effects on the carrier, even though it might be associated with disability in the applicant’s offspring. Cal. Ins. Code § 10143. These traits include, but are not limited to, Tay Sachs trait, sickle cell trait, thalassemia trait, and X-linked hemophilia A. Other states similarly prohibit insurance decisions based on specific genetic traits. See Fla. Stat. Ann. § 626.9706 (sickle-cell trait) (life); La. Rev. Stat. Ann. § 22:652.1(A), (D) (sickle-cell trait & severe disability) (life and disability-income); N.C. Gen. Stat. § 58-58-25 (sickle-cell trait & hemoglobin C trait) (life); Tenn. Code Ann. § 56-7-207 (sickle-cell trait & hemoglobin C trait) (life).

Finally, a number of state genetic statutes reiterate standards for underwriting that duplicate provisions of most state Unfair Practices Act, stating that the use of genetic information in underwriting must be based on an actuarial justification, may not be used for unfair discrimination, or must be reasonably related to risk. See Ariz. Rev. Stat. Ann. § 20-448(E) (life, disability-income, & long-term-care insurance); Kan. Stat. Ann. § 40-2259(d) (life insurance); 24A Me. Rev. Stat. Ann. § 2159-C(3) (life, disability-income, & long-term-care); Md. Code Ann., Ins. § 27-208(a)(3) (life, disability-income, & long-term-care insurance); Mass. Gen. Laws Ann. Ch. 175, § 120E (life, disability-income, & long-term-care insurance); Mont. Code Ann. § 33-18-206 (life, disability-income, & long-term-care insurance); N.J. Stat. Ann. § 17B:30-12(f) (life & disability-income insurance); N.M. Stat. Ann. § 24-21-4 (C) (life, disability-income, & long-term-care insurance); Vt. Stat. Ann. tit. 18, § 4724(3) (life, disability-income, & long-term-care insurance); Wis. Stat. Ann. § 631.89 (life & disability-income insurance).

The draft allows life insurers, disability-income insurers, and long-term-care insurers to require genetic tests and use genetic information for coverage and underwriting decisions only as scientific developments justify that use. The draft places a burden on insurers to show that a positive genetic test is reliably associated with increased medical risk of mortality or morbidity. If an insurer can demonstrate that to a reasonable degree of scientific certainty, it can use the information. If the available scientific evidence does not meet this standard, use of the genetic information would be a violation of state unfair practices insurance law.

SECTION 101. SHORT TITLE. This [act] may be cited as the Uniform Protection of Genetic Information in Employment and Insurance Act.

In the early stages of drafting, the act was named “Misuse of Genetic Information in Employment and Insurance Act.” In 2008, the ULC Executive Committee authorized changing the name of the act to “Protection of Genetic Information in Employment and Insurance,” which better reflects the scope of the act. The act deals not only with misuse, but also use, acquisition, retention, and disclosure of genetic information, setting a balance that provides appropriate protection for genetic information in all these contexts.

(1) “Credentialing authority” means a governmental or private entity that provides a license, registration, or credential or certifies competence that is necessary for an individual to qualify for employment or to participate in an occupation or profession.

(2) “Employee” means an individual who works for, or applies to work for, compensation, an individual using or applying to use the services of an employment agency, a member or applicant for membership in a labor organization, an apprentice, trainee or applicant for a training or retraining program, or an individual or applicant considered by a credentialing authority. The term includes an individual employed in, or applying for employment in, a supervisory, managerial, or confidential position. The term does not include an independent contractor.

(3) “Employer” means a person, including an agent of that person, that compensates [five] or more individuals for each working day in each of twenty or more calendar weeks in the current or preceding calendar year.

(4) “Employment agency” means a person, including an agent of that person, that regularly undertakes, with or without compensation, to procure employees for an employer or to procure for employees opportunities to work for an employer.

(5) “Employment entity” means an employer, employment agency, labor organization, credentialing authority, or joint labor-management committee.

(6) “Family medical history” means information about the manifestation of a disease or disorder in an individual’s family member.

(7) “Family member” includes a person who is a dependant of an individual as the result of marriage, birth, adoption, or placement for adoption and a person who is a first-degree, second-degree, third-degree, or fourth degree relative of the individual or of the individual’s dependant. The term includes deceased members of the family.

(8) “Genetic condition” includes a genetic trait and a genetic disease or disorder.

(A) assessing an individual’s genetic risk for an inherited genetic condition by interpreting family medical histories;

(B) providing nondirective education about the inheritance, testing, management, and prevention of a genetic condition;

(C) helping an individual to understand the risks and benefits of testing for a genetic trait to promote informed decision-making about whether or not to undergo genetic testing;

(E) providing support, informational resources, and referrals as appropriate to help an individual adapt to the medical, psychological, and familial implications of having or being at risk of having a genetic condition.

(10) “Genetic education” means the process by which an individual acquires information about the individual’s or the individual’s family member’s existing or suspected genetic condition.

(11) “Genetic information” means information, other than information about the age or sex of an individual, about the following:

(D) a request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by the individual or a family member of the individual; or

(E) the genetic test of a fetus carried by the individual or a family member of the individual or an embryo legally held by the individual or a family member of the individual.

(12) “Genetic monitoring” means a periodic examination of an employee to evaluate acquired modification to the employee’s genetic material, such as chromosomal damage or evidence of increased occurrence of mutations, that may have developed in the course of employment due to exposure to toxic substances in the workplace, in order to identify, evaluate, and respond to the effects of or control adverse environmental exposures in the workplace.

(13) “Genetic service” means a genetic test, genetic counseling, or genetic education. (14) “Genetic test” means an analysis of human deoxyribonucleic acid (DNA), ribonucleic acid (RNA), chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes. The term does not include an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes.

(15) “Individually-identifiable genetic information” means an individual’s genetic information that includes an identification of the individual or information that could reasonably be used to identify the individual.

(16) “Joint labor-management committee” means an entity, including an agent of that entity, that establishes, offers, or controls apprenticeship or other training or retraining programs, including on-the-job training programs.

(17) “Labor organization” means an organization, including an agent of the organization, in which employees participate that exists for the purpose, in whole or in part, of dealing with employers concerning grievances, labor disputes, wages, rates of pay, hours, or other terms or conditions of employment.

(18) “Labor organization member” means a member or an applicant for membership in a labor organization.

(19) “Manifested disease or disorder” means a disease or disorder that has been or could reasonably be diagnosed by a health care professional with appropriate training and expertise in the relevant field of medicine. It does not include a disease or disorder if the diagnosis is based principally on genetic information or on the results of one or more genetic tests.

(20) “Person” means an individual, corporation, business trust, estate, trust, partnership, limited liability company, association, joint venture, public corporation, government or governmental subdivision, agency or instrumentality, or any other legal or commercial entity.

(21) “Record” means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form.

(B) to attach to or logically associate with the record an electronic symbol, sound, or process.

Legislative Note: In the definition of “employer” states may replace [5] with a lesser number of employees in order to extend the coverage of the act.

Paragraph (1). (Credentialing authority) Credentialing authorities are included in the group of employment-related organizations labeled as “employment entities” and regulated in this article. The draft act’s inclusion of credentialing authorities extends the coverage of GINA.

Credentialing authorities serve as gatekeepers to certain types of employment by providing credentials that are required either under state law or by an employer. Examples include state bar and medical examination boards, which control entry to the practice of law and medicine, and state departments of motor vehicles, which issue commercial drivers licenses necessary for some employment. Acquisition or use of genetic information by a credentialing authority could have the same effects on employees and applicants for employment as acquisition or use by an employer.

California’s state EEO statute similarly expands the protections of federal employment law with regard to credentialing. It prohibits licensing boards from requiring an examination or establishing any other qualification that has an adverse impact on a class by virtue of race, creed, etc, unless the practice can be demonstrated to be job related. Cal. Gov. Code § 12944.

Pursuant to Section 210, the act does not affect occupational medical certifications, such as a medical examination required for a school bus driver, when the entity that certifies the medical qualification of the employee is a covered entity under HIPAA.

Paragraph (2). (Employee) The definition of employee is adapted from the National Conference of Commissioners on Uniform State Law’s Model Employment Termination Act. It differs from GINA’s definition, which defines an employee as an individual employed by an employer.

For drafting ease, the term employee is used to also cover individuals who are labor organization members, apprentices or trainees, or using employment agencies. Because GINA combines its definitions of employee and applicant, the definition also includes applicants for employment, labor organization membership, or an employment credential. The intent is to cover any individual who is subject to collection of information or an employment decision by an employment entity, which is defined as an employer, employment agency, labor organization, credentialing authority, or joint labor management committee.

The definition’s requirement for compensation is intended to exclude volunteers from the definition of employee. In addition, the Drafting Committee decided to exclude independent contractors from the definition of employee. This approach is not intended, however, to provide employers with an avenue to evade their obligations by classifying employees as independent contractors.

Paragraph (3). (Employer) GINA defines employment by reference to the Civil Rights Act of 1964. The draft follows the format of the underlying definition, using language adapted from Title VII (42 U.S.C. § 2000e (b)). However, Title VII and the proposed federal regulations implementing GINA define an employer as someone who employs an employee. The act avoids this circularity by defining the employment relationship in terms of compensation. It avoids the term employee because it is defined in this act to include applicants for employment, labor organization members, apprentices or trainees, and individuals using employment agencies.

Size of employers. Like Title VII of the Civil Rights Act of 1964, GINA covers employers with 15 or more employees. Many state employment discrimination statutes expand the scope of their coverage beyond that provided by Title VII by including employers with smaller workforces. The draft follows this approach by setting the threshold for coverage at 5 or more employees. Many states may want to reduce the number of employees required to trigger the act’s coverage and the legislative note gives them the option to do this.

In deciding whether to include smaller employers under the act’s coverage, states should consider the thresholds they have enacted in other statutes, such as their state employment discrimination statute and their workers compensation statute. For example, 16 jurisdictions cover all employers (i.e., employers with one or more employees) under their state employment discrimination acts. An additional 10 states have set a threshold below that of the draft, ranging from two to four employees.

Types of employers. The draft’s definition of employer is linked to the definition of “person.” It therefore encompasses all types of entities, including governmental and non-profit employers. This is consistent with the coverage specified by a number of states in their state versions of Title VII of the Civil Rights Act of 1964 on employment discrimination. (See, e.g., Hawaii, Iowa.)

Paragraph (5). (Employment entity) Employment entity is the term used in the act to collectively indicate an employer, an employment agency, a labor organization, a credentialing authority, or a joint labor-management committee that offers training programs. The definition expands GINA’s coverage by adding credentialing authorities.

The regulations implementing GINA use the term “covered entity” to group the organizations covered by the federal act. This term is not used in the draft because of the potential for confusion with the use of the term “covered entity” in HIPAA and because the act’s scope of coverage is slightly different from GINA, which does not include credentialing authorities.

Paragraph (6). (Family medical history) Family medical history is often a source of genetic information in that it is used to evaluate the likelihood that an individual carries an inherited trait. The act’s employment article follows GINA and includes family medical history within its definition of “genetic information.” The term “family medical history is not defined in GINA. This definition follows the definition in the proposed regulations implementing GINA. It is somewhat different from the definition in the prior draft, which was “information about a current or past medical condition of a family member of an individual.”

Paragraph (7). (Family member) The draft defines family member to encompass all individuals whose genotype could influence an employment decision. The term includes (1) dependants of an employee whose risk of future genetically-linked medical conditions could affect employer health care costs or the cost of family insurance coverage and hence affect employment decisions, (2) biological relations of an employee whose genetic information might provide information about the genetic make-up of the employee, and (3) biological relations of an employee’s dependants, whose genetic information might provide information about the genetic make-up of a dependant.

Definition’s relationship to GINA. The draft adopts the definition of family member used in the EEOC’s proposed GINA employment regulations. GINA itself defines “family member” by using the term “dependent” with reference to ERISA’s use of that term in its provisions on special enrollment periods for group health plans, 29 U.S.C. § 1181(f)(2). As used in ERISA, this status depends on the scope of health care coverage offered by the employer. A person can be a “dependent” only if a group health plan makes coverage available for them and the person they are dependent on is enrolled in the plan. The EEOC’s definition omits the reference to health care plans in order to “further Congress’s intent to prohibit genetic discrimination in the employment context, and provide[ ] [employers] with clear standards governing compliance with the law.”

The prior draft defined family member to mean “an individual’s spouse or [domestic partner], child, and all individuals related by whole or half blood within the fourth degree of consanguinity measured using the civil law method to the individual, the individual’s spouse or [domestic partner], or the individual’s child.” This differed from the current definition by including domestic partners on the rationale that many employers provide health insurance for employees’ unmarried partners and therefore, an unmarried partner can be a dependent whose risk of a genetically-linked medical condition could affect employment or insurance decisions. The brackets around this term were meant to indicate that a state should substitute the term it uses for a person in this relationship. The Drafting Committee decided to omit the provision covering domestic partners in order to further consistency between the act and GINA.

Degree of relationship to the individual or the individual’s dependents. The definition follows GINA and the proposed EEOC regulations by including relatives of an employee or the employee’s dependants to the fourth degree of consanguinity. Genetic counselors typically collect information on genetic diseases of family members related to the third degree of consanguinity and often to the fourth degree.

The proposed EEOC implementing regulations list these family members. The Drafting Committee considered listing family members within the fourth degree of consanguinity in the act’s definition, but decided to include this information in the notes instead.

Lineal consanguinity is the relationship between persons when one is directly descended from the other. Each generation in this direct line constitutes a degree. Collateral consanguinity refers to the relationship between persons who descend from the same common ancestor, but not from each other. The civil law method of calculating degree of collateral consanguinity counts the number of generations from one person up to the common ancestor and then down to the other person. The proposed GINA regulations state that they determine the degree of relationship by counting the generational levels separating the individuals. Although the civil law method of calculation is reportedly often used by the states to determine the degree of consanguinity, the chart below is based on the specifications in the proposed EEOC regulations. Each row represents a generation and the degree of consanguinity is given in parentheses.

Paragraph (8). (Genetic condition) This is a new definition in this draft. This term is used in the definitions of genetic counseling and genetic services. It is not used or defined in GINA. The definition is intended to give the term a broad interpretation. A genetic condition includes a manifested genetic disease or disorder as well as a genetic trait that may increase the likelihood of developing a disease or disorder. However, the term may also refer to a positive or benign trait or characteristic that is linked to a particular genotype.

Paragraph (9). (Genetic counseling) Genetic counseling is a key to an individual’s informed decision making about getting a genetic test, understanding the result, and authorizing its use, retention, or disclosure. GINA defines genetic counseling by inserting the following parenthetical about genetic counseling into its definition of a genetic service: “(including obtaining, interpreting, or assessing genetic information).” The Drafting Committee concluded that a more comprehensive definition is important because genetic counseling is a relatively new profession and state regulation of genetic counselors and genetic counseling is currently in flux. Some states license or certify genetic counselors and they tend to have a definition of genetic counseling. But the majority of states do not license genetic counselors or regulate genetic counseling and hence lack a definition.

It is important to note that the definition does not require that genetic counseling be performed by a genetic counselor. Physicians, geneticists, and nurse practitioners are also qualified to provide genetic counseling.

Genetic counseling is usually a two-step process consisting of 1) counseling before a test about the decision whether or not to have the test and 2) counseling after the test if the test indicates the individual is at risk. In addition, for some conditions counseling may also be appropriate if the test indicates the individual is not at risk. The functions listed in (A)-(C) of the definition of genetic counseling take place before an individual decides whether or not to have the test. The functions in (D) and (E) take place after the test, if necessary.

Paragraph (10). (Genetic education) Genetic education is one element of genetic services. It is typically less tailored to individual circumstances then a one-on-one genetic counseling session. The definition is meant to be broad enough to include information provided by support groups for genetic conditions to those who may have the condition. It is not meant to encompass general genetic education such as that received in biology class or medical school. This term is used, but not defined, in GINA.

Paragraph (11). (Genetic information) This definition of “genetic information” follows the definition in the employment title of GINA. It includes a family member’s genetic tests. It also includes family medical history more generally through a reference to the occurrence of a disease of disorder in family members of the individual.

The definition incorporates GINA’s provisions on the genetic information of fetuses, which are found, not in GINA’s definitions, but in § 209, codified at 42 U.S.C. § 2000ff-8. Under GINA, if an employee or family member is a pregnant woman, references to her genetic information include that of the fetus she is carrying. If an employee or family member is using assisted reproductive technology, references to that individual’s genetic information include the genetic information of any embryo held legally by that individual.

This definition of genetic information is consistent with many states that define “genetic information” to include information on genetic characteristics broadly, whether obtained from genetic tests or family medical history. (Cal, Conn, Hawaii, LA, Maine, MD, Mass, Mich, NJ, NMex, NC, RI, SD, TX, WA).

This definition now differs from the definition of genetic information used in Article 3 on life, disability-income, and long-term-care insurance. That article allows these insurers to continue to their traditional practice of collecting information on family history, even though family history is a major source of information to evaluate an individual’s genetic risks.

Paragraph (12). (Genetic monitoring) The definition of “genetic monitoring” follows the definition in GINA. It is drawn from the description in Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace 4 (1990). The focus in monitoring is not on inherited characteristics, but on genetic alterations in a group of exposed individuals over time. Genetic monitoring is typically undertaken by employers to identify risks for groups of employees who have been exposed to hazardous substances or to target work sites for safety and health measures. Testing for this purpose is permitted in Section 202.

Paragraph (13). (Genetic service) This definition follows the definition of “genetic services” in the employment title of GINA. “Genetic service” is a broader category than genetic testing. The term includes activities associated with obtaining genetic information that could create assumptions about an individual’s genetic status even in the absence of information about genetic test results or medical history. “Counseling” implies a one-on-one consultation, so the definition also includes “genetic education” in order to capture group information sessions on genetic conditions. While the definition of a “genetic service” does not separately define the term “genetic,” the term should be interpreted to be consistent with the definitions of “genetic test” and “genetic information.”

Paragraph (14). (Genetic test) This is identical to the definition of genetic test used in GINA employment provisions. “Genetic test” is defined in terms of (1) the material that the test analyzes and (2) what the test detects.

The first clause makes specific reference to the types of biological material that are currently analyzed in genetic tests. Note that genetic tests can be conducted not only on gene sequences, but also on biological products such as proteins or metabolites that can indicate genetic make-up. The second clause specifies that the test must function to determine an individual’s genetic make-up, either through the identification of a genotype or by looking for a mutation or chromosomal change.

Both clauses are equally important to the definition. First, some of the materials listed in the first clause, especially proteins and metabolites, are tested for many medical purposes. A test of a protein or metabolite does not constitute a genetic test unless it is administered to determine an individual’s genetic make-up as specified in the second clause.

Insurance industry representatives have expressed the fear that this definition is so broad that it will sweep in routine medical tests such as blood tests of lipoproteins to measure cholesterol levels. It is true that a cholesterol test analyzes proteins. A cholesterol test is not, however, given specifically to detect a genotype, genetic marker, mutation, or chromosomal change, so it would not be considered a genetic test under the draft. Instead, a high cholesterol reading may indicate a number of causal factors, including inappropriate diet, lack of exercise, and/or a condition called inherited familial high cholesterol. If the measurement of cholesterol leads a doctor or insurance company to do further testing to see if an individual has a specific genotype, then that would be a genetic test under the draft’s definition. Other common medical tests of proteins or metabolites that would not fall under the definition of “genetic test” include urine tests for kidney disease, blood protein and creatinin tests for diabetes, blood tests of liver enzyme proteins for liver function, urine tests measuring glucose to diagnose diabetes, blood tests measuring serum blood glucose for diabetes, and triglycerides for heart disease. The second sentence of the definition, although redundant, should reassure those who fear the definition will be used to sweep in medical tests that are not given to detect genotypes, mutations, or chromosomal changes.

The draft’s definition is consistent with state definitions of genetic testing that are not limited to identifying genotypes associated with diseases or impairments. (Fla, Haw, Mass, NH, Ore, UT). In contrast, many other states statutes limit their definition of “genetic test” to testing for disease-related genes. (Ariz, Ark, Del, Ill, Iowa, Kan, LA, Maine, MD, Mich, Minn, Nev, MO, Neb, NJ, NM, NY, NC, OK, OR, RI, TX, VT, VA, WI). These definitions are not as protective as the definition in GINA, and thus these statutes are likely preempted. While most of the reasons that an employer or insurer might currently seek or use genetic information probably involve a disease, disorder, or impairment, this may not always be the case. One can imagine, for example, that the presence or absence of behavioral traits might also be a criterion for selecting an employee. While the current evidence linking behavior to genes is tenuous, this area continues to be the subject of investigation.

Paragraph (15). (Individually-identifiable genetic information) This definition is included because the concept is used in the provisions allowing employment entities to acquire genetic information for the purpose of offering health and genetic services and conducting genetic monitoring programs. The concept is also used, but not defined, in the proposed GINA regulations and is drawn from the HIPAA Privacy Rule, which protects individually-identifiable health information. Under the Privacy Rule’s definition, individually-identifiable health information is health information that “identifies the individual[,] or [w]ith respect to which there is a reasonable basis to believe the information can be used to identify the individual.” 45 C.F.R. § 160.103.

The HIPPA Privacy Rule does not directly indicate what information triggers a reasonable basis to believe that it could be used to identify an individual, but it does provide a standard for “de-identification” of protected health information. Health information is not individually-identifiable if the following has been removed: names; all geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes (except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census, the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people); all elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; all ages over 89 and all elements of dates (including year) indicative of such age (except that such ages and elements may be aggregated into a single category of age 90 or older); telephone numbers; fax numbers; electronic mail addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identifiers and serial numbers, including license plate numbers; device identifiers and serial numbers; web Universal Resource Locators (URLs); internet Protocol (IP) address numbers; biometric identifiers, including finger and voice prints; full face photographic images and any comparable images; and any other unique identifying number, characteristic, or code. 45 C.F.R. § 164.514 (b).

Paragraph (16). (Joint labor-management committee) This definition is taken from the proposed regulations implementing GINA.

Paragraph (17). ( Labor organization) This definition is the one used in the proposed regulations implementing GINA, omitting GINA’s requirement that the organization be engaged in interstate commerce. It is similar to the following definition, which is commonly used in state EEO acts: “‘Labor organization’ means any organization which exists and is constituted for the purpose, in whole or in part, of collective bargaining or of dealing with employers concerning grievances, terms or conditions of employment, or of other mutual aid or protection in connection with employment.” (e.g., Cal., Colo., Hawai’i, Iowa, Minn, NY)

Paragraph (18). (Labor organization member). This definition is taken from GINA for the purpose of including applicants within the scope of the definition.

Paragraph (19). (Manifested disease or disorder). This definition is taken from the proposed EEOC regulations to implement GINA. It is relevant to the definition of genetic information in this section and to Section 212, which excludes from the act’s coverage medical information about a manifested disease or disorder that is not genetic information.

Paragraph (20). (Person) This draft uses the broad version of the standard National Conference of Commissioners on Uniform State Laws definition of “person.”

Paragraph (21). (Record) The definition of “record” is the standard National Conference of Commissioners on Uniform State Laws definition.

Paragraph (22). (Sign) The definition of “sign” is the standard National Conference of Commissioners on Uniform State Laws definition.

Paragraph (23). (Tribunal) The term “tribunal” refers collectively to the potential decision-makers in a litigation or arbitration context.

(1) request, require, purchase, or otherwise intentionally acquire genetic information of an employee or an employee’s family member; or

(2) unless allowed by law other than this [act], require, offer, or provide a genetic test to an employee or an employee’s family member.

(b) It is not a violation of this article if an employment entity inadvertently requests or requires genetic information of an employee or an employee’s family member.

(c) An employment entity may acquire an employee’s genetic information if the employee voluntarily submits the genetic information to the employment entity and authorizes the employment entity’s acquisition in accordance with Section 203.

(d) An employment entity may request or require family medical history from an employee to comply with the certification provisions of the Family Medical Leave Act, 29 U.S.C. § 2613, or of the [state family and medical leave act].

(e) An employment entity may obtain documents, other than by purchasing medical databases, that are publicly available, including newspapers, magazines, periodicals, and books, even if they contain an employee’s or an employee’s family member’s genetic information.

(f) An employment entity may acquire an employee’s or employee’s family member’s genetic information and may offer and provide genetic testing to an employee or employee’s family member in accordance with subsection (h) for use in providing health or genetic services to an employee or employee’s family member, including as part of a voluntary wellness program, if:

(1) an employment entity that offers a genetic test provides genetic counseling about the risks and benefits of a genetic test before the employee or employee’s family member considers authorizing the test unless the employee or employee’s family member knowingly and voluntarily waives counseling before the test in a signed record that contains information about the benefits of genetic counseling;

(2) the employee or employee’s family member authorizes the employment entity to acquire genetic information or the genetic testing in accordance with Section 203;

(3) the employee’s or employee’s family member’s genetic information is used only in providing health and genetic services to the employee or employee’s family member;

(4) individually-identifiable genetic information is provided only to the employee or, if the employee’s family member is receiving genetic services, to the employee’s family member, a health-care professional designated by the employee or employee’s family member, and a licensed health care professional or board-certified genetic counselor involved in providing the employment entity’s genetic services; and

(5) genetic information is not disclosed to the employment entity except in an aggregate form under circumstances that do not disclose the identity of the individual employee or employee’s family member.

(g) An employment entity may acquire an employee’s genetic information and may offer and provide genetic testing to an employee to conduct genetic monitoring of the biological effects of toxic substances in the workplace if:

(1) the employment entity provides written notice of the genetic monitoring to the employee;

(B) authorized by the employee in accordance with Section 203 after the employment entity provides and pays for genetic counseling for the employee about the risks and benefits of the genetic test, unless the employee knowingly and voluntarily waives counseling in a signed record that contains information about the benefits of genetic counseling;

(A) federal genetic monitoring regulations, including regulations that may be promulgated by the Secretary of Labor pursuant to the Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et seq., the Federal Mine Safety and Health Act of 1977, 30 U.S.C. 801 et seq., or the Atomic Energy Act of 1954, 42 U.S.C. 2011 et seq.; or

(B) this state’s genetic monitoring regulations if this state implements genetic monitoring regulations under the authority of the Occupational Safety and Health Act of 1970; 29 U.S.C. 651 et seq.;

(4) the employment entity pays for the genetic testing and the genetic counseling required by subsection (h);

(5) individually-identifiable genetic information is provided only to the employee, a health-care professional designated by the employee or employee’s family member, and a licensed health care professional or board-certified genetic counselor involved in providing the employment entity’s monitoring program; and

(6) genetic information is not disclosed to the employment entity except in an aggregate form under circumstances that do not disclose the identity of the individual employee.

(h) An employment entity that provides a genetic test to an employee or employee’s family member as part of health or genetic services offered under subsection (g) or for a genetic monitoring program under subsection (g) must:

(1) require the testing organization to report the test result to the tested individual and a health-care professional designated by the individual unless the individual directs otherwise;

(2) provide genetic counseling for the tested individual about a positive test result;

(3) require the destruction of the tested individual’s biological sample obtained for a genetic test as soon as permitted by law after the test is completed unless retention of the sample is authorized by the individual in a knowing and voluntary authorization indicated in a record signed by the individual, permitted by law other than this [act], or ordered by a tribunal.

(i) An employer that conducts DNA analysis for law enforcement purposes as a forensic laboratory or for purposes of identifying human remains may request or require genetic information or genetic testing of an employee to the extent necessary to analyze DNA identification markers for quality control to detect sample contamination.

(j) When an employee has placed the employee’s health at issue in a proceeding before a tribunal in which an employment entity is a party, the employment entity may obtain genetic information about the employee without the employee’s authorization only if:

(1) the genetic information is relevant to a claim or defense in the proceeding;

(2) on a motion by the employment entity, a tribunal orders the employee to take a genetic test or provide genetic information after finding that the employment entity has demonstrated a compelling need and that the information is otherwise unavailable; and

(3) the employment entity pays for the genetic test if one is ordered by the tribunal.

Legislative Note: In subsection (e), states should insert for [state family and medical leave act] the appropriate name for the state’s act.

Applicability of Article 2. This article is intended to apply broadly in the employment setting to any employment entity. Employment agencies, labor organizations, credentialing authorities, and joint labor-management committees offering training programs are included within the scope of the article in addition to employers because they control access to employment through referrals or licensing.

As explained in the Reporter’s Notes under section 201, the article expands the scope of GINA and makes it more protective of employees. It does this by 1) covering all employers, not only those with more than 15 employees and 2) by regulating credentialing authorities along with the other employment entities.

General approach to acquisition of genetic information. Section 202 imposes a general prohibition on genetic testing of employees or employee’s family members and on acquisition of their genetic information. It then establishes a number of limited exceptions for situations in which genetic testing by employment entities and/or their access to employee’s genetic information is acceptable. The exceptions provided in GINA are supplemented with additional provisions designed to provide greater protection for employees.

Rationale for prohibiting acquisition and testing. One rationale for limiting employer acquisition of genetic information is the view that an employee should be able to keep genetic information private. At least one state has a constitutional right of privacy that appears to be relevant to genetic information. (Alaska) Another rationale is to make genetic discrimination less likely. Unlike discrimination based on sex or race, an employer cannot discriminate on the basis of genetic characteristics unless it has access to genetic information.

Existing state law and its relationship to GINA and this act. There are many avenues by which employment entities obtain health information, which may include genetic information. These include employment applications, interviews, references, post-offer medical exams, post-offer releases of medical records, Family and Medical Leave Act requests, workers’ compensation claims, health insurance claims to self-insured employers, and voluntary disclosures by employees. Many states have tried to limit employer acquisition of genetic information. They have used a variety of approaches. Some statutes are consistent with GINA; others are less protective and thus preempted.

First, many states have statutes that prohibit an employer from obtaining genetic information. See, e.g., La. Rev. Stat. § 23:368 (employer may not “require, collect, or purchase” protected genetic information with respect to an employee); Mich. Comp. Laws § 37.1202 (no employer may “directly or indirectly acquire or have access to” an employee’s or family member’s genetic information unless an individual provides it voluntarily). These statutes do not provide as extensive protection as GINA, which additionally prohibits employers from asking for genetic information. The rationale for this protection is that in the context of at-will employment the need to retain one’s job may turn an employer’s request for genetic information into a demand that an employee dare not refuse. There are some state statutes that, like GINA, do prohibit such requests. See, e.g., Conn. Stat. Ann. § 46a-60(11) (employer may not “request or require” genetic information from employee); Nev. Rev. Stat. § 613.345 (unlawful employment practice to “ask or encourage” an employee to submit to a genetic test).

Many state statutes prohibit employers from obtaining information, and may also prohibit requests, but arguably they are not as protective as GINA because they prohibit acquisition of genetic information only for certain uses. See, e.g., Kan. Stat. Ann. § 44-1009(a)(9) (employer may not seek to obtain, obtain, or use testing information to distinguish employees or restrict a right or benefit); Md. Code Art. 49B § 16(a) (employer may not “request or require” genetic information as a condition for hiring or determining benefits); Mass. Gen. L. Art. 151B § 4(19) (unlawful to “collect, solicit or require disclosure of genetic information” as a condition of employment or “question a person about their genetic information or genetic information concerning their family members”); Minn. Stat. Ann. § 181.974(subd. 2) (employer may not “request, require, or collect” protected genetic information as a condition of employment); Neb. Rev. Stat. § 48-236 (employer may not require genetic information as a condition of employment or promotion); Utah Code Ann. § 26-45-103 (employer may not “access or otherwise take into consideration” private genetic information in connection with an employment decision); Wash. Rev. Code Ann. § 49.44.180 (unlawful to require employee to submit genetic information as condition of employment). While GINA (and this Uniform Act) prohibit certain uses of genetic information, they also place a value on employee privacy and, subject to limited exceptions, they prohibit the acquisition of genetic information without regard to its use.

Second, many states broadly prohibit employers from subjecting employees to genetic testing. See, e.g., Kan. Stat. Ann. § 44-1009(a)(9) (employer may not subject, directly or indirectly, any employee to any genetic screening or test); RI Stat. § 28-6.7-1 (employer may not “request, require, or administer” a genetic test). Again, however, many states prohibit genetic testing only for certain uses or when it is a condition of employment, which arguably is not as protective as GINA. See, e.g., Iowa Code Ann. § 729.6 (employer may not “solicit, require, or administer” a genetic test as a condition of employment); Md. Code Art. 49B § 16(a) (employer may not “request or require” genetic tests as a condition for hiring or determining benefits); Mass. Gen. L. Art. 151B § 4(19) (unlawful to “solicit submission to, require, or administer a genetic test” as a condition of employment); Mich. Comp. Laws § 37.1202 (no employer may require a genetic test as a condition of employment); Minn. Stat. Ann. § 181.974(subd. 2) (employer may not “administer a genetic test” as a condition of employment); Neb. Rev. Stat. § 48-236 (employer may not require a genetic test as a condition or employment or promotion); Nev. Rev. Stat. § 613.345 (unlawful employment practice to “require or administer” a genetic test as a condition of employment); N.H. Rev. Stat. § 141-H (may not “solicit, require, or administer” genetic testing as a condition of employment); Utah Code Ann. § 26-45-103 (employer may not “request or require” an individual or blood relative to submit to a genetic test in connection with an employment decision); Vt. Stat. Ann. § 9333 (may not require genetic testing as a condition of employment); Va. Code Ann. § 40.1-28.7-1 (employer may not “request, require, solicit, or administer” a genetic test as a condition of employment); Wash. Rev. Code Ann. § 49.44.180 (unlawful to require employee to submit to genetic screening as condition of employment); Wis. Stat. Ann. § 111.372 (employer may not “solicit, require, or administer” a genetic test as a condition of employment unless employee requests test). GINA does not contain prohibitions on testing, which is regarded as a form of acquiring genetic information and thus covered by the provisions limiting employer acquisition. The Uniform Act, in contrast, is more explicit. It contains a general prohibition on genetic testing and, in the narrow circumstances singled out as exceptions, provides employees with protections that relate specifically to testing.

Other states do not provide the protections required by GINA because they rely on state anti-discrimination statutes, which typically allow employers to compel testing or to require employees to provide genetic information under certain circumstances. Many of these states rely on disability statutes to regulate genetic information, usually following the Americans with Disabilities Act (ADA), which permits an employer to test an applicant and acquire an applicant’s medical records after a conditional offer of employment. 29 C.F.R. § 1630.14(b). This approach opens the door broadly to genetic information once an employer has made a conditional offer of employment. In addition, under the ADA and most state statutes modeled on it, after an employee is hired, an employer can obtain medical information if it has a reasonable belief that the employee is unable to perform the essential functions of his or her job due to a medical condition. 29 C.F.R. § 1630.14(c). Other states have amended their employment discrimination statutes to include genetics. Under the rubric of these statutes, genetic testing or collection of genetic information is typically permitted when it is relevant to “job-related qualifications” or justified by “business necessity.” The Drafting Committee considered and rejected these approaches because of a concern that tying the Act’s protections to the concept of “job-related” medical information would not provide adequate protection for genetic information. In interpreting the ADA, some courts have interpreted the category of “job-related” medical information broadly, thus permitting employers to access medical information and narrowing the scope of protection.

The draft’s approach also contrasts with California’s and Minnesota’s more comprehensive limitations on employer access, which prohibit employers from accessing non-job-related medical information at any time. An advantage of California’s and Minnesota’s approach is that it does not depend on how “genetic information” is defined. In addition, it does not rely on custodians of medical files to make a distinction between genetic information and medical information more generally, which are usually mixed in medical files. Practically speaking, when an employee signs a release permitting employer access to medical records, everything in the records is included. There are those who maintain that legislation is needed to limit an employer’s ability to obtain any non-job-related health information during the hiring process or employment. See Mark A. Rothstein, Genetic Exceptionalism and Legislative Pragmatism, 35 Hastings Center Report No. 4 (2005), at 35. The Drafting Committee discussed this approach, but declined to adopt it because it extends beyond the scope granted to the Committee.

Subsection (a) General prohibition on acquisition of genetic information and genetic testing. This subsection establishes a general prohibition on acquisition of genetic information by employment entities by prohibiting employment entities from “requesting, requiring, or purchasing” an employee’s genetic information. It also supplements GINA, which does not have provisions that specifically cover genetic testing, by establishing a general rule that an employment entity may not offer or provide genetic tests to employees. Subsections (b)-(j) establish limited exceptions to the prohibition on acquisition. Subsections (f)-(j) establish limited exceptions to the prohibition on genetic testing and set requirements for counseling and reporting that must be met if an employment entity provides a genetic test.

The prohibition on acquisition uses the language of GINA by making it a violation for an employer to “request, require, or purchase” genetic information. To avoid the possibility of a restrictive interpretation of that language and to emphasize in conjunction with subsection (b) that it is intentional acts by the employment entity that are prohibited, the subsection additionally prohibits any other intentional acquisition of genetic information. The prohibition of requests is intended to apply to inquires directed to other entities as well as to inquiries directed to the employee or the employee’s family member.

Because the definition of genetic information includes information about access to genetic services, the limitations in the act, like those of GINA, allow employees to keep private information that could lead to discrimination based on assumptions about genetics, even in the absence of actual genetic test results. If an individual is unable to keep private his use of genetic services such as counseling, the individual may be deterred from obtaining this service for fear that an employer will assume the employee has reason to think he has a genetic disorder. Protection of this information is consistent with provisions in a number of states that prohibit employers from acquiring or using information about an employee’s request for or use of genetic services. See, e.g., La. Rev. Stat. § 23:368 (employer may not “require, collect, or purchase” information about an employee’s request for or use of genetic services); Maine Rev. Stat. Ann. § 19302 (employer may not discriminate on basis that an individual received a genetic test or genetic counseling except when based on a bona fide occupational qualification); N.C. Gen. Stat. Ann. § 95-28.1A (unlawful to deny employment of account of request for genetic testing or counseling services); Utah Code Ann. § 26-45-103 (employer may not inquire into whether an individual or blood relative has taken or refused to take a genetic test); Vt. Stat. Ann. § 9333 (employer may not use the fact that genetic counseling or tested services have been requested or performed).

The prohibition on requesting genetic information is not intended to prevent an employer from informing an employee about the availability of a genetic test that is relevant to conditions in the workplace or from informing an employee about a genetic monitoring program.

Exceptions to the general prohibitions on acquisition and testing. Subsections (b)-(j), described individually below, provide situations in which employment entities’ access to genetic information and/or genetic testing is acceptable. The draft permits employment entities to acquire genetic information if they request it inadvertently, receive it from an employee who provides it voluntarily, request it under the Family Medical Leave Act, obtain it in certain publicly available documents, obtain it as part of offering a voluntary wellness program, use it for genetic monitoring, use it for quality control in forensic testing laboratories, or pursuant to a tribunal’s order in litigation. An employment entity may provide genetic testing as part of a wellness program and provide it or, when appropriate, require it for a genetic monitoring program, for quality control use in forensic testing laboratories, or pursuant to a tribunal’s order in litigation.

The Drafting Committee was informed that an employment entity that provides genetic testing under one of these exceptions should supply it through an outside medical organization. See Mark A. Rothstein, Genetics and the Workforce of the Next Hundred Years, 2000 Colum. Bus. L. Rev. 371 (2000). The act, however, recognizes that this may not be the case and includes these provisions to protect privacy in wellness and monitoring programs.

Subsection (b) Inadvertent requests. This subsection is included in the act for consistency with GINA. Congress enacted this provision to address the “water cooler problem” – when an employer unwittingly receives information through casual conversation or by overhearing conversations. While GINA’s exception is expressly limited to requests for family medical history, the proposed regulations expand it to include any genetic information on the theory that it should not matter whether the employee is discussing a genetic test or a relative’s disease. For consistency, the Uniform Act follows this approach.

The proposed EEOC regulations include examples of circumstances in which the acquisition of genetic information would be deemed inadvertent. These include overhearing conversations, receiving information that is not solicited, genetic information submitted in response to a request for medical information, and information submitted by an employee seeking an accommodation or leave.

Employment entities are urged, however, to take proactive measures and establish best practices to avoid even inadvertent acquisition of genetic information. For example, if an employer asks an employee to support a request for an accommodation by having a health care professional provide documentation about a disability, the request form should instruct the health care professional not to provide family medical history or other genetic information.

Subsection (c) Information voluntarily provided by employee. This section is not found in GINA. It is derived from the prior ULC draft to supplement GINA’s exception for information an employer obtains inadvertently by authorizing an employee to purposely provide an employer with genetic information at the employee’s initiative. This recognizes employee autonomy and would be protective of an employee if, for example, the employee sought reassignment to avoid exposure to a chemical which the employee might have a genetic susceptibility. In addition, when coupled with the authorization in section 203, it allows the employee to control the privacy of the information the employee provides to the employer. This provision would also protect an employer from liability under the act if an employee submits genetic information in a situation in which the employment entity’s acquisition is not inadvertent.

Employees who provide genetic information voluntarily may do so directly, through oral statements or by turning over reports of test results. They may also do so indirectly by permitting an employment entity to see medical records held by a third party. The prior draft required prior authorization by the employee only when the voluntary disclosure was made by a third party to an employer. The authorization requirement was changed in this draft to parallel GINA’s authorization requirements when an employee provides genetic information to an employment entity as part of a wellness program or for a genetic monitoring program that is based on employee consent. When medical records are provided to an employment entity by a third party, it is likely that the third party will be a covered entity under HIPAA and the employee will need to authorize the disclosure.

Subsection (d) Family Medical Leave Act. This subsection was added for consistency with GINA. The exception is limited to requests for family medical history. The exception is necessary because an employee seeking leave to care for an ill relative is asked about the relative’s illness on FMLA certification forms.

Subsection (e) Publicly-available documents. This subsection was added for consistency with GINA. GINA has an exception when employers “purchase” commercially available materials that may contain family medical history. The proposed EEOC regulations expand the scope of this provision to include any genetic information for the reasons discussed in the notes on subsection (b).

GINA explicitly includes newspapers, magazines, periodicals, and books as “excused” media and excludes medical databases and court records. The proposed EEOC regulations expand the list of excused media to include the internet, television, and movies.

The exception in this subsection differs from GINA and its implementing regulations in that it is not limited to the purchase of media on the excused list. The Drafting Committee decided that employment entities also should be permitted to obtain this material without cost. The Committee regards the acquisitions covered in this subsection as examples of situations in which an employment entity does not intend to acquire genetic information.

This subsection also differs from GINA in that GINA excludes purchasing court records from the exception, thus effectively prohibiting employment entities from obtaining certain court records. This draft excludes the purchase of medical databases, but not the purchase of court records. The inclusion of genetic information in court records does pose a threat to employee’s privacy in that data miners are obtaining information from court records to sell to employers, landlords, and others. However, court records are public records and the Drafting Committee concluded that under the First Amendment and the principle of open courts, a state may not statutorily prohibit access to court records by the public, including employment entities. In order to protect employee privacy, courts should therefore adopt strong policies to redact genetic information from court records.

Subsection (f) Employee health or genetic services. This subsection permits an employer that provides preventative health services to encourage a healthy workplace to include genetic testing and other genetic services as part of its program. These provisions are intended to encourage employers to provide their employees access to genetic services in this way. The employment entity must, however, meet the requirements listed in the statute as a prerequisite to the acquisition of genetic information for this purpose.

GINA provides that an employment entity may offer health or genetic services as part of a wellness program. This draft follows the proposed EEOC regulations in limiting the application of this subsection to wellness programs that are voluntary. This is a requirement set forth in the ADA. Under EEOC guidance, a wellness program is voluntary “as long as an employer neither requires participation nor penalizes employees who do not participate.” EEOC’s Enforcement Guidance on Disability-related Inquires and Medical Examinations of Employees under the Americans with Disabilities Act, 8 Fair Empl. Prac. Man. (BNA) 405, Question 22 (July 27, 2000), available at http://www.eeoc.gov/policy/docs/guidance-inquiries.html.

As under GINA, the ULC draft requires employee authorization before genetic information can be used in providing health or genetic services. Requirements for employee authorization for genetic testing and for acquisition of genetic information are set forth in Section 203.

The current draft includes GINA’s provision permitting access for a health care professional involved in providing the services for the employment entity. The Drafting Committee has been advised that employer-provided genetic counseling should normally be conducted by professionals – typically genetic counselors, geneticists, or physicians – from outside the employer organization. This act is not intended, however, to regulate the practice of medicine, and so it does not directly forbid an employer from using employees to provide these services. If an employer does use employees, it would be necessary for the health care professional providing genetic services to obtain the genetic information of participating employees. The intent of the current draft is to segregate that information so that it is used only in providing genetic services and others in the employment entity do not have access to the information in an individually-identifiable form. Hence, any genetic information otherwise acquired by the employment entity must be in an aggregate form that does not disclose the identity of the individual. However, employment entities that obtain aggregate information may still violate the act if a small number of participants or other factors make an individual’s genetic information readily identifiable from the aggregate information.

The draft also provides additional protections not found in GINA. In this subsection it requires employers to provide genetic counseling about the risks and benefits of the test before an employee considers signing the authorization for testing. The purpose of this counseling is so that the employee can make an informed decision about whether or not to have the test. The Drafting Committee decided that an employee may, however, decline the counseling. In addition, in subsection (h), the draft mandates additional protections whenever an employment entity provides genetic testing. These protections apply to both health or genetic services offered by an employment entity and to genetic monitoring programs.

Prior ULC drafts provided that the employer must pay for the genetic testing and genetic counseling. This differs from GINA. Because this testing is for the employee’s benefit and might be covered by health insurance, the payment provision is dropped from the current draft.

In addition to this subsection and GINA’s employment provisions and implementing regulations, Title I of GINA places restrictions on the genetic information that group health plans may request or require from covered individuals. Employment entities that sponsor or maintain group health plans that implement wellness programs should consult the regulations issued by the Department of Labor, Health and Human Services, and the Department of the Treasury concerning limitations on acquisition of genetic information by group health plans.

As provided in Section 210, the act is not intended to apply to uses of information covered by the privacy regulations (Privacy Rule) that implement the 1996 Health Insurance Portability and Accountability Act (HIPAA), which covers health insurers and other health practitioners. Nothing in this subsection should be read to apply to or restrict the acquisition use, or disclosure of genetic information that is subject to the HIPAA Privacy Rule. For example, if a university employee becomes a patient in the university’s hospital, in that setting the individual’s genetic information would be covered by the HIPAA Privacy Rule, not the provisions of this act.

Subsection (g) Genetic monitoring program. Monitoring for damage to employees’ genes from workplace exposure to harmful substances is another possible justification for testing. Genetic monitoring programs are typically undertaken by employers to identify risks for groups of employees who have been exposed to hazardous substances or to target work sites for safety and health measures. Monitoring is testing designed to detect whether the genetic material of a group of individuals has changed over time. The premise is that such changes could indicate increased risk of future illness. Aggregated data from tests for genetic damage is sufficient to allow an employer to reduce exposures to levels that do not affect individuals’ chromosome morphology or DNA. Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace 66 (1990). However, while monitoring may have predictive value for a group, the techniques that are used do not currently measure increased individual health risks.

This draft and GINA both permit genetic testing in conjunction with a genetic monitoring program with the authorization of the employee or, without employee authorization, when required by federal or state law. It expands GINA’s protections by including a provision for genetic counseling when the testing is conducted pursuant to an employee’s authorization. Both GINA and this draft limit employer access to aggregate genetic data, with an exception for employees administering the monitoring.

In addition, when an employer provides genetic testing as part of a genetic monitoring program, this draft provides protections for the employee in subsection (h) that go beyond GINA.

Reference to federal genetic monitoring regulations. GINA, and this draft, require that an employer’s genetic monitoring program must comply with federal regulations governing genetic monitoring programs. The intent is to include future federal regulations and amendments. Currently, the language refers to regulations that “may be promulgated.” One alternative suggestion is to refer to regulations that “have been or are hereafter promulgated.” The Drafting Committee seeks guidance from the Style Committee on appropriate wording to signal that the requirement includes compliance with both existing and future federal regulations, as amended.

Existing State law and its relationship to GINA. A number of states permit genetic monitoring, provided that the employee requests testing, provides informed consent or authorization, and the employer does not terminate the employee or take other adverse action as a result of testing. Iowa Code Ann. § 729.6(7); N.H. Rev. Stat. § 141-H:3; N.Y. Exec. Law § 296; Wis. Stat. Ann. § 111.372. In addition, Louisiana authorizes monitoring of biological effects of toxic substances in the workplace if the employee has provided authorization and is notified of the results. La. Rev. Stat. § 23:368. More generally, the definitions and prohibitions in many states’ statutes do not appear to restrict monitoring for genetic damage, or are ambiguous on this issue. Thus many state statutes do not appear to provide safeguards for employees consistent with GINA.

Subsection (h) Protections in conjunction with genetic testing. This subsection provides the employee with protections in the event that an employment entity provides testing as part of health or genetic services under subsection (f) or a genetic monitoring program under subsection (g). These protections supplement GINA’s provisions on health plans and monitoring.

Subsection (h)(1) provides for reporting genetic test results to the employee when an employment entity supplies testing. Not all individuals, however, wish to know their genetic information; some may decide not to learn test results because of the psychological burdens that may accompany such knowledge. So the draft also recognizes an employee’s right to decline to know the results of a genetic test.

Subsection (h)(2) mandates the availability of genetic counseling so that the test results can be interpreted for the employee if the test result is positive.

Subsection (h)(3) provides for destruction of the sample obtained for testing. The prompt destruction of a sample obtained for genetic testing supplied by an employer protects the employee’s privacy by preventing subsequent testing of the sample. It also recognizes, however, that a testing laboratory is required to retain samples for certain time periods for certification testing and other purposes. The provision follows statutes adopted in New Jersey and Oregon.

Possible alternative approaches (1) put the burden on the employee by requiring that the sample be destroyed promptly on the request of the individual tested or (2) specify that a sample may be retained for a period of time. Some provisions combine elements of more than one approach. In New York, for example, a sample may be retained for ten years if authorized by the individual from whom the sample was obtained. The Drafting Committee decided that the placing the burden for destruction of the sample on the employment entity best protects an employee’s privacy.

Subsection (i) Forensic testing laboratories. This subsection was added for consistency with GINA. It allows a limited subset of employers – those that perform genetic testing for identification for law enforcement purposes or to identify human remains – to collect DNA samples from employees in order to check for contamination of samples with the employees’ DNA.

Testing under this subsection is not subject to the protections in subsection (h) because testing for the purposes of quality control in an identification laboratory would be limited to the sections of the genome used for identification, which are not thought to have any medical or predictive significance.

Subsection (j) Legal proceedings. This subsection allows an employer to obtain an employee’s genetic information that is relevant to a claim or defense in a legal proceeding, through testing if necessary, if the employee places the employee’s health at issue in a legal proceeding. It supplements GINA and provides standards that give an employee greater protection than that afforded by civil litigation discovery standards for medical testing.

The employer’s ability to acquire genetic information under this subsection is limited in that it applies only if the employer has satisfied the burden of proof to show compelling need and that the information is otherwise unavailable. Only that portion of an employee’s genetic information that is relevant to a claim or defense may be provided. These procedures provide more protection than Rule 35 of the Federal Rules of Civil Procedure or state equivalents, which provide that a court may order a physical examination on motion for good cause shown. The Drafting Committee considered a requirement that the genetic test results be sealed or placed under a protective order, but decided to leave this to existing law.

The substance of the subsection follows Utah’s statute, which authorizes genetic testing when an employee has placed his or her health at issue in a proceeding, but only by order of a court or administrative agency after finding compelling need and that the information is otherwise unavailable. Utah Code Ann. § 26-45-103(2). Other states have more narrowly authorized employer testing to investigate a workers’ compensation claim. (NH, NY).

Employee susceptibility. One circumstance in which the prior draft allowed genetic testing is now omitted – genetic screening to determine the employee’s predisposing genetic characteristics that may create susceptibility to harm to the employee from a workplace condition. This was done based on the judgment that this provision would not provide greater protection to employees than GINA, and would thus be preempted. This note is retained to alert the Drafting Committee to this omission and to allow discussion, if desired, of the preemption issue and the desirability of retaining this exception.

Several states currently allow to test for screening purposes, with the consent of the employee. Iowa, Louisiana, New Hampshire, New York, and Wisconsin all have nearly identical provisions that permit genetic testing of an employee to determine an employee’s susceptibility to toxic substances if the employee requests testing, provides informed consent or authorization, and the employer does not terminate the employee or take other adverse action as a result of testing. Iowa Code Ann. § 729.6(7); N.H. Rev. Stat. § 141-H:3; N.Y. Exec. Law § 296; Wis. Stat. Ann. § 111.372.

The utility of testing for susceptibility to workplace exposures is illustrated by chronic beryllium disease. Beryllium is a lightweight metal used in many industries that poses the threat of this disease when dust or fumes are inhaled. Industry protections have greatly reduced exposure, but a small portion of the population can contract the disease even after a very brief exposure. A genetic marker has reportedly been identified for this extreme sensitivity that purports to show with certainty which individuals will contract beryllium disease and die from short exposure. Cynthia Nance, Paul Miller, & Mark Rothstein, Discrimination in Employment on the Basis of Genetics, 6 Employee Rights & Employment Policy Journal 57, 63-64 (2002). If so, testing could provide information that could define an individual’s risk from workplace exposure to beryllium.

Prior drafts allowed an employment entity to supply testing for such susceptibilities, but provided that unless the employee volunteered the test results, the employment entity was not authorized to obtain them.

Safety of other employees. The Drafting Committee considered, but did not adopt, a provision that would permit employers to supply genetic testing in order to protect the safety of other employees in the workplace. It would be very rare for a genetic marker to indicate a safety threat to other employees with sufficient certainty to justify a genetic test. The draft does not limit an employer’s ability to take an employee’s manifested medical condition into account for safety purposes, subject to the provisions of the Americans With Disabilities Act.

SECTION 203. EMPLOYEE AUTHORIZATION FOR ACQUISITION OF GENETIC INFORMATION AND GENETIC TESTING.

(a) Except as otherwise provided by law other than this [act], an employee’s or employee’s family member’s authorization for an employment entity’s acquisition of the individual’s genetic information or a genetic test must be knowing and voluntary and indicated in a record signed by the individual that complies with this section. An employment entity that receives a valid authorization may use the genetic information or provide a test only in accordance with the authorization. An authorization may not expand the acquisition or use of genetic information or the genetic testing permitted by this [article] and it may not include exculpatory language waiving any of the employee’s or employee’s family member’s legal rights.

(b) An authorization for an employment entity to acquire an employee’s or an employee’s family member’s genetic information pursuant to Section 202(c), (f), or (g)(2)(B) must:

(1) describe the genetic test to be performed, its purpose, and the permitted uses of the test result;

(2) inform the individual that only the authorized genetic test will be performed on the individual’s biological sample;

(3) explain the benefit of receiving genetic counseling before authorizing the test and inform the individual that the employment entity is obligated to provide and, if the test is part of a genetic monitoring program, pay for genetic counseling about the risks and benefits of the test before the individual decides to authorize the test unless the individual waives genetic counseling;

(4) inform the individual that the test result will be reported to the individual and a health-care professional designated by the individual unless the individual directs otherwise;

(5) explain the benefit of receiving genetic counseling about the test result and inform the individual that the employment entity is obligated to provide and, if the test is part of a genetic monitoring program, pay for genetic counseling about the test result unless the individual waives genetic counseling;

(6) include an opportunity for the individual to provide directions about reporting test results and genetic counseling;

(7) inform the individual that the individual’s biological sample will be destroyed as soon as permitted by law after the test is completed unless the individual authorizes retention of the sample or unless otherwise ordered by a tribunal;

I, _______________________, authorize ____________________________ to acquire my

☐ for a voluntary genetic monitoring program conducted by ____________________________.

☐ for ________________, a voluntary program to that provides health and genetic services that

Family medical history is information concerning diseases and disorders of family

members and other relatives. This information may be used for the following purposes:

Genetic tests are tests of DNA, RNA, chromosomes, or other material to determine

genetic characteristics. If _______________________________ will provide the genetic

tests, a separate authorization is necessary. The test results may be used for the following

Restrictions on Disclosure of Genetic Information. If this genetic information is provided for a

voluntary genetic monitoring program or a voluntary program to that provides health and genetic

services, only medical professionals involved in providing the program will have access to your

individual genetic information. Otherwise, ______________________________ will not have

access to your genetic information except in an aggregate form that will not identify you.

However, the genetic information may be disclosed to certain heath researchers, to government

officials investigating compliance with laws protecting the privacy of genetic information or

prohibiting genetic discrimination, to a public health agency if the test result concerns a life-

threatening contagious disease, if expressly ordered by a court, or if you request and authorize a

By signing this authorization, you do not lose any legal rights to which you are entitled. You are

Limited Authorization. Only the genetic tests that you authorize on this form will be

Availability of Genetic Counseling. Before you complete this authorization, it is highly

recommended that you receive genetic counseling. Genetic counseling will help you assess your

risk for an inherited condition based on your family medical history and will help you understand

the options for prevention and management of genetic conditions. It will help you understand

and evaluate the risks, benefits, and consequences for you and your family of having the test(s)

listed below. _________________________ will provide [and pay for] this genetic counseling.

Proposed Genetic Tests. ________________________ proposes to provide the following

This test is provided as part of a genetic monitoring program. The purpose of this test is

to monitor the effect of your exposure to ______________________. The result of the

purpose of the test is ______________________ . The result will be used only for the

Reporting Test Results and Genetic Counseling. The test results will be reported to you and

to a health-care professional whom you designate unless you direct otherwise. It is

recommended that you receive genetic counseling about the test results. Genetic counseling is

important for understanding the test results in the context of your medical and family history. It

can also provide you with support, informational resources, and referrals, as appropriate, that can

help you adapt to the implications of being at risk of a genetic condition. __________________

will provide and [pay for] genetic counseling about the test results unless you decline genetic

Restrictions on Disclosure of the Test Results. Other than the medical professionals involved in

providing this program, ______________________________ will not have access to the test

results of the individuals who authorize this test except in an aggregate form that will not identify

you. However, the test results may be disclosed to certain heath researchers, to government

officials investigating compliance with laws protecting the privacy of genetic information or

prohibiting genetic discrimination, to a public health agency if the test result concerns a life-

threatening contagious disease, if expressly ordered by a court, or if you request and authorize a

Destruction of your Biological Sample. After the genetic test, your biological sample will be

destroyed as soon as permitted by law unless you authorize otherwise in writing or a court,

By signing this authorization, you do not lose any legal rights to which you are entitled. You are

This section sets forth an authorization requirement for genetic testing and certain acquisitions of genetic information by an employment entity and specifies the elements that must be contained in an authorization form. It applies to the situations in which Section 202 permits an employment entity to acquire genetic information or conduct genetic testing with the consent of the employee or employee’s family member: providing genetic services as part of a wellnes program, conducting a genetic monitoring program, and (for acquisition only) at the employee’s behest. This authorization requirement, coupled with statutory limits and duties imposed on employment entities by the act, is designed to maintain privacy for genetic testing and genetic information.

The prior draft included a broader requirement for authorization for acquisition of genetic information and also included separate requirements for authorization for use, retention, and disclosure of genetic information. In order to be more consistent with GINA, the Drafting Committee decided to eliminate the detailed authorization requirements for any acquisition, use, retention, and disclosure. The current draft combines the prior draft’s provision for authorization for genetic testing with the authorization requirements in GINA for acquisitions in connection with wellness programs or genetic monitoring.

The term “authorization” is used instead of “informed consent” to avoid confusion with the use of that term in medical practice. The section’s requirements for the content of an authorization are more detailed and comprehensive than GINA. GINA requires employee authorization when an employer acquires genetic information in connection with providing health or genetic services and when an employer conducts a monitoring program that is not required by law. In those circumstances, GINA requires an employee authorization that is “prior, knowing, voluntary, and written.” In addition, the proposed GINA regulations also require that the authorization be written so that the person from whom the genetic information is being obtained is reasonably likely to understand the form; that the form describe the type of genetic information that will be obtained and the general purposes for which it will be used; and that the form describe the restrictions on disclosure of genetic information.

The Drafting Committee considered, but did not adopt, alternatives to authorization that would (1) establish a general property right in a biological sample an individual provides for genetic testing and in the resulting genetic information or (2) establish a limited property right in genetic information applicable only to the context of employment.

Subsection (a) Requirement for authorization for acquisition of genetic information and for genetic testing. Subsection (a) sets forth the basic requirements that authorization must be knowing and voluntary and memorialized in a record. It limits an employment entity’s use of genetic information and the tests it provides to those specified in the authorization and makes clear that the authorization should not be interpreted to waive any of the employee’s rights.

When an employee is considering authorizing genetic testing, the employee should have genetic counseling before signing the authorization in order to meet the requirement of this subsection that an authorization is knowing and voluntary. Genetic counseling provides employees with adequate information to make an informed decision about genetic testing. It also makes them aware of their options regarding reporting of test results and help in interpreting them through genetic counseling. An employment entity that offers a genetic test as part of a health program or genetic monitoring program has an obligation to provide genetic counseling under Section 202. Genetic counseling may be provided by a genetic counselor, but may also be provided by a qualified physician or geneticist. An employee may waive genetic counseling, but must first be made aware of the benefits of genetic counseling.

The power to authorize inherently and of necessity includes to power to revoke and the employee may revoke this authorization at any time.

The Drafting Committee anticipated that there might be circumstances in which an individual is incapacitated or incapable of authorizing a genetic test. Other law of the state may provide for a substitute decisionmaker or signer for the authorization if the employee is incapacitated or incompetent. Revocation of an authorization by a substitute is similarly left to existing law of the state that governs power of attorney, guardianship, or other substitute decision makers.

Subsection (b) Content of authorization for acquisition of genetic information. This subsection follows the GINA requirements for authorization for acquisition of genetic information and is consistent with the proposed implementing regulations.

Subsection (c) Content of authorization for genetic testing. Before any genetic testing can be performed, unless the testing is required by law, an employee must affirmatively authorize the genetic testing and the employment entity’s acquisition of the resulting genetic information. Section 202 limits the situations in which employment entities may request authorization for testing from employees: an employment entity may supply genetic tests as part of health or genetic services, but only with prior authorization from the employee, and as part of a genetic monitoring program, but only if required by law or with prior authorization from the employee.

This subsection builds on the GINA requirements for authorization for acquisition of genetic information so that it applies to the situation when that acquisition involves offering a genetic test. It draws on N.Y. Civ. Rights Law § 79-l (McKinney), which establishes requirements for consent for a genetic test.

The requirements in subsection (c)(3), (5), and (6) reflect the obligations of the employment entity to provide genetic counseling under Section 202(f), (g), and (h).

The notification provision for retention of the sample in (c)(7) is consistent with the employment entity’s obligation to ensure that the sample is destroyed under Section 202(h), which recognizes that the testing laboratory may be required to retain the sample for certification purposes.

Subsection (d) Authorization form. The use of a form following the pattern in this subsection would comply with the requirements of the section. This subsection provides guidance to employers on appropriate content for a form. The Drafting Committee previously decided that it preferred having the forms in the black-letter law instead of in the comments.

(a) An employer may not take an adverse employment action against an employee based on the employee’s genetic information, including but not limited to failing or refusing to hire, discharging, or discriminating against an employee in regard to compensation, terms, conditions, or privileges of employment.

(b) An employment agency may not take an adverse employment action against an individual based on the individual’s genetic information, including but not limited to failing or refusing to refer an individual for employment or discriminating against an individual.

(c) A labor organization may not take an adverse employment action against a labor organization member based on the member’s genetic information, including but not limited to excluding or expelling a labor organization member from membership in the organization or discriminating against any labor organization member.

(d) An employer, labor organization, or joint-labor management committee controlling an apprenticeship or a training or retraining program may not take an adverse employment action against an individual based on the individual’s genetic information, including but not limited to discriminating against an individual in admission to or employment in the program.

(e) A credentialing authority may not take an adverse employment action against an individual based on the individual’s genetic information, including but not limited to discriminating against an individual in the provision of credentials.

(f) An employment entity may not limit, segregate, or classify an individual, or fail or refuse to refer for employment an individual, in a way that would deprive or tend to deprive the individual of employment opportunities or otherwise adversely affect the status of the individual as an employee based on the individual’s or the individual’s family member’s genetic information.

(g) An employment agency, labor organization, joint labor-management training or apprenticeship program, or credentialing authority may not cause or attempt to cause an employer to discriminate against an employee in violation of this [article].

(h) An employment entity may not discriminate against an employee because the employee has opposed an act or practice in violation of this [article] or because the employee made a charge, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under this [article].

This section is based on the anti-discrimination provisions in GINA, supplemented with the provision from the prior ULC draft that prohibits employment entities from taking any adverse employment action based on genetic information. GINA has a separate statutory section defining unlawful employment practices for each type of employment entity. This version follows the proposed EEOC regulations, which consolidate the provisions as much as possible, using the terminology of GINA.

GINA does not contain the provision on retaliation in subsection (h), but the EEOC has added it into the regulations. This omission from the statute illustrates the dangers of enumerating adverse employment actions. Subsection (e) governing credentialing authorities is another departure from GINA. Both additional provisions provide employees greater protection.

Prohibition of adverse employment decisions. The act’s prohibition of adverse employment decisions based on genetic information is consistent with GINA and is included to make sure that employee protections are not limited by omission of an employment actions from the list in GINA. “Adverse employment decision” is a term of art in employment law that the Drafting Committee decided does not need to be defined in this act. The term should be interpreted broadly. One example of a broad statement of adverse employment actions can be found in the District of Columbia Human Rights Act, which makes it a discriminatory practice for an employer “[t]o fail or refuse to hire, or to discharge, any individual; or otherwise to discriminate against any individual, with respect to his compensation, terms, conditions, or privileges of employment, including promotion; or to limit, segregate, or classify his employees in any way which would deprive or tend to deprive any individual of employment opportunities or otherwise adversely affect his status as an employee.” D.C. Code § 2-1402.11.

Rationale for limiting actions of employment entities. The restrictions on employment actions in GINA and this draft are important because they will dispel uncertainty about how courts would otherwise apply federal statutes to decisions based on genetic information that predicts employee susceptibility to harm from workplace exposures. On one hand, in 1991 the United States Supreme Court held that a chemical company’s policy barring women of child-bearing age from employment opportunities that involved exposure to lead violated Title VII prohibitions on gender discrimination. International Union v. Johnson Controls, 499 U.S. 187 (1991). On the other hand, the ADA allows employers to act on health information, even in the case of disability, when there is a direct threat to the health or safety of others in the workplace. The Equal Employment Opportunity Commission (EEOC) has interpreted this ADA provision to apply when there is no risk to others but when an employer can show that an individual’s disability poses a significant risk of harm to the individual. The United States Supreme Court upheld this interpretation. Chevron v. Echazabal, 122 S. Ct. 2045 (2002). Although the Echazabal case did not involve a genetic characteristic, but rather a worker’s liver damage due to exposure to workplace solvents, the implication of the case is that in the absence of a prohibition in a state statute, an employer may make adverse employment decisions based on genetic screening or monitoring requested by an employee even if there is no threat to others. Section 204 does not permit an employer to take an adverse employment action under these circumstances. Harm to the employee or to others is not a justification. As a result, employers would not be able to use an employee’s genetic information in the way the employee’s health information was used in the Echazabal case.

Note that the section does not necessarily prevent an employer from making decisions based on the effects of an employee’s manifest genetic condition or disease in the workplace. This is because the protections in this section involve the use of “genetic information,” which is defined with reference to a “genetic test.” In addition, Section 209 makes clear that employment entities may acquire and use medical information about a manifested disease, even one with a genetic basis, if that medical information is not genetic information. In addition to the protections of this section, some employees with manifest genetic conditions would be covered under the ADA if the condition limits a major life activity. But there is no comprehensive protection for individuals with medical conditions that result from genetic traits. While some maintain that attempts to prevent genetic discrimination are mostly meaningless without protection for people who have genetic diseases, see Mark A. Rothstein, Genetic Privacy and Confidentiality: Why They are so Hard to Protect, 26 J. L. Med. & Ethics 181 (1998), others emphasize the difficulties with either policy choice, see Henry T. Greely, Genotype Discrimination: The Complex Case for Some Legislative Protection, 149 U. Pa. L. Rev. 1483, 1503 (2001).

Existing state law. Many state statutes limit use of genetic information by prohibiting discrimination among employees or applicants for employment on the basis of genetic information. (Ark, Ill, Kan, LA, Maine, MD, Mass, Mich, MO, Neb, Nev, NJ, NY, NC, OK, OR, RI, SD, Tex). These statutes do not all provide protections as comprehensive as those in GINA and this act. Other states more generally ban any use of genetic information in employment. For example, New Mexico’s 2005 statute provides simply that “[i]t is unlawful for a person to use genetic information in employment, . . . .” In Utah, employers may not take into account genetic information about an individual in connection with an employment decision. Similarly, in Iowa, an employer may not use genetic information to “affect the terms, conditions, or privileges of employment” of a person who gets a genetic test. Iowa Code Ann. § 729.6(2). Minnesota and Wisconsin prohibit adverse employment actions based on genetic information. Minn. Stat. § 181.974 subd. 2(a)(2) (may not “affect the terms or conditions of employment or terminate the employment of any person based on protected genetic information”); Wis. Stat. § 111.375 (may not “affect terms, conditions or privileges of employment, labor organization membership or licensure or terminate the employment or labor organization membership or licensure”).

(a) An employment entity that obtains genetic information as permitted by Section 202 may use the genetic information for purposes authorized by law, including:

(1) to provide health or genetic services to an employee or employee’s family member;

(2) to monitor the effects of an employee’s exposure to a workplace condition as part of a genetic monitoring program;

(3) for purposes of quality control if the employer conducts DNA analysis for law enforcement purposes as a forensic laboratory or for purposes of identifying human remains; or

(4) to defend a claim in a proceeding before a tribunal in which an employee has placed the employee’s health at issue.

The draft selectively authorizes ways that an employment entity may use genetic information. It is taken from the prior draft and clarifies GINA, which permits employers to acquire information for certain purposes, but fails to authorize those uses.

The Drafting Committee considered a provision that would have allowed adverse employment actions in the case of an employee with a predisposing genetic characteristic that poses a direct threat of harm to others. It decided not to include this provision because the Drafting Committee was unable to identify any known genetic trait that would qualify and if testing is permitted for this purpose it could be abused. In addition, such a provision would probably be preempted by GINA, which permits states to depart from federal law only to provide greater protections for employees.

Because of concerns about preemption, this draft does not include a provision from prior drafts that would have permitted an employer to use genetic information on employee susceptibility to harm in the workplace to reduce the potentially harmful exposure, but not to make an employment decision that would adversely affect the employee. The utility of this form of genetic information is described in the Reporter’s Notes to section 202.

SECTION 206. ACCESS TO GENETIC INFORMATION BY EMPLOYEE. An employee may inspect, request correction of, or obtain a copy of the employee’s genetic information in any record of an employment entity which contains the information. If an employee requests correction of genetic information in a signed record, the employment entity shall make the correction if justified.

This section supplements GINA and is more protective of the employee than the federal statute. GINA allows employment entities to provide an employee’s genetic information to the employee as an exception to its general prohibition on disclosure, but it does not give an employee a right to obtain this information. This section is based on the conclusion that an employee ought to be able to find out what genetic information an employer knows about an employee and to have the same information. It is modeled on 16 Del. Code § 1223.

This section also provides a mechanism for an employee to correct genetic information contained in employer records. The right to correct genetic information also includes expungement of information that should not be in a particular record. For example, an employer may have incorrectly placed genetic information in an employee’s personnel file instead of segregating it as required by Section 207.

If the employer supplied the genetic testing, information may also be kept in files at the laboratory that performed the testing. The employer’s responsibility to correct errors does not extend to the testing laboratory, which is regulated under the Clinical Laboratory Improvement Amendments, (CLIA), 42 U.S.C.§ 263a.

The Drafting Committee considered but rejected an exception that would have prohibited employee access to information an employment entity has compiled for litigation. This situation will be governed by normal discovery rules, which are unaffected by this section.

(a) An employment entity shall treat an employee’s genetic information as a confidential record.

(b) If an employment entity possesses an employee’s genetic information, the employment entity shall keep the genetic information in a record separate from the employee’s personnel file.

(c) The requirements of subsection (b) are satisfied if the employment entity keeps the genetic information in the record in which it maintains confidential medical information subject to section 102(d)(3)(B) or the Americans with Disabilities Act, 42 U.S.C. § 12112(d)(3)(B).

(d) Notwithstanding this section, an employment entity may retain genetic information obtained in aggregate form pursuant to Section 202(f) for use in providing health or genetic services and Section 202(g) for use in a genetic monitoring program.

Subsection (a) Confidentiality. This subsection declares that genetic information, which includes family medical history, is confidential in the employment context. “Genetic information” is a category that includes information about use of or request for genetic services, so this section also protects an employee’s authorizations concerning genetic tests or information. This subsection is consistent with GINA, which provides that genetic information shall be treated as a confidential medical record.

Subsection (b) Retention of genetic information. This provision follows the approach of GINA and operates if an employer “possesses” genetic information. It does not require an employee to authorize retention of the information. The protections apply to any genetic information maintained by the employment entity. They are not limited by the manner in which the employment entity obtained the genetic information and they apply to any genetic information from any source, even if the acquisition was inadvertent.

Employment entities may retain genetic information without the burden of obtaining employee authorization to maintain the information. They must protect the employee’s privacy, however, by maintaining it as confidential information and by segregating this information from the employee’s personnel file.

Subsection (c) Coordination with the Americans with Disability Act. This provision follows GINA. There is a need for coordination because many employers will acquire genetic information when they acquire an employee’s medical records (which they may request under the ADA after a conditional offer of employment or during employment for job-related purposes). Genetic information is likely to be interspersed throughout medical records and an employer that requests medical information is likely to receive an entire file, including genetic information. GINA addresses this by allowing employers to keep genetic information with confidential medical information acquired under the ADA so long as both types of information are retained as confidential records.

Subsection (d) Aggregate information for wellness or genetic monitoring programs. Under Section 202, an employment entity is allowed to acquire genetic information for the operation of a wellness program or a genetic monitoring program, but only in an aggregate form that does not identify individual employees. This subsection correspondingly allows an employment entity to retain, and Section 208(d) allows it to disclose, this aggregate genetic information. Retention and disclosure of aggregate information may be necessary in order to analyze trends or take action to reduce risk in the workplace.

(a) Except as otherwise permitted in this section, an employment entity may not disclose an employee’s or employee’s family member’s genetic information.

(b) An employment entity may disclose an employee’s or employee’s family member’s genetic information:

(1) to the employee or, if the genetic information is the employee’s family member’s, to the employee’s family member and to a health-care professional designated by the employee or employee’s family member at the written request of the employee or employee’s family member;

(2) at the request of the employee or, if the genetic information is the employee’s family member’s, the employee’s family member, to a person the employee or employee’s family member has authorized to receive the genetic information in a knowing and voluntary authorization indicated in a record signed by the employee or the employee’s family member;

(3) to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part 46 of title 45, Code of Federal Regulations;

(4) in response to an order by a tribunal, if disclosure of the genetic information is expressly authorized by the order;

(5) to government officials who are investigating compliance with this [act] or with the Genetic Information Nondiscrimination Act, 42 U.S.C. § 2000ff to 2000ff-11, if the information is relevant to the investigation;

(6) to the extent the disclosure is made to comply with the certification provisions of the Family Medical Leave Act, 29 U.S.C. § 2613, or the [state family and medical leave act];

(7) to a public health agency when the genetic information concerns the manifestation in an employee or an employee’s family member of a contagious disease that presents an imminent hazard of death or life-threatening illness; or

(8) in aggregate form in connection with health or genetic services provided pursuant to Section 202(f) or a genetic monitoring program operated pursuant to Section 202(g).

(1) the disclosure is made under subsection (b)(4) of this section and the tribunal’s order was secured without the knowledge of the employee; or

Legislative Note: In subsection (b)(6), states should insert for [state family and medical leave act] the appropriate name for the state’s act.

This section follows the format of GINA, which contains a general prohibition on disclosure of genetic information by employers coupled with exceptions. It supplements GINA by permitting disclosures at the request of the employee.

Existing state law. A number of states that have enacted (1) general privacy protections for genetic information that prohibit disclosure without informed consent or authorization (Alaska, Cal, Del, Fla, Maine, Mass, Nev, NH, NJ, NMex, NY, OR) or (2) specific protections against the disclosure of genetic information by employers (Ariz, Fla, LA, Mass, NH, NJ, Or, RI).

Subsection (a) General prohibition on disclosure of genetic information. This subsection follows GINA and establishes a blanket rule that employment entities may not disclose employee’s genetic information, subject to limited exceptions.

Subsection (b) Permitted disclosures. This subsection sets forth the circumstances under which an employer may disclose an employee’s genetic information.

Subsection (b)(1) permits an employment entity to disclose genetic information to the individual whom it concerns. This is consistent with the employee’s right of access to the employee’s genetic information established by Section 206. GINA includes a parallel provision.

Subsection (b)(2) goes beyond GINA and respects employee autonomy by providing for disclosures to third parties when an employee requests the disclosure and provides a knowing and voluntary authorization. The power to authorize inherently and of necessity includes to power to revoke and the employee may revoke this authorization at any time.

Other law of the state may provide for a substitute decisionmaker or signer for the authorization if the employee is incapacitated or incompetent. Revocation of an authorization by a substitute is left to existing law of the state that governs power of attorney, guardianship, or other substitute decision makers.

As a matter of good business practice, an employment entity should retain an employee’s authorization for disclosure of genetic information. An authorization for disclosure of genetic information contains genetic information and so should be kept separately from the employee’s personnel file.

Subsection (b)(3) is taken from GINA and permits disclosures to occupational and health researchers.

Subsection (b)(4) is taken from GINA and permits disclosures in response to an order from a court, arbitral tribunal, or administrative agency. Disclosure of genetic information is limited to genetic information explicitly included in the terms of the order. The provision does not authorize other disclosures in connection with litigation such as in response to a discovery request, unless ordered by the tribunal. Subsection (c)(1) requires the employer to give the employee notice of this disclosure if the tribunal’s order was issued without the employee’s participation in the proceeding.

Subsection (b)(5) is taken from GINA and permits disclosures to government officials investigating compliance with the act or with GINA.

Subsection (b)(6) is taken from GINA and permits disclosures made in conjunction with the Family Medical Leave Act or state or local leave law.

Subsection (b)(7) is taken from GINA and permits disclosure of genetic information to public health authorities in connection with a contagious disease that creates an imminent threat of death or life-threatening illness. If a disclosure is made under this subsection, the employer must provide notice to the employee under subsection (c).

Subsection (b)(8) permits disclosures of aggregate genetic information obtained as part of a heath or genetic services program or a genetic monitoring program under Section 202. This provision supplements GINA.

Subsection (c) Notice to employee of disclosures. These limited requirements that an employment entity provide notice to an employee of disclosure of genetic information are taken from GINA.

SECTION 209. MEDICAL INFORMATION THAT IS NOT GENETIC INFORMATION. An employment entity’s acquisition, use, retention, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee does not violate this [article] even if the manifested disease, disorder, or pathological condition has or may have a genetic basis.

This section is a paraphrase of section 210 of GINA, 42 U.S.C. § 2000ff-9. It is meant to signal that medical information about a manifested disease is not covered by the act if it is not genetic information, but that medical information is covered if it is genetic information. For example, an individual with breast cancer might learn from genetic testing that she is positive for a BRACA mutation and thus has an increased risk of ovarian cancer. Under this section, the fact that she has breast cancer is not protected, but information about the genetic mutation is protected.

Under this section an employment entity does not violate the act when it acquires, uses, retains, or discloses medical information about a manifest disease that is not genetic information. However, that information may be protected by HIPAA or the ADA.

SECTION 210. RELATIONSHIP TO HEALTH PRIVACY REGULATIONS. This [article] does not apply to genetic information that is protected health information subject to the regulations issued by the Secretary of Health and Human Services pursuant to section 264(c) of the Health Insurance Portability and Accountability Act, 42 U.S.C. § 1320d-2 note.

This is a new section in this draft. It concerns the interaction of provisions when an employment entity is also a covered entity under HIPAA. The section makes clear that when a covered entity obtains information that is protected health information under the HIPAA Privacy Rule, the entity is governed by the HIPAA rule. For example, if a hospital’s employee becomes a patient, the hospital’s acquisition and use of that patient’s genetic information is governed by the HIPAA privacy rule, not GINA or this act.

The language of this section follows the proposed EEOC regulation implementing GINA, 29 CFR § 1635.11(d). GINA section 206, 42 U.S.C. § 2000ff-5, takes a slightly different approach. It provides that the employment provisions of GINA shall not prevent a covered entity under HIPAA from any use or disclosure of health information that is authorized by the regulations issued pursuant to HIPAA. The Drafting Committee should consider whether to retain the language of the regulations or use the GINA formulation.

The GINA regulations also contain a reference to this exclusion from their scope in the regulation on confidentiality and disclosure. This states that “nothing in the regulations shall be construed to apply to the use or disclosure of genetic information that is protected health information subject to the regulations issued pursuant to [HIPAA]. 29 CFR § 1635.9(c) (proposed). The Drafting Committee may want to consider adding parallel language to the act’s sections on use and disclosure. For example, a subsection could be added to Section 208 that would state: “Nothing in this section shall apply to the disclosure of protected health information that is subject to the regulations issued pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. § 1320d-2 note.”

(a) A violation of this [article] creates a private cause of action on behalf of the aggrieved party for money damages or other relief. An individual may seek remedies provided by law other than this [act], but exhaustion of administrative remedies is not required before seeking relief for a violation of this [article].

(b) A tribunal shall award a prevailing employee reasonable attorney’s fees and costs unless justice requires otherwise.

(c) An individual may file an action authorized in subsection (a) not later than two years after the individual discovers the violation of this [article] or an individual exercising reasonable care should have discovered the violation. This limitations period may not be reduced by agreement between an employment entity and an employee. If an individual seeks remedies provided by law other then this [act], this limitations period shall be tolled during the pendency of administrative proceedings pursuant to that law. This subsection does not alter [tort claims notice provisions].

Legislative Note: In subsection (c), the state should insert for [tort claims notice provisions] a reference to the state statute that governs the notice provisions that are required for tort claims against the state.

For private employees, GINA adopts the enforcement and remedy structure of Title VII of the Civil Rights Act of 1964, incorporating it by reference. For the other employee groups it covers – state, federal, and congressional employees – GINA incorporates the slightly different remedy provisions of the other relevant federal EEO statutes. GINA explicitly excludes, however, claims for disparate impact, a cause of action for unintentional discrimination that is available under Title VII.

This section provides remedies that are more protective of employees that those available under GINA. This follows the pattern of many of the state EEO statutes that supplement Title VII and other federal civil rights statutes. The section provides a private cause of action that can be filed without exhausting administrative remedies and hence does not increase the burden on state fair employment agencies. It establishes a two-year statute of limitations. An aggrieved person also has the option to use the federal administrative apparatus and may pursue relief through state administrative avenues, if applicable, so the section provides a tolling provision for the statute of limitations during that time period. As in the federal EEO statutes, the section provides for fee shifting for prevailing employees to compensate for their cost to enforce the statute.

GINA’s administrative procedures and the federal private cause of action. Under Title VII, and hence by reference under GINA, if there is a state or local fair employment practice agency that is designated as a “deferral agency,” an individual seeking relief from employment discrimination must first file a charge with that agency and the EEOC must defer jurisdiction over the complaint for 60 days or until the state agency has terminated its action. Almost all the states have created agencies that qualify as deferral agencies under Title VII.

If there is no qualifying state fair employment practices agency, a complainant has 180 days from the violation to file a discrimination charge with the EEOC. When a state has a deferral agency, then a complainant must meet the state filing deadline but has 300 days to file with the EEOC but a complainant must also meet the state’s time limitation for filing an administrative claim. State time limitations range from 90 days (2 states) to one year (9 states), with a majority of states (31) setting the time limit at 180 days or 6 months. The EEOC and state fair employment agencies enter into annual work sharing agreements that provide that when a charge is filed with wither the EEOC or the state agency it is treated as dual filed with both of them.

The EEOC serves a notice on the person named in the charge and investigates the charge. If it finds reasonable cause to pursue the complaint, it must attempt to conciliate the matter. If the EEOC dismisses the case, or if settlement is not reached within 180 days from the time the charge was filed and the EEOC and Attorney General decide not to bring a court case, the EEOC issues a “right to sue letter.” An employee may take court action only after the EEOC issues this notice. The case must then be filed in court within 90 days.

Filing a timely administrative charge with the EEOC is a jurisdictional prerequisite to filing a suit under Title VII, McDonnell Douglas Corp. v. Green, 411 U.S. 792, 978 (1973), and courts in a number of sates have similarly interpreted statutes creating fair employment practice agencies to require exhaustion of state administrative remedies before a plaintiff may bring a private cause of action in state court. See, e.g., Strauss v. A.L. Randall Corp., 194 Cal. Rptr. 520, 524 (Cal. Ct. App. 1983); Melley v. Gillette Corp., 491 N.E.2d 252 (Mass. 1986); Bonham v. Dresser Indus., 569 F.2d 187 (3d Cirl 1977) (construing Pennsylvania Human Rights Act).

Subsection (a) Private cause of action. This subsection authorizes a private cause of action for violation of the employment article of the act. An aggrieved person may choose to use GINA’s administrative remedies, including filing with a state agency, but unlike under GINA is not required to do so. This elimination of the requirement for exhaustion of administrative remedies is consistent with statutory provisions in 17 states (as of 2005), in which private EEO causes of action may be brought without first filing a charge with an administrative agency. (Alaska, Arkansas, District of Columbia, Idaho, Kentucky, Louisiana, Maine, Minnesota, New Jersey, New York, North Dakota, Ohio, Oregon, Tennessee, Vermont, Virginia, Washington)

Given the privacy interests at stake with genetic information, there are special reasons for allowing a private cause of action without requiring exhaustion of administrative procedures. While state employment discrimination agencies have the expertise and the apparatus in place to enforce state civil rights and disability statutes, discrimination agencies do not have expertise in privacy violations and the typical remedies for employment discrimination are not necessarily appropriate for a privacy violation. Enforcement could be turned over to an agency with that expertise, but the Drafting Committee wish to avoid the cost of creating and funding a new agency. Moreover, the Drafting Committee did not want to impose the delay associated with administrative processes on an aggrieved employee.

Subsection (c) Statute of limitations and tolling. Subsection (c) establishes a limitations period of two years to file an action for a violation of the act’s employment article. This compares to state statutes of limitations for fair employment actions that range from six months (Colorado) to six years (Ohio), with many states providing for two years (e.g. NJ) or three years (e.g. Michigan, NY, Washington).

The subsection also provides that the limitations period may not be reduced by agreement of an employment entity and an employee. This provision is included because some employers have adopted a practice of inserting into applications for employment an agreement for six months statutes of limitations for claims related to employment, along with a waiver of any contrary limitation. See Joel C. Tuoriniemi & Roger W. Teinsch, Return to Camelot: A Statutory Model for Judicial Examination of Employment Agreements with Shortened Periods of Limitations, 35 Ohio N.U. L. Rev. 751 (2009). Some courts have enforced these contractual limitation periods, including in civil rights actions, reasoning in part that contractual modifications of limitation periods for these claims are not explicitly prohibited by statute. See, e.g., Clark v. Daimler Chrysler Corp., 706 N.W.2d 471 (Mich. Ct. App. 2005) (substitution of 6-month limitation period for Michigan’s statutory 3-year statute of limitations for a state age discrimination claim); Thurman v. Daimler Chrysler Corp., 397 F.3d 352 (6th Cir. 2004) (same for both state and Title VII race discrimination claim). The explicit prohibition in this subsection is designed to prevent courts from enforcing shorter limitations periods in employment applications or contracts for the private cause of action provided in this section.

The subsection provides that the statute of limitations shall be tolled during administrative proceedings on a claim if an aggrieved person opts to pursue administrative remedies. This provision avoids the risk that an administrative agency may fail to terminate a claim or issue a right-to-sue letter in a timely fashion and eliminates the need for a plaintiff to file a cause of action as a precautionary measure while pursuing administrative relief. The courts should not be relied upon to toll a statute of limitations for the completion of administrative proceedings on an employment discrimination claim. See, e.g., Barczak v. Rockwell Int’l Corp., 68 Mich. App. 759, 244 N.W.2d 24 (Mich. Ct. App. 1976) (refusing to toll statute of limitations for state claim of sex discrimination when complaint was filed with state Civil Rights Commission).

Finally, subsection (c) makes clear that when an action is brought against a state employer under this section the limitation period provided in this subsection does not alter a state’s notice requirements for tort claims brought against the state.

GINA’s remedies and damages. Title VII authorizes courts to issue injunctive relief and to order affirmative action as appropriate. This may include, but is not limited to, reinstatement or hiring of employees, with or without back pay, and any other equitable relief the court finds appropriate, such as promotion and front pay. Back pay may not extend for more than two years prior to the date the charge was filed with the EEOC, and it is offset by interim earnings or amounts that were earnable with reasonable diligence by the aggrieved individual. For intentional discrimination, the Civil Rights Act of 1991 added compensatory and punitive damages to the remedies available under Title VII. Punitive damages are available if the defendant acted with malice or reckless indifference to the employee’s federally protected rights, but are not available against federal, state, or local government employers. There is a cap on the total amount that may be awarded in punitive damages and compensatory damages for nonpecuniary and future pecuniary losses. The cap is graduated based on employer size as measured by the number of employees:

Number of employees	Cap on compensatory and punitive damages
more than 14 & less than 101	$ 50,000
more than 100 & less than 201	$ 100,000
more than 200 & less than 501	$ 200,000
more than 500	$ 300,000

Prevailing parties may be awarded a reasonable attorney’s fee as part of litigation costs. GINA differs from Title VII, however, in that it excludes remedies for claims of disparate impact, subject to future study by a Commission.

Remedies and damages under the Uniform Act. The employment article of the act is intended to provide remedies for privacy violations, employment determinations based on misuse of genetic information, and other harms. Privacy violations involve acquisition, retention, or disclosure of genetic information that does not comply with the Act. Employment determinations could include failure to license, hire, refer for employment, promote, or decisions to terminate, demote, reduce pay, reassign, or to take any other adverse action. Other harms could include torts such as intentional infliction of emotional distress. The appropriate remedy will vary with the type of violation.

The prior draft provided a right to jury trial and specified that compensatory damages, back pay, front pay, reassignment, reinstatement, injunctive relief, punitive damages, and expungement of records are available remedies for a violation of the article. This draft mor simply authorizes a private cause of action for “money damages or other relief.” It also authorizes fee and cost shifting to compensate prevailing employees for the cost of enforcing the statute.

The broad availability of remedies under the act follows the general approach of state fair employment practices acts. Prior to the availability of compensatory and punitive damages under federal law pursuant to the Civil Rights Act of 1991, many states provided for these damages either as agency remedies, court remedies, or both. Compensatory damages have typically been defined to include coverage for emotional distress, mental anguish, pain, suffering, humiliation, and the like. When punitive damages are available, the plaintiff usually must show that the defendant acted with malicious or intentional disregard for statutory rights. Attorney’s fees and costs are generally available under state fair employment practices acts.

The section does not increase the enforcement burden on state agencies. The primary remedy for a violation of the article is a private civil action. Fee and cost shifting are included to compensate prevailing employees for their costs to enforce the statute.

The act differs from provisions in several states that specify statutory damages. A privacy rights perspective assumes an intrinsic harm from the invasion of privacy, whether or not consequential damages are incurred. Because of difficulties in measuring damage to privacy interests, several states that provide a private right of action for privacy violations involving genetic information also specify statutory damages, with higher amounts when the violation is willful or leads to monetary gain for the violator. Alaska Stat. § 18.13.020 (actual damages plus $5,000, or plus $1,000 if there is monetary gain); N.H. Rev. Stat. § 141-H:6 (not less than $1,000 per violation); NM Stat. Ann. § 24-21-6 (economic loss plus damages of up to $5,000 if the violation results from willful or grossly negligent conduct). The Drafting Committee did not take this approach because statutory damages often become a limit on the recovery available.

Several states also make civil penalties available to remedy unlawful discriminatory practices. These penalties range from small (< $1000) to significant amounts (up to $50,000 or $100,000 per violation). Some states also authorize criminal penalties, although typically only for willful violations of agency orders.

(1) “Adverse insurance determination” means a denial of coverage or the offering of less favorable rates, terms, or conditions for insurance than would be available if the insurer did not use genetic information in making the determination.

(2) “Disability-income insurance” means insurance intended to protect against loss of occupational or professional earning capacity arising from injury, sickness, or disablement. The term includes insurance that provides benefits for overhead expenses of a business, occupation, or profession when the insured becomes disabled.

(3) “Family medical history” means information about a current or past medical condition of a family member of an individual.

(4) “ Family member” includes a person who is a dependant of an individual as the result of marriage, birth, adoption, or placement for adoption and a person who is a first-degree, second-degree, third-degree, or fourth degree relative of the individual or of the individual’s dependant. The term includes deceased members of the family.

(A) assessing an individual’s genetic risk for an inherited condition by interpreting family medical histories;

(B) providing nondirective education about the inheritance, testing, management, and prevention of a genetic condition;

(C) helping an individual to understand the risks and benefits of testing for a genetic trait to promote informed decision-making about whether or not to undergo genetic testing;

(6) “Genetic education” means the process by which an individual acquires information about the individual’s or the individual’s family member’s existing or suspected genetic condition.

(B) information based on the genetic test of an individual or an individual’s family member; or

(8) “Genetic test” means an analysis of human genetic material, including deoxyribonucleic acid, ribonucleic acid, chromosomes, proteins, and metabolites, that is intended to detect:

(9) “Genetic service” means a genetic test, genetic counseling, or genetic education.

(10) “Insured” means an individual who is covered by or applying to be covered by life, disability-income, or long-term-care insurance.

(11) “Insurer” means a person engaged in the business of life, disability-income, or long-term-care insurance in this state, regardless of where a contract of insurance is entered into or issued or a plan is administered. The term includes an insurance agent, broker, underwriter, and third-party administrator.

(13) “Long-term-care insurance” means insurance that provides coverage for not less than 12 consecutive months for one or more necessary diagnostic, preventive, therapeutic, rehabilitative, maintenance, or personal-care services provided in a setting other than an acute care unit of a hospital. The term includes a policy or rider that provides for payment of benefits based upon cognitive impairment or inability to perform the activities of daily living.

(14) “Person” means an individual, corporation, business trust, estate, trust, partnership, limited liability company, association, joint venture, public corporation, government or governmental subdivision, agency or instrumentality, or any other legal or commercial entity.

(15) “Predisposing genetic characteristic” means a gene variant or genetic marker that is determined from genetic information and is associated with an individual’s increased risk of developing a disease or medical condition for which the individual is presently asymptomatic.

(16) “Record” means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form.

(B) to attach to or logically associate with the record an electronic symbol, sound, or process.

Paragraph (1). (Adverse insurance determination) The use of genetic information makes an insurance determination adverse if it leads to denial of coverage or coverage on less favorable terms than would have been available absent the insurer’s consideration of the information. This definition is relevant to an individual’s ability to correct a faulty genetic test that has consequences for insurance eligibility or terms and conditions for issuance of insurance.

Paragraph (2). (Disability-income insurance) This definition of disability-income insurance is used in several state statutes on genetic testing. See, e.g., Cal. Ins. Code § 10147; N.H. Rev. Stat. Ann. § 141-H:1. The Committee discussed substituting the term “income” for “earning capacity,” but decided not to make this substitution.

Paragraph (3). (Family medical history) Family medical history is often a source of genetic information in that it is used to evaluate the likelihood that an individual carries an inherited trait. While the act’s employment article follows GINA and includes family medical history within its definition of “genetic information,” the definition of “genetic information” in the act’s insurance article does not encompass family medical history.

Paragraph (4). (Family member) The draft defines family member to encompass all individuals whose genotype could influence an insurance decision. The term includes (1) biological relations whose genetic information might provide information about the genetic make-up of an individual employee or insured, (2) dependants whose risk of future genetically-linked medical conditions could affect employer health care costs or family insurance coverage and hence affect insurance decisions, and (3) those dependants’ biological relations whose genetic information might provide information about the genetic make-up of a dependant.

Degree of relationship to the individual or the individual’s dependents. Genetic counselors typically collect information on genetic diseases of family members related to the third degree of consanguinity and often to the fourth degree, so this definition specifies the fourth degree. The Drafting Committee considered a provision that would replace the designation “fourth degree of consanguinity” with a list of family members, but decided instead to include information in the notes that designates which family members are included within the fourth degree of consanguinity. This information is included below.

Lineal consanguinity is the relationship between persons when one is directly descended from the other. Each generation in this direct line constitutes a degree. Collateral consanguinity refers to the relationship between persons who descend from the same common ancestor, but not from each other. The civil law method of calculating degree of collateral consanguinity is to count the number of generations from one person up to the common ancestor and then down to the other person. This is the method reportedly used in many states. For consistency with the employment article of this act, however, the following table is based on the proposed EEOC regulations implementing GINA, which determine the degree of relationship by counting generational levels separating individuals. The following table identifies the relatives within four degrees of collateral consanguinity from an individual. Each row represents a generation and the degree of consanguinity is given in parentheses.

Paragraph (5). (Genetic counseling) Genetic counseling is a key to an individual’s informed decision making about getting a genetic test, understanding the result, and authorizing its use, retention, or disclosure. Most states that license genetic counselors have a definition of genetic counseling, but the majority of states do not license genetic counselors or regulate genetic counseling. Note that the definition does not require that genetic counseling be performed by a genetic counselor. Physicians and geneticists are also qualified to provide genetic counseling.

The definition uses the term genetic “condition,” which is intended to have a broad interpretation. Genetic condition includes the concepts of genetic disease and disorder, but in some circumstances it may also refer to a positive or benign trait or characteristic that is linked to a particular genotype.

Paragraph (6). (Genetic education) Genetic education is one element of genetic services. It is typically less tailored to individual circumstances then a one-on-one genetic counseling session. The definition is meant to be broad enough to include information provided by support groups for genetic conditions to those who may have the condition. It is not meant to encompass general genetic education such as that received in biology class or medical school.

Paragraph (7). (Genetic information) This definition of “genetic information” differs from the definition in the employment article of the draft in that it excludes family medical history. Even though family history is a major source of information to evaluate an individual’s genetic risks, Article 3 does not change the practices of life, disability-income, and long-term-care insurers, which traditionally have collected information on family history.

Paragraph (8). (Genetic service) “Genetic service” is a broader category than genetic testing. The term includes activities associated with obtaining genetic information that could create assumptions about an individual’s genetic status even in the absence of information about genetic test results or medical history. “Counseling” implies a one-on-one consultation, so the definition also includes “genetic education” in order to capture group information sessions on genetic conditions. While the definition of a “genetic service” does not separately define the term “genetic,” the term should be interpreted to be consistent with the definitions of “genetic test” and “genetic information.”

This definition follows the definition of “genetic services” in the employment title of GINA, except that the GINA definition expands on the term “genetic counseling” by noting parenthetically that it “includ[es] obtaining, interpreting, or assessing genetic information.” The draft has an independent, more comprehensive definition of genetic counseling and requirements for employers and insurers to provide genetic counseling that exceed the protections of GINA.

Paragraph (9). (Genetic test) “Genetic test” is defined in terms of (1) the material that the test analyzes and (2) the purpose of the test. This draft retains the definition used in the prior draft. It now differs slightly from the definition in the employment article, which was changed to follow the wording of GINA. The primary difference between the definitions is that the one used in this article includes the concept of intent. It requires that the test be given with the intent to detect a genotype, mutation, or chromosomal change. This requirement is included to help assure insurance company representatives that the test will not be misused, as discussed below.

The first clause makes specific reference to the types of biological material that are currently analyzed in genetic tests. Note that genetic tests can be conducted not only on gene sequences, but also on biological products such as proteins or metabolites that can indicate genetic make-up. The second clause specifies that the test must be for the purpose of determining an individual’s genetic make-up, either through the identification of a genotype or genetic marker or by looking for a mutation or chromosomal change.

Both clauses are equally important to the definition. First, some of the materials listed in the first clause, especially proteins and metabolites, are tested for many medical purposes. A test of a protein or metabolite does not constitute a genetic test unless it is administered for the purpose of determining individual’s genetic make-up as specified in the second clause.

Second, some genetic diagnoses are made without laboratory tests of the type listed in the first clause. For example, a doctor may identify a genetic condition based on specific physical features occurring in combination, or “dismorphology.” This physical diagnosis of an individual’s genetic-make-up does not constitute a genetic test under the draft because it is not a test of “genetic material.”

The draft follows the example of states with definitions of genetic testing that are not limited to identifying genotypes associated with diseases or impairments. (Fla, Haw, Mass, NH, Ore, UT). In contrast, many other states statutes limit their definition of “genetic test” to testing for disease-related genes. (Ariz, Ark, Del, Ill, Iowa, Kan, LA, Maine, MD, Mich, Minn, Nev, MO, Neb, NJ, NM, NY, NC, OK, OR, RI, TX, VT, VA, WI). While most of the reasons that an insurer might currently seek or use genetic information probably involve a disease, disorder, or impairment, this may not always be the case. For example, an insurer could be interested in reliable predictions of addictive behavior. While the current evidence linking behavior to genes is tenuous, this area continues to be the subject of investigation.

Paragraph (10). (Insured) The definition of “insured” includes applicants. It encompasses individuals with the types of insurance policies covered by the act.

Paragraph (11). (Insurer) The definition of “insurer” is intended to cover broadly insurance companies and other persons and individuals that issue life, disability-income, or long-term-care insurance and all persons who might obtain, use, or disclose genetic information associated with that process. Nothing in this definition is intended to subject insurance agents, brokers, underwriters, or third-party administrators to insurance regulations to which they are not already subject.

Paragraph (12). (Life insurance) “Life insurance” is intended to be defined broadly. This definition is drawn from N.H. Rev. Stat. § 401:1(III).

Paragraph (13). (Long-term-care insurance) The starting point for the definition of “long-term-care insurance” is N.H. Rev. Stat. § 415-D:3(V). The definition is intended to include all coverage of this nature whether it is provided on an expense-incurred, indemnity, prepaid, or other basis.

Paragraph (14). (Person) This draft uses the broad version of the standard National Conference of Commissioners on Uniform State Laws definition of “person.”

Paragraph (15). (Predisposing genetic characteristic) A “predisposing genetic characteristic” refers to a genotype that signals an increased risk of a certain disease or condition. The term does not include symptomatic diseases or conditions or genetic characteristics that are manifest in a disease, medical condition, or disability. The broader terms “genetic test” and “genetic information” may include both predisposing and manifest genetic characteristics as well as genetic information that does not necessarily pertain to health.

While the terms “propensity” or “susceptibility” are often used, the actual manifestation of a disease or condition may depend on a complex chain of events and the degree to which risk is elevated may be quite small. The use of the term “predisposing” is meant to signal the tenuous connection between a genotype or marker and a physical manifestation.

Paragraph (16). (Record) The definition of “record” is the standard National Conference of Commissioners on Uniform State Laws definition.

Paragraph (17). (Sign) The definition of “sign” is the standard National Conference of Commissioners on Uniform State Laws definition.

Paragraph (18). (Tribunal) The term “tribunal” refers collectively to the potential decision-makers in a litigation or arbitration context.

(a) If an insurer files information on a genetic test that meets the standards of Section 306, an insurer may request or require an insured to take the genetic test in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance and, with prior authorization of the insured that meets the requirements of Section 303, may provide the test to the insured.

(b) An insurer that requests or requires a genetic test in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance shall provide and pay for genetic counseling for the insured about the risks and benefits of the genetic test before the insured decides to authorize the test. The insured may knowingly and voluntarily waive counseling in a signed record that informs the insured of the benefits of genetic counseling.

(c) An insurer that provides a genetic test to an insured in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance shall:

(2) require the testing organization to make a report of the test result to the insured and a health-care professional designated by the insured unless the insured directs otherwise;

(3) provide and pay for genetic counseling for the insured about a test result unless the insured knowingly and voluntarily waives counseling in a signed record that informs the insured of the benefits of genetic counseling; and

(4) require the destruction of the insured’s biological sample obtained for a genetic test as soon as permitted by law after the test is completed unless retention of the sample is authorized by the insured, permitted by law other than this [act], or ordered by a tribunal.

Applicability of Article 3. This article applies to life insurance, disability-income insurance, and long-term-care insurance issued on an individual, group, or other basis. Including individual policies is significant because individual insurance policies are subject to underwriting and many life, disability-income, or long-term-care insurance policies are issued on an individual basis. The draft does not distinguish between individual and group insurance, however, because most of the states that regulate genetic testing or the use of genetic information for issuing life, disability-income, or long-term-care insurance treat both individual and group insurance identically.

GINA, ERISA, and HIPAA regulate acquisition, use, retention, and disclosure of genetic information by health insurers. These statutes broadly preempt state regulation. There is, however, no federal regulation or preemption of acquisition and use of genetic information by life, disability-income, and long-term-care insurers. State regulation is important because life insurance plays a central role in the financial lives of many individuals and families. Disability-income and long-term-care insurance are increasingly viewed as a necessary adjunct to health insurance and many states regulate disability-income and long-term-care insurance as health insurance.

This draft treats life, disability-income, and long-term-care insurance identically in one article. There are, however, differences in underwriting principles among the three types of insurance. Life insurance underwriting is concerned with mortality and uses life expectancy tables. In contrast, disability-income underwriting is concerned with morbidity and long-term-care underwriting is a hybrid process.

Genetic testing and genetic information. This section and the section 304 limit acquisition of genetic information by insurers that provide life, disability-income, or long-term-care insurance. This section limits genetic testing and section 304 limits acquisition of genetic information in general. The limitations are based on the philosophy that insurers may continue current information gathering practices, but may not expand their collection of genetic information unless and until there is a strong scientific basis for its use to predict mortality and morbidity. It is the Drafting Committee’s understanding that life, disability-income and long-term-care insurers do not at present require applicants to take genetic tests, but do collect family history information for use in determining eligibility and in underwriting.

The Drafting Committee considered, but did not adopt, an approach to regulating genetic information for life, disability-income or long-term-care insurance based on the amount of the insurance policy. The suggestion was to prohibit genetic testing and consideration of genetic information for policies worth less than a specified monetary threshold. Above that value, insurers would be permitted to consider genetic information freely.

The arguments for restricting acquisition of genetic information by the insurance industry are that this information is particularly private and its predictive power is easily exaggerated. There are privacy concerns with commercial acquisition of sensitive genetic information and predictions that individuals will avoid genetic testing for fear of adverse effects on their insurability. There is also a possibility that insurers may require applicants to take genetic tests and then deny insurance or charge more based on genetic characteristics, unfairly making coverage unavailable to people who are not sick from the genetic condition and never will become sick from that condition. From the industry perspective, as with health insurance, insurers worry about adverse selection. If applicants seek coverage because a genetic characteristic exposes them to risk, but the insurer does not have this information, this puts the insurer at a financial disadvantage. See generally Mark A. Rothstein, ed., Genetics and Life Insurance: Medical Underwriting and Social Policy (2004).

A 1997 study by the Human Genetics Advisory Commission in the United Kingdom concluded that it is unlikely that actuarially-sound genetic predictions of adult death will be validated and available anytime in the near future. Genetic tests need to be connected to medical and epidemiological research to establish what consequences for health and life-span can be inferred from a given genetic test. The Commission concluded that a requirement to disclose genetic tests as a condition of obtaining insurance would be acceptable only after research has established an association between a given pattern of test results and life events that are relevant for the insurance product. It recommended continuing a moratorium on requiring test results. Human Genetics Advisory Commission, The Implications of Genetic Testing for Insurance (1997).

Genetic testing. This section prohibits insurers from requiring applicants to have genetic testing as a condition of obtaining life, disability-income or long-term-care insurance unless scientific developments support a conclusion that a test provides a relevant prediction. The section is consistent with genetic testing prohibitions in force in California, Massachusetts, and Vermont, except that it allows the prohibition to be modified as justified by scientific developments. Vermont and Massachusetts prohibit insurers from requiring applicants to take a genetic test as a condition of obtaining or renewing a policy. California prohibits long-term-care insurers from requiring genetic testing for use in determining insurability or in underwriting. See Cal. Ins. Code § 10233.1 (long-term-care insurance); Mass. Gen. L. Ann. 175 § 120E (life insurance); Mass. Gen. L. Ann. 175 § 108I (disability and long-term-care insurance); Vt. Stat. Ann. § 9334 (any insurance).

The section also sets forth requirements similar to those imposed on employers who provide genetic tests.

Genetic Counseling. This section requires insurers who have applicants take genetic tests to provide genetic counseling. The counseling occurs in two stages: before the test to assist in the decision to take the genetic test and after the test to interpret results if the test indicates the individual is at risk. Counseling is an important component of the testing process in the field of genetics for several reasons. Tests may indicate a risk of a condition for which there is no treatment and the information may have implications for family members who are not tested directly. The outcomes require interpretation of complex probabilities which can be easily misunderstood. The genetic counseling that is required before the test is covered in subsection (b) and the counseling that is appropriate after a test is covered in subsection (c).

The Committee received differing opinions from industry participants on this issue which ranged from opposition to any obligation to provide counseling to a view that if insurance companies request the tests they should provide and pay for counseling in conjunction with the test.

(a) An insured’s authorization for the genetic test requested or required under Section 302 must be knowing and voluntary and indicated in a record signed by the insured that complies with subsection (b) of this section. An insurer that receives a valid authorization for genetic testing may provide a test only in accordance with the authorization. An authorization may not expand the genetic testing permitted by this [act] and may not include exculpatory language waiving any of the insured’s legal rights.

(b) An authorization for a genetic test for life insurance, disability-income insurance, or long-term-care insurance must:

(1) describe the genetic test to be performed, its purpose, and its permitted uses;

(2) state that only the authorized genetic test will be performed on the insured’s biological sample;

(3) inform the insured that the insurer is obligated to provide and pay for genetic counseling about the risks and benefits of the test before the insured decides to authorize the test;

(4) inform the insured that the insurer is obligated to provide and pay for genetic counseling about the test result unless the insured waives genetic counseling;

(5) state that the test result will be reported to the insured and a health-care professional designated by the insured, unless the insured directs otherwise;

(6) include an opportunity for the insured to provide directions about reporting test results;

(7) inform the insured that the insured’s biological sample will be destroyed as soon as permitted by law after the test is completed unless the insured authorizes retention of the sample or unless otherwise ordered by a tribunal; and

Limited Authorization. Only the genetic tests that you authorize on this form will be performed

on your biological sample. These tests are voluntary, but refusing a test requested by

Availability of Genetic Counseling. Before you complete this authorization, it is highly

recommended that you meet with a genetic counselor who will help you understand and evaluate

the risks, benefits, and consequences for you and your family of having the tests listed below.

Proposed Genetic Tests. Based on a review of your family medical history, ________________

The purpose of this test is to determine if you have a predisposition for _________________ .

If you authorize__________ to have access to the test result, it will be used only for the

Reporting Test Results and Genetic Counseling. The test results will be reported to you and to a

health-care professional whom you designate unless you direct otherwise. It is recommended that

you receive genetic counseling about the test results. Genetic counseling is important for

understanding the test results in the context of your medical and family history. It can also

provide you with support, informational resources, and referrals, as appropriate, that can help you

adapt to the implications of being at risk of a genetic condition. ______________________ [Name of insurer]

will provide and pay for genetic counseling about the test results unless you decline genetic

Destruction of your Biological Sample. After the genetic test, your biological sample will be

destroyed as soon as permitted by law unless or a court, arbitral tribunal, or administrative

agency requires retention of the sample or you sign a written authorization for _______________

Retention of Legal Rights. By signing this authorization, you do not lose any legal rights to

This section sets forth an authorization requirement for genetic testing and the elements that must be contained in an authorization form. The term “authorization” is used instead of “informed consent” to avoid confusion with the use of that term in medical practice.

The Drafting Committee decided that the best method to protect privacy for genetic testing and genetic information is to establish an authorization requirement that is coupled with statutory limits and duties imposed on insurers. Under this approach, an insured must affirmatively authorize any genetic testing or acquisition, use, retention, or disclosure of genetic information. The authorization requirement is not simply a procedural step because Article 3 establishes limitations on the situations in which insurers may request authorization from insureds.

The Drafting Committee considered, but did not adopt alternatives that would (1) establish a general property right in a biological sample an individual provides for genetic testing and in the resulting genetic information or (2) establish a limited property applicable only to the context of insurance.

Subsection (a) Requirement for authorization for genetic testing. Under Section 302, an insurer may require a genetic test as a condition of obtaining life, disability-income, or long-term-care insurance if the test has been filed and meets the standards of Section 306. This subsection adds an additional requirement that genetic testing is permitted only with the prior authorization of the insured.

In order to meet the requirement that an authorization be knowing and voluntary, an employee or insured should have genetic counseling before signing the authorization. Genetic counseling provides insureds with adequate information to make an informed decision about genetic testing. It also makes them aware of their options regarding reporting of test results and help in interpreting them through genetic counseling. Genetic counseling may be provided by a genetic counselor, but may also be provided by a qualified physician or geneticist.

Other law of the state may provide for a substitute decisionmaker or signer if the employee is incapacitated or incompetent. This situation is left to existing law of the state that governs power of attorney, guardianship, or other substitute decision makers.

Subsection (b) Content of authorization for testing. The section draws on N.Y. Civ. Rights Law § 79-l (McKinney), which establishes requirements for consent for a genetic test.

The limitation in (b)(2) to the authorized test is consistent with the requirements for prior authorization in Section 302.

The notification provision regarding destruction of the sample in subsection (b)(7) is consistent with the insurer’s obligation to ensure the sample is destroyed under Section 302(c)(4), which recognizes that the testing laboratory may be required to retain the sample for certification purposes.

Subsection (c). Authorization form. The subsection provides a form that may be used to authorize an insurance company to provide a genetic test. The use of a form following this pattern would comply with the requirements of the section.

(a) Unless an insurer has filed information on a genetic test that meets the standards of Section 306, an insurer may not knowingly obtain or directly or indirectly inquire about, request, or require an insured to provide the insured’s genetic information based on a genetic test in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance.

(b) Nothing in this [article] prohibits an insurer from obtaining medical records of an applicant for insurance that contain genetic information in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance.

(c) An insurer may request or require an insured to provide family medical history in connection with the provision of life insurance, disability-income insurance, or long-term-care insurance.

This section limits the extent to which an insurance company may acquire genetic information or the results of genetic testing based on the rationale discussed in the reporter’s notes to Section 302. Subsection (a) permits acquisition of genetic information if it is based on a genetic test that meets the standards set forth in Section 306.

Subsection (b) is included to reassure the industry that its traditional access to medical records is preserved, despite the fact that medical records may contain genetic information.

The prohibition on acquisition of genetic information does not apply to family medical history, which is not included in the definition of “genetic information.” Subsection (c), moreover, explicitly permits insurers to seek information about family medical history, which they have traditionally used for underwriting.

SECTION 305. PROHIBITION ON USE OF GENETIC INFORMATION. Unless genetic information is based on a genetic test that has been filed and meets the standards provided in Section 306, an insurer may not use the genetic information about an insured’s predisposing genetic characteristics to determine eligibility for or rates, terms, and conditions of life insurance, disability-income insurance, or long-term-care insurance.

The determination of eligibility for coverage includes decisions made in connection with the offer, sale, continuation, or renewal of an insurance policy. The determination of rates, terms, and conditions includes establishing premiums, limiting coverage, limiting or conditioning benefits, or making any other underwriting decisions.

This section prohibits the use of genetic information for determining eligibility or underwriting of life, disability-income, and long-term-care insurance unless the genetic test has been filed and meets that standards provided in Section 306. Traditional insurance underwriting has been based on medical histories and tests that indicate existing medical conditions. The draft permits those practices to continue. Using predictions based on predisposing genetic characteristics that have not been expressed as a disease or condition would be a new step, however, and there is a great risk that such predictions would not be reliable in the context of insurance.

The restriction on use of genetic information in life, disability-income & long-term-care insurance applies only to predisposing genetic characteristics. Therefore, insurers are not restricted from using genetic information with regard to a medical condition that has been diagnosed as manifest in an individual.

The section ties use of genetic information about predisposing characteristics to the process in Section 306 for ensuring that the genetic test provides a reliable prediction of individual mortality or morbidity. If an insurer has filed information to show that a genetic test is valid, it may use the results of that test in underwriting. Otherwise, life, disability-income and long-term-care insurers may not use genetic information about predisposing characteristics for determining eligibility or in underwriting.

This prohibition is consistent with regulation in a number of states. Because genetic tests are not yet routine in medical care and few individuals have previously taken genetic tests when they apply for insurance, the prohibitions on requiring tests in California, Massachusetts, and Vermont have the effect of preventing the use of genetic information in insurance determinations. In addition, a number of states directly prohibit insurers from using genetic information to determine eligibility or in underwriting. See Colo. Rev. Stat. § 10-3-1104.7(3)(b) (group disability-income & long-term-care); Kan. Stat. Ann. § 40-2259(d) (disability-income & long-term-care); Or. Rev. Stat. § 746.135 (genetic information from a blood relative for life, disability-income & long-term-care insurance); Vt. Stat. Ann. tit. 18, § 9334(a) (same). See also Ariz. Rev. Stat. Ann. § 20-448(F) (permitting disability-income and long-term-care insurers to use genetic information only if there is an actual diagnosis of a genetic condition).

The insurance industry maintains that any restrictions on their ability to use genetic information will undermine the availability and pricing structure of life, disability-income & long-term-care insurance. However, there is broad international consensus that the use of genetic information in life insurance should be restricted. Numerous countries have enacted restrictions, as have the states noted above. There is no evidence, moreover, that these restrictions have been associated with adverse selection, increased pricing, reduced availability of policies, or decreased profitability of the insurance industry. Without some supporting evidence, these industry concerns do not outweigh the importance of protecting against new uses of information that would diminish privacy and that carry a high risk of irrational discrimination.

With the draft’s narrow definition of “genetic information,” an insurer would be able to use genetic data revealed by an individual’s family medical history to determine eligibility or to underwrite without restriction. One member of the Committee raised the question of whether there should be any limits on insurers’ use of family medical history. The question was motivated by a concern that even if disclosures to insurers do not change, insurers may be able to do more with those disclosures using ever more sophisticated computer technology. The Drafting Committee did not consider if it would be desirable to prevent new uses of family history information or what limits would be appropriate.

SECTION 306. REQUIRED DETERMINATION AND FILING FOR GENETIC TESTING AND ACQUISITION AND USE OF GENETIC INFORMATION. A life insurer, disability-income insurer, or long-term-care insurer may request or require a genetic test or acquire and use genetic information based on the results of a genetic test if the insurer files with the [state commissioner of insurance] the test and documentation supporting to a reasonable degree of scientific certainty the test’s analytical validity, clinical validity, and a scientific association between the test and an increased risk of morbidity or mortality. The insurer’s use of genetic information about an insured’s predisposing genetic characteristic to determine eligibility or rates, terms, or conditions for life insurance, disability-income insurance, or long-term-care insurance without a filing by the insurer that meets this standard is a violation of the [state unfair practices insurance law].

Legislative Note: [State unfair practices insurance law] should be replaced with the title of the relevant statute and [state commissioner of insurance] should be replaced with the appropriate title.

The risk of misuse of genetic information is increasing because of the explosion of genetic tests available, the general lack of governmental oversight for these tests, and common misperceptions about the extent to which a genetic test can predict a future medical disease or condition. In addition, the pathways for gene expression remain uncertain. Links between most genetic characteristics and the incidence of disease are extremely complex and depend on the interrelation of many factors, both genetic and environmental.

Even with draft’s restrictions on genetic testing by insurance companies, access to genetic information in medical records will increase. More than 1,000 genetic tests are available clinically as of early 2007; hundreds more are available to researchers. Some are marketed directly to consumers with claims that they can be used to individually customize vitamins and diet as well as test for future disease. There is no government oversight of the validity of the tests used for research or available through medical professionals. Through the mechanisms of this section that protect against the premature or improper use of predictions based on genetic information, the draft provides assurance that insurance companies are permitted to use genetic information, but not misuse it.

The insurance industry has expressed a view that it must be able to develop its use of genetic information along with the rapid development of knowledge in the genetic field. The section provides a mechanism that will allow use of genetic information to evolve, in response to new scientific information that may justify the use of genetic information for eligibility and underwriting determinations as determined by an evidence-based review process.

The Drafting Committee considered and rejected an approach that would have established regulatory oversight of the use of genetic information by insurers by requiring a prior finding of an association with mortality or morbidity by state insurance regulators in consultation with state public health authorities. The Committee also considered and rejected an approach that would have required that the appropriate finding be made by a geneticist or genetic counselor. Instead, the Drafting Committee decided that the insurance industry should be responsible for determining the accuracy and completeness of the data on a genetic test and the reliability of the prediction possible with the genetic information.

The approach selected by the Committee requires an insurance company to identify genetic tests that it plans to use and to file documentation supporting the validity of the test with the state insurance commissioner. This documentation would then be open to public scrutiny, creating transparency that can provide a check on a company’s determination. This process will allow an insurer’s use of genetic information to change as research develops reliable connections between genetic characteristics and risk of mortality or morbidity.

The process required here contemplates the type of evidence-based review of genetic tests conducted by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group formed under the auspices of the Centers for Disease Control National Office of Public Health Genomics. See http://www.cdc.gov/genomics/gtesting/EGAPP/about.htm.

As explained in the following excerpt from the Final Report of the Task Force on Genetic Testing, Promoting Safe and Effective Genetic Testing in the United States (1997) (available at http://www.genome.gov/10001733), before relying on a genetic test, there must be scientific evidence to (1) establish a reliable relationship between a disease, genes, and inherited mutations; (2) establish the analytical validity of the test; and (3) establish the clinical validity of the test.

In developing genetic tests, scientists must first be confident that the DNA segments under investigation play a role in the disease in question. These segments might be apparently functionless markers that appear to be spatially linked on a chromosome to a disease-related gene. Linkage is demonstrated when, within families, one form of the marker is found in those with the disease more often than in blood relatives in whom the disease is absent. Because such associations might be due to chance, as was the case for the linkage claimed between bipolar affective disorder and markers on chromosome 11, and between schizophrenia and markers on chromosome 5, stringent statistical standards must be satisfied before accepting linkage, and the findings much be confirmed in additional families with the disease. . . .

Further research leads scientists from the linked, functionless marker to a nearby gene suspected of being casually related to the diseases in question. The proof depends on finding mutations in the gene that are only present (in gene dosage sufficient to cause disease) in family members with disease. Further proof that a gene is causally related to disease comes from demonstrating that the protein encoded by the gene is absent, not synthesized in adequate amounts, or manifests a structural or functional aberration that plausibly accounts for symptoms and signs of the disease.

Another approach to identifying a disease-related gene does not depend on linkage but on suspecting that a gene that has been previously identified (“candidate gene”) plays a role in a specific disease. Here too, mutations must be found only in those with the disease.

The DNA segments associated with a disease might be functional, common, polymorphic gene variants. Recently, attention has been given to the association between the apolipoprotein E polymorphism and Alzheimer disease (AD). A higher proportion of people with apoE4 will develop AD than those with other forms of the polymorphism. Some people with AD, however, will not inherit apoE4 and other with apoE4 will never develop AD; the polymorphism is neither a necessary nor sufficient cause for the disease. It is not clear whether polymorphic variants themselves predispose to the disease, whether the association is spurious (unlikely in the case of apoe4 and AD), or whether a marker liked to both the polymorphic gene and the disease-related gene is responsible. The following criterion must be satisfied before either linked markers or putative disease-related mutations are used as the basis of a genetic test. The genotypes to be detected by a genetic test must be shown by scientifically valid methods to be associated with the occurrence of a disease. The observations must be independently replicated and subject to peer review.

For DNA-based tests, analytical validity requires establishing the probability that a test will be positive when a particular sequence (analyte) is present (analytical sensitivity) and the probability that the test will be negative when the sequence is absent (analytical specificity). In contrast to DNA-based tests, enzyme and metabolite assays measure continuous variables (enzyme activity or metabolic concentration). One key measure of their analytical validity is accuracy, or the probability that the measured value will be within a predefined range of the true activity or concentration. Another measure of analytical validity is reliability, or the probability of repeatedly getting the same result.

[V]alidation includes performing replicate determinations to ensure that a single observation is not spurious, and “blind” testing of coded positive samples (from patients with the disease in whom the alteration is known to be present) and negative samples (from controls). Organizations engaged in new test development should have access to a sufficient number of patient samples to have statistical confidence in the validation. In validating a new test analytically, the laboratory techniques should be as similar as possible to those used when the test will be performed clinically once it is validated.

Analytical sensitivity and specificity of a genetic test must be determined before it is made available in clinical practice.

Clinical validity involves establishing several measures of clinical performance including (1) the probability that the test will be positive in people with the disease (clinical sensitivity), (2) the probability that the test with be negative in people without the disease (clinical specificity), and (3) the probability that people with positive test results will get the disease (positive predictive value (PPV)) and that people with negative results will not get the disease (negative predictive value.) Predictive value depends on the prevalence of the disease in the group or populations being studied, as well as on the clinical sensitivity and specificity of the test.

Two intrinsic features of genetic diseases, heterogeneity and penetrance, affect clinical validity.

Heterogeneity. The same genetic disease might result from the presence (in the necessary gene dosage) of any of several different variants (alleles) of the same gene (allelic diversity) or of different genes (locus heterogeneity). With current technology, all disease-related alleles cannot always be identified, particularly when there are many of them, which is often the case. This failure to detect all disease-related mutations reduces a test’s clinical sensitivity.

Penetrance. The probability that disease will appear when a disease-related genotype is present is the penetrance of the genotype. When penetrance is incomplete, PPV is reduced. Penetrance is incomplete when other genetic or environmental factors must be present. In high-risk breast cancer families, 10 to 15 percent of women with inherited susceptibility mutations of the BRCA1 gene will never develop breast cancer. Environmental factors and possibly other inherited factors are required as well. In women without a family history of breast cancer, the penetrance of a BRCA1 or BRCA2 is even lower. Allelles at other gene loci and similar environments are more likely to be shared by relatives than by people in the general population.

Parameters of clinical validity will depend in part on the group r population in which the test will be used. For instance, the frequency of disease-related alleles might differ between ethnic groups, making it difficult if not impossible to extrapolate the test sensitivity from one group to another. This is the case for cystic fibrosis and breast cancer in which certain alleles can predominate in one ethnic group or geographical area but not in others. Penetrance can also differ among ethnic groups. The prevalence of allele frequencies will have a marked effect on PPV; the greater the prevalence, the higher the PPV. Age will also affect allele prevalence; in a population older than the age at which the disease usually causes death, the allele frequency will be lower than in a younger population. For all these reasons, validation studies should be conducted in a group representative of the one in which the test is intended for clinical use.

When tests are developed for one purpose are used for another, there is no assurance that the sensitivity or PPV will be the same. . . .

The three following criteria help ensure that appropriate data on the clinical validity of genetic tests will be collected during the developmental stages.

• Data to establish the clinical validity of genetic tests (clinical sensitivity, specificity, and predictive value) must be collected under investigative protocols.

• In clinical validation, the study sample must be drawn from a group of subjects representative of the population for whom the test is intended.

SECTION 307. CORRECTION OPTION FOR GENETIC INFORMATION. If an insurer uses an insured’s genetic information to make an adverse determination regarding eligibility or rates, terms, or conditions for life insurance, disability-income insurance, or long-term-care insurance, the insurer shall provide notice of that use to the insured. The insured may choose to repeat a genetic test to verify the analysis used in the adverse determination. If the initial test was performed at the request of the insurer, the insurer shall pay for a repeat test requested by the insured. If the first analysis is found to be inaccurate, the insurer shall reconsider the adverse determination.

Under this section, an insured is provided an opportunity to correct mistakes in genetic information. The section is modeled on Florida procedures which require the DNA analysis to be repeated in the event of an adverse determination. Fla. Stat. § 760.40(3). Delaware also has a special provision that allows an individual to access his genetic records and to correct those records. 16 Del. Code Ann. § 1223.

SECTION 308. CONFIDENTIALITY; RETENTION OF GENETIC INFORMATION. An insured’s genetic information is a confidential medical record. Except as otherwise provided by law other than this [act], a life insurer, disability-income insurer, or long-term-care insurer may keep an insured’s genetic information only with authorization of the insured in accordance with Section 310.

This section permits insurers to retain genetic information under certain circumstances. It follows the practice of the states with statutes that require authorization or informed consent for the retention of genetic information and do not treat life, disability-income, or long-term-care insurers differently than others who might retain such information. It departs from the approach of some other states, however, that exempt these insurers from their requirements for authorization or informed consent. (E.g., Mass., Nev., NH, NMex, Ok)

There are arguments that insurers should not be limited in retaining genetic information. They typically have two years to rescind a policy for misrepresentation, and may need the information submitted with the application in order to show misrepresentation. In addition, reinsurers may audit underwriting practices several years after a policy issues. Insurance industry representatives state that under current practice, information is retained indefinitely because of the risk of class action suits.

(a) Except as otherwise provided in Section 310, a life insurer, disability-income insurer, or long-term-care insurer may disclose an insured’s genetic information to a person other than the insured only if the insurer has obtained the insured’s prior authorization for the disclosure in accordance with Section 310.

(b) An insured, upon request, may inspect and obtain a copy of genetic information from the insurer’s files on the insured.

Subsection (a). This subsection restricts the ability of life, disability-income, and long-term-care insurers to disclose genetic information without authorization of the insured.

The insurance industry argues that disclosures are necessary for business purposes and that a special disclosure provision for genetic information is unnecessary because a number of states have adopted statutes based on National Association of Insurance Commissioners’ model laws dealing with general privacy of information. In the Drafting Committee’s view, disclosures of genetic information are not protected adequately when there are broad exceptions that allow this information to be shared for business purposes.

Subsection (b). Under this subsection, an insured is allowed to access an insurer’s records of his genetic information. In combination with the procedure in Section 307, this enables an insured to correct those records.

SECTION 310. AUTHORIZATION FOR ACQUISITION, USE, RETENTION, OR DISCLOSURE OF GENETIC INFORMATION.

(a) Except as otherwise provided by this [act] or law other than this [act], an insurer may not acquire, use, keep, or disclose an insured’s genetic information without the insured’s knowing and voluntary authorization indicated by a record signed by the insured that complies with subsection (c) of this section. An insurer that receives a valid authorization may acquire, use, keep, or disclose genetic information only in accordance with the authorization. An authorization shall not expand the acquisition, use, retention, or disclosure of genetic information permitted by this [article] and may not include exculpatory language waiving any of the insured’s legal rights.

(b) Except as otherwise provided by this [act] or law other than this [act], a person who receives genetic information disclosed by an insurer must maintain the confidentiality of the insured’s genetic information and may not disclose the information without the insured’s knowing and voluntary authorization indicated by a record signed by the insured that complies with subsection (c) of this section. A recipient that receives the insured’s valid authorization to disclose genetic information may disclose the information only in accordance with the authorization. An authorization may not expand the disclosure of genetic information permitted by this [article] and may not include exculpatory language waiving any of the insured’s legal rights. When an insurer discloses an insured’s genetic information, it must notify the recipient of the information about these obligations.

(1) describe the genetic information to be acquired, used, kept, or disclosed in a specific and meaningful fashion;

(2) identify or describe the person that is authorized to acquire, use, keep, or disclose the genetic information;

(3) if the authorization is for acquisition of genetic information through disclosure by another person to an insurer, identify or describe the person authorized to make the disclosure;

(4) if the authorization is for use of genetic information, describe the permitted uses;

(5) if the authorization is for retention of genetic information, describe where the information will be kept and identify or describe the custodian of the information;

(6) if the authorization is for disclosure to a third person, identify or describe the third person to which the authorized person may disclose the genetic information;

(7) indicate the duration of the authorization with an expiration date if any or expiration event that relates to the insured or to the purpose of the acquisition, use, retention, or disclosure;

(8) state that the insured may revoke the authorization at any time in a signed record, subject to the right of an insurer or other person that acted in reliance on the authorization before receiving notice of revocation, and provide instructions on how to revoke an authorization; and

__________________ requests your authorization to acquire the following genetic test results and

☐ Access to the results of the test for __________________________________. The purpose

of this test is to determine if you have a genetic characteristic that predisposes you towards the

following medical condition: ______________. _________________ will use this information

☐ Disclosure by _________________________ of genetic information about _______________

_____________to ___________________. _________________ will use this information

You may revoke this authorization for acquisition and use at any time by sending a letter to

__________________ unless _________________ has ________________________________

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled. This authorization is valid until _________________.

I, _________________, authorize ___________________ to acquire and use my genetic

_________________ requests your authorization to keep the following genetic information:

You may revoke this authorization for ________________ to keep your genetic information at

any time by sending a letter to __________________ unless ________________________

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled. This authorization is valid until _________________.

I, __________________, authorize ____________________ to keep the genetic information

_________________ seeks your authorization to disclose the following genetic information to

_________________________________. _________________ will notify _______________

____________________ that __________________________________ is legally obligated

to maintain the confidentiality of this information and that if may not make further disclosures

You may revoke this authorization for disclosure at any time by sending a letter to

__________________ unless __________________ has already disclosed the information.

You are entitled to a copy of this authorization. By signing this authorization, you do not lose

any legal rights to which you are entitled. This authorization is valid until _______________. [date or event]

disclose my genetic information checked above to __________________________________.

This section requires an insured to provide an authorization before an insurer may acquire, use, keep, or disclose genetic information. The provisions differ from those in the employment context in that insurers are permitted to continue their traditional use of family medical history without special authorization requirements.

The draft does not disturb existing law that allows a minor to seek repudiation of consent and expunge records when the minor reaches the age of majority.

Subsection (a) General requirement for authorization. This subsection would establish a requirement that an insurer must be authorized by the insured before it may acquire, keep, or disclose genetic information, except as provided elsewhere in the act. In order to give a valid authorization, the insured must be informed as provided in the subsection (b) and must act voluntarily. Subsection (a) also includes a requirement that an authorization must be indicated by a signed record. The authorization requirement is coupled with limitations on acquisition, use, retention, and disclosure in Sections 304, 305, 306, 308, and 309.

Subsection (b) Obligation of recipient of authorized disclosure. One of the difficulties in authorizing disclosure is control over the information once it has been disclosed. The Drafting Committee decided that regulation over the initial disclosure is ineffective without a continuing obligation of confidentiality that is binding on the recipient. Hence under this subsection a recipient may not redisclose the genetic information without the insured’s authorization. This provision extends beyond the privacy protections provided by HIPAA. States are permitted to depart from HIPAA privacy provisions if they impose more stringent protections. 45 C.F.R. § 160.203(b).

The Committee considered and rejected several approaches to the issue, including 1) a notice to the insured that the genetic information disclosed by the authorized person may be subject to redisclosure by the recipient and not longer protected, and 2) a provision that an insured could enter into a confidentiality agreement with recipients of their genetic information.

Subsection (c) Content of authorization. The provision on authorization for acquisition, use, retention, or disclosure of genetic information is adapted from the HIPAA Privacy Rule regulations for “uses and disclosures for which an authorization is required.” 45 C.F.R. §§ 164.508 (a) and (c), 164.512(a). The subsection adapts these regulations to apply to genetic information and expands them to include authorization for acquisition and retention as well as for use and disclosure.

An advantage of using the HIPAA regulations as the foundation for the authorization requirements is that the requirements to authorize a disclosure by a health care provider to an insurer would be similar to the requirements that health care provider must follow as a covered entity under HIPAA. The context of the HIPAA regulations is different enough, however, that they cannot be transported directly into the Act without modification. Moreover, states are permitted to impose their own, more stringent, privacy requirements. 45 C.F.R. § 160.203(b). Some have enacted statutes with different requirements for disclosing health care information, which reduces the uniformity that would theoretically be achieved by using the HIPAA format. Therefore, while the structure of this subsection is modeled on the HIPAA regulations, it includes some additional provisions from various state statutes. See, e.g., Me. Rev. Stat. Ann. tit. 22 § 1711-C.

Subsection (d). Authorization form. This subsection provides forms that may be used for an insured to provide authorization for use, retention or disclosure of genetic information. Forms following these examples would comply with this section.

(a) Except as otherwise provided in subsection (b) or by law other than this [act], an insured may revoke an authorization provided under this [article] at any time in a signed record.

(1) to the extent that an insurer or other person has taken action in reliance on the authorization; or

(2) if the authorization was granted as a condition of obtaining insurance and other law provides the insurer with a right to contest a claim under, or the validity of, the policy.

This section is adapted from the HIPAA regulation that governs revocation of an authorization. 45 C.F.R. § 164.508 (b) (5). It is similar to provisions governing health care information that have been adopted by some of the states. Long-term-care insurers are subject to HIPAA, but life insurers and disability-income insurers are not, so this section extends the law in order to give an insured greater control over his genetic information.

Subsection (b)(2) is included because Section 302 permits an insurer to condition the availability of life, disability-income, or long-term-care insurance on an applicant’s authorization for a genetic test or access to genetic information about the test, if the test meets the standards of Section 306 for providing a reliable prediction of mortality or morbidity. An insurer needs to continue to access this information in order to protect against fraud or misrepresentation in an insurance application; it has two years in which to contest the validity of the insurance contract. Records are also kept for reinsurance purposes and for reapplications by the insured.

SECTION 312. RETENTION OF AUTHORIZATION. An insurer that receives an authorization under this [article] shall keep a record of the authorization for six years after the expiration date of the authorization or, if the authorization has no expiration date, for six years from the date the authorization was created.

This section on the length of the obligation to keep an authorization is adapted from the HIPAA regulations that govern documentation and retention of a signed authorization. 45 C.F.R. §§ 164.508 (b) (6), § 164.530(j).

(a) An individual aggrieved by a violation of this [article] may initiate an appropriate proceeding with the [state commissioner of insurance] for whatever action the [commissioner] may be authorized to take under the [state unfair practice insurance law].

(b) An individual may initiate the administrative action authorized in subsection (a) not later than two years after the individual discovers the violation of this [article] or an individual exercising reasonable care should have discovered the violation.

Legislative Note: States should insert for [state commissioner of insurance] the appropriate title of this department. [The state unfair practices insurance law] should be replaced with the title of the relevant statute.

The draft’s remedy section is written to respond to privacy violations as well as discrimination or misuse of genetic information in insurance. It has been rewritted to eliminate a private right of action for an individual. An aggrieved individual may seek enforcement through the State Commissioner of Insurance. An administrative remedy such as this is typical in state statutes that prohibit discrimination in health insurance based on genetic testing or information. These statutes declare that a violation is an unfair and deceptive insurance act or practice under the state insurance code. They often provide that the State Commissioner of Insurance shall enforce the prohibitions.

The Committee considered and rejected statutory damages as a remedy for a privacy violation for the reason that statutory damages often serve primarily to limit recovery.

SECTION 401. UNIFORMITY OF APPLICATION AND CONSTRUCTION. In applying and construing this uniform act, consideration must be given to the need to promote uniformity of the law with respect to its subject matter among states that enact it.

SECTION 402. RELATION TO ELECTRONIC SIGNATURES IN GLOBAL AND NATIONAL COMMERCE ACT. This [act] modifies, limits, and supersedes the federal Electronic Signatures in Global and National Commerce Act, 15 U.S.C. Section 7001, et seq., but does not modify, limit, or supersede Section 101(c) of that act, 15 U.S.C. Section 7001(c), or authorize electronic delivery of any of the notices described in Section 103(b) of that act, 15 U.S.C. Section 7003(b).

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				Great-great- grandparents (4)
			Great-grandparents (3)
		Grandparents (2)	Great Aunts and Great Uncles (3)
	Parents (1)	Aunts and Uncles (2)
Individual	Sisters and Brothers and half-siblings (1)	First Cousins (3)
Children (1)	Nieces and Nephews (2)	First Cousins once-removed (4)
Grandchildren (2)	Grandnieces and Grandnephews (4)
Great- grandchildren (3)
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