At The Regulatory Review, Nabil Shaikh L’24 explores the perspective that Congress and the FDA should treat risky clinical artificial intelligence tools as medical devices.
Should Congress broaden the definition of a “medical device” to encompass risky products that rely on artificial intelligence (AI), and should the U.S. Food and Drug Administration (FDA) exercise regulatory oversight over the makers of some of these products?
From The Regulatory Review:
When the U.S. Congress defined the term “medical device” in the Food, Drug, and Cosmetic Act, it mostly had in mind physical hardware products, such as knee replacements, pacemakers, and surgical instruments.
But today, patients and providers often rely on software tools to improve health. Examples include the Apple Watch’s electrocardiogram app and a smart camera that tells ophthalmologists whether a diabetes patient is at risk of blindness.
In a recent article, professor Sara Gerke of Penn State Dickinson Law proposes that Congress broaden the definition of a “medical device” to encompass risky products that rely on artificial intelligence (AI), and that the U.S. Food and Drug Administration (FDA) exercise regulatory oversight over the makers of some of these products.
Admittedly, FDA has adopted a regulation that treats as medical devices any software used for “medical purposes”—disease prevention, treatment, and diagnosis.
But not all software services related to health care serve medical purposes. FDA clarified in 2019 that software tools that only help users maintain “a general state of health or a healthy activity” are not medical devices. A smartphone app that monitors your exercise activity, for example, is currently not considered a medical device. Neither is software intended to reduce an individual’s risk of chronic diseases or conditions, such as an AI service that helps Type 2 diabetes patients eat a balanced diet for their condition.
In her proposal, Gerke calls for Congress to define such “clinical decision” software as medical devices. Doing so would include many risky AI-based health care products that FDA currently does not regulate, Gerke contends.
Gerke offers AI-based mortality prediction models as a telling example… .
The Regulatory Review is a daily online publication that provides accessible coverage of regulatory policymaking and enforcement issues across a full range of regulatory topics and from a variety of perspectives.
Launched in 2009 and operating under the guidance of Cary Coglianese, Edward B. Shils Professor of Law and Professor of Political Science, The Review is edited by students at Penn Carey Law. It is part of the overarching teaching, research, and outreach mission of the Penn Program on Regulation (PPR), which draws together more than 60 faculty from across the University of Pennsylvania.