As FDA has noted, artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform healthcare. These technologies could be used at the agency, by other agencies involved in healthcare regulation and finance, by private participants in the healthcare delivery system, and by medical device manufacturers. They can also be embedded in conventional medical devices or, indeed, serve as standalone medical devices. For several years now, FDA has been exploring how its existing medical device framework applies, or should be adapted to apply to, software “as” a medical device as well as software “in” a medical device. In this post, I review four recent law review articles exploring legal and policy issues presented by the emergence of artificial intelligence and machine learning in medical devices and the healthcare setting more generally.Continue reading “Artificial Intelligence & Machine Learning: Recent Scholarship”
The 2020 annual conference of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (at Harvard Law School) will focus on the future of medical device regulation. If you’re interested in participating, abstracts are due on October 14, final papers are due March 27, and the conference is May 8. (Here’s a link to the call for papers.) I’m working on an empirical project relating to device premarket approval and patent term restoration, but sadly the dataset won’t be ready in time. Meanwhile, here’s a run-down of some interesting legal scholarship on medical device regulation in the last year and a half.Continue reading “SSRN Reading List . . . or Device Regulation: What Role for Tort Law?”
Continuing with FDA-related scholarship posted on SSRN in February and March: Professor Noah explores the possibility of “reverse switches” from over-the-counter (OTC) status back to prescription status (or perhaps, he suggests “behind the counter” status) in response to new safety information. Professor Paradise explains the provisions of the 21st Century Cures Act that contemplate greater patient involvement in medical product development, and Professors Evans and Ossorio evaluate the 21st Century Cures Act exclusion of clinical decision software from the agency’s medical device authority.