Tag: devices

What Now?

Published on by Erika LietzanLeave a comment

This is the second in a series of posts on food and drug law scholarship posted to SSRN from January to June 2026.   The 1980s were my decade, and as I read these three pieces, the lyrics to Once in a Lifetime started — and then would not stop — in my head.  They consider … where we find ourselves. 

You may ask yourself, “Where does that highway go to?”
And you may ask yourself, “Am I right, am I wrong?”
And you may say to yourself, “My God, what have I done?”

(Same as it ever was?  Maybe a little bit. See below.)

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Artificial Intelligence & Machine Learning: Recent Scholarship

Published on by Erika LietzanLeave a comment

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. 

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SSRN Reading List . . . or Device Regulation: What Role for Tort Law?

Published on by Erika Lietzan2 Comments

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. 

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