The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device

NPJ Digit Med. 2020 Apr 7;3:53. doi: 10.1038/s41746-020-0262-2

Posted: 24 May 2021

See all articles by Sara Gerke

Sara Gerke

Pennsylvania State University, Dickinson Law

Boris Babic

Independent

Theodoros Evgeniou

INSEAD

I. Glenn Cohen

Harvard Law School

Date Written: May 20, 2021

Abstract

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition.

Keywords: Artificial Intelligence, Machine Learning, FDA law, Software as a Medical Device, System View

JEL Classification: I1, K

Suggested Citation

Gerke, Sara and Babic, Boris and Evgeniou, Theodoros and Cohen, I. Glenn, The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device (May 20, 2021). NPJ Digit Med. 2020 Apr 7;3:53. doi: 10.1038/s41746-020-0262-2, Available at SSRN: https://ssrn.com/abstract=3849803

Sara Gerke

Pennsylvania State University, Dickinson Law ( email )

150 S College St
Carlisle, PA 17013
United States

Boris Babic

Independent ( email )

Theodoros Evgeniou

INSEAD ( email )

Boulevard de Constance
77305 Fontainebleau Cedex
France

I. Glenn Cohen (Contact Author)

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

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