Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine

JAMA. 2019 Dec 17;322(23):2285-2286. doi: 10.1001/jama.2019.16842.

Authors

Thomas J Hwang^{1

2}, Aaron S Kesselheim³, Kerstin N Vokinger^{3

4}

Affiliations

¹ Harvard Medical School, Boston, Massachusetts.
² Laboratory for Technology, Markets, and Regulation, University of Zurich, Zurich, Switzerland.
³ Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
⁴ Institute of Law and Laboratory for Technology, Markets, and Regulation, University of Zurich, Zurich, Switzerland.

PMID: 31755907
DOI: 10.1001/jama.2019.16842

No abstract available

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Artificial Intelligence*
Government Regulation*
Humans
Machine Learning*
Software / legislation & jurisprudence*
United States
United States Food and Drug Administration