The need for a system view to regulate artificial intelligence/machine learning-based software as medical device.

Gerke, Sara; Babic, Boris; Evgeniou, Theodoros; Cohen, I Glenn.

Afiliação

Gerke S; 1Project on Precision Medicine, Artificial Intelligence, and the Law; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard University, Cambridge, MA USA.
Babic B; 2INSEAD, 1 Ayer Rajah Ave, Singapore, 138676 Singapore.
Evgeniou T; 3INSEAD, Boulevard de Constance, 77300 Fontainebleau, France.
Cohen IG; 4Harvard Law School; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard University, Cambridge, MA USA.

NPJ Digit Med ; 3: 53, 2020.

Article em En | MEDLINE | ID: mdl-32285013