Genetic database software as medical devices.

"data sharing european union fda genomics law medical device public genetic variant databases regulation software source-schema-version-number 2 0 component-id humu23621"

"CONFLICT OF INTERESTS The authors have no known conflicts of interest."

"This research is supported by the Can‐SHARE project supported by Genome Quebec, Genome Canada, the government of Canada, the Ministère de l’Économie, Innovation et Exportation du Québec, and the Canadian Institutes of Health Research (fund #141210), as well as the Génome Québec/Génome Canada/CIHR project entitled PERSPECTIVE (Personalized Risk Stratification for Prevention and Early Detection of Breast Cancer). Professor Knoppers would like to acknowledge the support of the Canada Research Chair in Law and Medicine. The authors would also like to thank Dr. Amanda Spurdle for commenting on drafts of this manuscript. Both Alison Hall and Johan Ordish are employees of the PHG Foundation, a health policy think tank, part of University of Cambridge."