Andis Robeznieks reports: The Food and Drug Administration (FDA) has basic rules for regulating wearable devices and other digital health tools, but those rules may change as rapid innovation continues and the agency creates new pathways to ensure the safety and efficacy of new consumer-facing products. AMA experts outlined this and other need-to-know facts for…
Category: Healthcare
Alberta Mental Health Act found unconstitutional after man held for nine months
Canadian Press reports: An Alberta judge has found parts of the province’s Mental Health Act unconstitutional after it was used to hold a man against his will for nine months and treat him with psychiatric drugs. “(The man) suffered multiple breaches of his fundamental rights to life, liberty and security,” wrote Queen’s Bench Justice Kristine…
The European Data Protection Board and the European Data Protection Supervisor consider the European Commission to be a processor of patient data in the eHealth Digital Service Infrastructure
Kristof Van Quathem and Anna Oberschelp de Meneses of Covington & Burling write: On July 12, 2019, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) issued a joint opinion on the processing of patient data and the role of the European Commission within the eHealth Digital Service Infrastructure (“eHDSI”). […]…
Employees Sue Yale Over Wellness Program
Kenneth Terrell of the AARP reports: As many as 5,400 workers at Yale University were forced to either share their private medical information with their employer or pay an expensive fine, according to a class action lawsuit AARP Foundation filed today on their behalf. The lawsuit argues that by charging some employees $1,300 annually —…