On Oct. 27, in a vote split along party lines, the Federal Communications Commission (“FCC”) approved a new regulatory regime staking its claim to privacy regulation of both fixed and mobile Internet service providers (“ISPs”) like Comcast, Verizon, and AT&T. The FCC’s rules follow its decision in the Open Internet Order, released last year and analyzed here, to classify broadband Internet access service as a common-carrier telecommunications service. The FCC’s new rules are intended to give consumers control over the ways in which ISPs use and share their customers’ private information. While the FCC has yet to release its Report and Order, the FCC’s Fact Sheet and statements by the commissioners indicate that the new privacy rules in many respects track the proposed rules the FCC put forward earlier this year, which seek to make the FCC the “toughest” privacy regulator in the Internet ecosystem by imposing on ISPs significantly more onerous and restrictive requirements for use and collection of consumer data than the Federal Trade Commission (“FTC”) imposes on its non-ISP competitors.Continue Reading FCC Issues New Privacy Rules for Internet Service Providers: Safeguarding Consumers or Lulling Them Into A False Sense of Privacy?
U.S. FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?
On February 9, 2015, the United States’ Food & Drug Administration (“FDA”) issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that (1) meet the definition of medical devices under section 201(h) of the Federal Food Drug and Cosmetic Act, and (2) could pose a risk to a patient’s safety if the app did not function as intended. The FDA will not exercise authority over apps that are not medical devices under section 201(h), nor will it enforce its rules and regulations against the numerous apps that meet the definition of medical devices but present only minimal risk to consumers or patients.
Continue Reading U.S. FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?