FTC Health Breach Proposal Could Create Confusion For HIPAA Entities
Medtech Insight followed up with Invitae’s Deven McGraw about further possible confusion that could be caused by the Federal Trade Commission’s proposed amendments to the Health Breach Notification Requirements (HBNR).
You may also be interested in...
Former deputy privacy director of HHS Deven McGraw spoke to Medtech Insight about the shortfalls of the FTC’s proposed health breach notification amendments.
Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases
The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.
Researchers from the Brigham and Women’s Hospital and Harvard Medical School argue that the Ensuring Patient Access to Critical Breakthrough Products Act is “a step in the wrong direction.”