The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how medical device manufacturers should address cybersecurity threats (81 Fed. Reg. 3803, 1/22/16). The draft guidance proposes that manufacturers “implement a structured and systematic comprehensive cybersecurity risk management …
FDA Draft Guidance on Cybersecurity in Medical Devices Read more »
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights recently issued guidance on individuals’ rights to access medical records under the Privacy Rule (45 C.F.R. 160; 45 C.F.R. 164, Subparts A & E) of the Health …
HHS Guidance on Rights to Access Medical Records Read more »
The U.S. Food and Drug Administration has just updated its blood donor deferral policy, recommending that men who have sex with men (MSM) be deferred only if they have had sexual contact with another man within the past 12 months. …
The U.S. Food and Drug Administration (FDA) is conducting a Moving Forward: Collaborative Approaches to Medical Device Cybersecurity workshop, at the FDA White Oak campus in Silver Spring, MD, on 20-21 January 2016. This free public workshop is being conducted …
1/20-21/16 FDA Medical Device Cybersecurity Workshop Read more »
The Director of the U.S. National Institutes of Health (NIH), Francis S. Collins, MD, PhD, has just announced that the NIH will no longer support biomedical research on chimpanzees. This decision follows the recent U.S. Fish and Wildlife Service final …
NIH Ends Support of Biomedical Research on Chimpanzees Read more »
