A key event in Congress affecting health information technology occurred last week when two members of the Senate HELP Committee issued a discussion draft of their bipartisan legislation on health information technology (health IT). This ambitious bill addresses many of the same areas as other recent bills, including information blocking, transparency, a star rating system
Privacy
FDA Publishes Cyber Guidance for Medical Devices
By Kathryn A. Linsky & David Bodenheimer on
Posted in FDA, HIPAA & Privacy
On October 2, 2014, the FDA released a set of comprehensive guidelines governing the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidelines are intended to provide direction for manufacturers of medical devices on how to appropriately safeguard devices from a potential security breach; particularly in light of the sensitive…