FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for October 2014

Posted on Thursday, October 16 2014 at 6:06 pm by -

FDA Issues Final Cybersecurity Guidelines

On October 2, 2014, the United States Department of Health and Human Services, Food and Drug Administration (“FDA”) released the final version of a guidance document entitled “Content of Premarket Submissions for Management Cybersecurity in Medical Devices” (the “Final Guidance”). The Final Guidance reiterates several of the key points that FDA made in the draft guidance and is meant to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.”
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Posted on Monday, October 6 2014 at 6:03 pm by -

HIPAA Clarity for the Mobile Health Industry

On September 18, Congressmen Tom Marino (R-PA) and Peter DeFazio (D-OR) sent a letter to the Secretary of the Department of Health and Human Services (HHS) asking HHS to clarify and update the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, (collectively, HIPAA) guidance for mobile app companies. The September 18 letter was sent shortly after the Congressmen’s receipt of a letter from The App Association, urging Congress to adopt more sensible implementation of health privacy laws to ensure that the implementation better fits today’s mobile world.
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