The health subcommittee of the House Energy and Commerce committee met this week to question Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, about the medical device user fee amendments (MDUFA).
MDUFA is an agreement between the FDA and industry in which the FDA agrees to do certain things in return for industry groups supporting the agency’s work by paying fees...
At a congressional hearing on mobile medical apps today, experts from different sectors of the industry weighed in on the ways they think federal regulation needs to change to create a robust digital health industry while still protecting the safety and wellbeing of patients. The conversation spanned various regulatory bodies and federal programs including HIPAA, the FDA, the FTC, and Medicare.
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As expected, the third and final (for now, at least) congressional hearing focused on the FDA's regulation of mobile medical apps was the only one that provided new information for those already well-versed in mobile health. While the past two days of testimonies likely helped members of Congress better understand the concerns of those working or lobbying for the healthcare and technology...
We are live blogging old school today: Hit the refresh button every few minutes for updates! (Liveblogging is now concluded!)
10:26AM: The hearing is now adjourned! Apparently they cut it short to vote.
10:25AM: Final question goes to Mostashari from Burgess around why the ONC doesn't just make interoperability happen.
10:23AM: Rep Griffith is now asking about the diagnostic device that was...
