April 8, 2014
By Bradley Merrill Thompson
I don’t know about you, but when I read the FDASIA Health IT Report released by HHS on April 3, I found it to be largely quite predictable. Indeed I’ve been scanning the media coverage of the report and I haven’t seen anyone so far express shock or surprise at what was in the report. How is it that we all pretty much knew what would be in there? Quite simply the three...
April 4, 2014
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the...
March 19, 2014
Six US senators sent the FDA a letter this week to check in on the agency's interactions with mobile health app developers since it published its final guidelines for mobile medical app regulation last year. The senators who signed the letter -- Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner, and Richard Burr -- stated that they wanted to ensure the agency's oversight over...