Rep. Marsha Blackburn (R-Tenn) plans to reintroduce the SOFTWARE Act, a bipartisan bill that would establish a new regulatory framework for health information technology, early next year. Blackburn announced the news at a Bipartisan Policy Center event yesterday.
"In 1938, Congress passed the Federal Food Drug and Cosmetic Act, which gave authority to the FDA to oversee the safety and efficacy of...
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...
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...
By Bradley Merrill Thompson
This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation.
Current...
Rep. Gregg Harper (R- Mississippi)
Calling Obamacare a contentious topic between Republicans and Democrats in the US House of Representatives would be something of an understatement. But that doesn't mean there's no bipartisan momentum in healthcare legislation. One bill currently in the House would expand Medicare and Medicaid coverage for telehealth, while another would restrict the FDA's...
