Bradley Merrill Thompson Quoted in “6 Takeaways from New FDASIA Report”Government Health IT April 2, 2014
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "6 Takeaways from New FDASIA Report."
Following is an excerpt:
Two years ago in the Food and Drug Administration Safety Innovation Act (FDASIA), Congress mandated a new workgroup to issue a report to offer its advice on how to regulate the growing mobile health world. Yesterday, that report arrived. ?...
Bradley Merrill Thompson served as co-chair of the regulations working group that offered input into this report last summer. At first blush, here are some of his top conclusions from the report:
- FDA will not expand its regulatory scope;
- ONC will play a very central role in the development and use of standards;
- The agencies seem to adopt the recommendations of the Bipartisan Policy Center made in January 2013 that health IT should be stratified into three categories, with the lowest risk category - administrative software - being completely unregulated; ...