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.
Some hoped it would solve all the debate about the extent to which regulators should be able to get involved, but most saw it in the light in which they already see this issue. If threatened by the FDA’s growing involvement, some felt it was a sign of that continuing, or even getting worse. For those who are pleased with the FDA, they seemed to see the bright side of the report, which is intended to inform Congress.
With the release of the long-awaited report from the FDASIA working group, I asked Bradley Merrill Thompson, a healthcare attorney specializing in FDA with Epstein Becker & Green to give his take on the key points from the document.
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:
1. FDA will not expand its regulatory scope;
2. ONC will play a very central role in the development and use of standards;
3. 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;
4. That with regard to the middle tier of software - health management software - we should avoid regulation and instead use voluntary standards and certification and other private sector tools;
5.That adverse event reporting is important and should be improved, and can be approved by the creation of a quasi- governmental entity - the Health IT Safety Center - that would be controlled by the agencies in partnership with other stakeholders. At least one of the goals of creating that separate organization would be reducing the perceived liability and adverse publicity risks for an organization reporting adverse events;
6.The report recommends taking numerous steps designed to facilitate the interoperability of medical devices and health IT generally, used in systems. “That's the important aspect that's been missing from other HIT policy initiatives,” Thompson said.