mHealth experts analyze FDASIA report

With the attention that the ICD-10 delay and SGR vote have been getting this week, it would have been easy to overlook the release of the FDASIA report. But the long-awaited guidelines to federal regulation of health IT will have a lasting impact that can't be ignored.

The report, mandated by the U.S. Food and Drug Administration Safety Innovation Act of 2012 and conducted by the FDA, the Health and Human Services Department's Office of the National Coordinator for Health IT, and the Federal Communications Commission, lays the groundwork for governance of mHealth. For that reason, its release was eagerly anticipated by mHealth experts.

Two of them, Bradley Merrill Thompson and Robert Jarrin, offered observations to mHealth News on the report's impact.

Thompson, an attorney with the Washington law firm of Epstein, Becker & Green, listed some of the document's more salient points:

1. The FDA will not expand its regulatory scope;
2. The ONC will play a very central role in the development and use of standards;
3. The agencies seem to have adopted 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 an important aspect that's been missing from other HIT policy initiatives.

Jarrin, senior director of government affairs for Qualcomm and a member of the FDASIA External Working Group – which submitted its own report late last year – had a few observations as well.

1. Since the proposed framework focuses on 'Health Management HIT' products, these will likely be overseen primarily by the ONC through the new Health IT Safety Center. As the report states, 'If such health management health IT functionality meets the statutory definition of a medical device, FDA does not intend to focus its regulatory oversight on such functionality because the Agencies’ proposed strategy and recommendations for a risk-based framework for health management health IT, outlined in Section 5, can help to assure a favorable benefit-risk profile of these functionalities.'

"Importantly, this category has 'most clinical decision support' software and also includes health information and data exchange, data capture and encounter documentation, electronic access to clinical results, medication management; electronic communication and coordination, provider order entry, 'knowledge management,' patient identification and matching – arguably many of these functionalities are found in EHRs," Jarrin said.

2. That new 'Health IT Safety Center' - formed from members of the ONC, FDA, FCC and Agency for Healthcare Research and Quality (AHRQ) - will serve as the forum for developing HIT best practices, including transparent reporting, aggregation and analysis of safety issues. It will also develop HIT best practices, quality systems principles, technology standards, and validation and assessment tools.


"This to me seems right in line with discussions and recommendations that the FDASIA regulatory sub-working group had which called for the creation of a 'National Transportation Safety Board'-styled organization which we informally referred to as a 'Health IT Safety Board.'" Jarrin said. "The idea being to create an organization that would be tasked with event reporting for all stakeholders in the event something went wrong within the health IT interoperable ecosystem."

"I feel this document extends the intent by the agencies to provide more clarity to help innovators determine which health functionalities would fall under FDA, including areas where FDA is expected to issue guidance," Jarrin concluded. "Those areas include the distinction between wellness and disease-related medical device claims, medical device accessories, CDS software, medical device software modules and inter-agency guidance.  We’re all eager to get more clarity in all of those topics."