As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communication Commission (FCC) – are following a specific mandate under Section 618(a) of the Food and Drug Administration Safety and Innovation Act (FDASIA) to pursue a collaborative approach in regulating HIT.
The three agencies formed the FDASIA Workgroup to gather industry intelligence that will help the HHS Secretary “publish a report [by January 2014] that will offer a proposed strategy and recommendations for an appropriate risk-based Health IT regulatory framework.” And last week,the ONC, in coordination with the FDA and FCC, issued a notice of public meeting and request for comments (the “Notice”) that will inform the report’s content.
The FDASIA Workgroup’s membership includes agency officials and a wide range of stakeholders such as patients, consumers, health care providers, start-up companies, health plans and other third party payors, venture capital investors, IT and HIT vendors, small businesses, purchasers, and employers. The purpose of the FDASIA Workgroup is to provide feedback on issues relevant to the report, but the Notice provides the public an opportunity to contribute as well. The Notice requests comments in three general subject areas: taxonomy, risk and innovation, and regulation. The agencies are particularly concerned about:
- the types of HIT that should be addressed in the report (including HIT related to mobile medical apps);
- how HIT may pose risks that impact patient safety, how high the likelihood is of patient safety risks arising from HIT, and the impact of these considerations on a risk-based approach;
- factors or approaches that could be included in a risk-based regulatory approach for HIT that also promote innovation and protect patient safety; and
- current areas of regulatory overlap among FDA, ONC, and/or FCC as well as approaches to avoid duplicative or overlapping regulatory requirements.
Comments are due by June 30, 2013. The Notice also announced in-person FDASIA Workgroup meetings that occurred May 30 and 31, 2013, in Washington, D.C. Over the two days, the FDASIA Taxonomy and Risk Assessment and Innovation subgroups made presentations, held open meetings, and conducted breakout sessions to discuss the progress they are making in gathering the intelligence needed to inform the HIT regulatory framework. Parties desiring to comment on the Notice should review the presentations and consider whether to reinforce or refute any assumptions or approaches that the FDASIA is considering.
Overall, the agencies appear to recognize that HIT regulation must catch up to innovation. Taking a measured approach to such regulation will hopefully ensure that innovation gets promoted and not stifled.