The path toward a risk-based regulatory framework for health IT

By: Jodi Daniel, Bakul Patel and Matthew Quinn 

Yesterday, the Health IT Policy Committee (HITPC) accepted and approved recommendations from the Food and Drug Administration Safety and Innovation Act (FDASIA) working group for a risk-based regulatory framework for health information technology. The working group’s recommendations suggest a scope for an IT framework, risk and innovation criteria, and approaches for avoiding regulatory duplication. 

Only six short months ago, the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and Federal Communications Commission (FCC) kicked off the FDASIA workgroup of the HITPC to provide stakeholder input into a report on a risk-based regulatory framework that promotes safety and innovation and reduces regulatory duplication, consistent with section 618 of FDASIA. This provision permitted the Secretary of Health and Human Services (HHS) to form a workgroup in order to obtain broad stakeholder input from across the health care, IT, patients and innovation spectrum. The FDA, ONC, and FCC actively participated in these discussions with stakeholders from across the health care, IT, patients and innovation spectrum. The working group met more than 28 times, and yesterday FDASIA workgroup chair, David Bates, presented the final recommendations to the HITPC. 

In recognition of this important milestone, and on behalf of the three agencies, we want to express our deep appreciation to the members of the workgroup (and a special thanks to David Bates) for committing themselves to this aggressive timeline and delivering a suite of thoughtful recommendations.

Next Steps

As the FDASIA workgroup’s efforts conclude, the agencies’ efforts now intensify. Over the next few months the FDA, ONC, and FCC will review the HIT Policy Committee’s recommendations and the public comments submitted through the docket we opened on regulations.gov. Using these thoughtful inputs, ONC, FDA, and FCC will work closely together to develop a report (by the January 2014 statutory deadline) that proposes an overarching health IT regulatory strategy and provides recommendations on ways to appropriately promote innovation, protect patient safety, and avoid regulatory duplication. 

We recognize the complex nature of health IT and its importance to our nation’s health.  Therefore, we intend to provide an opportunity for public comment and additional stakeholder input on the draft report following its publication in January 2014. We look forward to continued collaboration with all stakeholders as we advance our thinking on this important topic. 

Jodi Daniel is Director, Office of Policy and Planning, Office of the National Coordinator for Health IT

Bakul Patel is Senior Policy Advisor, FDA’s Center for Devices and Radiological Health

Matthew Quinn is Director of Healthcare Initiatives, Federal Communications Commission (FCC)