FDASIA Workgroup Will Not Call for FDA Premarket Oversight of Health IT

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Alex Ruoff  


Health information technologies and mobile medical applications should not be subject to Food and Drug Administration premarket oversight except as accessories to medical devices, a federal advisory group said July 26.

Although some health IT tools are known to prompt medical errors, regulation of them should focus on post-market surveillance and certification programs, David Bates, chair of the Food and Drug Safety and Innovation Act (FDASIA) workgroup, an advisory group to the Office of the National Coordinator for Health Information Technology, said.

The FDASIA workgroup will present recommendations Aug. 7 to the Health IT Policy Committee for a report to Congress with proposals for a risk-based regulatory framework for health IT that includes policies for regulating mobile medical applications. The Health IT Policy Committee is the main advisory panel for ONC.

The FDASIA workgroup drafted recommendations during its July 26 meeting that include a call for registering health IT tools with FDA “which are considered to represent at least some risk, if a nonburdensome approach can be identified to doing so.”

The workgroup is part of a congressionally mandated partnership between the Department of Health and Human Services, the Federal Communications Commission, and FDA. The three agencies are charged with issuing a report on possible regulation of health IT tools, including mobile medical applications.


Currently, FDA can regulate health IT tools, such as electronic health records and computerized physician order entry tools, as medical devices but does not actively do so, Bakul Patel, a senior policy advisor to the Centers for Devices and Radiological Health at FDA, said. FDA does not require medical devices or tools it considers low risk for patients, EHRs included, to undergo premarket scrutiny.

Several industry organizations recently warned the FDASIA workgroup against recommending FDA regulation of health IT, particularly premarket regulation or certification, claiming such oversight could stifle the industry's growth and evolution (see previous article).

Bates said he agreed that FDA oversight could prove burdensome for technology developers without improving safety efforts significantly.

He said safety risks associated with health IT are not well documented or understood and the “magnitude of harm and impact of health IT on patient safety is uncertain,” he said.

The workgroup will recommend better safety event reporting standards for health IT tools to allow for data collection concerning patient safety issues caused by health IT. This recommendation is meant to complement a recently finalized plan by ONC for reducing medical errors caused by health IT tools by promoting the reporting of health IT-related patient safety incidents (see previous article).

Further Recommendations

FDA should subject only certain forms of high risk clinical decision support software to premarket regulations, such as those that significantly influence clinical outcomes or decisions, Bates said.

FDA should also “take steps to strongly discourage [health IT] vendors from engaging in practices that discourage or limit the free flow of safety-related information,” Bates said.

The workgroup will also recommend three areas for further development:

• creation and adoption of needed standards;

• private certification of interoperable products to be used in health information exchange networks; and

• a public process for health IT customer ratings.


Post-Market Testing

FDASIA workgroup members said ONC should improve its post-market surveillance of health IT tools and begin testing the accuracy of EHR systems after they are implemented into clinical settings.

Currently, ONC certifies testing and accrediting laboratories to certify health IT products, particularly EHRs, before they are implemented.

However, Bates said, certification regimens “should be used judiciously” and ONC should expand its existing certification program rather than introduce a new one.

Materials from the meeting are at http://www.healthit.gov/policy-researchers-implementers/policy-fdasia-workgroup.

Request Health Care on Bloomberg Law