Workgroup: Don't subject health IT to FDA pre-market requirements

The Food and Drug Administration Safety and Innovation Act workgroup--tasked with developing a report that contains a proposed strategy and recommendations on a regulatory framework for health IT--submitted draft recommendations for that strategy at a Health IT Policy Committee meeting in Washington, D.C., Wednesday.

Specifically, the workgroup said that health IT should not be subject to the FDA's pre-market requirements, except in the case of:

  • Medical device accessories
  • Certain forms of high-risk clinical decision support to be defined more clearly by the FDA
  • Higher risk software use cases

The workgroup also said that vendors should be required to list products considered to represent some risk if a "non-burdensome approach" to doing so is identifiable.

Additionally, the workgroup recommended taking a collaborative approach to creating better post-market surveillance of health IT, saying that "spontaneous reporting" and post-implementation testing could help to ensure the inclusion of safety-related decision support.

"FDA and other agencies need to take steps to strongly discourage vendors from engaging in practices that discourage or limit the free flow of safety-related information," the committee report--presented by FDASIA workgroup chair David Bates--said. Bates is senior vice president for quality and safety for both the Brigham and Women's Hospital and the Brigham and Women's Physicians Organization in Boston. He's also a professor of medicine at Harvard Medical School.

Last month, a coalition of 15 patient groups urged the FDASIA workgroup to take its time in crafting the regulatory framework in a letter sent to federal officials. That letter piggybacked on a similar letter written in June that called on the Obama administration to work with congress on health IT oversight.

The Office of the National Coordinator for Health IT, in July, released its own health IT safety plan.

To learn more:
- view the workgroup's draft recommendations (.pdf)

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