ONC workgroup may consult FDA on EHR certification

The FDA may get a role in certifying electronic health records because of that agency's long history of monitoring other products for patient safety.

The certification workgroup of the federal Health IT Policy Committee is pondering whether the FDA could help ONC develop EHR certification criteria that ensures certified products promote patient safety and whether the regulatory agency might offer lessons in post-market surveillance of certified EHRs. In the latter case, ONC may turn to the FDA to set up a means for reporting vendors that aren't meeting certification criteria.

"The certification organization could then issue a warning or revoke the vendor's certification," Paul Egerman, co-chair of the certification workgroup, said, according to InformationWeek. "That's a powerful lever, and the FDA can help us figure out the process, because the devil is in the details," added Egerman, a healthcare software entrepreneur.

However, at least one representative of a major health IT vendor disagreed. "If the mission is to build a safer system, I don't know that the FDA can contribute toward that mission," said workgroup member Carl Dvorak, executive VP of Epic Systems, Verona, Wis. Dvorak suggested instead that CMS would be better suited to enforce IT requirements at pharmacies and other ancillary providers.

HIT Policy Committee Co-chair Dr. Paul Tang said the workgroup should at least listen to the FDA. "The FDA has advice to give us, so we don't want to not talk with them. They want to talk with us," he said.

For more on this debate:
- check out this InformationWeek story

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