Health IT Oversight Guidance Expected From Federal Agencies by End of March

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By Alex Ruoff

Feb. 25 --A trio of federal agencies will publish by the end of March a long-awaited draft proposal for how health information technology tools, such as electronic health records and mobile medical applications, should be regulated in the future.

“We are shooting really hard to get the [draft guidance] out by the end of March. That's our goal internally,” Bakul Patel, director of the FDA's Center for Devices and Radiological Health, said Feb. 25 at the Healthcare Information and Management Systems Society (HIMSS) annual conference in Orlando, Fla.

The FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission were charged by Congress in the Food and Drug Administration Safety and Innovation Act with developing the guidance.

The draft guidance “is by no means a final word, it's the beginning of the conversation.”


--Bakul Patel, the FDA's Center for Devices and Radiological Health

Even after the draft guidance is published, federal advisory workgroups and the FDA will continue to work on ideas for improving the interoperability of health IT systems and how a lack of interoperability among systems could influence patient safety, Patel said.

The draft guidance “is by no means a final word, it's the beginning of the conversation,” Patel said.

Jodi Daniel, director of the ONC's Office of Policy and Planning, said her agency and the FDA will continue to explore the safety issues around the use of clinical decision support (CDS) tools by health-care providers.

“CDS needs more discussion,” she said.

Daniel and Patel said they could not discuss details of the soon-to-be-released draft guidance. However, Daniel said the document “focuses on functionality.”

“We're thinking in terms of functionality. What an EHR is is different depending on who you're talking to or what part of the technology you focus on,” she said. “We're looking at the difference from a functionality perspective, we're saying an EHR or CDS is defined by its function.”

To contact the reporter on this story: Alex Ruoff in Washington at

To contact the editor responsible for this story: Kendra Casey Plank at

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