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Health IT regulations: FDA is weighing deeper involvement

Jean DerGurahian

Health IT regulations could be affected dramatically by a proposed rule that has been floating around the Food and Drug Administration (FDA) for two years -- and that's causing concern among health IT professionals.

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The Medical Device Data System (MDDS) proposal, released in 2008, would reclassify health IT and put it into Class I, a broad category that requires general regulatory control. Health IT already is regulated through the FDA, under a stricter, Class III designation that requires developers to submit products for review before they go to market.

The FDA, which regulates devices through its Center for Devices and Radiological Health (CDRH), usually has not enforced the Class III review requirement, and the reclassification of health technology to Class I would remove it.

However, the "general regulatory control" that Class I requires leads to the question of what constitutes "health technology." For example, providers sometimes access health software applications through Apple Inc.'s iPhone; that might require Apple to become an FDA-regulated entity under the classification. And having the FDA step in with additional regulation of health IT at a time when medical professionals and vendors are trying to navigate federal meaningful use, standards and certification requirements might cause even more delays in the effort to increase its adoption.

There has been no official move to finalize the MDDS -- nor any indication from the FDA that it plans to enforce its current policies more strictly -- but health IT professionals are still concerned and are warning that FDA involvement in IT regulations is a possibility.

It's a little too arbitrary where [FDA] involvement begins and ends.

Marc Probst, vice president and CIO, Intermountain Healthcare Inc.

The FDA does indeed exercise some of its regulatory muscle now -- and where it does, there are complications, according to Marc Probst, vice president and chief information officer of Intermountain Healthcare Inc. The Salt Lake City-based health system had to slow down a research project in which doctors were implementing decision-support tools to better manage patients' blood sugar levels. The FDA had concerns about the protocols that researchers were using, to the point that the IT regulation became invasive. "It's a little too arbitrary where [FDA] involvement begins and ends," he said.

The federal Health IT Policy Committee addressed some of these concerns during its April 21 meeting. The committee, which advises the Office of the National Coordinator for Health Information Technology (ONC), endorsed recommendations that it work with the FDA and use its experience when it comes to monitoring technology safety, particularly when monitoring involves reporting adverse events or incidents in which technology does not work appropriately. David Blumenthal, the physician who chairs the policy committee and heads ONC, said the office has been "actively consulting" with the FDA throughout the process of rolling out health IT adoption initiatives.

CDRH Director Dr. Jeffrey Shuren said the FDA could play a role in ensuring safety by using its regulatory framework and analytics tools alongside other policies established by the ONC. "The agency is very willing to be flexible," he said.

Shuren, who also testified during a February health IT safety hearing, said the FDA is used to tackling issues that look beyond just devices or technology and incorporating the questions of who is using health technology and how. In particular, the agency's Quality Systems Review program can be customized to meet the needs of developers. "Our industries rely on incremental innovation all the time," he said.

Let us know what you think about the story; email Jean DerGurahian, News Writer.


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