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FDA decides medical-device data systems don't need its oversight


By Darius Tahir
Posted: June 20, 2014 - 2:00 pm ET
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As recently as January 2011, the Food and Drug Administration judged medical-device data systems—medical devices and software intended to facilitate the flow and storage of data—to be among the highest-risk technologies in healthcare. Now the FDA considers the category so safe it has declined to oversee them.

The agency outlined its decision in draft guidance released today. In a blog post accompanying the decision, Bakul Patel, senior policy advisor for the FDA's Center for Devices and Radiological Health, suggested that the FDA's changed thinking is the result of the “additional experience” the agency has gained since February 2011, when it first started easing burdens on the device category.

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“Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical-device data systems,” Patel concluded, meaning that developers in the product category will no longer need to register with the FDA, or fulfill quality system obligations associated with category's new Class I, or low-risk, status.

The change means that software that collects data from a glucometer or a weight scale, for example, and conveys or stores that data, will no longer need to comply with FDA rules.

“These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT,” Patel wrote.

The decision was met with approval by industry observers.

“I think it's a big deal both for what it does, and the message that it sends,” said Dr. Joseph Smith, chief medical and science officer of the West Health Institute, a medical research organization. The change should further promote the interoperability of devices, he said, a major goal for his organization.

“You can save money, time, and probably prevent a lot of adverse events by having information move smoothly from one device to another,” Smith said. “Instead of people running around, writing things on the edges of their scrubs, and then moving them from one device to another,” he said, entrepreneurs will be able to provide software solutions that convey the information seamlessly, and they'll be encouraged by the new freedom to do so.

The move also marks another shift in the broader debate about digital healthcare and its governmental regulation. The FDA—along with the Federal Communications Commission and HHS' Office of the National Coordinator for Health Information Technology—have been working to craft an oversight framework for the sector.

Some critics, however, argue that digital healthcare needs to be even more independent from regulation to achieve its full potential—and the debate has become political. Lawmakers in the House and Senate have introduced bills that define a more circumscribed federal role. Recently, House Republicans sent a letter to ONC head Dr. Karen DeSalvo asking whether the agency had the statutory authority to carry out its proposed responsibilities under the draft framework it has introduced with the FCC and the FDA.

Patel's blog post addresses that debate. While drafting the framework, he wrote, the FDA “sought extensive public feedback” and the decision to further deregulate such data systems came “in light of those discussions.”

West Health's Smith, who served on a work group that advised the three federal agencies on their proposed framework, said he was glad that the change honors that process by responding to input. “I think there's been a drumbeat of deregulation” of digital health by the FDA, Smith concluded, and he welcomes it.

Bradley Thompson, a lawyer at Epstein Becker Green, also served on the work group. Thompson felt it was a big, welcome change, but raised one objection as a “nerdy lawyer”: “I'm pretty bothered that they are choosing to do this through a guidance document. That's a sloppy way to regulate. There is a regulation on the books that needs to be changed.”

Some industry sources suggested that the change might also allow data systems to avoid the medical-device excise tax imposed under the Patient Protection and Affordable Care Act. Shielding the digital health sector from the tax has been a key aim of lawmakers pushing legislation that frees manufacturers from regulation. The House and Senate bills would explicitly remove “clinical software and health software” from the realm of medical devices subject to federal regulation.

Thompson, however, isn't buying it. “I'm not sure that's true, although I suspect some people think it is.” He explained that the regulation referring to data systems as medical devices remains in effect, meaning that they could still be taxed. That uncertainty is one weakness of the FDA's use of guidance rather than rulemaking, Thompson said.

Follow Darius Tahir on Twitter: @dariustahir


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