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FDA report hints at relaxed approach to IT rule-making

“Health IT” no longer applies just to a hospital’s scheduling or billing system.

Increasingly, the term denotes a more complex mix of technologies, beyond those performing administrative tasks. It includes software that processes a patient’s electronic health records to suggest treatment, machines that can perform surgery and medical devices that relay information to a physician’s smartphone.

For the first time, the Food and Drug Administration is attempting to draw up a framework for multi-agency oversight of these technologies, all called “health IT.”

In a draft report released last week, the FDA, advised by the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, proposed to focus its oversight on medical-device IT — robotic surgery, for instance, or software that could help a specialist detect a patient’s tumor. Technologies posing less potential risk to patients would fall under the purview of the health IT national coordinator’s office, which is part of the Department of Health and Human Services.

The FDA also proposed creating a Health IT Safety Center, through a public-private partnership, that would group existing health IT programs across federal agencies, including the FCC.

The report, open to public comment for about 90 days, signals that the FDA might pursue a loose regulatory framework for some elements of health-care IT, allowing technologists to innovate without being burdened by federal oversight, said Gartner analyst Wes Rishel.

“All told, it represents a relaxation of concerns for unexpected regulation. It represents a relaxation of concerns for the Nike wristbands, and the home market blood oxygen testers and things like that, that are sold at Best Buy,” he said.

The draft follows a move by Congress directing the FDA to consult with the national coordinator’s office and the FCC on recommendations for rules. Rishel said the proposal is unusual because the FDA also identified areas it does not plan to regulate. Administrative software, for instance, does not require additional oversight, the FDA said in the report.

“The FDA has historically stayed away” from boundaries, Rishel said. “They have never taken a position about whether they should regulate those or not, and Congress essentially forced them to draw a bright line and declare themselves on the issue. That’s what they have done on the draft level in this report.”

In the report, the FDA said it was working to clarify its focus within medical-device health IT — this might include software or medical mobile apps, for instance. It noted that the national coordinator’s office and the FCC might have complementary oversight in areas such as data exchange between medical devices and electronic records and the wireless spectrum.

The national coordinator’s office would continue to oversee health management technology, such as electronic health record software, according to the report. The FDA proposed creating basic guidelines and certification standards for industry players that would encourage safety without stifling innovation.

“Overall, we do not believe that regulation should be or needs to be the first approach used to reach this outcome,” the agency said in the report.

“We’re not looking to expand the footprint of the FDA, and we’re not going to be looking at new authorities,” Jeff Shuren, the agency’s director for the Center for Devices and Radiological Health, said in an interview.

When deciding what to regulate as technology evolves, agencies will consider a system’s function, not the platform it’s on. Take electro-cardiograms: “Traditionally, it’s a box, it comes on a table. Today, there’s a software program we’ve cleared and it will transform your smartphone into an EKG machine. It’s used for the same purpose, and we treat it the same,” Shuren said.

“It’s the same kind of function we’ve been regulating . . . [if it’s] the kind of stuff we’ve approached and approved to classify we still regulate it. It doesn’t matter if it’s in a big box or a small box.”



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