Feds: Draft med device interoperability standards could come this spring

Draft interoperability standards for medical devices could be on their way as soon as April, according to officials from the Office of the National Coordinator of Health IT and the U.S. Food and Drug Administration, speaking at the Health Care Innovation Day event hosted by the West Health Institute in Washington, D.C., Thursday.

"We talked about the standards. We'll continue the efforts. We'll have more things rolling out," Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (pictured), said during a panel discussion with ONC and West Health representatives. "We're going to put out draft guidance this coming year about how we think about interoperability and recommendations for how device developers should think about it."

Shuren said FDA has been working with the software and medical device community, and anticipates something going out to the public in the next two months. He said all parties have been brainstorming on what to do to accelerate the process, and want to make clear to manufacturers that the FDA is not standing in their way. Manufacturers should know patients have the rights to their own data, Shuren said.

Cybersecurity is a concern, as well, Shuren said. He warned that the government can't develop anything that's fail proof, but they have to look at the risks. With interconnected devices comes a bigger chance of hacking.

Doug Fridsma, chief science office & director of the Office of Science & Technology at ONC, said defining interoperability is important--developers must define why they want devices to talk to each other and the functionality they want to see.

"When it comes to things like interoperability, my first question is, if somebody says 'Are the two systems interoperable?' the first question is, 'Well, what do you want to do?' Fridsma said. "Because that will tell you whether or not they can actually connect and are interoperable. So what that does is there's a whole series of things that come from that definition. The first thing is that it has to be grounded in things that you want to accomplish."

For a policy that will work to align business incentives and ensure people are focused on interoperability, the government doesn't necessarily have "all the pieces it needs," Fridsma said, but Meaningful Use has given them a "turn of the crank," and some existing standards can be leveraged for other purposes.

"We have to take the path of least regret," he said. "We don't know what the future is going to hold. We're constantly scanning for new technology and new ways to do things."

Shuren added: "We're not there yet. There's more to do. Standards follow technology and [will always] play catchup."

Also on Thursday, National Coordinator for Health IT Karen DeSalvo said interoperability will inspire trust and confidence in the public and empower consumers to be more engaged in their care.

In an editorial published last fall, FierceHealthIT's Gienna Shaw wrote that medical device interoperability is an "intensive, mission-critical mess that the industry must address." 

An analysis by West Health last spring found that the healthcare industry could save roughly $30 billion if it fixes the interoperability problem, including $12 billion in savings when highly trained people are providing care instead of transcribing data from one device or system to another.


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