IEEE's standards for medical devices are also used in hospitals, but that's not the focus of its collaboration with Continua, which is committed to developing "end-to-end, plug-and-play interoperability for personal connected health," according to a press release.
The two organizations have been working together informally for some time to expand the implementation of the IEEE 11073 family of personal health device standards. The Food & Drug Administration (FDA), in a recently released final rule on the design, testing and use of wireless medical devices, referenced the IEEE standards a number of times, pointing out that several of the 11,073 specs are applicable to "point of care medical communications."
IEEE and Continua have interpreted those references to mean that the FDA rule strengthens the case for using IEEE standards, said Chuck Parker, executive director of Continua Health Alliance, in an interview with InformationWeek Healthcare.
[ Read about other interoperability movements afoot: Device Interoperability Effort Seeks Hospital Leaders. ]
"They're recognizing the underlying standards of these devices," said Parker. "So if you build to those IEEE specifications, and you present your device to the FDA, it will be easier for you to get it certified and get an FDA classification."
The other recent FDA announcement that increases the momentum for interoperability, he noted, is the agency's final rule on mobile medical apps. That rule said the FDA would regulate only software that turns smartphones or tablets into medical devices and apps that function as accessories to regulated medical devices. This ruling provides regulatory certainty to developers of mobile health apps that help consumers monitor their conditions, he noted.
Device interoperability, which has safety benefits, is also claimed to save money. According to Parker, the cost of home hubs, which collect and transmit data from wireless monitoring devices in the home, has dropped by a factor of 10 in the past couple of years. "Some of that is because of interoperability, and some of it is because of new competitors in the market that are touting the ability to do plug and play," he said.
The IEEE-Continua news release also cites a study that PWC did for West Health Institute on the benefits of medical device interoperability. The paper estimated that improving the interoperability between medical devices and EHRs in hospitals could save more than $30 billion a year while improving patient care and safety.
Joseph M. Smith, MD, chief medical and science officer of West Health Institute, told InformationWeek Healthcare that medical device makers had little incentive to standardize their interfaces, partly because the introduction of standards would lower the barrier of market entry, creating more competition for the manufacturers.
Parker agreed that some companies do view interoperability from that perspective. But he added, "In the future, I think we'll see a push from buyers to change that." Even if healthcare providers are using system integrators, those integrators will have lower costs in an interoperable environment, he said.
Using 15 of the IEEE's 29 medical device specs, Continua has created what Parker calls a "reference architecture" for plug-and-play device standards. Although Continua's members don't have to use those in their legacy devices, he said, "more and more of them are moving to the reference architecture when they build new devices… Interoperability drives costs lower for application developers and for device manufacturers. It lowers their cost of developing new devices because they're building it into a common platform. They don't have to create a proprietary architecture."
Without interoperability he said, a firm that developed a blood pressure monitor would have to create a portal and a back-end data service to connect it to a healthcare entity. With interoperability, it can let someone else manage the portal and back-end data service. "That can help smaller firms get into the game."
The interoperability between conforming devices and EHRs has already been taken care of, he said. Any EHR that is certified for Meaningful Use Stage 2, he pointed out, must be able to receive a Continuity of Care Document (CCD) in the C-CDA format. Continua's standards require devices to be able to output data to a CCD so they can be transmitted seamlessly to these certified EHRs.