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Apps Developers Say Interoperability, FDA's Guidance Key Concerns for Industry
House Subcommittee Hearing on Mobile Medical Apps

Washington, June 27, 2013 -

Bloomberg BNA

By Kendra Casey Plank

(BNA) -- House Subcommittee Hearing on Mobile Medical Apps

Key Point: Health IT vendors are not voluntarily adopting common interoperabilty standards.

Chief Concern: Vendors are awaiting final guidance from FDA on mobile medical apps oversight.

The health care technology industry is not lacking interoperability standards for health information and medical record systems, but vendors have no incentive to agree on common standards for their products, a panel of mobile medical applications developers told a House subcommittee June 27.

One witness suggested the federal government force health IT vendors to use common interoperability standards, charging that failure to do so could derail health reform efforts that rely on data sharing among providers and hospitals. In addition, witnesses told lawmakers they are awaiting final guidance from the Food and Drug Administration that will specify where their products fit in the federal government's regulatory framework.

The comments were made during a hearing of the House Small Business Committee's Health and Technology Subcommittee on mobile medical applications. Witnesses showcased mobile medical apps developed for use by patients and providers to access data, including information from federal programs.

Alan Portela, chief executive officer of AirStrip, a health IT contractor for the Department of Defense, said IT vendors have agreed on widespread use of just one interoperability standard—HL7, for continuity of care documents. And, even for that standard, he explained, there are variations and deviations from a single way of handling data.

Without government intervention to push common interoperability standards, Portela cautioned, it is unlikely vendors will adopt such common standards on their own.

In written testimony, Portela said the health IT industry has “largely over-promised and under-delivered when it comes to vendors playing nice in the sandbox,” and it has not integrated systems, made medical devices interoperable, or made data available across the care continuum.

Portela described mobility as an answer to some interoperability challenges, because most solutions provide access to data from various platforms in disparate locations.

“Mobility also overcomes what we've always known as the traditional barriers to interoperability—disparate data sources on the back end and conflicting and varied user preferences on the front end,” he said in his prepared testimony.

Mobile Access Solution

Christopher Burrow, executive vice president for medical affairs at health IT vendor Humetrix, told the committee that although large IT systems developed by various vendors might not be interoperable, giving patients mobile access to their health records through blue button technology could overcome some barriers. Blue button tools allow consumers to download their health information via an online patient portal.

For example, he said, blue button products—including the iBlueButton app developed by Humetrix—give patients the ability to use their smartphones to share summary medical records with their doctors and hospitals.

“That helps solve part of the interoperability problem,” Burrow said.

Expecting Final FDA Guidance

FDA published draft guidance on mobile medical apps in July 2011 (139 HCDR, 7/20/11). The agency proposed to focus its oversight on mobile medical applications that were used as accessories to medical devices or that, by nature of their function, turned a mobile device (such as a smartphone) into a medical device.

However, the guidance has yet to be made final, and in March, House Republicans raised concerns with FDA leadership about the delay, in part because how FDA decides to regulate the apps could determine whether some are taxed as medical devices under the Affordable Care Act (44 HCDR, 3/6/13).

Portela said he welcomed more FDA regulation of mobile medical apps developers, saying such oversight was necessary to ensure quality of care for patients.

“Traditionally, the FDA has focused on regulating hardware devices, but companies producing software-only medical device apps or even websites need to be regulated as well,” Portela said in his written testimony. Today, many websites or apps have crept into FDA-regulated territory without scrutiny by adding features or functionality that position them as clinical decision support systems.”

Portela said those products, because they are used in the treatment and diagnosis of patients deserve greater FDA scrutiny than they are receiving.

Testimony from the hearing is at /calendar/eventsingle.aspx?EventID=326859.

The above story appeared in:

Health Care Daily Report