European Commission to develop mHealth app guidelines

A working group representing European citizens, research and industry organizations will kick off an effort in March to develop guidelines for verifying mHealth app data.

The 20-member group, established by the European Commission (EC), is investigating quality criteria and assessment methods that stakeholders, from consumers to payers, can use in determining reliability and validity of apps.

"The large number of lifestyle and wellbeing apps available, combined with no clear evidence on their quality and reliability, is raising concerns about the ability of consumers to assess their usefulness," an announcement notes. "This could limit the effective uptake of mHealth apps to the benefit of public health."

Mobile health apps in the U.S. also are under scrutiny given little federal agency oversight and studies indicating many of the thousands of mHealth apps have not been vetted or assessed as needed. A Journal of the American Medical Association article published last year revealed the number of viable, safe and beneficial mHealth apps is a big unknown.

Yet not everyone believes deeper review and critique of apps is necessary. An ex-Food and Drug Administration deputy commissioner and a former special assistant to FDA chief counsel believes the agency should exempt most health and wellness apps from premarket review.

The EC effort follows public consultation regarding mobile health technology and the challenges facing the mHealth market.

"Safety and transparency of information were identified by the respondents to the consultation as one of the main issues for mHealth uptake," according to the announcement. "Ensuring quality of the data that health apps collect and process is also essential for linking apps to electronic health records and for their effective uptake in clinical practice."

The working group expects to finalize the guidelines by the end of this year. The ultimate goal, notes a National Law Review post, is providing physicians the confidence to start including app data into clinical assessments and patient electronic health records.

For more information:
- read the European Commission announcement
- read the article at the National Law Review

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