But 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.
Fortunately in Europe a working group representing 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 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 with the confidence to start including app data into clinical assessments and patient electronic health records.