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Cover Focus | Apr 2016

What Can mHealth Do for You(r Patients)?

Regulations are coming for mobile health apps.

Did you know that there are nearly 100,000 mobile health (mHealth) applications (apps) available to consumers on the global market? Or that the top 20 free sports, fitness, and health apps account for 231 million downloads worldwide? Or that, by 2017, it is estimated that nearly half of the 3.4 billion people who own smartphones will be using mHealth apps?1


• The European Commission is working to create guidelines that will help to evaluate the validity and reliability of the data that mHealth apps collect and process.

• These guidelines should be published by the end of 2016.

Even if you did not know these statistics, it is likely that you at least know that mHealth apps are steadily gaining in popularity. (All you have to do is count the number of your friends or family members wearing a FitBit or similar technology on their wrists.) What might not be as plain to see, however, is whether and how these apps are deemed appropriate and safe for public use.

In order to address this concern and others regarding mHealth, the European Commission (EC) recently expressed an intent to create guidelines that will help to evaluate the validity and reliability of the data that mHealth apps collect and process. This initiative is in answer to the results of the EC’s Green Paper on Mobile Health, which indicated that two barriers to mHealth app adoption are safety and the transparency of health data information.2 In other words, consumers are finding it difficult to identify which mHealth apps reliably produce quality data. On top of this, production of quality data is indispensable to the process of linking mHealth apps to electronic health records.

These limiters could affect the uptake by the general public of mHealth apps, an industry that could save the European Union an estimated 99 billion in health care costs in 2017 alone.1

This issue also affects health care practitioners, the European Commission pointed out: “In order to fully benefit from the mobile health apps that people increasingly use to monitor their lifestyle and health status or to manage their chronic disease, it should be possible in the future to link data from these apps to [patients’] electronic health records,” EC staffers wrote in a news release. “Also, health professionals need reassurance about the reliability of [mHealth] apps, in order to be able to recommend apps to their patients and take apps’ data into consideration in a treatment/monitoring process.”

According to the EC news release, a working group consisting of 20 associations, research institutes, nongovernmental organizations, and corporations met for the first time in March.

“The group will seek to provide common quality criteria and assessment methodologies that could help different stakeholders in assessing the validity and reliability of mobile health applications,” the EC release said.

Once in place, the guidelines will help stakeholders—consumers, electronic health record vendors, and app developers, to name a few—to assess the quality of health app data. The guidelines should be published by the end of this year.

1. Healthcare in your pocket: Unlocking the potential of mHealth [press release]. European Commission website. April 10, 2014. http://europa.eu/rapid/press-release_IP-14-394_en.htm. Accessed March 8, 2016.

2. Green Paper on Mobile Health. European Commission website. October 4, 2014. https://ec.europa.eu/digital-single-market/en/news/green-paper-mobile-health-mhealth). Accessed March 8, 2016.