European Commission seeks clinic-ready mHealth apps

The European Commission is set to release guidelines for mHealth apps to enable their use by healthcare professionals by the end of 2016. The guidelines are expected to focus on ensuring data quality to let doctors trust mHealth app's output, separating lifestyle and well-being apps available with no clear evidence on their quality from apps that have clinical validation, enabling a degree of quality control for the diverse mHealth app ecosystem. 

A European Commission (EC) working group will draft voluntary guidelines on the reliability of data used in mobile health (mHealth) apps, according to an EC document. The working group, which includes representatives from industry, the research sector, and consumers, plans to come up with recommendations by the end of the year.

The advice is intended for use by public authorities, hospitals, and healthcare professionals, as well as consumer groups and software developers.

In the document laying out the group's responsibilities, the EC said it is essential to ensure that the data are high quality in order to persuade doctors to use them in clinical practice.

"The large number of lifestyle and well-being apps available with no clear evidence on their quality and reliability is raising concerns about the ability of consumers to assess their usefulness, thus potentially limiting their effective uptake for the benefit of public health," the EC writes.

Peteris Zilgalvis, an EC official, said that a lack of quality control prevented consumers from making informed choices of mHealth apps and that a lack of standards impeded the use of these apps in preventive care and disease management, according to an article in Politico.

The guidelines are supposed to provide information on the purpose of an app, the standards it is based on, the methods used in validating it, and contact information for the developer, according to Zilgalvis.

The work on these quality guidelines follows the drafting of a voluntary code of privacy practices for mHealth app developers, which is now available for public comment and should be finalized soon, according to Politico.

Apps in the US, and Elsewhere

A study published in September 2015 in BMC Medicine found that mobile health applications accredited by the United Kingdom's National Health Service do not adequately protect the privacy of users' personal health information. Lead author Kit Huckvale said he believed the same was true of many other mHealth apps.

From a reliability standpoint, the US Food and Drug Administration (FDA) regulates only a small portion of mHealth apps, including those that transform a smartphone or other mobile platform into an FDA-regulated medical device; those meant to be accessories to regulated devices; and apps that diagnose patients or recommend treatments.

Most of the research being done on the reliability of mHealth apps is occurring in the private sector. The Scripps Translational Science Institute and the Center for Connected Health at Partners Healthcare, for example, both perform such studies. But they are able to assess only a small portion of the apps on the market.

In October, the National Institutes of Health (NIH) announced it would support development of an mHealth research platform to increase the use of this technology in clinical trials. The NIH awarded the University of California San Francisco $9.75 million to develop an Internet platform that researchers can use to conduct mHealth research. The NIH hopes that developers can use the same platform to validate the clinical usefulness of new mHealth technologies. The investigators plan to enroll a million participants over the next 5 years to share their mHealth data in the study.