Regulatory agencies' light touch on 'lower risk' mobile medical apps

By John DeGaspari

With the explosive growth of mobile medical apps, is it time for regulatory agencies to issue guidance on the use of these tools? In both Britain and the U.S., the answer is a qualified yes.

In April, the Royal College of Physicians, in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA) and the General Medical Council, an independent group, issued a fact sheet for medical practitioners. The guidance defines medical apps as those that support diagnosis, make calculations that determine diagnosis or treatment, or are used for any medical purpose classed as medical devices.

The guidance offers two key pieces of advice for physicians: They should not use medical apps, including web apps, that do not have a CE mark, which signifies that the product conforms with European Union regulations that apply to it; and they should always exercise professional judgment before relying on information from an app. Significantly, even apps that bear the CE mark do not necessarily meet the latest evolving best practices.

Regulatory developments around mobile medical aps have been taking place in the U.S. as well. In February 2015, the Food and Drug Administration issued new guidance on mobile medical apps, which replaces its earlier version from 2013.

As noted by VentureBeat, the FDA has taken a generally "hands off" approach for mobile medical apps that don't pose a real health threat if they malfunction. Apps that help users track basic health metrics or self-manage a disease without providing specific treatment advice will be left alone.

An article on PLoS Blogs agrees with that assessment, saying the FDA has taken a clinical approach of what types of apps fall into its domain. Yet the article also states that even lower risk medical apps could be harmful if it contains misleading or harmful medical information. Again, education and literacy--judgment--is critical when it comes to mobile medical apps.

To learn more:
- here's the fact sheet (.pdf)