Unclear regs challenge pharmaceutical mHealth strategies

Despite complicated regulatory hurdles, pharmaceutical companies continue to evolve their mHealth strategies in compliance with the U.S. Food and Drug Administration and European Medicines Agency's "ever-changing and obscure guidelines," according to a new study by Research Triangle Park, N.C.-based consulting firm Cutting Edge Information.

The study, "Pharmaceutical Mobile Health: Transforming Brand Marketing, Healthcare Communication and Patient Adherence," concludes that many regulatory bodies, including the FDA and EMA, are only beginning to understand the potential benefits of mHealth apps.

In Europe, while the EMA's ban on direct-to-consumer advertising has limited the marketing potential of mHealth, it has not prevented pharma companies from communicating unbranded disease awareness efforts, according to Cutting Edge Information. However, in the U.S., the FDA's "lack of clear mobile guidelines and inconsistent enforcement, have kept U.S. companies struggling with mHealth strategies," according to an announcement touting the study.

Nevertheless, Michelle Vitko, senior research analyst at Cutting Edge, says that despite all of the uncertainties in government regulation, the outlook for mHealth in pharma is "optimistic."

A recent article published on the mHIMSS website by attorneys at Arent Fox law firm in Washington, D.C. reviewed some of the regulatory issues that made mHealth news from 2012 that they believe will spill over into 2013. At the top of the lawyers' list was the FDA's ongoing efforts to finalize guidance for industry on mobile medical applications; the guidance is intended to establish a pathway for regulating certain MMAs as medical devices.

To learn more:
- read the announcement
- download the study