Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology. Two years following the FDA’s issuance of draft guidance on mobile medical applications, without issuing final regulations, opinions are divided on how to resolve such regulatory uncertainty. Industry is asking questions such as “Who should regulate mHealth?” and taking sides on whether FDA final guidance or other regulations should be issued at this time.
On July 21, 2011, the FDA issued draft guidance on mobile medical applications. The FDA has yet to finalize this guidance as it approaches its two-year anniversary. The health care and mhealth industries continue to watch for final guidance from the FDA – as well as input from other government actors. The Food and Drug Administration Safety Innovation Act of 2012 (FDASIA) Workgroup is working to inform the development of a report due by January 2014, as required by Section 618 of the FDASIA. The FDASIA charged the Secretary of the U.S. Department of Health and Human Services (acting through the Commissioner of the FDA in consultation with the National Coordinator for Health Information Technology (ONC) and the Chairman of the Federal Communications Commission) with publishing a report that expresses “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”
In December 2012, the ONC published its own Health Information Technology Patient Safety Action & Surveillance Plan for Public Comment that builds on the recommendations of a November 2011 Institute of Medicine report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” which recommended improving transparency in the reporting of health IT safety incidents and enhancing monitoring of health IT products.
Final FDA guidance on mobile medical applications may be next, but it is unclear when, or even whether the FDA will issue such guidance, even after two years.