Mobile medical applications have transformed the practice of modern medicine.1 The proliferation of smart phones, tablets, and other mobile devices among medical professionals and patients has led to an exponential growth in the number of mobile medical applications. Some reports estimate that there are over 40,000 medical applications available for download on smartphones and tablets.2 As of 2011, the market for mobile medical applications on smart phones had reached $718 million.3 The industry for mobile medical applications, however, has been forced to expand without specific regulatory or statutory guidance. The Food and Drug Administration (FDA) still has not yet finalized draft guidelines for mobile medical applications that were released more than a year ago.4 In the absence of definitive action by the FDA, the Congress may step in to clarify what limits, if any, should be placed on mobile medical applications.
On March 4, 2013, the Republican leaders of the House Energy & Commerce Committee, which has jurisdiction over FDA matters, sent a letter to FDA Commissioner Margaret Hamburg.5 The Committee sought information on when the guidance would be finalized and whether mobile devices will be considered by the FDA to be regulated medical devices if those devices make use of medical applications. The Committee also asked a number of questions about FDA approval of mobile medical applications, including the timeline for such approval and whether any applications have been removed from the market by FDA oversight. The Committee has asked the FDA to respond to the letter by March 15, 2013.
On February 21, 2013, Sen. Michael Bennet (D-CO), a member of the Senate Health, Education, Labor, & Pensions, announced that the Department of Health and Human Services (HHS) has formed a workgroup of experts from the business, patient, and consumer communities to provide input on health information technology, including mobile medical applications. Bennet commented that, "It’s more common for us to turn to our smartphones or tablets to get information, including medical advice, and it is important that we create the appropriate set of regulations to keep people safe without getting in the way of innovation."6
Although legislation has not yet been introduced during the current 113th Congress to address mobile medical applications, bills from the 112th Congress may be instructive of the types of steps that Congress may take if the FDA fails to act.
- On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (S. 3187) became law, which requires the FDA to report on a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications.
- Rep. Mike Honda (D-CA) introduced the Health Care Innovation and Marketplace Technologies Act of 2012 (H.R. 6626).7 Although the bill did not see any movement during the 112th Congress, the bill would have directed the Health Information Technology Research Center to address mobile medical applications and created a new Office of Wireless Health Technology within the FDA to coordinate with federal agencies, offices, institutes, and centers involved in the regulation of wireless health technology.
According to one independent study, the FDA has given 510(k) clearance to seventy-five (75) different mobile medical applications.8 The FDA, however, is moving much more slowly than the rapid expansion of the mobile medical applications industry. Regulatory uncertainty in this area could hinder the utilization of technological advancements among doctors and patients. The Congress has clearly indicated that it is willing to pass legislation to address mobile medical applications in the absence of FDA regulations.