The mHealth Regulatory Coalition (MRC) on June 21 sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius urging HHS, through the U.S. Food and Drug Administration (FDA), to publish the final guidance on mobile medical applications (MMA) "as soon as reasonably possible."
The FDA, an agency within HHS, released draft MMA guidance in July 2011 and has publicly stated that they will issue their final guidance by the end of fiscal year 2013. However, according to the MRC, that guidance cannot be finalized fast enough.
"Industry has been awaiting FDA's final guidance on mobile medical apps for nearly two years," states a June 19 MRC position paper that was included with the letter to Sebelius. "There has been some discussion recently regarding whether FDA should delay the release of the final guidance until after the Secretary [of HHS] develops its comprehensive regulatory strategy for all health IT as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of July 9, 2012. We disagree with that view."
FDASIA directs the HHS Secretary, acting through the FDA Commissioner, and in consultation with the HHS Office of the National Coordinator (ONC) for Health Information Technology (IT) and the Chairman of the Federal Communications Commission, to publish a report that will offer a proposed strategy and recommendations for an appropriate risk-based Health IT regulatory framework that would include mobile medical applications.
"The Health IT regulatory strategy required by FDASIA will not provide the level of detail needed by the industry and included in the FDA guidance," argues the MRC position paper. "To delay the release until after the comprehensive Health IT strategy is finalized would only perpetuate the confusion that plagues the mHealth industry today without providing the clarity and direction to enable and accelerate mHealth innovation."
When asked about the validity of MRC's concerns regarding a potential delay, an ONC spokesman told FierceMobileHealthcare that "because the mobile medical apps guidance is FDA's, it wouldn't be appropriate for us to comment."
Formed in 2010, MRC was established to help make certain that the "regulatory environment for mHealth technologies allows for innovation while at the same time protecting patient safety." The organization, which represents device manufacturers and medical app developers, touts itself as the "voice of the mHealth technology stakeholders" with offices in both Washington, D.C. and Brussels, Belgium.
"The timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community," states the letter to Sebelius from Bradley Merrill Thompson, who serves as MRC's general counsel and whose Washington-based law firm, Epstein Becker & Green, assists with the development of the organization's policy and government relation strategies.
In March, Thompson similarly testified on behalf of MRC in front of the House Energy and Commerce Subcommittee on Technology and Communications, calling for the FDA to release its final guidance as soon as possible. Since then, he argues that MRC has "come to learn that some people mistakenly believe that the final guidance will expand FDA jurisdiction." In fact, Thompson says in his letter to Sebelius that "the final guidance, if it is even close to the draft guidance, will be de-regulatory in nature."
"Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear," he states in his letter to HHS. All the more reason that MRC believes "this level of detail is needed by industry" from the FDA's final MMA guidance, which the organization says will "help unlock investment in the mHealth market."
To learn more:
- read the MRC position paper