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As part of a broad effort to develop recommendations to the Food and Drug Administration on how the federal agency should regulate mobile health technologies, the Health Regulatory Coalition has published a white paper laying out key questions facing the mobile health industry as it navigates the regulatory obligations for its products.
Topping the list of challenges for mobile health technology developers is determining which of their products the FDA might consider as being intended for diagnosing, treating, or preventing diseases, thus defining them as medical devices subject to federal regulation, the coalition said in the Dec. 22, 2010, report, A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth.
While many mobile health technologies are intended to help patients make better lifestyle choices, and as such promote healthy living, the group said there remains a “gray area” about when those mobile health products begin to be used for more complex health care applications.
“The overarching question is at what point does a product cease serving a wellness function and start serving a medical purpose?” the group asked in the report.
For example, the report questioned when a weight management product, such as a scale with wireless features that transmits patient data among patients and providers, does more than assist in health conditioning and begins aiding in the prevention or treatment of obesity.
Given the uncertainty about how the FDA might classify mobile health products based on how their intended uses are defined, the group also questioned whether mobile health product manufacturers could manage the scope of their products' intended uses through their stated claims about products, in promotional materials, and with marketing approaches.
“To what extent can manufacturers discuss the natural implications of wellness, such as reduced risks of heart disease or diabetes, without creating a medical device claim?” the group questioned in the report.
The coalition did not recommend solutions to the challenges it raised in the report, but instead said the analysis of industry issues would be used to develop recommendations to the FDA for issuing industry guidance on mobile health technologies not currently regulated at the federal level but which the agency might have the authority to pull under its oversight umbrella.
The mHealth Regulatory Coalition was formed in July 2010 and is comprised of information technology developers and vendors and IT industry groups. The coalition, started by health care attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, and heath IT executive Dane Stout, with the IT consulting firm Anson Group, spent five months working on the white paper that will be used to launch its next phase of developing solutions to the challenges raised in the report.
In addition to concerns about how the FDA might classify the intended uses of mobile health technologies, the coalition said it also is concerned with how the agency might use the so-called accessory rule to regulate mobile health products that do not meet federal standards for regulation as stand-alone medical devices.
The FDA already regulates some accessories to medical devices--products that are distributed to end users (including patients) separately from medical devices but are intended to be used with medical devices.
The coalition said in the report that given how broadly the accessory rule could be applied, and absent guidance from the FDA on the matter, any manner of mobile device that could be used for a health care purpose could be subject to FDA oversight.
“Indeed, if the current accessory rule were applied equally across the spectrum of mobile and wireless-enabled medical devices, mobile phones, entire cellular networks operated by carriers such as AT&T and Verizon, and even the Internet itself, could potentially be considered accessories to a device,” the group wrote in the report, calling that potentially broad application of the rule “huge and overly burdensome for the public, the FDA, and the future of mHealth technology.”
The coalition likewise raised questions about federal regulation of software used for mobile health purposes, including what software applications are considered a medical device by FDA, which software applications are considered medical devices but meet FDA standards for certain oversight exemptions, and which software applications could be considered medical device accessories and regulated as such.
While the coalition said it will continue its work on developing recommendations to the FDA for how mobile health technologies should be regulated, it said it intends for the report also to help the FDA in its existing efforts to develop guidance on how mobile health products will be regulated by the agency.
The white paper is available at http://mhealthregulatorycoalition.org/wp-content/uploads/2010/12/mrcwhitefinal122210.pdf.
Additional information about the mHealth Regulatory Coalition is available at http://mhealthregulatorycoalition.org.
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