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Will ONC shakeup affect mHealth ruling from FDA?

By Jennifer Bresnick

mHealth advocates are worried that Dr. Farzad Mostashari’s sudden departure from the ONC might interfere with pending regulations expected this fall from the Food and Drug Administration (FDA).  The ONC is in the middle of a study viewed as critical to the future of the nation’s health IT infrastructure, including the role of the FDA and other bodies in the role of regulating medical devices and mHealth applications.

“A leadership change at ONC will come at an awkward time for the timely completion of the FDASIA 618 committee work and sorting out the confusion over the regulation of mobile health and clinical decision support software,” said Robert McCray, president and CEO of the San Diego-based Wireless Life Sciences Alliance.  “For the sake of consumers and patients we urge (Health and Human Services Secretary Kathleen Sebelius) to quickly identify a knowledgeable replacement with consensus-building skills and a desire to unleash the power of technology in healthcare, including self-care.”

The workgroup known as FDASIA 618 has been charged with publishing a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications, which promotes innovation, protects patient safety, and avoids regulatory duplication.”  Once the report has been completed, HHS will work with the ONC, FDA, and Federal Communications Committee (FCC) to develop a framework for health IT initiatives, including mHealth.

If the FDASIA 618 report is delayed by the ONC shakeup, or pushed lower down the list of priorities by a new ONC chief, the hotly anticipated mHealth regulations may be delayed even further.  Developers and manufacturers have been waiting since 2011 to see where their products will fall when it comes to FDA regulation, and some industry leaders believe the wait has stunted the growth of a hugely popular consumer market.  At stake is a 2.3% excise tax that would be applied to devices that fall under certain regulations, and naturally, vendors are hoping their offerings won’t be subjected to the fee.

“Dr. Farzad Mostashari certainly recognized the adoption and increased use of mobile devices by everyone in our daily lives. Dr. Mostashari was an ardent supporter of further integrating mobile devices into our meaningful interactions with healthcare providers,” said Thomas Martin, manager of mHIMSS. “What lies ahead remains clarifying and articulating policies surrounding the use of mobile and wireless devices to aid existing polices, harness the vast power of this innovative technology, to ultimately improve the efficacy and efficiency of our healthcare system.”

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