Electronic Health Records

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Congresswoman pushes for additional mHealth app legislation

By Jennifer Bresnick

Representative Marsha Blackburn (R-Tenn.) is proposing additional clarity for the FDA’s recent final guidance on mHealth regulation.  While the Food and Drug Associate promised relatively little involvement in the monitoring of health-related applications for tablets and smartphones, Blackburn is planning to introduce a bill that would codify the risk-based categorization of medical applications and devices in order to focus the FDA’s efforts on the appropriate areas of its oversight.

After keeping the industry waiting for more than two years, the FDA released their guidance on mHealth to sighs of relief from developers and vendors with the confirmation that most apps posing a low risk to consumer health would not need the department’s approval before going to market.  Weight trackers, exercise coaches, and reference and diagnosis apps geared towards patients are not subject to enforcement, leaving a large proportion of the approximately 100,000 apps available in popular mobile marketplaces unregulated.

The bi-partisan bill, H.R. 3303, discussed at the recent Telecommunications Industry Association meeting, would attempt to clarify oversight while maintaining the freedom to innovate.  “Our legislation takes the necessary steps to protect technological innovation that is filtering into growth sectors like health care,” Blackburn said in a press release. “This bill would provide the FDA with the tools it needs to effectively protect consumers who use high risk technologies, while allowing the innovation of low risk technologies to continue without being caught up in the expensive and time consuming FDA approval process all while protecting patient safety.”

mHealth is one of the fastest growing segments of the health IT market, with the sector slated to be work $26 billion by 2017, reaching 1.7 billion users worldwide.  Physicians and patients alike are embracing smartphone apps at an incredible pace, with 93% of physicians believing that a marriage of mHealth and EHR technologies could improve patient outcomes.  The ability to send reminders, conduct administrative tasks, and receive patient-reported health data are among the benefits of mHealth, according to the poll.

“The app economy is characterized by low barriers to entry, quick time to market, and the ability to adapt to quickly changing user needs,” added Rep. Greg Walden (R-Ore.), a co-sponsor of the bill. “Medical devices, on the other hand, face a long and costly pre-market approval process at the FDA. We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine?  Our common-sense legislation gives regulatory clarity to this innovative industry while focusing efforts on potential risks to human health.”




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