Who should regulate Mobile Health?

Eric Wicklund | Government Health IT | July 12, 2013

Not everyone is eager to see the U.S. Food and Drug Administration [FDA] issue its final guidance on mobile medical app regulation.

While the mHealth Regulatory Coalition and several mHealth advocates have asked the FDA to release its long-delayed guidance – which has been in the works since the agency issued preliminary guidelines in late 2011 – a coalition of roughly 120 health IT stakeholders has asked the government to put the brakes on the FDA until a much more wide-ranging study of HIT regulations is finished.

..."The most important thing to understand is that the FDA guidance does not provide certainty and won't provide regulatory certainty," said Dan Haley, vice president of government and regulatory affairs for athenahealth.

...“While proper oversight of health IT is critical to ensuring patient safety, such oversight must be implemented in a balanced way that also fosters innovation and encourages adoption of these technologies,” the letter stated. "The thoughtful, comprehensive, and inclusive approach being taken by the administration to inform Congress will be critical as it develops this new regulatory framework for health IT."