Who should oversee mHealth regs?
'FDA guidance ... does not create the state of certainty that everyone wants.'
Not everyone is eager to see the U.S. Food and Drug Administration 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.
In fact, some are wondering if the FDA is the right agency to oversee mHealth regulation.
"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. "It does not create the state of certainty that everyone wants."
[See also: mHealth app market poised for big growth.]
On June 18, the group of HIT stakeholders – including the College of Health Information Management Executives, American College of Emergency Physicians, American College of Physician Executives, American Medical Group Association, American Medical Informatics Association, American Nurses Association and a score of HIT companies – sent a letter to President Barack Obama asking that any new regulations on the industry be delayed until a workgroup created by the FDA Safety Innovation Act of 2012 finishes its review of the HIT regulatory framework.
The FDASIA workgroup has been meeting regularly, Haley said, and may complete its work before the mandated deadline of the end of this year. At that time, and also mandated by the FDASIA, the Health and Human Services Department will work with the FDA, Federal Communications Commission and the Office of the National Coordinator for Health IT to draft a report for Congress that outlines a proposed strategy for regulating health IT, including mobile technology.
“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."
[See also: Sparks fly over mHealth regs.]
Haley pointed out that both the FDA and ONC are "jockeying for jurisdiction" of the mHealth landscape. The FDA recently issued a warning to medical device makers, healthcare providers and other parties about the dangers of cyber attacks on devices – a move that Haley said caught the industry by surprise. More recently, the ONC launched its own Health IT Patient Safety Action & Surveillance Plan, which left some wondering if the two agencies were competing against each other.
"There's a lot of distracting conversation about the health IT field," Haley said. "We're asking everyone to take a breath."
That, however, is not what the mHealth Regulatory Coalition wants. In a letter issued after the HIT stakeholders' plea and directed to HHS Secretary Kathleen Sebelius, the coalition urged the FDA to issue its final guidance as soon as possible.
"The MRC believes 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," wrote Bradley Merrill Thompson, a Washington DC attorney and coalition member, in the June 21 letter. The guidance, he said, "is needed by industry and will help unlock investment in the mHealth market. Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear."
"(Sebelius') objectives are different from the FDA regulatory framework on mobile medical apps. The secretary is charged with making broad policy recommendations on a comprehensive strategy for all Health IT," the MRC concluded in a position paper that accompanied Thompson's letter. "FDA’s guidance, on the other hand, is focused on providing specific details of whether different mobile medical apps will be regulated or not – this is the level of regulatory detail app developers need now."
In response, Haley said Sebelius and the FDASIA committee have to determine how the entire industry should be regulated, not allow individual departments or agencies to stake their claim to different segments like mHealth. He pointed out that the FDASIA calls for an end to "unnecessary regulatory duplication," and that the FDA's final guidance document "might contradict that."
At least one organization is convinced the FDA isn't fit to oversee mHealth. In 2011, the Institute of Medicine issued a report – after being directed to do so by the ONC – advising that the FDA isn't the right agency to regulate HIT. The report indicated the FDA would likely hinder market innovation, which could also jeopardize patient safety, and has neither the manpower nor the investigative capabilities to regulate medical devices.
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