Health IT groups and mobile application developers' reaction to FDA's release of final guidance for mobile health apps is mixed, the Baltimore Sun reports (Wells/Clarke, Baltimore Sun, 9/23).
Details of Final Rule
According to the final guidance issued Monday, FDA will focus oversight on apps that:
- Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
- Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 9/23).
Responses From Health IT Groups
Bradley Merrill Thompson -- general counsel for the mHealth Regulatory Coalition -- said the group is "absolutely delighted that FDA published this guidance" before the end of fiscal year 2013, as the agency had promised lawmakers.
Thompson said the coalition is "particularly pleased that FDA is looking for innovative ways to communicate on a more ongoing basis the kinds of technologies that are regulated, and the kinds that are not."
However, he said MRC is disappointed that "the final guidance is fundamentally like the proposed guidance, and omits some very important areas," including:
- The definition of which apps will be regulated;
- Differences between disease-intended uses and unregulated wellness-intended uses; and
- The exact meaning of an accessory to a medical device (Slabodkin, FierceMobileHealthcare, 9/23).
Meanwhile, the Health IT Now Coalition in a release said FDA "endorsed an old framework" in the final rule.
"We think the administration and Congress ought to work together on updating the 1970s era law to meet the needs of the 2013 and beyond mobile health community," the group said (Health IT Now Coalition release, 9/24).
Reactions From App Developers
Chris Bergstrom -- chief strategy and commercial officer at WellDoc, a developer of mobile apps for managing chronic disease -- said FDA's final guidance does not have any "surprises," adding, "Removing the uncertainty will allow some dollars to come in and more innovation" (Baltimore Sun, 9/23).
Bettina Experton -- president and CEO of Del Mar, a mobile app developer -- said the final rule is "consistent with what [FDA has] said all along." She also said that "there is no conflict of regulation" between the new guidance and requirements of the meaningful use program.
Under the 2009 federal economic stimulus package, health care providers who demonstrate meaningful use of certified electronic health record systems can qualify for Medicaid and Medicare incentive payments (Conn, Modern Healthcare, 9/23).