A widely anticipated report from the U.S. Food and Drug Administration and other agencies may finally clear the air on how healthcare IT – and mHealth in particular – will be regulated.

The Department of Health and Human Services' Office of the National Coordinator for Health IT and the Federal Communications Commission joined the FDA in drafting the report, which was mandated under the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012. The report now goes on to Congress.

Dan Haley, vice president of government and regulatory affairs and assistant general counsel at athenahealth, said he sees “a lot of good language,” in the report. That language was taken from an industry collaboration of 100 or more experts, including athenahealth, led by the Bipartisan Policy Center (BPC). 

"I think it implies that many of the functionalities found in HIT software and related products that may currently warrant regulation may no longer do so," Robert Jarrin, senior director for government affairs for Qualcomm and a member of the FDASIA External Working Group told mHealth News. "If that is the case, developers of HIT software and products such as CDS can rest assured that they will not run afoul of FDA regulation.”

Bradley Merrill Thompson, an attorney with Epstein Becker & Green, P.C., said that he's pleased the report is out “because we can now start in earnest discussion of next steps.”

Thompson added that the agencies did “an excellent job of following the recommendations of the working group.” Because of that, the report doesn’t hold many surprises, he said.

“I think all of those are good ideas, and frankly I think it shows that people in industry, on Capitol Hill, and in the agencies are largely in agreement,” he said. “Indeed, it seems that all three sectors are saying about 90 percent the same things. The bottom line is that HHS, and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for all of the HIT developers producing wonderful, important, cutting-edge new technologies.”

Thompson continued that the report does, however lack a high level of detail for some of the burning questions in the industry, including the distinction between wellness and disease; exactly what constitutes medical device accessories; exactly what constitutes clinical decision support software that FDA would regulate, and the parsing of medical device software modules for regulation.

New in the report is the proposal to rely heavily on ONC to direct standards, certification, private-sector partnerships and the issuance of best practices for this category.

"By stating that FDA will not actively oversee what the report calls 'Administrative HIT products' and 'Health Management HIT,' even if they meet the FDA's definition of a medical device – this could be pretty huge," Jarrin added.  "I found the line on the executive summary quite telling: 'We believe a limited, narrowly-tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities is prudent.  We also recommend that no new or additional areas of FDA oversight are needed.'"  

Athenahealth’s Haley added that this report looks a lot like the guidance FDA issued in September. 

“Like the mHealth guidance, it relies heavily on specific examples that will be obsolete in short order,” Haley said. “And it also assumes wide agency enforcement discretion to determine on a case-by-case basis what will be regulated and when. There are some very encouraging indications in here. But, ultimately Congress needs to codify an oversight framework. That is how the system is supposed to work: Congress sets the parameters within which the agencies regulate.”

Also weighing in was ACT, an international grassroots organization representing more than 5,000 small-and mid-sized app developers and IT firms.

"ACT is pleased that the FDASIA recommendations promote medical app innovation within a risk-based framework that protects patient safety," executive director Morgan Reed said in a press release. "ACT welcomes the report’s conclusion that functionality should be the key regulatory determinant. A product’s function — as opposed to its platform — should determine how it is regulated. It is essential to keep a clear path for innovation, but we agree this must begin with patient safety. We support the report’s findings that regulation need not be the first approach to provide safe and effective mobile healthcare solutions." 

We strongly support the report’s recommendation to create a Health IT Safety Center," Reed added. "Convening stakeholders to identify sustainable, innovative health IT systems is critical, and ACT will provide significant input through this open and transparent process. We look forward to bringing our expertise in mobile app privacy, security, COPPA, and other regulatory frameworks to this discussion."

Download the report on FDA's website here.

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