A long awaited and anticipated report from the U.S. Food and Drug Administration as well as other agencies has finally addressed how healthcare IT, in particular mHealth, 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 will not be submitted to Congress for final review.
Vice President of government and regulatory affairs, Dan Haley, stated that there is “a lot of good language,” in the report.
The language was taken from a collaboration of more than 100 experts and led by the Bipartisan Policy Center (BPC).
Robert Jarrin, Senior Director for Government Affairs said “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. 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.”
In another statement, Bradley Merril Thompson with Epstein Becker & Green, P.C. saidthat he’s pleased the report is out “because we can now start in earnest discussion of next steps. The agencies “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.”
The only thing that Thompson had to offer as criticism is that the repot did lack some high level detail for some of the burning questions in the industry.
Some of these burning questions include the distinction between wellness and disease, exactly what constitutes medical device accessories, what constitutes clinical decision support software that FDA would regulate, and the parsing of medical device software modules for regulation.
“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.'”
Other than this there is strong support for the report’s recommendations to create a Health IT Safety Center.
“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.”
You can download the entire report on the FDA website here.