In the next few days — after two years of waiting — the FDA will publish its final guidelines for mobile medical apps. That was the plan, anyway.
News of the imminent publication of the guidelines prompted the Bipartisan Policy Center to make moves to put pressure on HHS to stop it. Last week the group got 129 companies and associations to sign a letter that urges the administration to hold off on publishing the FDA’s final guidelines on mobile medical apps until an ONC workgroup focused on developing a risk-based framework for health IT regulations finishes its work.
The formation of this workgroup was not mandated by the FDASIA legislation that passed last year. As MobiHealthNews reported at the time of the law’s passage last July, the House and Senate agreed to keep an amendment that calls for the Secretary of HHS to work with the FDA, ONC and FCC to develop a report to be delivered to Congress within 18 months that includes “a strategy for coordinating the regulation of health information technology in order to avoid regulatory duplication” and “recommendations on an appropriate regulatory framework for health information technology, including a risk-based framework.” Language that originally required the FDA to wait until this report was completed was removed so that the final guidelines could be published when ready. The law also left it up to the Secretary of HHS to decide whether she should form a committee of outside stakeholder to help inform the required report. That’s why HHS decided to form the FDASIA workgroup.
Now, on the eve of the FDA’s publication of the final guidelines, the Bipartisan Policy Center and companies that include McKesson, Microsoft, Oracle, athenahealth, Epocrates, Siemens, UnitedHealth Group, Teladoc, the Silicon Valley Chapter of Health 2.0 and StartUp Health have asked HHS to delay the FDA’s final guidelines on mobile medical apps until the workgroup finishes. Currently the FDASIA workgroup’s recommendations are not likely to be finished until after the deadline that the agency (kind of) promised Congress — the end of its fiscal year in September. (CORRECTION: The list above incorrectly included Verizon as a signatory of the BPC letter. Verizon did not sign the BPC letter.)
Meanwhile, the mHealth Regulatory Coalition, which includes about 20 companies that represent many of the pioneers of mobile health — WellDoc, AgaMatrix, GreatCall and more — has sent its own letter to HHS urging it to let the FDA publish its guidelines without haste. Here’s how the MRC’s letter concludes:
“The Secretary’s 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. 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.”
I was surprised to find that health academy StartUp Health was on the list of companies in favor of delaying FDA final guidance for mobile medical apps. I asked Unity Stoakes, StartUp Health co-founder and president why they signed the BPC’s letter.
“We want to make sure that there is sufficient time to develop guidelines and a process that is entrepreneur friendly so that we don’t inadvertently slow the pace of innovation or discourage progress. It’s essential that patient safety comes first, but a process for oversight doesn’t stifle innovation. We look forward to continuing to work with the Administration as well as Congress to ensure that health IT is regulated in a way that achieves the goals of improving the quality, safety and cost-effectiveness of care.”
If the FDA doesn’t publish its final guidelines in the next week or so, it is likely the BPC coalition convinced HHS to intervene and regulatory clarity for mobile health will continue to be left in the lurch.