The FDASIA Workgroup, a coalition of healthcare stakeholders including members of the mHealth industry, governmental agencies, and patient safety advocates, released its final recommendations to the HIT Policy Committee last week regarding the regulation of the mobile health industry. The workgroup’s report clearly stated that the FDA should hasten the completion of its long-awaited guidance framework, promised in 2011 to a slew of eager developers, manufacturers, and vendors.
At its meeting on September 4, the Health IT Policy Committee, which advises HHS through the ONC, accepted the draft recommendations of the FDASIA and agreed to pass on the information to the FDA, ONC, and FCC for further action. The workgroup’s report states that the “FDA should expedite guidance on HIT software, mobile medical apps and related matters,” and explains that the preliminary report includes “current regulatory frameworks, potential new approaches and deficiencies, ambiguities and duplication in current frameworks,” as well as “what we believe will be helpful to promote innovation in both the short and long term and maintain patient safety.”
The FDASIA’s recommendations for the regulation of mHealth, home monitoring equipment, and other medical devices includes the suggestion that most health IT devices should not be subject to FDA regulations unless they fall under the specific category of “medical device accessories” or perform certain high-risk functions, including clinical decision support, that should be under government oversight. The workgroup notes that the FDA should take a collaborative approach for post-market surveillance that includes stakeholder input and cooperation with other federal agencies.
The committee also proposes that the FDA periodically review its frameworks and rulings as technology advances and products change in function and scope, as well as encouraging the Agency to establish a firmer line between “wellness” products and more clinically rigorous apps and devices.
“It is incredibly important for companies to understand if their app will not be regulated,” states a position paper from the mHealth Regulatory Coalition (MRC) urging the FDA to speed the release of official regulatory guidance. “Right now, many companies are sitting on the sidelines and not developing higher risk apps because the rules are unclear. They do not want to invest in developing a quality system, taking the time to develop evidence, and submitting that evidence to FDA as needed, if their competition is going to be able to undercut them by not investing in FDA compliance. The final guidance will clarify those higher risk apps that are subject to FDA regulation and help level the playing field for companies in that segment.”