If you have been following MobiHealthNews’ series of contributed articles penned by Bradley Merrill Thompson, a strategic counsel at EBG Advisors, you know that the regulatory environment facing the mobile health industry is one of the sector's biggest barriers.
As we reported earlier this year, Thompson and Dane Stout, Executive Director of the Anson Group, have formed a “temporary” mHealth Regulatory Coalition that aims to work with the FDA to determine where that line should be drawn and to subsequently make that information readily available. The group plans to disband once it accomplishes it objectives -- hopefully within the next six to 12 months.
The coalition's first meeting took place last week so we caught up with Thompson to hear how it went.
"About 50 people participated in the opening meeting," Thompson told MobiHealthNews. "About half participated in-person while half of the group phones in." Thompson noted that this meeting was open to all comers so the second meeting might be a better indication of how large the group really is. The attendees decided on three key objectives for the coalition. The objectives each focus on three different dimensions of FDA policy:
1. The difference between medical and wellness claims. The FDA has long regulated medical claims, which is the scope given to them by the statute. Much of the activity in the mHealth space is about getting people to be more accountable for their own personal health and to equip them with the tools they need to manage weight, diet, exercise and other habits. The group aims to suggest clarifications for which wellness use cases likely fall outside of the FDA's purview.
2. The limits of FDA's accessory rule. In a nutshell, the FDA regulates any physical items that connect to a medical device just as it regulates the "parent" device. In connected health, however, everything is connected. The beginning and end of the medical device becomes very unclear in this context so the accessory rule needs an update and clarification. (more on FDA accessory regulation here)
3. Software. FDA has a term for certain software called "standalone" software, which is software that is not acting as an accessory to the device. Part of this discussion is included in the MDDS proposal -- systems of systems -- that the FDA never made a final ruling on. The group is going to try to come up with an appropriate approach for which software gets regulated and what doesn't. (more on FDA regulation of software)
These suggestions are proposals for the FDA to consider. Once outlined, the group will meet with the FDA and recommend that they adopt them.