Organizations Submit Comments to FDA on mHealth Regulation

The mHealth Regulatory Coalition (MRC) and the Health Information & Management Systems Society (HIMSS) have each recently submitted comments to the FDA regarding proposed regulations for mobile medical applications.

In its letter, the MRC urged that the FDA clarify which types of mobile health products will be regulated and which types will not be regulated, adding that the agency should focus regulation on moderate- to high-risk devices and exempt low-risk ones; consider whether accessories to medical devices should always be regulated in the same manner as their parent devices; clarify the roles and responsibilities of entities involved in mHealth systems, urging in particular that regulation of an application should fall on the producer of the app alone and not the app store that distributes it or the maker of the smartphone that is used to run it; and encourage the use of standard software design principles and develop classification regulations for mHealth software to facilitate appropriate risk-based regulation. To download a pdf of the MRC’s full letter, click here.

In its letter, HIMSS urged the FDA to educate hospitals, health systems, providers, and developers regarding FDA policies and procedures, since many in these groups do not have experience being regulated by the FDA as mobile medical device manufacturers. To download a pdf of the HIMSS’s full letter, click here.