Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “Multiple Risk Classifications Sought for mHealth Software Apps.”
Following is an excerpt:
A coalition of mobile health technology stakeholders is calling for certain types of multi-purpose software to be regulated at different levels based on various uses and not at one all-encompassing risk level. The mHealth advocacy coalition also offers a list of classifications for a slew of mobile health software devices and delineates the types of devices that it believes should not be regulated by FDA, outlining its proposals in guidance it developed on regulating these technologies.
The coalition attempted to take a new approach to the issue of multi-purpose software rather than regulating the full package at the riskiest level, said mHealth Regulation Coalition General Counsel Bradley Merrill Thompson, and the group recommended that each element of the software be considered separately. “That really is the goal — to say just because you have a software package that does lots of different things doesn’t mean it gets regulated to the highest level,” he said. “There’s ways to break it apart into chunks and regulate each chunk differently.” He noted that such a method is used in the aeronautic industry.
Thompson added that, historically, if a software part is considered a Medical Device Data System (MDDS) but some of it also conducts trend analyses on data taken from a Class II medical device, the whole software package has been considered as Class II, the moderate risk category.