Bradley Merrill Thompson Featured in Article About Mobile Medical AppsFierceMobileHealthcare July 19, 2011
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Science practice, in the Washington, DC, office, was featured in an article titled "Highest-Risk Mobile Medical Apps are Focus of FDA's Draft Guidance."
Following is an excerpt:
Transform the mobile platform into a medical device.
It is crucial to note that decision-support apps will be on FDA's radar. This is an important distinction, and one that many unfamiliar with FDA regulation might miss, said Thompson.
Control an existing medical device's use, function, modes, or energy source.
Thompson said, "In most cases, the level of regulation will directly correspond to the classification of the primary medical device."
Overall, these are the two types of apps likely to be placed in Class II or III, requiring more significant controls. Which class they'll fall into, exactly, is still in question, but using the FDA's current list of medical devices, users can make a solid guess, Thompson said.
Thompson feels that this particular issue needs more clarity, but says that will only come about through full rule-making, with the FDA officially placing different mobile medical apps into specific classifications.
Another area that Thompson believes still needs a more granular description is the "intended use" issue concerning health/wellness apps vs. disease-specific apps. FDA officials indicated they will regulate apps that provide disease- and patient-specific recommendations--such as a smartphone app that tracks a diabetic person's glucose levels, diet and exercise routine and recommends a caloric intake for the day, Thompson explained.
As for apps that essentially do the same thing--for example, tracking weight, diet, exercise, etc.--to give the user a general recommendation on ways to stay healthy? Those aren't likely to be cleared. " We need a level of specificity beyond that," Thompson said.