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 “More Health Apps Out There, But Regulation Lagging.”
Following is an excerpt:
The number of mobile health applications available for smartphones and other mobile communication devices is exploding, but the Food and Drug Administration has yet to offer final guidance about which of these apps it will regulate.
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said in an email that scientists are working on apps that would be connected to sensors that would measure different patient health statuses. One example he gave is a “smart pill” app. Patients would ingest pills with sensors. Information from the sensors in the pills would be displayed on a mobile phone so that patients could keep track of such things as exactly when they took their medicine. This pill tracking app could help doctors too because they would have an exact record of which medicine a patient took and when.
A working group was created to provide input on the development of this framework to the ONC. The group began holding meetings earlier this year and is supposed to issue a report to ONC’s Health IT Policy Committee by January. There is some speculation that the group could finish its work earlier than that.
Thompson, a member of the working group, said that further delay of the final FDA guidance would be “industry unfriendly” because it could prevent IT startups and larger companies from investing in mobile health app technologies. In an email, Thompson said FDA guidance, written in more layman’s terms would, “help entrepreneurs who just want to understand what [the] existing rules are.”