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 "mHealth Regs Spark Debate."
Following is an excerpt:
A fire continues to burn unchallenged as various stakeholders take sides over the anticipated depth and timing of mobile app regulation. It appears this most recent iteration flamed up after the Food and Drug Administration issued an "it has come to our attention" letter to Biosense for its UChek urine analyzer.
Brad Thompson, attorney for the mHealth Regulatory Coalition, submitted a letter to regulators the same week urging the release of mobile app regulations as soon as possible. Thompson is a member of the workgroup preparing the report. He wants to make it clear he doesn't speak for the workgroup; however, as a member, he said he's "pretty familiar with what that group is doing, and I don't see publishing the FDA guidance as frustrating that at all."
Mobile app developers need regulations now in order to know if their product needs FDA approval. Without it, they could be breaking a federal statute if they go to market. "It's unconscionable to not have regulations," Thompson said.
