On Wednesday, a bipartisan group of six senators sent a letter to FDA Commissioner Margaret Hamburg asking for clarification on the agency’s regulations for mobile health applications, The Hill’s“Healthwatch” reports (Viebeck, “Healthwatch,” The Hill, 3/19).
In September 2013, FDA issued final guidance for mobile health applications. The guidance said FDA will focus oversight on apps that:
Meanwhile, FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT are expected to provide Congress with a risk-based regulatory framework for health IT by the end of March.
The report, which was due to Congress by January 2014, is required under the Food and Drug Administration Safety and Innovation Act (iHealthBeat, 2/26).
The letter was signed by Sens.:
In the letter, the senators praised FDA’s work on mobile medical applications. However, they requested more details on the agency’s plans for oversight of mobile medical apps and asked if the agency needed the support of legislation.
They wrote, “[M]ore transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” adding that the FDA should be careful “that innovation is not stifled through uncertainty or over regulation” (Ethridge, CQ Roll Call, 3/19).
The lawmakers asked FDA to provide details on: