Coverage of Congressional Hearings on FDA Guidance on Mobile Medical Applications
Today was the third day of Congressional hearings in a three-part series on the potential impact of regulation on health technologies. In July 2011, FDA issued draft guidance on mobile medical applications to clarify the types of mobile apps to which the FDA “intends to apply its authority”. However, draft guidance simply conveys current thinking of the agency, rather than legally enforceable rules. Thus, there has been significant anticipation from the public on when final guidance will be issued and how it will impact health technology, innovation, and patient care. This anticipation came to a political head earlier this month, when leaders of the House Energy and Commerce Committee wrote to FDA to gather more information on how they plan to regulate mobile medical applications in final guidance. Among the questions they sought to answer were:
- When will FDA issue final guidance on regulatory pathways for mobile medical applications?
- What effect, if any, would the medical device tax have on the development of mobile medical applications?
- What has been the process and approval of mobile medical applications to date?
The hearings of the past three days were called to allow experts, including representatives of the administration, to comment on the current state of regulation and proposed guidance. On Tuesday, the Communications and Technology Subcommittee examined the potential impact of regulation and taxes on mobile applications and devices. Yesterday, the Health Subcommittee discussed health information technologies, mobile medical applications, and potential benefits to American patients and consumers. Today, the Oversight and Investigations Subcommittee heard testimony from representatives of FDA and HHS regarding the Obama administration’s perspective and plans.
Full video coverage and submitted witness testimony of all three days of hearings is available here.