Examining Federal Regulation of Mobile Medical Apps and Other Health Software
Subcommittee on Health
House Commerce Committee
Tuesday, November 19, 2013
The hearing will examine a final guidance by the Food and Drug Administration to regulate mobile medical applications and certain health-related software. As technology rapidly evolves affecting patients’ access to care, the committee will review FDA’s guidance and seek to understand how it will move forward with the rule. The subcommittee will examine a proposal sponsored by full committee Vice Chairman Marsha Blackburn (R-TN), the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, (H.R. 3303) to improve the agency’s approach on mobile medical application regulation. The hearing follows up on the committee's three-day hearing series last spring in which the committee worked to provide much-needed certainty for patients, providers, and innovators. At the time, the FDA pledged not to regulate and tax consumers' smartphones and tablets.