Congressional Hearings On Potential Regulations of Mobile Apps Conclude

Coverage of Testimony at Three Days of Hearings

The Committee on Energy and Commerce (E&C) has concluded three days of hearings discussing the role of technology in healthcare, and specifically mobile. The hearings resulted in part from a letter sent by committee leaders on March 1, 2013 to FDA Commissioner Margaret Hamburg seeking more information on possible FDA regulation of smartphones, tablets, and mobile apps.  The Hearings were broken down as follows:

  • On Tuesday the technology subcommittee discussed how consumers use existing health and fitness apps
  • On Wednesday the health subcommittee examined how health care practitioners and patients use health apps for diagnoses
  • Today the oversight and investigation subcommittee heard from the FDA and HHS officials including Dr. Farzad Mostashari, National Coordinator of Health Information Technology.

Brian Ahier followed the hearings closely on all three days and has provided an incredibly detailed and thorough overview of the hearings for each day including YouTube videos. From his Healthcare, Technology, and Government 2.0 blog on today’s hearing:

On Thursday, the Subcommittee on Oversight and Investigations heard from HHS and FDA as the final heaing in the series with a look at Administration Perspectives on Innovation and Regulation.

Dr. Farzad Mostashari, National Coordinator of Health Information Technology, gave testimony saying, “To truly transform delivery, health care providers must also redesign and reengineer workflow of care. This does not happen overnight. Health IT holds tremendous promise for delivering “smart health” to patients right at their fingertips to help all of us achieve the best possible outcome for each individual. We must carefully balance the need for the widest innovation possible, with protection of patient privacy, security, and safety.”

Also providing testimony was Ms. Christy Foreman Director, Office of Device Evaluation, Center for Devices and Radiological Health at the FDA. She said: “Just as importantly as what our policy proposes is what our policy does not propose. It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities that exclusively distribute mobile medical apps, such as the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers. It would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. It would not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes. And, it would not apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.”

These three days of hearings look to be a game changer for mobile health technology. Following today’s hearing, the E&C issued this press release, After Multi-Day E&C Hearing Series Highlighting Uncertainty Created by Medical Device Taxes and Regulations, Obama Administration Finally Goes on Record with Pledge Not to Tax Consumers’ Smartphones and Tablets.

Read Brian’s complete coverage of the hearings.