The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.”

The subcommittee heard from five witnesses. Unlike the first day of hearings, which focused mainly on MMAs, day two discussion involved broader questions of health information technology (“HIT”) such as the rate of adoption of electronic health records (“EHR”) and other types of software used in medical facilities. The witnesses’ main points were as follows:

  • The widespread adoption of EHR and other HIT platforms is encouraging and has already provided benefits in terms of communications between healthcare facilities, providers, and patients; improved patient safety; and reduced medical error rates. Broader adoption of MMAs are just a part of this expansion of healthcare.
  • Despite this widespread expansion, the panelists acknowledged that the current HIT systems are not perfect and that meaningful federal leadership is needed. The witnesses called on FDA to finalize the draft guidance to MMA developers issued in July 2011. They also advocated for a nimble, risk-based system of regulation that accounts for stakeholder input and provides clarity for all HIT, not just MMAs. The witnesses expressed concern that FDA is already failing to keep up with regulations relative to MMAs and HIT more broadly.

The subcommittee on Oversight and Investigations held day 3 of hearings on Thursday.