On April 3, 2014, the Health and Human Services (“HHS”) announced that it had released a draft of a congressionally mandated report that includes a proposed strategy and recommendations for a health information technology (Health IT) oversight framework. According to HHS, this report was developed by the US Food and Drug Administration (“FDA”) in consultation with HHS’ Office of the National Coordinator for Health IT (“ONC”), the Federal Communications Commission (“FCC”), as well as health IT experts and consumer representatives. HHS Secretary Kathleen Sebelius stated “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”
The draft report’s recommendations aim to support FDA’s oversight over higher risk technologies through a framework of the following three health IT categories, which are based on each product’s function and level of risk presented to patients:
- administrative health IT functions that pose little or no risk to patient safety and require no additional oversight (i.e. billing and claims processing);
- health management health IT functions that are of sufficiently low risk that FDA does not intend to focus its oversight on them so long as they meet the statutory definition of a medical device (i.e. software for health information and data management, and most clinical decision support software); and
- medical device health IT functions that FDA should continue to regulate because they could potentially pose greater risks to patients if they do not perform as intended (i.e. computer-aided detection software, software for bedside monitor alarms, and radiation treatment software).
The proposed framework includes a proposal for ONC to create a public-private Health IT Safety Center that would work on best practices to ensure patient safety; this Center would be developed in collaboration with the FDA, the FCC, HHS’ Agency for Healthcare Research and Quality (AHRQ) and other stakeholders. FCC’s narrow but important role is to oversee the authorization of equipment using the radio frequency spectrum and to govern the interference potential of equipment to radio services.
Read the draft report, which has been posted on the ONC, FDA and FCC websites as required under the Food and Drug Administration Safety and Innovation Act of 2012. Comments are requested for which a docket will soon be available and a public meeting will be announced.