An Oversight Framework for Assuring Patient Safety in Health Information Technology

The widespread adoption of health IT largely stems from recognition of the important role that it plays in improving health care quality and safety. However, there are also instances in which it has the potential to create harm if not effectively developed, implemented, or used.

Through a collaborative effort, the Bipartisan Policy Center (BPC) has both conducted research and engaged more than 100 experts and stakeholders representing clinicians, consumers, health plans, hospitals, patient safety organizations, research institutions, and technology companies to develop a set of principles and recommendations for an oversight framework for health IT. The framework protects patient safety, is risk-based, promotes innovation, is flexible enough to meet the needs of a rapidly changing health care system, avoids regulatory duplication, and has the support of experts and stakeholders across every sector of health care.

This effort was in response to the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, which calls for the Secretary of Health and Human Services (HHS) to work with the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to post a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.