The Bipartisan Policy Center (BPC) has submitted its response to the Department of Health and Human Services (HHS)’s request for comments on a regulatory framework for Health IT.
In the comments, BPC recommended that any oversight framework for safety recognize and support the important role that health IT plays in improving the quality, safety, and cost-effectiveness of care. Further, any framework for patient safety in health IT should be risk-based, flexible, and not stifle innovation.
The framework, which is being developed in response to requirements of the Food and Drug Administration’s Safety and Innovation Act of 2012 (FDASIA), will be the joint effort of the HHS Secretary, Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC).
BPC says it conducted research and engaged more than 100 clinicians, consumers, health plans, hospitals and other providers, mobile technology companies, patient safety organizations, research institutions, and technology companies, to develop a set of principles and recommendations for an oversight framework that protects patient safety. It also focused on a framework that is risk-based and flexible, promotes innovation, leverages existing quality and patient safety-related systems and processes, and avoids regulatory duplication.
"Health IT plays a significant, foundational role in rapidly emerging innovations designed to improve the cost, quality, and patient experience of care," Janet Marchibroda, director of BPC's Health Innovation Initiative, said in a statement. "A new framework is needed to support the ongoing oversight of health IT: one which engages those who develop, implement, and use health IT in a learning environment that encourages reporting, promotes collaborative assessment, facilitates rapid response, and most importantly, advances continuous innovation and improvement."