Bipartisan Policy Center Calls for Congressional Action on Risk-Based Regulatory Framework for Health Information Technology
There is broad consensus on the need for a risk-based framework for health IT–one that protects patient safety, promotes innovation and avoids regulatory duplication.
Federal Government’s Proposed Risk-Based Regulatory Framework for Health IT: A Step in the Right Direction
On April 7, 2014, the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) released the FDASIA Health IT Report: Proposed Strategies and Recommendations for a Risk-Based Framework (FDASIA Report). That report fulfilled the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, which was passed and signed into law in July 2012. Today, BPC’s Health Innovation Initiative submitted public comments on the report to the FDA, ONC, and FCC.
FDASIA Workgroup Key Themes: Innovation, Accountability and a Learning Environment, Align with BPC Oversight Framework
A workgroup established by the Department of Health and Human Services (HHS) to provide input into the development of recommendations for a risk-based regulatory framework for health information technology (IT), including mobile medical applications, held its final meeting last week….