Yesterday’s FDASIA Report Highlights the Need for Regulatory Reform
Yesterday the U.S. Department of Health and Human Services (HHS) released the highly anticipated FDASIA report, mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA). This report offers a proposed strategy and draft recommendations to address the problems and shortcomings of the outdated framework for regulating health information technologies. The report makes suggestions to enhance a risk-based regulatory and oversight structure to help foster innovation, and better ensure the safety and efficacy of a technology enabled healthcare system.
In responding to the report’s release, Joel White, the Executive Director of the Health IT Now Coalition, made the following statement:
“The HHS report outlines a strategy for addressing the outdated way the Federal government helps ensure the safety and efficacy of health information technologies. We are pleased the Department has offered these suggestions, which specifically address the need for interoperability of technologies to improve safety. It also includes suggestions for a better environment for reporting medical errors and problems associated with technologies. These suggestions are steps in the right direction toward creating a risk based framework, based on a technology’s functionality so these innovations can safely and effectively improve patient outcomes and lower costs.
“The report’s recommendations highlight the importance of Congressional action to clarify the law as to how health IT products are, in fact, regulated. Developers, health care providers, patients and others still face ambiguity, which is why it is imperative that Congress update the regulatory framework for health IT – a product of the 1970s — in order to facilitate innovation in use of technologies to improve health.
“Our hope is that the FDA, ONC, and FCC will continue to work with Congress to update the laws in these areas. We also look forward to participating in the opportunities for stakeholder input over the coming months.”
The FDASIA report can be found here.