Health IT is essential to a high quality, efficient healthcare system. Health IT increases patient safety, helps to minimize medical errors, improves healthcare quality and promotes lower costs. Unfortunately this cutting edge technology is currently subject to regulations based on a law written more than four decades ago.
McKesson actively promoted inclusion of a provision requesting recommendations from the Administration on an appropriate, risk-based regulatory framework pertaining to health IT in the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in July 2012.
McKesson’s advocacy for an appropriate risk-based regulatory framework for health IT was embraced by others in the healthcare community. This concept became part of a Bipartisan Policy Center report, An Oversight Framework for Assuring Patient Safety in Health Information Technology. This report includes principles and recommendations for a new health IT oversight framework that protects patient safety, promotes innovation, and is flexible to accommodate a rapidly changing healthcare system.
McKesson supports updating federal statute to create a new risked-based regulatory framework specific to health IT that supports both patient safety and innovation. We continue to engage with the Administration, Congress and other stakeholders in support of legislation to highlight the distinction between health IT and traditional medical devices.
To learn more about this issue and McKesson’s position, please read the related information below.
Congressional Testimony and Letters to Congress
Regulatory Comment Letters