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
- Congressional testimony by McKesson’s Jackie Mitus, M.D. on Health Information Technologies: How Innovation Benefits Patients (March 20, 2013) (PDF, 527 KB)
- Congressional testimony by McKesson’s Michael Marchlik on McKesson’s support of H.R. 3303 (November 19, 2013) (PDF, 745 KB)
- Congressional testimony by McKesson’s Jonathan Niloff 21st Century Technology for 21st Century Cures (July 17, 2014) (PDF, 194 KB)
- McKesson Letter in 113th Congress in Support of H.R. 3303(PDF, 33 KB)
- H.R. 3303 or the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013(PDF, 33 KB)
- McKesson Letter in 113th Congress in Support of S. 2007(PDF, 27 KB)
Regulatory Comment Letters
- McKesson letter to the Office of National Coordinator for Health IT on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology (June 28, 2013) (PDF, 14 KB)
- McKesson’s Supplemental Response for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology (August 31, 2013) (PDF, 190 KB)
- McKesson’s Comments on the FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (July 7, 2014) (PDF, 275 KB)