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NDHI NAT IONAL DIALOGUE FOR Healthcare Innovation Oversight Framework to Assure Patient Safety in Health IT Organization Overview • McKesson is the oldest and largest healthcare company in the nation, serving more than 50% of U.S. hospitals, 20% of physicians, and 96% of the top 25 health plans • The company collaborates with health care organizations of all types to strengthen the health of their businesses, by helping them control costs, develop efficiencies, and improve quality • The company delivers one-third of all medications used daily in North America Background Healthcare information technology (health IT) is the management, storage, analysis, and exchange of health data across systems. Due to rapid advances in technology and innovation in healthcare, health IT is constantly changing. Today, the Food and Drug Administration (FDA) regulates health IT products in a category called ‘medical devices.’ However, the Food, Drug, and Cosmetic Act, which regulates medical devices, was written in the 1970s and does not properly distinguish between traditional medical products and health IT. The Food and Drug Administration Safety and Innovation Act was enacted in 2012, calling for various federal administrations to develop a proposed strategy and recommendations for an appropriate, riskbased regulatory framework pertaining to health IT. To impact this policy, McKesson joined a multi-company, multi-sector collaboration led by the Bipartisan Policy Center (BPC). McKesson has brought vendors, patient safety groups, and provider-led organizations into the BPC collaboration to: • Develop and promote a set of principles, recommendations, and ultimately legislation for an oversight framework for health IT, in order to: –– Protect patient safety –– Promote innovation –– Offer flexibility to meet the needs of a rapidly changing health care system • Garner the support of experts and stakeholders across every sector of healthcare The BPC-led collaboration now has about 100 experts and stakeholders, representing clinicians, consumers, health plans, hospitals, patient safety organizations, research institutions, and technology companies (including athenahealth, an HLC member). The collaboration aims to pass legislation recognizing that: 1. FDA oversight of health IT should be limited to only the highest-risk forms of software 2. The vast majority of health IT is not appropriate for FDA regulation An Initiative of the 97 | Oversight Framework to Assure Patient Safety in Health IT
NDHI NAT IONAL DIALOGUE FOR Healthcare Innovation The collaboration includes stakeholder meetings, meetings with government (both in Administration and Congress), workgroups, research, and regulatory comment letters. Value Delivered The potential value of this reform is its ability to promote the development of new innovations in health IT while ensuring patient safety. To date, the collaboration has been successful in passing policy reform through the House of Representatives: • Legislation has been introduced that addresses the coalition’s concerns, through the SOFTWARE Act (H.R. 2396) • This legislation has passed the House of Representatives as part of the 21 st Century Cures Act (H.R. 6) –– Sec. 2241 defines the term ‘health software’ and creates an exemption from FDA regulation for this category, with specified exceptions Path Forward • The effort to pass the Senate-equivalent legislation (as part of the MEDTECH Act) continues today • McKesson hopes to enable the passage of this legislation before the end of this Congress • Potential barriers to passing this legislation include competing agendas in Congress and a focus away from legislating, due to the upcoming elections Oversight Framework to Assure Patient Safety in Health IT | 98
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Foreword The U.S. healthcare indust
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