VIable

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