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Governance and Use of Patient Data in Health IT Products

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Work Group Charter

There has been huge growth and large expectations for the use of patient data in health care, particularly as an adjuvant to clinical decision-making. From image interpretation to diagnosis, payer, provider and life science companies are forming partnerships with technology and data analytics companies to develop new tools and capabilities. However, payer, provider and life science companies face potential public backlash and regulatory scrutiny over data privacy concerns when engaging outside partners to analyze PHI and non-PHI data, and use of patient data in new ways may create health disparities and pose other ethical challenges for payer, provider and life science companies. While the FDA regulates AI tools that are used in diagnosis or treatment, the lack of guidelines for how AI should be developed, how patient data should be used, how AI is applied to various populations (e.g., across races or age groups) and how AI intellectual property is handled puts payer, provider and life science companies at risk. The goal of this Work Group is to articulate standards for responsible innovation to shape the partnerships between payer, provider and life science companies and developers of AI and other analytics and to guide the product development process of data tools for the clinical setting.

Co-Chairs

  • Aneesh Chopra, President, CareJourney

  • Steve Klasko, MD, President & CEO, Thomas Jefferson University & Jefferson Health System

Industry Adviser

  • Arien Malec, SVP R&D Clinical and Administrative Networks, Change Healthcare

  • Todd Gottula, Co-founder, President & Chief Product Officer, Clarify Health

Work Group Partner

Work Group Fellows

Amy Abernethy, MD, PhD, Verily; formerly FDA

Mike Berger, Mount Sinai Health System

Michael Blum, UCSF Health

Aneesh Chopra, CareJourney

Brent Davidson, Intuitive Surgical, Inc.

Ellen Duffield, Gateway Health Plan

Todd Gottula, Clarify Health Solutions

Gary Guthart, PhD, Intuitive Surgical, Inc.

Eric Hargan, former Deputy Secretary of the US Department of Health and Human Services

David Horrocks, Chesapeake Regional Information System for Patients

Azam Khan, Eli Lilly and Company

Steve Klasko, MD, Thomas Jefferson University Hospital

Alice Leiter, eHealth Initiative

Carolyn Magill, Aetion

Arien Malec, Change Healthcare

Ken Mandl, MD, Boston Childrens Hospital

Deven McGraw, Citizen

Rob Metcalf, Concert Genetics

Peter Neupert, Adaptive Biotechnologies

Brenda Pawlak, Manatt

Cris Ross, Mayo Clinic

Eric Schneider, MD, The Commonwealth Fund

David Vawdrey, PhD, Geisinger

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