Convener on Artificial Intelligence and Health Law: Designing a Trusted Framework for the Application of AI in Health Care

AHLA hosted a virtual convener on AI and Health Law on November, 2, 2020. The meeting brought together more than a dozen thought leaders including regulators, clinicians, private practitioners, and other leading authorities for an in-depth discussion of AI in health care. Although AHLA conveners are closed to the public and press to ensure a full and open dialogue among invited stakeholders, the main perspectives and themes from the discussion have been summarized and consolidated into a white paper for the health law community.

Convener Participants

• Elise Anthony, Executive Director of Policy, HHS Office of the National Coordinator for Health Information Technology
• Daniel Barth-Jones, Assistant Professor of Clinical Epidemiology, Columbia University Mailman School of Public Health
• Elisabeth Belmont, Corporate Counsel, MaineHealth
• Stephanie Cason, Product Counsel, Google Health
• Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law, Harvard Law School, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics
• Nathan Leong, Senior Attorney, Director US Health & Life Sciences, Microsoft
• Michael Lipinski, Division Director of Federal Policy & Regulatory Affairs, HHS Office of the National Coordinator for Health Information Technology
• Belinda Luu, Leader of Enterprise Data Management and Governance; Senior Counsel at Kaiser Foundation Health Plan
• Ryan Mehm, Federal Trade Commission, Division of Privacy and Identity Protection
• Bakul Patel, Director, Division of Digital Health, FDA
• Nicholson Price, University of Michigan School of Law
• Jack Resneck Jr., MD, Immediate Past Chair, Board of Trustees, American Medical Association
• Ingrid Vasiliu-Feltes, MD, Chief Quality and Innovation Officer, MEDNAX

Convener Planning Workgroup/Moderators

• Bernadette Broccolo, McDermott Will & Emery LLP
• Leeann Habte, Best Best & Krieger LLP
• Jackie Olson, Apple
• Kristen Rosati, Coppersmith Brockelman PLC
• Alaap Shah, Epstein Becker & Green PC

Topics for Discussion

The following resources are organized according to the topics that were discussed at the Convener on Artificial Intelligence and Health Law.

I. Overview of AI's Current and Emerging Role in Health Care

• Fiduciary Engagement in Artificial Intelligence Innovation: A Governance Imperative, Bernadette M. Broccolo and Michael W. Peregrine (Health Law Connections, June 2021)
• Remarks of Commissioner Rebecca Kelly Slaughter, Algorithms and Economic Justice, Federal Trade Commission (January 2020)
• Artificial Intelligence and Health Care, Dina Ross, Annual Meeting (June 2019)
• Artificial Intelligence and Health Care: Legal and Practical Considerations, Dina Ross and Carolyn Metnick, Annual Meeting (June 2019)
• Coping with the Mystery and Reality of Artificial Intelligence in Health Care, Bernadette M. Broccolo, In-House Counsel Program (June 2019)
• When the Planet of the Apes Becomes the Planet of A.I., Caitlin C. Podbielski and Angelique M. Salib, AHLA Connections (May 2019)
• Artificial Intelligence in Health Care: Welcome to the Machine, Scott Bennett and Leeann Habte, AHLA Connections (June 2018)
• What if My Doctor Is a Robot?, Gary Marchant, AHLA Annual Meeting (June 2018)

II. Use of Data in AI

• More Data Please! The Challenges of Applying Health Information Privacy Laws to the Development of Artificial Intelligence (AHLA Connections, February 2020)
• Is Anonymization of Genomic Information and Other Big Data a Fallacy?, Daniel C. Barth-Jones, Barbara J. Evans, and Charles Sawyers, Academic Medical Centers and Teaching Hospitals Institute (January 2020)
• The Evolving Regulatory and Commercial Environment for Digital Health and AI, Sharon Klein and Karen Shin, Academic Medical Centers and Teaching Hospitals Institute (January 2020)
• Opening the Pod Bay Doors: The Impact of Artificial Intelligence on Program Integrity, Paul Westfall, Fraud and Compliance Forum (September 2018)
• Big Data: A Tool for Inclusion or Exclusion? Federal Trade Commission (January 2016)
• The 'Re-Identification' of Governor William Weld's Medical Information: A Critical Re-Examination of Health Data Identification Risks and Privacy Protections, Then and Now, Daniel Barth-Jones (September 2015)
• Public Policy Considerations for Recent Re-Identification Demonstration Attacks on Genomic Data Sets: Part 1 (Re-Identification Symposium), Daniel Barth-Jones, Harvard Law Petrie-Flom Center (2013)
• Press and Reporting Considerations for Recent Re-Identification Demonstration Attacks: Part 2 (Re-Identification Symposium), Daniel Barth-Jones, Harvard Law Petrie-Flom Center (2013)
• Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3 (Re-Identification Symposium), Daniel Barth-Jones, Harvard Law Petrie-Flom Center (2013)

III. Regulating Development and Use of AI

• Machine Learning and Medical Devices Connecting Practice to Policy (and back again), Sebastian Holst, Morgan Reed and Brian Scarpelli, Connected Health Initiative (October 2020).
• Regulating the Future of Artificial Intelligence (AHLA Connections, February 2020)
• The State of Regulation of Medical Software and AI: Considerations for Clinicians and Providers, Nate Brown and Caroline Kessler, Academic Medical Centers and Teaching Hospitals Institute (January 2020)
• The Future of Health Care: Recent Legal Developments Impacting the Use of Artificial Intelligence, Megan B. Webb, Hospitals and Health Systems Practice Group (October 2018)
• When Health Care Meets Technology: What Lawyers Need to Know in the Era of Health IT and Digital Health, Jackie Olson (Moderator),  Afia Asamoah, Cora T. Han, and Lucia C. Savage, Annual Meeting (June 2017)

IV. Liability Issues

• Corporate Practice of Medicine Statutes in the Age of Artificial Intelligence, Erin M. Eiselein and Anna-Liisa Mullis (Health Law Connections, August 2021)
• Medical Frontiers in AI Liability (AHLA Connections, February 2020)
• Understanding the Impact of "Artificial Intelligence" on the Future Practice of Law and Medicine, Gordon J. Apple and Haavi Morreim, Physicians and Hospitals Law Institute (February 2020)
• AI Health Care Liability: From Research Trials to Court Trials, Gary E. Marchant and Lucille M. Tournas, Journal of Health & Life Sciences Law (February 2019)

V. Contracts for Development of AI/Intellectual Property Issues

• Negotiating with Health Care IT Vendors, Wade Kerrigan, Kris Kappel, and David M. Solberg, Practice Group Briefing (March 2016)
• Health Care Organizations as Data Owners and the Intellectual Property Associated with Health Care IT Contracts, Amy Jo Davis and Seth M. Wolf, Health Information and Technology Practice Group Executive Summary (December 2016)