Artificial Intelligence and Health Law

AHLA AI and Health Law Convener 

AHLA is hosting a virtual convener on AI and Health Law on November, 2, 2020. This meeting will bring 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 will be summarized and consolidated into a white paper that will be distributed to convener attendees, AHLA leaders and members, and the public.

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
• 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
• Peter Turk, Senior Counsel, AI and Platform, Change Healthcare
• 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 will be discussed at the AI and Health Law Convener.

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

• 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)
• 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

• 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)