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From Genetics to Genomics: Facing the Liability Implications in Clinical Care
Gary Marchant1, Mark Barnes1, James P Evans1
1Gary Marchant, B.SC., Ph.D., J.D., M.P.P., is Regents' Professor, Lincoln Professor of Emerging Technologies, Law & Ethics, and Faculty Director of the Center for Law, Science & Innovation at ASU. He researches, teaches and speaks about governance of a variety of emerging technologies including genomics, biotechnology, neuroscience, nanotechnology and artificial intelligence. Prior to starting at ASU in 1999, he was a partner in the Washington, DC office of Kirkland & Ellis. Mark Barnes, J.D., LL.M., is a partner in the life sciences practice at Ropes & Gray LLP; teaches health care law and the law of biomedical research at Yale Law School; and is founder and co-director of the Multi-Regional Clinical Trials Center (MRCT Center) of Harvard University and Brigham and Women's Hospital. James P. Evans, M.D., Ph.D., is a Medical Geneticist and Internist who is currently retired, but pursued a long-standing interest in genomics and its broad social implications. He is Professor Emeritus, University of North Carolina at Chapel Hill, Department of Genetics. Bonnie LeRoy, M.S., L.G.C., is a licensed genetic counselor with over 20 years of clinical experience. She developed and now directs the Graduate Program in Genetic Counseling at the University of Minnesota. She is a past president of the National Society of Genetic Counselors, the American Board of Genetic Counseling, and the Association of Genetic Counseling Program Directors. Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; and Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota. She is a Principal Investigator on the LawSeq project funded by NIH. Institutions are listed for author identification only.
Healthcare is shifting from genetics to genomics, introducing new liability risks for providers and labs. This article outlines 11 key risk areas and offers management strategies for genomic medicine.
Area of Science:
- Genomic Medicine
- Medical Liability
Background:
- Healthcare is evolving from single-gene genetics to comprehensive genomics.
- Genomic testing (panels, sequencing) is increasingly used for diagnosis, prediction, prognosis, and treatment.
Purpose of the Study:
- To describe the transition from genetics to genomics in healthcare.
- To identify and analyze increased or novel liability risks associated with genomic testing.
- To provide recommendations for managing these risks.
Main Methods:
- Review of the transition in medical care and liability.
- Identification of 11 specific areas of potential liability risk.
- Development of recommendations for healthcare and legal professionals.
Main Results:
- The shift to genomics introduces complex liability challenges.
- Eleven distinct areas of increased or novel liability risk have been identified.
- Specific recommendations are proposed to mitigate these risks.
Conclusions:
- Healthcare providers and laboratories face new liability exposures due to genomic advancements.
- Proactive risk management strategies are essential for navigating the evolving landscape of genomic medicine.
- Collaboration between healthcare and legal sectors is crucial for addressing these challenges.
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