ArticleThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2020
How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?
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Article in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Clinical translation of polygenic scores for prostate cancer screening.Nature reviews. Urology · 2026Review
- Regulating Laboratory Tests: What Framework Would Best Support Safety and Validity?The Milbank quarterly · 2024Article
- Implementing Reporting Standards for Polygenic Risk Scores for Atherosclerotic Cardiovascular Disease.Current atherosclerosis reports · 2023Review
- Effective and Efficient Delivery of Genome-Based Testing-What Conditions Are Necessary for Health System Readiness?Healthcare (Basel, Switzerland) · 2022Article
- Expanding the Vision of Quality and Safety in Genomic Medicine.Journal of general internal medicine · 2022Article
- Meeting the Moment: Addressing Barriers and Facilitating Clinical Adoption of Artificial Intelligence in Medical Diagnosis.NAM perspectives · 2022Review
- Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.Clinical pharmacology and therapeutics · 2022Review
- The Future of DTC Genomics and the Law.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020Article
- Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020Article
- The Streetlight Effect: Regulating Genomics Where the Light Is.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020Article
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Authors and funding
9 authors.
Barbara J EvansBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Gail JavittBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Ralph HallBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Megan RobertsonBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Pilar OssorioBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Susan M WolfBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Thomas MorganBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Ellen Wright ClaytonBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
LawSeq Quality Task ForceBarbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. 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. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Funding
Genetic Privacy and Identity in Community Settings - GetPreCiSeRM1HG009034 · NHGRI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI CLAYTON, ELLEN WRIGHT, MALIN, BRADLEY A. · 2016 to 2024
$8.3MLawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical ApplicationR01HG008605 · NHGRI · UNIVERSITY OF MINNESOTA · PI CLAYTON, ELLEN WRIGHT, LAWRENZ, FRANCES PATRICIA · 2016 to 2018
$2.2MNHGRI NIH HHS R01 HG008605NHGRI NIH HHS RM1 HG009034
Abstract
Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles - the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA - effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
Indexed as
High-Throughput Nucleotide SequencingQuality of Health CareSequence Analysis, DNACenters for Medicare and Medicaid Services, U.S.GenomicsHumansLaboratoriesMedical Device LegislationSoftwareUnited StatesUnited States Food and Drug Administration
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.