How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?

Centers for Medicare and Medicaid Services, U.S. Genomics / legislation & jurisprudence High-Throughput Nucleotide Sequencing Humans Laboratories / legislation & jurisprudence Medical Device Legislation Quality of Health Care Sequence Analysis, DNA Software / legislation & jurisprudence United States United States Food and Drug Administration

Journal

The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
ISSN: 1748-720X
Titre abrégé: J Law Med Ethics
Pays: England
ID NLM: 9315583

Informations de publication

Date de publication:
03 2020
Historique:
entrez: 29 4 2020
pubmed: 29 4 2020
medline: 13 3 2021
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1177/1073110520916995 PMID: 32342785 PMC: PMC7447152
pubmed: 32342785
doi: 10.1177/1073110520916995
pmc: PMC7447152
mid: NIHMS1608348
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural

Langues

eng

Pagination

44-68

Subventions

Organisme : NHGRI NIH HHS
ID : R01 HG008605
Pays : United States
Organisme : NHGRI NIH HHS
ID : RM1 HG009034
Pays : United States

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Auteurs

Barbara J Evans (BJ)

Barbara 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 Javitt (G)

Barbara 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 Hall (R)

Barbara 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 Robertson (M)

Barbara 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 Ossorio (P)

Barbara 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 Wolf (SM)

Barbara 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 Morgan (T)

Barbara 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 Clayton (EW)

Barbara 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.
Barbara 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.

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Classifications MeSH

questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Health Care Financing Administration (USA) › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Disciplines des sciences naturelles › Disciplines des sciences biologiques › Biologie › Génétique › Génomique › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Analyse de séquence › Séquençage nucléotidique à haut débit › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Établissements de santé › Laboratoires › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Organisations et économie des soins de santé › Contrôle social formel › Législation comme sujet › Législation médicale › Législation sur les dispositifs médicaux › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Analyse de séquence › Analyse de séquence d'ADN › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Sciences de l'information › Méthodologies informatiques › Logiciel › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › How Can Law and Policy Advance Quality in...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › How Can Law and Policy Advance Quality in...