From Genetics to Genomics: Facing the Liability Implications in Clinical Care

Author:

Marchant Gary,Barnes Mark,Evans James P.,LeRoy Bonnie,Wolf Susan M.,

Abstract

Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference144 articles.

1. Medical Malpractice

2. Clinical Genomics

3. Whole-Genome Sequencing in Healthy People

4. 134. See, e.g., Pennsylvania, 28 Pennsylvania Code § 115.29 (“Upon the death of a patient, the hospital shall provide, upon request, to the executor of the decedent's estate or, in the absence of an executor, the next of kin responsible for the disposition of the remains, access to all medical records of the deceased patient.”); Louisiana, West's Louisiana Statutes Annotated: Revised Statutes, 40:1165.1 (“[A] patient or his legal representative, or in the case of a deceased patient, the executor of his will, the administrator of his estate, the surviving spouse, the parents, or the children of the deceased patient…shall have a right to obtain a copy of the entirety of the records in the form in which they exist, except microfilm, upon furnishing a signed authorization.”); Georgia, Georgia Code Annotated, § 31-33-2 (“If the patient is deceased, such request may be made by the following persons: (A) The executor, administrator, or temporary administrator for the decedent's estate if such person has been appointed; (B) If an executor, administrator, or temporary administrator for the decedent's estate has not been appointed, by the surviving spouse; (C) If there is no surviving spouse, by any surviving child; and (D) If there is no surviving child, by any parent.”); New Hampshire, New Hampshire Revised Statutes § 332-I:13 (“Where there is no estate administration, the surviving spouse or next of kin of the deceased is designated the personal representative of the deceased for the limited purpose of obtaining the medical records of the deceased.”); North Carolina, North Carolina Administrative Code 10A.13B.3904 (“Upon the death of a patient, the executor of the decedent's estate, or in the absence of an executor, the next of kin responsible for the disposition of the remains, shall have access to all medical records of the deceased patient.”).

5. 126. Safer v. Estate of Pack, 677 A.2d 1188 (N.J. App. 1996), cert. denied, 683 A.2d 1163 (N.J. 1996).

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