title: The effect of genomics on health services management: ethical and legal perspectives.
abstract: The growing use of genetic testing for diagnostic and predictive purposes, and for the purpose of selecting therapeutic regimens with better risk-benefit ratios for patients, raises numerous legal and ethical challenges. Researchers and institutional review boards must pay careful attention to the need to obtain informed consent from subjects. The FDA will face increased pressure to more carefully regulate the accuracy of genetic testing. Clinicians will need to safeguard the privacy and confidentiality of sensitive patient information, especially when testing is performed in settings in which the information may be readily accessible to insurers and employers. Novel genomic treatments may increase liability for drug manufacturers, but physicians and other healthcare providers, including health plans' drug formularies, will bear the primary liability risk. Difficult questions of distributive justice also must be faced if third-party payers resist covering genomic services because of their cost. Down the road, more aggressive gene therapy techniques and the ability to test for non-disease traits will tax our notions of fairness, equality, and the limits of professional authority.
authors: Law-Medicine Center, Case Western Reserve University, Cleveland, Ohio, USA.
authors: M J
authors: MJ
authors: Mehlman
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D015195:Drug Design; D004992:Ethics, Medical; D023281:Genomics / Q000331:legislation & jurisprudence* / Q000592:standards*; D006297:Health Services Accessibility; D006298:Health Services Administration / Q000331:legislation & jurisprudence* / Q000592:standards*; D016045:Human Genome Project; D006801:Humans; D016365:Liability, Legal; D017751:Safety Management / Q000331:legislation & jurisprudence; D014481:United States