US system of oversight for genetic testing: a report from the Secretary’s Advisory Committee on Genetics, Health and Society
Abstract
As genetic testing technology is integrated into healthcare, increasingly detailed information about individual and population genetic variation is available to patients and providers. Health professionals use genetic testing to diagnose or assess the risk of disease in individuals, families and populations and to guide healthcare decisions. Consumers are beginning to explore personalized genomic services in an effort to learn more about their risk for common diseases. Scientific and technological advances in genetic testing, as with any newly introduced medical technology, present certain challenges to existing frameworks of oversight. In addition, the growing use of genetic testing will require a significant investment in evidence-based assessments to understand the validity and utility of these tests in clinical and personal decisionmaking. To optimize the use of genetic testing in healthcare, all sectors of the oversight system need to be strengthened and yet remain flexible in order to adapt to advances that will inevitably increase the range of genetic tests and methodologies.
Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
Bibliography
- 1 Katsanis SH, Javitt G, Hudson K: A case study of personalized medicine. Science320(5872),53–54 (2008).Crossref, Medline, CAS, Google Scholar
- 2 Balas EA: Information systems can prevent errors and improve quality. J. Am. Med. Inform. Assoc.8,398–399 (2001).Crossref, Medline, CAS, Google Scholar
- 3 Alvarez R: The electronic health record: a leap forward in patient safety. Healthcare Papers5,33–36 (2004).Crossref, Medline, Google Scholar
- 4 Employee Retirement Income Security Act of 1974 (ERISA), Pub. L. No. 93–406, 88 Stat. 829 (1974) (codified at 29 U.S.C. §1001 et seq.). See, e.g., ERISA §§ 514(a), (b)(2)(A), and (b)(2)(B) at 29 U.S.C. §§ 1144(a), (b)(2)(A), and (b)(2)(B) which can have the effect of preempting State tort lawsuits against ERISA health insurance plans for alleged misuses of genetic information in medical necessity determinations.Google Scholar
- 5 Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. No. 104–191, 110 Stat. 1936 (1996) (codified at scattered sections of the U.S. Code). See also, HIPAA privacy regulations at 45 C.F.R. Parts 160, 164, which set forth medical privacy rules affecting use and disclosure of genetic information by HIPAA-covered entities.Google Scholar
- 6 Americans with Disabilities Act of 1990 (ADA), Pub. L. No. 101–336, 104 Stat. 327 (1990) (codified at 42 U.S.C. §§ 12101 – 12213. See Equal Employment Opportunity Commission (EEOC) Compliance Manual, Vol. 2 (2 EEOC Compl. Man. (BNA) § 902:0045 (Mar. 1995)) interpreting ADA as potentially applying to pre-symptomatic individuals with a genetic predisposition for a disabling condition.Google Scholar
- 101 Department of Health and Human Services. Personalized Health Care: Goals. (Accessed on April 1, 2008) www.dhhs.gov/myhealthcare/goals/index.html#Goal3Google Scholar
- 102 Secretary’s Advisory Committee on Genetics, Health, and Society. (Accessed on April 1, 2008) www4.od.nih.gov/oba/sacghs.htmGoogle Scholar
- 103 Secretary’s Advisory Committee on Genetics, Health, and Society. US system of oversight of genetic testing: a response to the charge of the secretary of HHS. See p. iii-v. (Accessed on May 1, 2008) www4.od.nih.gov/oba/sacghs/reports/SACGHS_oversight_report.pdfGoogle Scholar
- 104 Secretary’s Advisory Committee on Genetics, Health, and Society. US system of oversight of genetic testing: a response to the charge of the secretary of HHS. (Accessed on May 1, 2008) www4.od.nih.gov/oba/sacghs/reports/SACGHS_oversight_report.pdfGoogle Scholar
- 105 US FDA: Center for Devices and Radiological Health. (Accessed on April 23, 2008) www.fda.gov/cdrh/Google Scholar
- 106 Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). (Accessed on April 1, 2008) www.cms.hhs.gov/clia• Provides information on the CLIA program.Google Scholar
- 107 GeneTests. (Accessed on April 15, 2008) www.genetests.org•• Example of a test registry.Google Scholar
- 108 Evaluation of Genomic Applications in Practice and Prevention (EGAPP). (Accessed on April 13, 2008) www.egappreviews.org/•• Source for evidence-based reviews and recommendations for genetic tests.Google Scholar
- 109 American Health Information Community Personalized Health Care Work Group. (Accessed on April 23, 2008) www.hhs.gov/healthit/ahic/healthcare/Google Scholar
- 110 National Coalition for Health Professional Education in Genetics. (Accessed on April 23, 2008) www.nchpeg.org/Google Scholar
- 111 Approved package insert for trastuzumab (Herceptin™). (Accessed on April 23, 2008) www.fda.gov/cder/foi/label/2000/trasgen020900LB.htmGoogle Scholar
- 112 Approved package insert for atomoxetine HCl (Strattera™). (Accessed on April 23, 2008) www.fda.gov/cder/foi/label/2002/21411_strattera_lbl.pdfGoogle Scholar
- 113 Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA), Categorization of Tests. (Accessed on June 10, 2008) www.cms.hhs.gov/CLIA/10_Categorization_of_Tests.asp#TopOfPageGoogle Scholar
