US system of oversight for genetic testing: A report from the Secretary's Advisory Committee on Genetics, Health and Society

Personalized Medicine

Volumn 5, Issue 5, 2008, Pages 521-528

  Ferreira Gonzales, Andrea ^a   Teutsch, Steven ^b   Williams, Marc S ^c   Au, Sylvia M ^d   FitzGerald, Kevin T ^e   Miller, Paul Steven ^f   Fomous, Cathy ^g  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c INTERMOUNTAIN HEALTHCARE   (United States)

^d Hawaii Department of Health   (United States)

^e GEORGETOWN UNIVERSITY   (United States)

^f UNIVERSITY OF WASHINGTON   (United States)

^g NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Analytical validity; CLIA; Clinical decision support; Clinical utility; Clinical validity; Genetic testing; Health communication; Oversight; Proficiency testing; US FDA

Indexed keywords

ARTICLE; CLINICAL LABORATORY; CONFIDENTIALITY; DECISION SUPPORT SYSTEM; GENETIC ANALYSIS; GENETIC RISK; GENETIC VARIABILITY; GENOMICS; GOVERNMENT REGULATION; HUMAN; POPULATION GENETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH; QUALITY CONTROL; RISK ASSESSMENT; UNITED STATES; VALIDITY;

EID: 56149102040     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/17410541.5.5.521     Document Type: Article

References (6)

1. Katsanis SH, Javitt G, Hudson K: A case study of personalized medicine. Science 320(5872), 53-54 (2008).
2. Balas EA: Information systems can prevent errors and improve quality. J. Am. Med. Inform. Assoc. 8, 398-399 (2001).
3. Alvarez R: The electronic health record: a leap forward in patient safety. Healthcare Papers 5, 33-36 (2004).
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.
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.
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.