Regulatory changes raise troubling questions for genomic testing

Genetics in Medicine

Volumn 16, Issue 11, 2014, Pages 799-803

  Evans, Barbara J ^a   Dorschner, Michael O ^b,c   Burke, Wylie ^b   Jarvik, Gail P ^c  

^a UNIVERSITY OF HOUSTON   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

access rights; CLIA; FDA; HIPAA; return of results

Indexed keywords

DNA;

ACCESS TO INFORMATION; ARTICLE; BIOETHICS; CLINICAL LABORATORY; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; GENOMICS; HEALTH INSURANCE; HUMAN; INFORMED CONSENT; LAW; MEDICAL RESEARCH; PRIVACY; UNITED STATES; DNA SEQUENCE; HIGH THROUGHPUT SEQUENCING; LABORATORY; LEGISLATION AND JURISPRUDENCE; PATIENT RIGHT; PRACTICE GUIDELINE;

GENETIC TESTING; HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HUMANS; LABORATORIES; PATIENT ACCESS TO RECORDS; PRACTICE GUIDELINES AS TOPIC; SEQUENCE ANALYSIS, DNA; UNITED STATES;

EID: 84908879578     PISSN: 10983600     EISSN: 15300366     Source Type: Journal    
DOI: 10.1038/gim.2014.127     Document Type: Article

References (18)

1. U.S. Department of Health and Human Services. CLIA program and HIPAA privacy rule:. patients access to test reports. Federal Register 2014;79:7290-7316 (6 February 2014).
2. Young MJ, Scheinberg E, Bursztajn H. Direct-to-patient laboratory test reporting: balancing access with effective clinical communication. JAMA 2014;312:127-128.
3. 45 C.F.R. § 160.103.
4. Rehm HL, Bale SJ, Bayrak-Toydemir P, et al.; Working Group of the American College of Medical Genetics and Genomics Laboratory Quality Assurance Committee. ACMG clinical laboratory standards for next-generation sequencing. Genet Med 2013;15:733-747.
5. Gargis AS, Kalman L, Berry MW, et al. Assuring the quality of next-generation sequencing in clinical laboratory practice. Nat Biotechnol 2012;30:1033-1036.
6. 45 C.F.R. § 164.501.
7. Marabello ex rel. Marabello v. State, 964 N.Y.S.2d 863 (Ct. Cl. 2013).
8. Wellstar Health System, Inc. v. Jordan, 743 S.E.2d 375 (Ga. 2013).
9. U.S. Department of Health and Human Services. Standards for privacy of individually identifiable health information. Federal Register 2000;65:82,462-82,829, at 82,606 (28 December 2000).
10. Green RC, Berg JS, Grody WW, et al.; American College of Medical Genetics and Genomics. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 2013;15:565-574.
11. 45 C.F.R. §§ 164.524(a)(2)-(4).
12. 45 C.F.R. § 164.524(a)(2)(iii).
13. Vorhaus D. DNA DTC: the return of direct to consumer whole genome sequencing, Genomics Law Report (29 November 2012). http://www. genomicslawreport.com/index.php/2012/11/29/dna-dtc-the-return-of-directto-consumer-whole-genome-sequencing/. Accessed 6 July 2014.
14. U.S. Department of Health and Human Services. HHS strengthens patients right to access lab reports (3 February 2014). http://www.hhs.gov/news/press/2014pres/02/20140203a.html. Accessed 6 July 2014.
15. 42 C.F.R. § 493.2.
16. 42 C.F.R. § 493.3(b)(2).
17. Letters of Sally Howard, Deputy Commissioner, Policy, Planning, and Legislation, FDA to the Honorable Tom Harkin, Chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate and to the Honorable Fred Upton, Chairman, Committee on Energy and Commerce, House of Representatives (31 July 2014). http://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm407409.pdf. Accessed 4 August 2014.
18. 21 U.S.C. § 396.