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

Author:

Aspinall M1,Au S M2,Billings P3,Dreyfuss R4,Evans J P5,Ferreira-Gonzalez A6,FitzGerald K T7,Fomous C8,Licinio J9,Burns McGrath B10,Miller P S11,Telfair J12,Teutsch S13,Williams M S14,Wise P15

Affiliation:

1. Genzyme Corporation, Cambridge, MA 02142, USA

2. Hawai'i Department of Health, Genetics Program, Honolulu, HI 96816, USA

3. Cellpoint Diagnostics, Mountain View, CA 94043, USA and, Signature Genomics Laboratories, LLC, Spokane, WA 99202, USA

4. New York University School of Law, New York, NY 10012-1099, USA

5. University of North Carolina at Chapel Hill, Departments of Genetics and Medicine, Chapel Hill, NC 27599-7624, USA

6. Virginia Commonwealth University, Richmond, VA 23298-0248, USA

7. Georgetown University Medical Center, Department of Oncology, Washington, DC 20057, USA

8. NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, USA.

9. University of Miami, Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, UM/JMH Mental Health Hospital Center, Miami, Florida 33136, USA

10. University of Washington, School of Nursing, Seattle, WA 98195, USA

11. University of Washington School of Law, Seattle, WA 98195, USA

12. University of North Carolina at Greensboro, Department of Public Health Education, Greensboro, NC 27402-6170, USA

13. Merck & Co., Inc., West Point, PA 19486-0004, USA

14. Intermountain Healthcare, Clinical Genetics Institute, Salt Lake City, UT 84103, USA

15. Stanford University, Stanford, CA 94305-6019, USA

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.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Molecular Medicine,General Medicine

Reference19 articles.

1. A Case Study of Personalized Medicine

2. Information Systems Can Prevent Errors and Improve Quality

3. The Electronic Health Record: A Leap Forward in Patient Safety

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.

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