Bibliography
- Katsanis SH , JavittG, HudsonK: A case study of personalized medicine.Science320(5872) , 53–54 (2008).
- Balas EA : Information systems can prevent errors and improve quality.J. Am. Med. Inform. Assoc.8 , 398–399 (2001).
- Alvarez R : The electronic health record: a leap forward in patient safety.Healthcare Papers5 , 33–36 (2004).
- 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.
- 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.
- 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.
Websites
- Department of Health and Human Services. Personalized Health Care: Goals. (Accessed on April1, 2008) www.dhhs.gov/myhealthcare/goals/index.html#Goal3
- Secretary‘s Advisory Committee on Genetics, Health, and Society. (Accessed on April1, 2008) www4.od.nih.gov/oba/sacghs.htm
- 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 May1, 2008) www4.od.nih.gov/oba/sacghs/reports/SACGHS_oversight_report.pdf
- 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 May1, 2008) www4.od.nih.gov/oba/sacghs/reports/SACGHS_oversight_report.pdf
- US FDA: Center for Devices and Radiological Health. (Accessed on April23, 2008) www.fda.gov/cdrh/
- Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). (Accessed on April1, 2008) www.cms.hhs.gov/clia
- GeneTests. (Accessed on April15, 2008) www.genetests.org
- Evaluation of Genomic Applications in Practice and Prevention (EGAPP). (Accessed on April13, 2008) www.egappreviews.org/
- American Health Information Community Personalized Health Care Work Group. (Accessed on April23, 2008) www.hhs.gov/healthit/ahic/healthcare/
- National Coalition for Health Professional Education in Genetics. (Accessed on April23, 2008) www.nchpeg.org/
- Approved package insert for trastuzumab (Herceptin™). (Accessed on April23, 2008) www.fda.gov/cder/foi/label/2000/trasgen020900LB.htm
- Approved package insert for atomoxetine HCl (Strattera™). (Accessed on April23, 2008) www.fda.gov/cder/foi/label/2002/21411_strattera_lbl.pdf
- Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA), Categorization of Tests. (Accessed on June10, 2008) www.cms.hhs.gov/CLIA/10_Categorization_of_Tests.asp#TopOfPage