HIPAA Privacy Rule 2.0

78 Fed. Reg. 5566–5702 (Jan. 25, 2013), amending 45 C.F.R. Parts 160, 164.

Pub. L. No. 111–5, 123 Stat. 226 (2009), codified at 42 U.S.C. §§ 300jj et seq.; §§ 17901 et seq.

Pub. L. No. 110–233, 122 Stat. 881 (2008).

78 Fed. Reg. at 5567 (2013).

45 C.F.R. § 164.534 (2002).

See Department of Health and Human Services, Office for Civil Rights, “HIPAA – Frequently Asked Questions,” available at <www.hhs.gov/ocr/privacy/hipaa/faq/index.html> (last visited May 7, 2013).

45 C.F.R. § 164.502(a)(5)(ii).

Id.

45 C.F.R. § 164.508(b)(4)(i).

45 C.F.R. Part 46, Subpart A.

45 C.F.R. § 46.116.

45 C.F.R. § 164.508(b)(3).

Rothstein M. A. , “Research Privacy under HIPAA and the Common Rule,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 154–159.

78 Fed. Reg. at 5613 (2013).

Rothstein M. A. , “Expanding the Ethical Analysis of Biobanks,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 89–101, at 94.

45 C.F.R. § 164.502(f) (2003). It should be noted that only living individuals may be research subjects under the Common Rule and therefore there is no prohibition on the use of the records for research.

45 C.F.R. § 164.502(f) (2013).

78 Fed. Reg. at 5614.

National Committee on Vital and Health Statistics, Minutes of the Meeting of the Subcommittee on Privacy and Confidentiality, January 11, 2005, at 24, available at <http://www.ncvhs.hhs.gov/050111.htm> (last visited January 25, 2013).

American Medical Association, Code of Medical Ethics § 5.051, Confidentiality of Medical Information Postmortem, 2011–2012 ed. (Chicago: American Medical Association).

GINA § 105.

See, e.g., Bekris L. Yu C. Bird T. D. Tsuang D. W. , “Genetics of Alzheimer Disease,” Journal of Geriatric Psychiatry and Neurology 23, no. 4 (2010): 213–227;

Bettens K. Sleegers K. Van Broeckhoven C. , “Genetic Insights into Alzheimer's Disease,” The Lancet Neurology 12, no. 1 (2013): 92–104.

45 C.F.R. § 164.502(a).

See Rothstein M. A. , “Predictive Genetic Testing for Alzheimer's Disease in Long-Term Care Insurance,” Georgia Law Review 35, no. 2 (2001): 707–733.

GINA § 102(a)(4).

78 Fed. Reg. at 5663.

See Rothstein M. A. , “GINA, the ADA, and Genetic Discrimination in Employment,” Journal of Law, Medicine & Ethics 36, no. 4 (2008): 837–840.

78 Fed. Reg. at 5668.

Id.

American Medical Association, Code of Medical Ethics § 2.131 Disclosure of Familial Risk in Genetic Testing, 2011–2012 ed., Chicago.

American Society of Human Genetics, “Professional Disclosure of Familial Genetic Information,” American Journal of Human Genetics 62, no. 2 (1998): 474–483.