See CapronA.M., “Protection of Research Subjects: Do Special Rules Apply in Epidemiology?,”Journal of Clinical Epidemiology, 44, Supp. I (1991): At 88S.
2.
See SieglerM., “Confidentiality in Medicine: A Decrepit Concept,”N. Engl. J. Med., 307 (1982): 1518–21; and GostinL.O., “Privacy and Security of Personal Information in a New Health Care System,”JAMA, 270 (1993): 2487–93.
3.
Council on Ethical and Judicial Affairs, supra note 1, Op. 5.05.
4.
See GostinL.O.LazzariniZ.FlahertyK.M., Legislative Survey of State Confidentiality Laws, with Specific Emphasis on HIV and Immunization (Washington D.C.: Georgetown University Law Center, 1997) (presenting the results of a survey of state health departments). Our legal search found the following statutes that permit disclosure by providers to researchers: Cal. Civ. Code § 56.10(c) (West 1994); Conn. Gen. Stat. § 52–146 (1997); Ga. Code Ann. § 31-7-6 (Supp. 1997); 1997 Minn. Laws § 3:23 (amending Minn. Stat. Ann. § 144.335 subdiv. 3a(d) (West 1992)); Mont. Code Ann. § 50-16-529 (1995); R.I. Gen. Laws § 5–37.3–4 (1997); Tex. Rev. Civ. Stat. Ann. art. 4495b, § 5.08 (West 1997); Utah Code Ann. § 26-25-1 (1996); Wash. Rev. Code § 70.02.050 (1996); Wis. Stat. § 146.82 (1996); and Wyo. Stat. Ann. § 35-2-609 (Michie 1995). Other state statutes permit disclosure to the state departments of health for research and other purposes. See GostinLazzariniFlaherty, id.
5.
See DonaldsonM.S.LohrK.N., eds., Health Data in the Information Age: Use, Disclosure, and Privacy (Washington D.C.: National Academy Press, 1994).
6.
See Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104–191, 110 Stat. 1936 (1996). For a discussion of medical record confidentiality and data collection, particularly in light of provisions under the Health Insurance Portability and Accountability Act, see Symposium, Journal of Law, Medicine & Ethics, 25 (1997): 85–138.
7.
Federal bills introduced over the last three years include: Medical Record Confidentiality Act of 1995, S. 1360, 104th Cong. (1995); Medical Privacy in the Age of New Technologies Act of 1996, H.R. 3482, 104th Cong. (1996); Medical Privacy in the Age of New Technologies Act of 1997, H.R. 1815, 105th Cong. (1997); Fair Health Information Practices Act of 1997, H.R. 52, 105th Cong. (1997); Medical Information Privacy and Security Act, S. 1368, 105th Cong. (1997); Health Care Personal Information Nondisclosure Act of 1998, S. 1921, 105th Cong. (1998); and Patient Protection Act of 1998, H.R. 4250, 105th Cong. (1998) (approved by the House of Representatives, July 24, 1998).
8.
See Office of Technology Assessment, Protecting Privacy in Computerized Medical Information (Washington D.C.: U.S. Government Printing Office, OTA-TCT-576, 1993); Committee on Maintaining Privacy and Security in Health Care Applications of the National Information Infrastructure, Computer Science and Telecommunications Board, National Research Council, For the Record: Protecting Electronic Health Information (Washington D.C.: National Academy Press, 1997); and LowranceW.W., Privacy and Health Research (Washington D.C.: U.S. Department of Health and Human Services, May 1997).
9.
See state statutes cited supra note 5.
10.
Annas, supra note 1, at 2346.
11.
See LevineR.J., “Postmarketing Surveillance—Some Ethical Considerations,”Journal of Rheumatology, 15, Supp. 17 (1988): 34–39.
12.
See Fla. Stat. Ann. § 381.026 (West Supp. 1997); and Vt. Stat. Ann. tit. 18, § 1852 (Supp. 1996).
13.
See Mass. Gen. Laws ch. 111, § 70E (Supp. 1997).
14.
See 45 C.F.R. § 46.102(f) (1997).
15.
See CannC.I.RothmanK.J., “IRBs and Epidemiologic Research: How Inappropriate Restrictions Hamper Studies,”IRB: Review of Human Subjects Research, 6, no. 7 (1984): 5–7.
16.
45 C.F.R. § 46.116(d).
17.
See VeatchR.M., “Limits to the Right of Privacy: Reason, not Rhetoric,”IRB: Review of Human Subjects Research, 4, no. 4 (1982): 5–7.
18.
Privacy Protection Study Commission, Personal Privacy in an Information Society (Washington D.C.: U.S. Government Printing Office, 1977): At 313.
19.
See MeltonL.J.III, “The Threat to Medical-Records Research,”New Engl. J. Med., 337 (1997): 1466–70.
20.
The seminal case recognizing a duty to warn of threatened harm is Tarasoff v. Regents of the University of California, 131 Cal. Rptr. 14, 17 Cal. 3d 425, 551 P.2d 334 (1976). For a good review of how the duty has affected clinical practices, see AnfangS.A.AppelbaumP.S., “Twenty Years after Tarasoff: Reviewing the Duty to Protect,”Harvard Review of Psychiatry, 4 (1996): 67–76.
21.
See CarmanD.BrittenN., “Confidentiality of Medical Records: The Patient's Perspective,”British Journal of General Practice, 45 (1995): 485–88; and WeissB.D., “Confidentiality Expectations of Patients, Physicians and Medical Students,”JAMA, 247 (1982): 2695–97.
22.
See SankarP.MerzJ.F., “Confidentiality Assurances,”JAMA, 279 (1998): 116.
23.
See Patient Self-Determination Act of 1990, Pub. L. No. 101–508, § 4206, 104 Stat. 1388 (codified at 42 U.S.C. § 1395cc(f) (1993)).
24.
See Confidentiality of Individually-Identifiable Health Information, Recommendations of the Secretary of Health and Human Services Pursuant to Section 264 of the Health Insurance Portability and Accountability Act of 1996 (Washington D.C.: Department of Health and Human Services, Sept. 11, 1997).