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How Research Will Adapt to HIPAA: A View from Within the Healthcare Delivery System

Published online by Cambridge University Press:  06 January 2021

Mary L. Durham
Mary L. Durham*
Affiliation:
Center for Health Research, Northwest and Hawaii, Oregon Health and Sciences University, Department of Sociology at Portland State University, University of Oklahoma
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Extract

While the new Health Insurance Privacy and Accountability Act (HIPAA) research rules governing privacy, confidentiality and personal health information will challenge the research and medical communities, history teaches us that the difficulty of this challenge pales in comparison to the potential harms that such regulations are designed to avoid. Although revised following broad commentary from researchers and healthcare providers around the country, the HIPAA privacy requirements will dramatically change the way healthcare researchers do their jobs in the United States. Given our reluctance to change, we risk overlooking potentially valid reasons why access to personal health information is restricted and regulated. In an environment of electronic information, public concern, genetic information and decline of public trust, regulations are ever-changing. Six categories of HIPAA requirements stand out as transformative: disclosure accounting/tracking, business associations, institutional review board (IRB) changes, minimum necessary requirements, data de-identification, and criminal and civil penalties.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 28 , Issue 4 , December 2002 , pp. 491 - 502
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2002

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Footnotes

†

A version of these remarks was given as the Fourth Annual Justice Louis Brandeis Lecture, delivered at the 24th Annual Meeting of the Massachusetts Health Data Consortium, Boston, Mass., April 12, 2002; sponsored by Nutter, McClennen & Fish, LLP.

References

The author wishes to acknowledge the assistance of Jen Coury and Michelle S. Blake in the preparation of this manuscript. Their many efforts in preparation for the Justice Louis Brandeis Lecture are also greatly appreciated.

1 Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936 (1996) (codified in scattered sections of 26 U.S.C., 28 U.S.C. and 42 U.S.C.).

2 See Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 53,182 (Aug. 14, 2002)Google Scholar (codified at 45 C.F.R. pts. 160 & 164).

3 John A. Robertson, Dire Warnings and Baseless Fears, SOCIETY, Nov.-Dec. 1980, at 45.

4 Jennifer Kulynych & David Korn, The Effect of the New Federal Medical-Privacy Rule on Research, NEW ENG. J. MED. 201, 204 (2002).

5 Jennifer Kulynych, Statement on “Standards for Privacy of Identifiable Health Information; Final Rule”, Association of American Medical Colleges (AAMC) Government Affairs and Advocacy (Aug. 22, 2001), available at http://www.aamc.org/advocacy/library/hipaa/testimony/2001/082201.htm (statement of Jennifer Kulynych, J.D., Ph.D., Director of Biomedical and Health Sciences Research at AAMC to National Committee on Vital and Health Statistics).

6 Kulynych & Korn, supra note 4, at 201.

7 AAMC, Letter to Secretary Thompson on Impact of Medical Privacy Rule (Nov. 20, 2001), at http://www.aamc.org/advocacy/library/hipaa/corres/2001/112001.htm (expressing concern over the Department of Health and Human Services rule “Standards for Privacy of Individually Identifiable Health Information”).

8 See supra note 3 and accompanying text.

9 NAT’L COMM’N FOR THE PROT. OF HUMAN SUBJECTS OF BIOMEDICAL & BEHAVIORAL RESEARCH, U.S. DEP't OF HEALTH, EDUC. & WELFARE, THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH Appendix (1978).

10 TRIALS OF WAR CRIMINALS BEFORE THE NUERNBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW NO. 10 70, 181(U.S. Gov't Printing Office 1946-1949).

11 See Seto, Belinda, History of Medical Ethics and Perspectives on Disparities in Minority Recruitment and Involvement in Health Research, 322 AM. J. MED. SCI. 248 (2001)CrossRefGoogle ScholarPubMed.

12 Jean Heller, Syphilis Victims in U.S. Study Went Untreated for 40 Years, N.Y. TIMES, July 26, 1972, at 1, 8; THE TUSKEGEE SYPHILIS STUDY LEGACY COMMITTEE, Report of the Tuskegee Syphilis Study Committee Final Report (May 20, 1996), available at http://www.med.virginia.edu/hslibrary/historical/apology/report.html.

13 Id.

14 ADVISORY COMM. ON HUMAN RADIATION EXPERIMENTS, FINAL REPORT 178 (1995), available at http://tis-nt.eh.doe.gov/ohre/roadmap/achre/chap3_2.html.

15 Id.

16 Id. at 174.

17 45 C.F.R. § 46 (2001).

18 Id.

19 Wax, Murray L. & Capron, Alexander M., Overseeing Regulations or Intimidating Researchers, 3 IRB: A REVIEW OF HUMAN SUBJECTS RESEARCH 8, 9 (1981)CrossRefGoogle ScholarPubMed (citing Dr. Wax's letter to Morris B. Abram, Chairman, President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research).

20 Sidney Dymond, The Strengths and Weaknesses of University Review Committees to Protect Human Rights, 55 ANNALS OF THE ROYAL COLLEGE OF SURGEONS OF ENGLAND 59, 60 (1974).

21 Ithiel de Sola Pool, Censoring Research, SOCIETY, Nov.-Dec. 1980, at 39.

22 de Sola Pool, Ithiel, Protecting Human Subjects of Research: An Analysis on Proposed Amendments to HEW Policy, 12 PS 452, 453 (1979)CrossRefGoogle ScholarPubMed.

23 Anthony Lewis, Abroad at Home: Pettifog on the Potomac, N.Y. TIMES, Jan. 15, 1979, at A19.

24 See Robertson, supra note 3, at 45.

25 Eisenberg, John M., Can You Keep a Secret? Measuring the Performance of Those Entrusted with Personal Health Information, 16 J. GEN. INTERNAL MED. 132, 132 (2001)CrossRefGoogle Scholar.

26 Welch, Charles A., Sacred Secrets—The Privacy of Medical Records, 345 NEW ENG. J. MED. 371 (2001)CrossRefGoogle ScholarPubMed.

27 Eisenberg, supra note 25, at 132.

28 Id.

29 INST. OF MED., CROSSING THE QUALITY CHASM: A NEW HEALTH SYSTEM FOR THE 21ST CENTURY 164-77 (2001).

30 Annas, George J., The Limits of State Laws to Protect Genetic Information, 345 NEW ENG. J. MED 345 385 (2001)CrossRefGoogle ScholarPubMed.

31 See generally Annas, George J., Privacy Rules for DNA Databanks: Protecting Coded “Future Diaries”, 270 JAMA 2346 (1993)CrossRefGoogle Scholar.

32 Sue A. Blevins, Testimony Before the Pennsylvania Senate Communications and High Technology Committee, Hearing on Privacy and Security in the Information and Technology Age (June 4, 2001), available at www.forhealthfreedom.org/Publications/Privacy/PennTestimony.html.

33 Schlesinger, Mark, A Loss of Faith: The Sources of Reduced Political Legitimacy for the American Medical Profession, 80 MILBANK Q. 185 (2002)CrossRefGoogle ScholarPubMed.

34 Inst. of Med., supra note 29, at 174.

35 See generally MASS. GEN. LAWS ch. 183, § 70G (2002); MINN. STAT. § 72A.139 (2001); OR. REV. STAT. § 192.533 (2001); see also Lenox, Bryce A., Genetic Discrimination in Insurance and Employment: Spoiled Fruits of the Human Genome Project, 23 U. DAYTON L. REV. 189, 200-09 (1997)Google Scholar (comparing Oregon's broad legislative attempts to control genetic discrimination to Minnesota's legislation which is narrow and only applies in limited situations).

36 See, e.g., Lenox, supra note 35, at 201 n.83.

37 45 C.F.R. §§ 46.101-46.124 (2000).

38 Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 14,776, 14,793 (Mar. 27, 2002) (codified at 45 C.F.R. pts. 160 &164).

39 See 45 C.F.R. § 164.501 (2001).

40 Id.

41 Id.

42 See id. § 164.508.

43 Id.

44 Id. § 164.528.

45 Id.

46 Id. § 164.504.

47 See Charlene M. Hoffman, Federal Support for Education: Fiscal Years 1980-1999, EDUC. Q., Dec. 1999.

48 Personal communication from HIPAA subgroup of the HMO Research Network Executive Committee (June 2001).

49 45 C.F.R. § 164.508.

50 Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 14,776, 14,793 (Mar. 27, 2002) (codified at 45 C.F.R. pts. 160 &164).

51 45 C.F.R. § 164.520(b).

52 Id. § 164.512(i).

53 Id.

54 See id.

55 Id. § 164.514(d).

56 Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 53,182, 53,196 (Aug. 14, 2002) (codified at 45 C.F.R. pts. 160 &164).

57 45 C.F.R. § 164.514.

58 Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 14,776, 14,794 (Mar. 27, 2002) (codified at 45 C.F.R. pts. 160 & 164).

59 45 C.F.R. § 164.514(b)(2)(i)(A)-(R).

60 Standards for Privacy of Individually Identifiable Health Information, 67 Fed. Reg. 14,776, 14,798 (Mar. 27, 2002) (codified at 45 C.F.R. pts. 160 &164).

61 Id. at 14785.

62 42 U.S.C. §§ 1320d-5(a)(1), 1320d-6(b) (2000).

63 Annas, George J., Medical Privacy and Medical Research—Judging the New Federal Regulations, 346 NEW ENG. J. MED. 216, 219 (2002)CrossRefGoogle ScholarPubMed.

64 Studdert, David M., Direct Contracts, Data Sharing and Employee Risk Selection: New Stakes for Patient Privacy in Tomorrow's Health Insurance Markets, 25 AM. J.L. MED. 233, 263 (1999)CrossRefGoogle ScholarPubMed. For statutory language requiring the appointment of this type of privacy officer, see 45 C.F.R. § 164.530(a)(1) (2001).

65 Interview with Pierre LaChance, Privacy Officer, Kaiser Permanente's Center for Health Research (2002).

66 Wynia, Matthew K. et al., Shared Expectations for Protection of Identifiable Health Care Information: Report of a National Consensus Process, 16 J. GEN. INTERNAL MED. 100 (2001)CrossRefGoogle ScholarPubMed.

67 See 45 C.F.R. § 164.514.

68 Thomas, Johnson Urge Changes in Records Privacy Rule to Prevent “Great Damage” to Medical Research, WASH. HEALTHBEAT, Mar. 1, 2002 (quoting letter to President George W. Bush from Representatives Bill Thomas and Nancy Johnson advocating for changes in the administration's medical records confidentiality rule).

69 Seto, Belinda, History of Medical Ethics and Perspectives on Disparities in Minority Recruitment and Involvement in Health Research, 322 AM. J. MED. SCI. 248, 251 (2001)CrossRefGoogle ScholarPubMed.