The brave new world of medical standards of care

Journal of Law, Medicine and Ethics

Volumn 29, Issue 9999, 2001, Pages 323-334

  Kinney, Eleanor D ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL MEDICINE; HEALTH CARE QUALITY; HEALTH INSURANCE; HUMAN; LEGAL ASPECT; STANDARD; UNITED STATES;

CLINICAL MEDICINE; HUMANS; MANAGED CARE PROGRAMS; QUALITY ASSURANCE, HEALTH CARE; UNITED STATES;

EID: 0035467923     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720x.2001.tb00351.x     Document Type: Article

References (167)

1. See ECRI, Healthcare Standards Directory (Plymouth Meeting, Pennsylvania: ECRI, 2001);
2. M.C. Toepp et al., Directory of Clinical Practice Guidelines 1997: Titles, Sources, and Updates (Chicago: American Medical Association, 1997); National Guideline Clearinghouse, Agency for Healthcare Research and Quality, at 〈http://www.guideline.gov/index.asp〉 (last visited September 1, 2001).
3. Institute of Medicine, Clinical Practice Guidelines: Directions for a New Program (Washington, D.C.: National Academy Press, 1990): at 8.
4. See R.R. Bovbjerg, C.C. Griffin, and C.E. Carroll, "U.S. Health Care Coverage and Costs: Historical Development and Choices for the 1990s," Journal of Law, Medicine & Ethics, 21, no. 2 (1993): 141-62.
5. P. Starr, The Social Transformation of American Medicine (New York: Basic Books, 1982): at 338-63;
6. T.A. Brennan and D.M. Berwick, New Rules: Regulation, Markets, and the Quality of American Health Care (San Francisco: Jossey-Bass, 1996): at 105-07.
7. A. Donabedian, "Evaluating the Quality of Medical Care," Milbank Memorial Fund Quarterly: Health and Society, 44, no. 3 (1966): 166-203.
8. "Structure" criteria pertain to organizational characteristics of the institution and address the underlying capacity to deliver quality care. "Process" criteria pertain to the delivery of care and address such issues as the appropriateness of particular treatment decisions and the manner of performing particular services and other functions. "Outcome" criteria pertain to whether the care results in a positive outcome, such as the improvement of the patient's medical condition or the patient's satisfaction with care. See A. Donabedian, The Definition of Quality and Approaches to its Assessment (Ann Arbor: Health Administration Press, 1980): at 79-84.
9. See Donabedian, supra note 6.
10. See J.S. Roberts, J.G. Coale, and R.R. Redman, "A History of the Joint Commission on Accreditation of Hospitals," JAMA, 258 (1987): 936-40;
11. T.S. Jost, "The Joint Commission on the Accreditation of Hospitals: Private Regulation of Health Care and the Public Interest," Boston College Law Review, 24 (1983): 835-923, at 849-52.
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13. C.W Parker, "Practice Guidelines and Private Insurers," Journal of Law, Medicine & Ethics, 23, no. 1 (1995): 57-61.
14. See M.R. Chassin, "Standards of Care in Medicine," Inquiry, 25(1988): 437-53;
15. E.D. Kinney and M. Wilder, "Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities," University of California at Davis Law Review, 22 (1989) 421-50, at 422-38.
16. See L.J. White and J. Ball, "Clinical Efficacy Assessment Project of the American College of Physicians," International Journal of Technology Assessment in Health Care, 1, no. 1 (1985): 69-74;
17. D. Tennenbaum, "Blue Cross and Blue Shield Association's Perspective on the Common Diagnostic Testing Guidelines," Journal of General Internal Medicine, 4, no. 6 (1989): 553-54.
18. J. Kelly and J. Swartwout, "Development of Practice Parameters by Physician Organizations," Quality Review Bulletin, 16, no. 2 (1990): 54-57.
19. Council of Medical Specialties, Standards of Quality in Patient Care: The Importance and Risks of Standard Setting (published proceedings from Invitational Conference of the Council of Medical Specialty Societies, Washington, D.C., September 25-26, 1987).
20. See J. Schwartz, "The Role of Professional Medical Societies in Reducing Practice Variations," Health Affairs, 3, no. 2 (1984): 90-101.
21. See, e.g., C.M. Grogan et al., "How Will We Use Clinical Guidelines? The Experience of Medicare Carriers," Journal of Health Politics, Policy and Law, 19, no. 1 (1994): 7-26;
22. D. Eddy, "Benefit Language: Criteria that Will Improve Quality While Reducing Costs•" JAMA, 275 (1996): 650-57;
23. E.D. Kinney, "National Coverage Policy in the Medicare Program: Problems & Proposals for Change," Saint Louis University Law Journal, 32 (1988): 869-970.
24. Physician Payment Review Commission, Annual Report to Congress (Washington, D.C.: Physician Payment Review Commission, 1988): at 230.
25. W. Roper et al., "Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice," N. Engl. J. Med., 319 (1988): 1197-202;
26. W. Roper and G. Hackbarth, "HCFA's Agenda for Promoting High-Quality Care," Health Affairs, 7, no. 1 (1988): 91-98.
27. J.H. Ferguson, "The NIH Consensus Development Program," Joint Commission Journal on Quality Improvement, 21, no. 7 (1995): 332-36;
28. J. Kosecoff et al., "Effects of the National Institutes of Health Consensus Development Program on Physician Practice," JAMA, 258 (1987): 2708-13.
29. Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239, § 6103, 103 Stat. 2189 (codified at 42 U.S.C. § 299, adding Title IX to the Public Health Service Act, and 42 U.S.C. § 1142 to the Social Security Act).
30. See H.R. Rep. No. 247, 101st Cong., 1st Sess., at 3 (1989), reprinted in 1989 U.S.C.C.A.N. 2101, at 2104. See also Institute of Medicine, supra note 2.
31. See E.D. Kinney, "Behind the Veil Where the Action Is: Private Policy Making and American Health Care," Administrative Law Review, 51 (1999): 145-97, at 166-69;
32. W.R. Trail and B.A. Allen, "Government Created Medical Practice Guidelines," Journal of Law & Health, 10 (1996): 231-58.
33. S.C. Schoenbaum and D.N. Sundwall, Using Clinical Practice Guidelines to Evaluate Quality of Care (Rockville: Maryland: Agency for Health Care Quality and Research, 1995).
34. See also C.R. Gaus, "Future Directions for the Agency for Health Care Policy and Research," American Journal of Medical Quality, 11, no. 1 (1996): S26-29.
35. Healthcare Research and Quality Act of 1999, Pub. L. 106-129, § 2(a), 113 Stat. 1653 (codified at 42 U.S.C. § 299 et seq.).
36. Agency for Healthcare Research and Quality, AHRQ Profile: Quality Research for Quality Health Care (Rockville, Maryland: Agency for Healthcare Research and Quality, 2000).
37. See D. Orentlicher, "Practice Guidelines: A Limited Role in Resolving Rationing Decisions," Journal of American Geriatrics Society, 46 (March 1998): 369-72;
38. K.N. Lohr, "Guidelines for Clinical Practice: What They Are and Why They Count," Journal of Law, Medicine & Ethics, 23, no. 1 (1995): 49-56;
39. R.L. Kane, "Creating Practice Guidelines: The Dangers of Over-Reliance on Expert Judgment," Journal of Law, Medicine & Ethics, 23, no. 1 (1995): 62-64;
40. S.J. Tanenbaum, "Knowing and Acting in Medical Practice: The Epistemological Politics of Outcomes Research," Journal of Health Politics, Policy and Law, 19 (1994): 27-44;
41. R.H. Brook, "Practice Guidelines and Practicing Medicine: Are They Compatible?," JAMA, 262 (1989): 3027-30.
42. See A.C. Enthoven, "The History and Principles of Managed Competition," Health Affairs, 12, no. 1 (Supp. 1993): 24-47, at 29-31.
43. See T.S. Jost, "Oversight of the Quality of Medical Care: Regulation, Management, or the Market?," Arizona Law Review, 37 (1995): 825-68.
44. See M.R. Chassin, "Assessing Strategies for Quality Improvement," Health Affairs, 16, no. 3 (1997): 151-61;
45. P.B. Ginsburg and G.T. Hammons, "Competition and the Quality of Care: The Importance of Information," Inquiry, 25 (1988): 108-15.
46. H.R. 3600, Health Security Act, 104th Cong., 1st Sess. (1993). See T.S. Jost, "Health System Reform: Forward or Backward with Quality Oversight," JAMA, 271, no. 19 (1994): 1580-611.
47. Balanced Budget Act of 1997, Pub. L. No. 105-33, §§ 4001-4003, 111 Stat. 251, at 275-331 (codified as amended in scattered sections of 42 U.S.C. § 1395w-2) (Medicare); Balanced Budget Act of 1997 §§ 4702-4704 (to be codified at 42 U.S.C. § 1396u-2) (Medicaid).
48. G.A. Jensen et al., "The New Dominance of Managed Care: Insurance Trends in the 1990s," Health Affairs, 16, no. 1 (1997): 125-36.
49. See S.D. Pearson et al., "Ethical Guidelines for Physician Compensation Based on Capitation," N. Engl. J. Med., 339 (1998): 689-93;
50. F.H. Miller, "Foreword: The Promise and Problems of Capitation," American Journal of Law & Medicine, 22, nos. 2 and 3 (1996): 167-72;
51. D. Orentlicher, "Paying Physicians to Do Less: Financial Incentives to Limit Care," University of Richmond Law Review, 30 (1996): 155-97.
52. See M.A. Rodwin, "Conflicts in Managed Care," N. Engl. J. Med., 332 (1995): 604-07;
53. Council on Ethical and Judicial Affairs, American Medical Association, "Ethical Issues in Managed Care," JAMA, 273 (1995): 330-35;
54. E.J. Emanuel and N.N. Dubler, "Preserving the Physician-Patient Relationship in the Era of Managed Care," JAMA, 273 (1992): 323-29;
55. M.A. Bobinski, "Autonomy and Privacy: Protecting Patients from Their Physicians," University of Pittsburgh Law Review, 55 (1994): 291-388;
56. J.P Little, "Managed Care Contracts of Adhesion: Terminating the Doctor-Patient Relationship and Endangering Patient Health," Rutgers Law Review, 49 (1997): 1397-478;
57. M.J. Mehlman, "Fiduciary Contracting: Limitations on Bargaining Between Patients and Health Care Providers," University of Pittsburgh Law Review, 51 (1990): 365-418.
58. This useful conceptual framework was developed in J.A. Marsteller and R.R. Bovbjerg, Federalism and Patient Protection: Changing Roles for State and Federal Government (Washington, D.C.: The Urban Institute, 1999).
59. See R.J. Blendon and J.M. Benson, "Americans' Views on Health Policy: A Fifty Year Historical Perspective," Health Affairs, 20, no. 2 (2001): 33-46;
60. R.J. Blendon et al., "Understanding the Managed Care Backlash," Health Affairs, 17, no. 4 (1998): 80-94;
61. A. Gawande et al., "Does Dissatisfaction with Health Plans Stem from Having No Choice?," Health Affairs, 17, no. 5 (1998): 181-94.
62. T. Bodenheimer, "The HMO Backlash - Righteous or Reactionary?," N. Engl. J. Med., 335 (1996): 1601-04.
63. See C.C. Havighurst, "The Backlash Against Managed Health Care: Hard Politics Make Bad Policy," Indiana Law Review, 34, no. 4 (2001): 395-417;
64. C.C. Havighurst, "Contract Failure in the Market for Health Services," Wake Forest Law Review, 29 (1994): 47-69;
65. A.C. Enthoven, H.H. Schauffler, and S. McMenamin, "Consumer Choice and the Managed Care Backlash," American Journal of Law & Medicine, 27 (2001): 1-14.
66. Blendon et al., supra note 35; Gawande et al., supra note 35.
67. T.S. Jost, "The Necessary and Proper Role of Regulation to Assure the Quality of Health Care," Houston Law Review, 25 (1988): 525-98, at 530-31.
68. Brennan and Berwick, supra note 4, at 41.
69. D.M. Fox, "Health Policy and the Politics of Research in the United States," Journal of Health Politics, Policy and Law, 15 (1990): 481-99; Brennan and Berwick, supra note 4, at 109-22.
70. See, e.g., J.E. Wennberg and A.M. Gittelsohn, "Small Area Variations in Health Care Delivery: A Population-Based Health Information System Can Guide Planning and Regulatory Decision Making," Science, 182 (1973): 1102-08;
71. D.M. Eddy, "Variations in Physician Practice: The Role of Uncertainty," Health Affairs, 3, no. 2 (1984): 74-89.
72. See R. Brook and K. Lohr, "Efficacy, Effectiveness, Variations, and Quality: Boundary Crossing Research," Medical Care, 23 (1985): 710-22;
73. D.M. Eddy and J. Billings, "The Quality of Medical Evidence: Implications for Quality of Care," Health Affairs, 7, no. 1 (1988): 19-32.
74. A.S. Rehlman, "The Third Revolution in Medical Care," N. Engl. J. Med., 319 (1988): 1220-22;
75. P. Ellwood, "Shattuck Lecture - Outcomes Management: A Technology of Patient Experience," N. Engl. J. Med., 318 (1988): 1549-56;
76. S. Schroeder, "Outcome Assessment 70 Years Later: Are We Ready?," N. Engl. J. Med., 316 (1986): 160-62;
77. M.J. Mehlman, "Assuring the Quality of Medical Care: The Impact of Outcome Measurement and Practice Standards," Law, Medicine & Health Care, 18, no. 4 (1990): 368-84;
78. B.R. Furrow, "The Changing Role of the Law in Promoting Quality in Health Care: From Sanctioning Outlaws to Managing Outcomes," Houston Law Review, 26 (1989): 147-90.
79. See Brennan and Berwick, supra note 4, at 124-33; M.M. Melum and M.K. Sinioris, Total Quality Management: The Health Care Pioneers (Chicago: American Hospital Publishing, 1992).
80. See D.M. Berwick et al., Curing Health Care: New Strategies for Quality Improvement (San Francisco: Jossey-Bass, 1990);
81. G. Laffel and D. Blumenthal, "The Case for Using Industrial Quality Management Science in Health Care Organizations," JAMA, 262 (1989): 2869-73;
82. D.M. Berwick, "Continuous Improvement as an Ideal in Health Care," N. Engl. J. Med., 320 (1989): 53-56.
83. E. Marszalek-Gaucher and R.J. Coffey, Transforming Healthcare Organizations: How to Achieve and Sustain Organizational Excellence (San Francisco: Jossey-Bass, 1990); Brennan and Berwick, supra note 4.
84. D.S. O'Leary, "Agenda for Change Fosters CQI Concepts," Joint Commission Perspectives, 2, no. 1 (1992): 3.
85. See Institute of Medicine, The Computer-Based Patient Record: An Essential Technology For Health Care, rev. ed. (Washington, D.C.: National Academy Press, 1987).
86. C.J. McDonald et al., "The Regenstrief Medical Record System: A Quarter Century Experience," International Journal of Medical Informatics, 54 (1999): 225-53.
87. See Institute of Medicine, supra note 48, at 120-21; R.D. Andrews and C. Beauchamp, "A Clinical Database Management System for Improved Integration of the Veterans Affairs Hospital Information System," Journal of Medical Systems, 13, no. 6 (1989): 309-20.
88. J.A. Marsteller et al., "The Resurgence of Selective Contracting Restrictions," Journal of Health Politics, Policy and Law, 22 (1997): 1133-89;
89. K.A. Jordan, "Managed Competition and Limited Choice of Providers: Countering Negative Perceptions Through a Responsibility to Select Quality Network Physicians," Arizona State Law Journal, 27 (1995): 875-952.
90. See 42 U.S.C. §§ 1395y(a)(1) and 1395ff (1994 & Supp. V 1999).
91. See W.K. Mariner, "Standards of Care and Standard Form Contracts: Distinguishing Patient Rights and Consumer Rights in Managed Care," Journal of Contemporary Health Law and Policy, 15(1998): 1-55.
92. See J.E. Shuren, "Legal Accountability for Utilization Review in ERISA Health Plans," North Carolina Law Review, 77 (1999): 731-82; Kinney, supra note 15;
93. S.H. Wilson, "Benefit Cutbacks in the Medicare Program through Administrative Agency Fiat Without Protections: Litigation Approaches on Behalf of Beneficiaries," Gonzaga Law Review, 16 (1981): 533-78.
94. See S. Leichter, "The Silent Standards in Diabetes Care: Millman and Robertson," Clinical Diabetes, 19 (2000): 140.
95. See A.A. Noble and T.A. Brennan, "The Stages of Managed Care Regulation: Developing Better Rules," Journal of Health Politics, Policy and Law, 24 (2000): 1275-305.
96. Institute of Medicine, supra note 48, at 6-7.
97. Id. at 7.
98. M.G. Weiner and E. Pifer, "Computerized Decision Support and the Quality of Care," Managed Care, May 2000, available at 〈http://www.managedcaremag.com/archives/ 0005/0005.weiner.html〉.
99. Andrews and Beauchamp, supra note 50.
100. W.M. Tierney et al., "Computerizing Guidelines to Improve Care and Patient Outcomes: The Example of Heart Failure," Journal of the American Medical Informatics Association, 2, no. 5 (1995): 316-22;
101. R.B. Elson and D.P. Connelly, "Computerized Patient Records in Primary Care: Their Role in Mediating Guideline-Driven Physician Behavior Change," Archives of Family Medicine, 4 (1995): 698-706.
102. See J.M. Overhage et al., "Computer Reminders to Implement Preventative Care Guidelines for Hospitalized Patients," Archives of Internal Medicine, 156 (1996): 1551-56;
103. R.C. Buracketal., "Promoting Screening Mammography in Inner City Settings: A Randomized Controlled Trial of Computerized Reminders as a Component of a Program to Facilitate Mammography," Medical Care, 32 (1994): 609-24;
104. I. McDowell, C. Newell, and W Rosser, "Computerized Reminders to Encourage Cervical Screening in Family Practice," Journal of Family Practice, 28 (1989): 420-24;
105. C.J. McDonald et al., "Reminders to Physicians from an Introspective Computer Medical Record," Annals of Internal Medicine, 100 (1984): 130-38;
106. C.J. McDonald, "Computer Reminders, the Quality of Care and the Nonperfectability of Man," N. Engl. J. Med., 295 (1976): 1351-55.
107. See Weiner and Pifer, supra note 59 (presenting a table summarizing different research projects involving use of medical standards of care in clinical settings).
108. See, e.g., H. MacMahon et al., "Computer-Aided Diagnosis of Pulmonary Nodules: Results of a Large Scale Observer Test," Radiology, 213 (1999): 723-26;
109. S.L. Pestotnik et al., "Implementing Antibiotic Practice Guidelines Through Computer-Assisted Decision-Support: Clinical and Financial Outcomes," Annals of Internal Medicine, 124 (1996): 884-90. See Weiner and Pifer, supra note 59 (containing table summarizing evaluations of computerized support for medical decision-making).
110. See J.P. Kassirer, "A Report Card on Computer Assisted Diagnosis - The Grade: C," N. Engl. J. Med., 330 (1994): 1811-25.
111. C.M. Clark, Jr., et al., "A Systematic Approach to Risk Stratification and Intervention within a Managed Care Environment Improves Diabetes Outcomes and Patient Satisfaction," Diabetes Care, 24 (2001): 1079-86.
112. E.A. Balas et al., "The Clinical Value of Computerized Information Services: A Review of 98 Randomized Clinical Trials," Archives of Family Medicine, 5 (1996): 271-78;
113. D.M. Rind et al., "Effect of Computer-Based Alerts on the Treatment and Outcomes of Hospitalized Patients," Archives of Internal Medicine, 154 (1994): 1511-17;
114. W.M. Tierney, S.L. Hui, and C.J. McDonald, "Delayed Feedback of Physician Performance Versus Immediate Reminders to Perform Preventive Care: Effects on Physician Compliance," Medical Care, 24 (1986): 659-66.
115. D.L. Hunt et al., "Effects of Computer-Based Clinical Decision-Support Systems on Physician Performance and Patient Outcomes," JAMA, 280 (1998): 1339-45;
116. D. Lobach et al., "Computerized Decision Support Based on a Clinical Practice Guideline Improves Compliance with Care Standards," American Journal of Medicine, 102 (1997): 89-98.
117. Weiner and Pifer, supra note 59; Tierney, Hui, and McDonald, supra note 66.
118. Weiner and Pifer, supra note 59; D. Davis et al., "Changing Physician Performance: A Systematic Review of the Effect of Continuing Medical Education Strategies," JAMA, 274 (1995): 700-05;
119. J. Ende, "Feedback in Clinical Medical Education," JAMA, 250 (1983): 777-81.
120. A.D. Epstein, "Performance Reports on Quality - Prototypes, Problems, and Prospects," N. Engl. J. Med., 333 (1995): 51-61;
121. B.R. Furrow, "Regulating the Managed Care Revolution: Private Accreditation and a New System," Villanova Law Review, 43 (1998): 361-407, at 400-07.
122. U.S. General Accounting Office, Report Cards: A Useful Concept but Significant Issues Need to Be Addressed (Washington, D.C.: Government Printing Office, 1994).
123. See National Committee for Quality Assurance, State of Managed Care Quality (Washington, DC: National Committee for Quality Assurance, 1999).
124. See Brennan and Berwick, supra note 4, at 159-62; J.K. Iglehart, "The National Committee for Quality Assurance," N. Engl. J. Med., 335 (1996): 995-99; Furrow, supra note 69.
125. National Committee for Quality Assurance, Health Plan Employer Data and Information Set (Washington, D.C.: National Committee for Quality Assurance, 2001). See Furrow, supra note 69, at 400-07;
126. M. Dalzell, "Physician, HEDIS Thyself," Managed Care, March 1999, available at 〈http://www.managedcaremag.com/archives/9903/9903. hedis2000.shtml〉.
127. See B.R. Furrow, "Managed Care Organizations and Patient Injury: Rethinking Liability," Georgia Law Review, 31 (1997): 419-509;
128. V Randall, "Managed Care, Utilization Review, and Financial Risk Shifting: Compensating Patients for Health Care Cost Containment Injuries," University of Puget Sound Law Review, 17 (1993): 1;
129. J. Blum, "An Analysis of Legal Liability in Health Care Utilization Review and Health Care Management," Houston Law Review, 26 (1989): 191.
130. See M.M. Mello, "Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation," University of Pennsylvania Law Review, 149 (2001): 645-710;
131. M.L. Sheetz, "Toward Controlled Clinical Care Through Clinical Practice Guidelines: The Legal Liability for Developers and Issuers of Clinical Pathways," Brooklyn Law Review, 63 (1997): 1341-80;
132. A.L. Hyams et al., "Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective," Journal of Health Politics, Policy and Law, 21 (1996): 289-313;
133. T.A. Brennan, "Practice Guidelines and Malpractice Litigation: Collision or Cohesiont," Journal of Health Politics, Policy and Law, 16 (1991): 67-86;
134. C.C. Havighurst, "Practice Guidelines as Legal Standards Governing Physician Liability," Law and Contemporary Problems, 54 (1991): 87-117;
135. M. Hall, "The Defensive Effect of Medical Practice Policies in Malpractice Litigation," Law and Contemporary Problems, 54 (1991): 119-45;
136. Kinney and Wilder, supra note 11. See also E. Hirshfeld, "Should Practice Parameters Be the Standard of Care in Malpractice Litigation?," JAMA, 266 (1991): 2886-91;
137. E.D. Kinney, "Malpractice Reform in the 1990s: Past Disappointments, Future Success?," Journal of Health Politics, Policy and Law, 20 (1995): 99-136.
138. Fla. Stat. ch. 408.02 (1998); Ky. Rev. Star. Ann. § 342.035 (Michie 1997); Me. Rev. Stat. Ann. tit. 24, §§ 2971-2979 (West Supp. 2000); Md. Code Ann., Health - Gen. I § 19-1602 (2000). See D.W. Shuman, "The Standard of Care in Medical Malpractice Claims, Clinical Practice Guidelines, and Managed Care: Towards a Therapeutic Harmony?," California Western Law Review, 34 (1997): 99-113, at 105.
139. See E.H. Morreim, "Managed Care Playing Doctor: Corporate Medical Practice and Medical Malpractice," University of Michigan Journal of Law Reform, 32 (1999): 939-1040.
140. Pub. L. No. 93-406, 88 Stat. 832 (codified as amended at 29 U.S.C. §§ 1001-1191c).
141. 29 U.S.C. § 1144 (1994 & Supp. V 1999).
142. See P.D. Jacobson and S.D. Pomfret, "Form, Function, and Managed Care Torts: Achieving Fairness and Equity in ERISA Jurisprudence," Houston Law Review, 35 (1998): 985-1078;
143. K.A. Jordan, "Tort Liability for Managed Care: The Weakening of ERISA's Protective Shield," Journal of Law, Medicine & Ethics, 25, nos. 2 and 3 (1997): 160-79;
144. J.K. Kilcullen, "Groping for the Reins: ERISA, HMO Malpractice, and Enterprise Liability," American Journal of Law & Medicine, 22, no. 1 (1996): 7-50. See also Pegram v. Herdrich, 530 U.S. 211 (2000), rev'g, 54 F.3d 362 (7th Cir. 1998).
145. See W.M. Sage, "UR Here: The Supreme Court's Guide for Managed Care," Health Affairs, 19, no. 5 (2000): 219-23.
146. See W.M. Sage, "Enterprise Liability and the Emerging Managed Health Care System," Law & Contemporary Problems, 60, nos. 1 and 2 (1997): 159-210;
147. C.C. Havighurst, "Making Health Plans Accountable for the Quality of Care," Georgia Law Review, 31 (1997): 587-648.
148. B.R. Furrow et al., Health Law: Cases, Materials and Problems, 4th ed. (St. Paul, Minnesota: West Group, 2001): §§ 4-32-4-33.
149. See, e.g., A.M. Jurevic, "When Technology and Health Care Collide: Issues with Electronic Medical Records and Electronic Mail," UMKC Law Review, 66 (1998): 809-36;
150. B. Woodward, "Medical Record Confidentiality and Data Collection: Current Dilemmas," Journal of Law, Medicine & Ethics, 25, nos. 2 and 3 (1997): 88-97;
151. P.T. Cuzmanes and C.P. Orlando, "Automation of Medical Records: The Electronic Superhighway and its Ramifications for Health Care Providers," Journal Pharmacy & Law, 6 (1997): 19-32;
152. L.O. Gostin, "Health Information Privacy," Cornell Law Review, 80 (1995): 451-528;
153. W.H. Minor, "Identity Cards and Databases in Health Care: The Need for Federal Privacy Protections," Columbia Journal of Law and Social Problems, 28 (1995): 253-96.
154. Pub. L. No. 104-191, 110 Stat. 2021 (1996) (codified at 42 U.S.C. § 1320d (Supp. V 1999)).
155. U.S. Department of Health and Human Services, HHS Fact Sheet: Protecting the Privacy of Patients' Health Information (May 9, 2001), available at 〈http://aspe.hhs.gov/admnsimp/ final/pvcfact2.htm〉.
156. 42 U.S.C. § 1320d-2 (Supp. V 1999).
157. Standards for Privacy of Individually Identifiable Health Information, 64 Fed. Reg. 59,918 (proposed November 3, 1999).
158. Standards for Privacy of Individually Identifiable Health Information, 65 Fed. Reg. 82,462 (December 28, 2000) (to be codified at 45 C.F.R. pts. 160, 164), as corrected by Technical Corrections to Final Rule, 65 Fed. Reg. 82,944 (December 29, 2000).
159. 45 C.F.R. §§ 164.502(a)(1)(ii) and 164.506(a)(1) (2001).
160. Id. § 160.103.
161. Id. § 164.502(b)(1).
162. Id. §§ 164.520(b)(1) and 164.528.
163. Id. § 164.508.
164. Id. § 160.203.
165. See C. Scott "Is Too Much Privacy Bad for Your Health? An Introduction to the Law, Ethics, and HIPAA Rule on Medical Privacy," Georgia State University Law Review, 17 (2000): 481-528;
166. A.J. Rosoff, "Informed Consent in the Electronic Age," American Journal of Law & Medicine, 25, nos. 2 and 3 (1999): 367-86;
167. J.G. Hodge, Jr., et al., "Legal Issues Concerning Electronic Health Information: Privacy, Quality, and Liability," JAMA, 282 (1999): 1466-71.