Hostname: page-component-cd9895bd7-7cvxr Total loading time: 0 Render date: 2024-12-26T08:56:19.043Z Has data issue: false hasContentIssue false

The Brave New World of Medical Standards of Care

Published online by Cambridge University Press:  01 January 2021

Extract

There have always been medical standards of care in the American health-care sector. However, never before have they been so deeply incorporated in the delivery of health care as they are today. With the increased delivery of care through integrated delivery systems, as well as the development of the computerized patient record, medical standards of care are now used in innovative ways by providers and health plans in delivering health care to individual patients. There is great potential for even more innovative uses of medical standards of care in the future.

This article first presents a taxonomy of the medical standards of care that are involved in health-care delivery today Next, the article traces the historical evolution of medical standards of care since the early 1980s. Included in this discussion are the origins of the standard-setting movement as well as the developments that led to the way standards of care are currently used by large institutional providers and managed care plans to improve the quality of their health-care services. The article concludes with a brief analysis of the key legal issues that affect how standards of care can be used to improve the health care of patients.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 2001

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

See ECRI, Healthcare Standards Directory (Plymouth Meeting, Pennsylvania: ECRI, 2001); Toepp, M.C. 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).Google Scholar
Institute of Medicine, Clinical Practice Guidelines: Directions for a New Program (Washington, D.C.: National Academy Press, 1990): at 8.Google Scholar
See Bovbjerg, R.R., Griffin, C.C. and Carroll, C.E., “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.CrossRefGoogle Scholar
Starr, P., The Social Transformation of American Medicine (New York: Basic Books, 1982): at 338–63; Brennan, T.A. and Berwick, D.M., New Rules: Regulation, Markets, and the Quality of American Health Care (San Francisco: Jossey-Bass, 1996): at 105-07.Google Scholar
Donabedian, A., “Evaluating the Quality of Medical Care,” Milbank Memorial Fund Quarterly: Health and Society, 44, no. 3 (1966): 166203.CrossRefGoogle Scholar
“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 Donabedian, A., The Definition of Quality and Approaches to its Assessment (Ann Arbor: Health Administration Press, 1980): at 7984.Google Scholar
See Donabedian, supra note 6.Google Scholar
See Roberts, J.S., Coale, J.G. and Redman, R.R., “A History of the Joint Commission on Accreditation of Hospitals,” JAMA, 258 (1987): 936–40; Jost, T.S., “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.CrossRefGoogle Scholar
Gornick, M. et al., “Twenty Years of Medicare and Medicaid: Covered Populations, Use of Benefits, and Program Expenditures,” Health Care Finance Review (Supp. 1985): 1359, at 35-45.Google Scholar
Parker, C.W., “Practice Guidelines and Private Insurers,” Journal of Law, Medicine & Ethics, 23, no. 1 (1995): 5761.CrossRefGoogle Scholar
See Chassin, M.R., “Standards of Care in Medicine,” Inquiry, 25(1988): 437–53; Kinney, E.D. and Wilder, M., “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.Google Scholar
See White, L.J. and Ball, J., “Clinical Efficacy Assessment Project of the American College of Physicians,” International Journal of Technology Assessment in Health Care, 1, no. 1 (1985): 6974; Tennenbaum, D., “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.CrossRefGoogle Scholar
Kelly, J. and Swartwout, J., “Development of Practice Parameters by Physician Organizations,” Quality Review Bulletin, 16, no. 2 (1990): 5457.CrossRefGoogle Scholar
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). See Schwartz, J., “The Role of Professional Medical Societies in Reducing Practice Variations,” Health Affairs, 3, no. 2 (1984): 90101.CrossRefGoogle Scholar
See, e.g., Grogan, C.M. et al., “How Will We Use Clinical Guidelines? The Experience of Medicare Carriers,” Journal of Health Politics, Policy and Law, 19, no. 1 (1994): 726; Eddy, D., “Benefit Language: Criteria that Will Improve Quality While Reducing Costs,” JAMA, 275 (1996): 650-57; Kinney, E.D., “National Coverage Policy in the Medicare Program: Problems & Proposals for Change,” Saint Louis University Law Journal, 32 (1988): 869-970.CrossRefGoogle Scholar
Physician Payment Review Commission, Annual Report to Congress (Washington, D.C.: Physician Payment Review Commission, 1988): at 230.Google Scholar
Roper, W. et al., “Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice,” N. Engl. J. Med., 319 (1988): 1197–202; Roper, W. and Hackbarth, G., “HCFA's Agenda for Promoting High-Quality Care,” Health Affairs, 7, no. 1 (1988): 91-98.CrossRefGoogle Scholar
Ferguson, J.H., “The NIH Consensus Development Program,” Joint Commission Journal on Quality Improvement, 21, no. 7 (1995): 332–36; Kosecoff, J. et al., “Effects of the National Institutes of Health Consensus Development Program on Physician Practice,” JAMA, 258 (1987): 2708-13.CrossRefGoogle Scholar
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).Google Scholar
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.Google Scholar
See Kinney, E.D., “Behind the Veil Where the Action Is: Private Policy Making and American Health Care,” Administrative Law Review, 51 (1999): 145–97, at 166-69; Trail, W.R. and Allen, B.A., “Government Created Medical Practice Guidelines,” Journal of Law & Health, 10 (1996): 231-58.Google Scholar
Schoenbaum, S.C. and Sundwall, D.N., Using Clinical Practice Guidelines to Evaluate Quality of Care (Rockville: Maryland: Agency for Health Care Quality and Research, 1995). See also Gaus, C.R., “Future Directions for the Agency for Health Care Policy and Research,” American Journal of Medical Quality, 11, no. 1 (1996): S26-29.Google Scholar
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.).Google Scholar
Agency for Healthcare Research and Quality, AHRQ Profile: Quality Research for Quality Health Care (Rockville, Maryland: Agency for Healthcare Research and Quality, 2000).Google Scholar
See Orentlicher, D., “Practice Guidelines: A Limited Role in Resolving Rationing Decisions,” Journal of American Geriatrics Society, 46 (March 1998): 369–72; Lohr, K.N., “Guidelines for Clinical Practice: What They Are and Why They Count,” Journal of Law, Medicine & Ethics, 23, no. 1 (1995): 49-56; Kane, R.L., “Creating Practice Guidelines: The Dangers of Over-Reliance on Expert Judgment,” Journal of Law, Medicine & Ethics, 23, no. 1 (1995): 62-64; Tanenbaum, S.J., “Knowing and Acting in Medical Practice: The Epistemological Politics of Outcomes Research,” Journal of Health Politics, Policy and Law, 19 (1994): 27-44; Brook, R.H., “Practice Guidelines and Practicing Medicine: Are They Compatible?,” JAMA, 262 (1989): 3027-30.CrossRefGoogle Scholar
See Enthoven, A.C., “The History and Principles of Managed Competition,” Health Affairs, 12, no. 1 (Supp. 1993): 2447, at 29-31.CrossRefGoogle Scholar
See Jost, T.S., “Oversight of the Quality of Medical Care: Regulation, Management, or the Market?,” Arizona Law Review, 37 (1995): 825–68.Google Scholar
See Chassin, M.R., “Assessing Strategies for Quality Improvement,” Health Affairs, 16, no. 3 (1997): 151–61; Ginsburg, P.B. and Hammons, G.T., “Competition and the Quality of Care: The Importance of Information,” Inquiry, 25 (1988): 108-15.Google Scholar
H.R. 3600, Health Security Act, 104th Cong., 1st Sess. (1993). See Jost, T.S., “Health System Reform: Forward or Backward with Quality Oversight,” JAMA, 271, no. 19 (1994): 1580–611.CrossRefGoogle Scholar
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).Google Scholar
Jensen, G.A. et al., “The New Dominance of Managed Care: Insurance Trends in the 1990s,” Health Affairs, 16, no. 1 (1997): 125–36.CrossRefGoogle Scholar
See Pearson, S.D. et al., “Ethical Guidelines for Physician Compensation Based on Capitation,” N. Engl. J. Med., 339 (1998): 689–93; Miller, F.H., “Foreword: The Promise and Problems of Capitation,” American Journal of Law & Medicine, 22, nos. 2 and 3 (1996): 167-72; Orentlicher, D., “Paying Physicians to Do Less: Financial Incentives to Limit Care,” University of Richmond Law Review, 30 (1996): 155-97.CrossRefGoogle Scholar
See Rodwin, M.A., “Conflicts in Managed Care,” N. Engl. J. Med., 332 (1995): 604–07; Council on Ethical and Judicial Affairs, American Medical Association, “Ethical Issues in Managed Care,” JAMA, 273 (1995): 330-35; Emanuel, E.J. and Dubler, N.N., “Preserving the Physician-Patient Relationship in the Era of Managed Care,” JAMA, 273 (1992): 323-29; Bobinski, M.A., “Autonomy and Privacy: Protecting Patients from Their Physicians,” University of Pittsburgh Law Review, 55 (1994): 291-388; Little, J.P., “Managed Care Contracts of Adhesion: Terminating the Doctor-Patient Relationship and Endangering Patient Health,” Rutgers Law Review, 49 (1997): 1397-478; Mehlman, M.J., “Fiduciary Contracting: Limitations on Bargaining Between Patients and Health Care Providers,” University of Pittsburgh Law Review, 51 (1990): 365-418.CrossRefGoogle Scholar
This useful conceptual framework was developed in Marsteller, J.A. and Bovbjerg, R.R., Federalism and Patient Protection: Changing Roles for State and Federal Government (Washington, D.C.: The Urban Institute, 1999).Google Scholar
See Blendon, R.J. and Benson, J.M., “Americans' Views on Health Policy: A Fifty Year Historical Perspective,” Health Affairs, 20, no. 2 (2001): 3346; Blendon, R.J. et al., “Understanding the Managed Care Backlash,” Health Affairs, 17, no. 4 (1998): 80-94; Gawande, A. et al., “Does Dissatisfaction with Health Plans Stem from Having No Choice?,” Health Affairs, 17, no. 5 (1998): 181-94. Bodenheimer, T., “The HMO Backlash — Righteous or Reactionary?,” N. Engl. J. Med., 335 (1996): 1601-04.Google Scholar
See Havighurst, C.C., “The Backlash Against Managed Health Care: Hard Politics Make Bad Policy,” Indiana Law Review, 34, no. 4 (2001): 395417; Havighurst, C.C., “Contract Failure in the Market for Health Services,” Wake Forest Law Review, 29 (1994): 47-69; Enthoven, A.C., Schauffler, H.H. and McMenamin, S., “Consumer Choice and the Managed Care Backlash,” American Journal of Law & Medicine, 27 (2001): 1-14.Google Scholar
Blendon, et al., supra note 35; Gawande, et al., supra note 35.Google Scholar
Jost, T.S., “The Necessary and Proper Role of Regulation to Assure the Quality of Health Care,” Houston Law Review, 25 (1988): 525–98, at 530-31.Google Scholar
Brennan, and Berwick, supra note 4, at 41.Google Scholar
Fox, D.M., “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.CrossRefGoogle Scholar
See, e.g., Wennberg, J.E. and Gittelsohn, A.M., “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; Eddy, D.M., “Variations in Physician Practice: The Role of Uncertainty,” Health Affairs, 3, no. 2 (1984): 74-89.CrossRefGoogle Scholar
See Brook, R. and Lohr, K., “Efficacy, Effectiveness, Variations, and Quality: Boundary Crossing Research,” Medical Care, 23 (1985): 710–22; Eddy, D.M. and Billings, J., “The Quality of Medical Evidence: Implications for Quality of Care,” Health Affairs, 7, no. 1 (1988): 19-32.CrossRefGoogle Scholar
Rehlman, A.S., “The Third Revolution in Medical Care,” N. Engl. J. Med., 319 (1988): 1220–22; Ellwood, P., “Shattuck Lecture — Outcomes Management: A Technology of Patient Experience,” N. Engl. J. Med., 318 (1988): 1549-56; Schroeder, S., “Outcome Assessment 70 Years Later: Are We Ready?,” N. Engl. J. Med., 316 (1986): 160-62; Mehlman, M.J., “Assuring the Quality of Medical Care: The Impact of Outcome Measurement and Practice Standards,” Law, Medicine & Health Care, 18, no. 4 (1990): 368-84; Furrow, B.R., “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.Google Scholar
See Brennan, and Berwick, supra note 4, at 124-33; Melum, M.M. and Sinioris, M.K., Total Quality Management: The Health Care Pioneers (Chicago: American Hospital Publishing, 1992).Google Scholar
See Berwick, D.M. et al., Curing Health Care: New Strategies for Quality Improvement (San Francisco: Jossey-Bass, 1990); Laffel, G. and Blumenthal, D., “The Case for Using Industrial Quality Management Science in Health Care Organizations,” JAMA, 262 (1989): 2869-73; Berwick, D.M., “Continuous Improvement as an Ideal in Health Care,” N. Engl. J. Med., 320 (1989): 53-56.Google Scholar
Marszalek-Gaucher, E. and Coffey, R.J., Transforming Healthcare Organizations: How to Achieve and Sustain Organizational Excellence (San Francisco: Jossey-Bass, 1990); Brennan, and Berwick, supra note 4.Google Scholar
O'Leary, D.S., “Agenda for Change Fosters CQI Concepts,” Joint Commission Perspectives, 2, no. 1 (1992): 3.Google Scholar
See Institute of Medicine, The Computer-Based Patient Record: An Essential Technology For Health Care, rev. ed. (Washington, D.C.: National Academy Press, 1987).Google Scholar
McDonald, C.J. et al., “The Regenstrief Medical Record System: A Quarter Century Experience,” International Journal of Medical Informatics, 54 (1999): 225–53.CrossRefGoogle Scholar
See Institute of Medicine, supra note 48, at 120–21; Andrews, R.D. and Beauchamp, C., “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.CrossRefGoogle Scholar
Marsteller, J.A. et al., “The Resurgence of Selective Contracting Restrictions”, Journal of Health Politics, Policy and Law, 22 (1997): 1133–89; Jordan, K.A., “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.CrossRefGoogle Scholar
See 42 U.S.C. §§ 1395y(a)(1) and 1395ff (1994 & Supp. V 1999).Google Scholar
See Mariner, W.K., “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): 155.Google Scholar
See Shuren, J.E., “Legal Accountability for Utilization Review in ERISA Health Plans,” North Carolina Law Review, 77 (1999): 731–82; Kinney, supra note 15; Wilson, S.H., “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.Google Scholar
See Leichter, S., “The Silent Standards in Diabetes Care: Millman and Robertson,” Clinical Diabetes, 19 (2000): 140.Google Scholar
See Noble, A.A. and Brennan, T.A. “The Stages of Managed Care Regulation: Developing Better Rules,” Journal of Health Politics, Policy and Law, 24 (2000): 1275–305.CrossRefGoogle Scholar
Institute of Medicine, supra note 48, at 67.Google Scholar
Weiner, M.G. and Pifer, E., “Computerized Decision Support and the Quality of Care,” Managed Care, May 2000, available at <http://www.managedcaremag.com/archives/0005/0005.weiner.html>..>Google Scholar
Andrews, and Beauchamp, supra note 50.Google Scholar
Tierney, W.M. 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; Elson, R.B. and Connelly, D.P., “Computerized Patient Records in Primary Care: Their Role in Mediating Guideline-Driven Physician Behavior Change,” Archives of Family Medicine, 4 (1995): 698-706. See Overhage, J.M. et al., “Computer Reminders to Implement Preventative Care Guidelines for Hospitalized Patients,” Archives of Internal Medicine, 156 (1996): 1551-56; Burack, R.C. et al., “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; McDowell, I., Newell, C. and Rosser, W., “Computerized Reminders to Encourage Cervical Screening in Family Practice,” Journal of Family Practice, 28 (1989): 420-24; McDonald, C.J. et al., “Reminders to Physicians from an Introspective Computer Medical Record,” Annals of Internal Medicine, 100 (1984): 130-38; McDonald, C.J., “Computer Reminders, the Quality of Care and the Nonperfectability of Man,” N. Engl. J. Med., 295 (1976): 1351-55.Google Scholar
See Weiner, and Pifer, supra note 59 (presenting a table summarizing different research projects involving use of medical standards of care in clinical settings).Google Scholar
See, e.g., MacMahon, H. et al., “Computer-Aided Diagnosis of Pulmonary Nodules: Results of a Large Scale Observer Test,” Radiology, 213 (1999): 723–26; Pestotnik, S.L. 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).CrossRefGoogle Scholar
See Kassirer, J.P., “A Report Card on Computer Assisted Diagnosis — The Grade: C,” N. Engl. J. Med., 330 (1994): 1811–25.Google Scholar
Clark, C.M. 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.CrossRefGoogle Scholar
Balas, E.A. et al., “The Clinical Value of Computerized Information Services: A Review of 98 Randomized Clinical Trials,” Archives of Family Medicine, 5 (1996): 271–78; Rind, D.M. et al., “Effect of Computer-Based Alerts on the Treatment and Outcomes of Hospitalized Patients,” Archives of Internal Medicine, 154 (1994): 1511-17; Tierney, W.M., Hui, S.L. and McDonald, C.J., “Delayed Feedback of Physician Performance Versus Immediate Reminders to Perform Preventive Care: Effects on Physician Compliance,” Medical Care, 24 (1986): 659-66. Hunt, D.L. et al., “Effects of Computer-Based Clinical Decision-Support Systems on Physician Performance and Patient Outcomes,” JAMA, 280 (1998): 1339-45; Lobach, D. et al., “Computerized Decision Support Based on a Clinical Practice Guideline Improves Compliance with Care Standards,” American Journal of Medicine, 102 (1997): 89-98.CrossRefGoogle Scholar
Weiner, and Pifer, supra note 59; Tierney, , Hui, and McDonald, supra note 66.Google Scholar
Weiner, and Pifer, supra note 59; Davis, D. et al., “Changing Physician Performance: A Systematic Review of the Effect of Continuing Medical Education Strategies,” JAMA, 274 (1995): 700–05; Ende, J., “Feedback in Clinical Medical Education,” JAMA, 250 (1983): 777-81.Google Scholar
Epstein, A.D., “Performance Reports on Quality — Prototypes, Problems, and Prospects,” N. Engl. J. Med., 333 (1995): 5161; Furrow, B.R., “Regulating the Managed Care Revolution: Private Accreditation and a New System,” Villanova Law Review, 43 (1998): 361-407, at 400-07.Google Scholar
U.S. General Accounting Office, Report Cards: A Useful Concept but Significant Issues Need to Be Addressed (Washington, D.C.: Government Printing Office, 1994).Google Scholar
See National Committee for Quality Assurance, State of Managed Care Quality (Washington, DC: National Committee for Quality Assurance, 1999).Google Scholar
See Brennan, and Berwick, supra note 4, at 159–62; Iglehart, J.K., “The National Committee for Quality Assurance,” N. Engl. J. Med., 335 (1996): 995–99; Furrow, supra note 69.Google Scholar
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; Dalzell, M., “Physician, HEDIS Thyself,” Managed Care, March 1999, available at <http://www.managedcaremag.com/archives/9903/9903.hedis2000.shtml>.Google Scholar
See Furrow, B.R., “Managed Care Organizations and Patient Injury: Rethinking Liability,” Georgia Law Review, 31 (1997): 419509; Randall, V., “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; Blum, J., “An Analysis of Legal Liability in Health Care Utilization Review and Health Care Management,” Houston Law Review, 26 (1989): 191.Google Scholar
See Mello, M.M., “Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation,” University of Pennsylvania Law Review, 149 (2001): 645710; Sheetz, M.L., “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; Hyams, A.L. et al., “Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective,” Journal of Health Politics, Policy and Law, 21 (1996): 289-313; Brennan, T.A., “Practice Guidelines and Malpractice Litigation: Collision or Cohesion?,” Journal of Health Politics, Policy and Law, 16 (1 991): 67-86; Havighurst, C.C., “Practice Guidelines as Legal Standards Governing Physician Liability,” Law and Contemporary Problems, 54 (1991): 87-117; Hall, M., “The Defensive Effect of Medical Practice Policies in Malpractice Litigation,” Law and Contemporary Problems, 54 (1991): 119-45; Kinney, and Wilder, supra note 11. See also Hirshfeld, E., “Should Practice Parameters Be the Standard of Care in Malpractice Litigation?,” JAMA, 266 (1991): 2886-91;CrossRefGoogle Scholar
Kinney, E.D., “Malpractice Reform in the 1990s: Past Disappointments, Future Success?,” Journal of Health Politics, Policy and Law, 20 (1995): 99136.Google Scholar
Fla. Stat. ch. 408.02 (1998); Ky. Rev. Stat. 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 Shuman, D.W., “The Standard of Care in Medical Malpractice Claims, Clinical Practice Guidelines, and Managed Care: Towards a Therapeutic Harmony?,” California Western Law Review, 34 (1997): 99113, at 105.Google Scholar
See Morreim, E.H., “Managed Care Playing Doctor: Corporate Medical Practice and Medical Malpractice,” University of Michigan Journal of Law Reform, 32 (1999): 9391040.Google Scholar
Pub. L. No. 93-406, 88 Stat. 832 (codified as amended at 29 U.S.C. §§ 1001–1191c).Google Scholar
29 U.S.C. § 1144 (1994 & Supp. V 1999).Google Scholar
See Jacobson, P.D. and Pomfret, S.D., “Form, Function, and Managed Care Torts: Achieving Fairness and Equity in ERISA Jurisprudence,” Houston Law Review, 35 (1998): 9851078; Jordan, K.A., “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; Kilcullen, J.K., “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). See Sage, W.M., “UR Here: The Supreme Court's Guide for Managed Care,” Health Affairs, 19, no. 5 (2000): 219-23.Google Scholar
See Sage, W.M., “Enterprise Liability and the Emerging Managed Health Care System,” Law & Contemporary Problems, 60, nos. 1 and 2 (1997): 159210; Havighurst, C.C., “Making Health Plans Accountable for the Quality of Care,” Georgia Law Review, 31 (1997): 587-648.CrossRefGoogle Scholar
Furrow, B.R. et al., Health Law: Cases, Materials and Problems, 4th ed. (St. Paul, Minnesota: West Group, 2001): §§ 4-32-4-33.Google Scholar
See, e.g., Jurevic, A.M., “When Technology and Health Care Collide: Issues with Electronic Medical Records and Electronic Mail,” UMKC Law Review, 66 (1998): 809–36; Woodward, B., “Medical Record Confidentiality and Data Collection: Current Dilemmas,” Journal of Law, Medicine & Ethics, 25, nos. 2 and 3 (1997): 88-97; Cuzmanes, P.T. and Orlando, C.P., “Automation of Medical Records: The Electronic Superhighway and its Ramifications for Health Care Providers,” Journal Pharmacy & Law, 6 (1997): 19-32; Gostin, L.O., “Health Information Privacy,” Cornell Law Review, 80 (1995): 451-528; Minor, W.H., “Identity Cards and Databases in Health Care: The Need for Federal Privacy Protections,” Columbia Journal of Law and Social Problems, 28 (1995): 253-96.Google Scholar
Pub. L. No. 104-191, 110 Stat. 2021 (1996) (codified at 42 U.S.C. § 1320d (Supp. V 1999)).Google Scholar
42 U.S.C. § 1320d-2 (Supp. V 1999).Google Scholar
Standards for Privacy of Individually Identifiable Health Information, 64 Fed. Reg. 59,918 (proposed November 3, 1999).Google Scholar
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).Google Scholar
45 C.F.R. §§ 164.502(a)(1)(a) and 164.506(a)(1) (2001).Google Scholar
Id. § 160.103.Google Scholar
Id. § 164.502(b)(1).Google Scholar
Id. §§ 164.520(b)(1) and 164.528.Google Scholar
Id. § 164.508.Google Scholar
Id. § 160.203.Google Scholar
See Scott, C. “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): 481528; Rosoff, A.J., “Informed Consent in the Electronic Age,” American Journal of Law & Medicine, 25, nos. 2 and 3 (1999): 367-86; Hodge, J.G. Jr. et al., “Legal Issues Concerning Electronic Health Information: Privacy, Quality, and Liability,” JAMA, 282 (1999): 1466-71.Google Scholar