The Adverse Event of Unaddressed Medical Error: Identifying and Filling the Holes in the Health-Care and Legal Systems

Kohn L.T. Corrigan J.M. Donaldson M.S. , eds., Committee on Quality of Health Care in America, Institute of Medicine, To Err Is Human: Building a Safer Health System (Washington, D.C.: National Academy Press, 2000 [originally released Nov. 1999]), available at <http://books.nap.edu/books/0309068371/html/R1.html#pagetop> [hereafter cited as IOM Report].

Id.

See U.K. Department of Health, An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS (London: HMS Pub., 2000);.

Tito F. , Compensation and Professional Indemnity in Health Care. Review of Professional Indemnity Arrangements for Health Care Professionals (Canberra: Commonwealth Department of Human Services and Health, 1994);.

Wilson L.L. , “Quality Management: Prevention Is Better Than Cure,” Australian Clinical Review, 13 (1993): 75–82.

Recent literature in patient safety has covered a wide array of topics, including adverse drug events, clinical medicine, culture and organizational issues, legislation and the legal system, error reporting, and the use of technology. See, e.g., for adverse drug events: American College of Clinical Pharmacy, “A Vision of Pharmacy's Future Roles, Responsibilities, and Manpower Needs in the United States,” Pharmacotherapy, 20 (2000): 991–1020.

for clinical medicine: Balas E.A. , “Improving Preventive Care by Prompting Physicians,” Archives of Internal Medicine, 160 (2000): 301–08;.

Bischoff W.E. , “Handwashing Compliance by Health Care Workers: The Impact of Introducing an Accessible, Alcohol-Based Hand Antiseptic,” Archives of Internal Medicine, 160 (2000): 1017–21.

for organizational culture issues: Alicke M.D. , “Culpable Control and the Psychology of Blame,” Psychological Bulletin, 126 (2000): 556–74;.

Dauer E.A. Marcus L.J. Payne S.M. , “Prometheus and the Litigators: A Mediation Odyssey,” Journal of Legal Medicine, 21 (2000): 159–86;.

Liang B.A. , “Promoting Patient Safety Through Reducing Medical Error: A Paradigm of Cooperation Between Patient, Physician, and Attorney,” Southern Illinois University Law Journal, 24 (2000): 541–68.

for reporting errors: Blank C. , “Voluntary Reporting, Confidentiality Seen as Key to Preventing Errors,” Drug Topics, 144 (2000): 24–25;.

Liang B.A. , “Risks of Reporting Sentinel Events,” Health Affairs (September/October 2000): 112–20.

for use of technology: Chyna J.T. , “Electronic Medical Records,” Healthcare Executive, 15 (2000): 14–16;.

Gillespie G. , “IT Helps Show Error of Providers' Ways,” Health Data Management, 8 (2000): 62–64.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 542–43.

Because the nature of medical care is so complex, even when providers are working at a 99 percent level of proficiency — and medical personnel “are among the most careful professionals in our society” — this level is still less than industrial processes, and even a 99.9 percent level of proficiency may not be enough in complex systems. See Leape L.L. , “Error in Medicine,” JAMA, 272 (1994): 1851–57.

I am using this figure from the Institute of Medicine report and its accompanying citations, supra note 1.

I do not wish to enter into a debate on the actual number of deaths. Interested readers may wish to consult the report and compare the citations therein with McDonald C.J. Weiner M. Hui S.L. , “Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report,” JAMA, 284 (2000): 93–95.

Leape L.L. , “Institute of Medicine Medical Error Figures Are Not Exaggerated,” JAMA, 284 (2000): 95–97;.

Hayward R.A. Hofer T.P. , “Estimating Hospital Deaths Due to Medical Errors: Preventability Is in the Eye of the Reviewer,” JAMA, 286 (2001): 415–20. Note, however, that other estimates of inpatient deaths are even higher than that described in the IOM report.

See, e.g., Wilson R.M. , “The Quality in Australian Health Care Study,” Medical Journal of Australia, 163 (1995): 458–71.

As well, the specific number of errors may be an inappropriate focus given the progress medicine has made. See, e.g., Brennan T.A. , “The Institute of Medicine Report on Medical Errors — Could It Do Harm?,” N. Engl. J. Med., 324 (2000): 1123–25.

See Reason J. , Human Error (New York: Cambridge University Press, 1990).

Maurino D. Reason J. Johnston N. Lee R. , Beyond Aviation Human Factors (Aldershot, United Kingdom: Ashgate Publishing, 1995): at 83.

See Reason , supra note 8.

See Leape , supra note 6, at 1854.

See Reason , supra note 8.

See, e.g., Liang B.A. , “Error in Medicine: Legal Impediments to U.S. Reform,” Journal of Health Politics, Policy and Law, 24 (1999): 27–58;.

Foushee H.C. Helmreich R.L. , “Group Interaction and Flight Crew Performance,” in Wiener E.L. Nagel D.C. , eds., Human Factors in Aviation (San Diego: Academic Press, 1988);.

Lauber J.K. Kayten P.J. , “Sleepiness, Circadian Dysrhythmia, and Fatigue in Transportation System Accidents,” Sleep, 11 (1988): 503–12;.

Maurino Reason Johnston Lee , supra note 9.

Reason , supra note 8.

See, e.g., Leape , supra note 6, at 1851;.

Voelker R. , “‘Treat Systems, Not Errors,’ Experts Say,” JAMA, 276 (1996): 1537;.

Leape L.L. , “Promoting Patient Safety by Preventing Medical Error” (editorial), JAMA, 280 (1998): 1447–49;.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 542–43.

See Liang , supra note 13, at 28–30.

See, e.g., Reason , supra note 8.

Leape , supra note 6;.

Leape , supra note 14.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 545.

See Moore D. , “JCAHO Urges ‘Do Tell’ in Sentinel Event Fight: Aviation's Lesson — Learn from Experience,” Modern Healthcare, March 2, 1998, at 60 (quoting Lucian Leape).

See Liang , supra note 13, at 39;.

Lucas D.A. , “Organizational Aspects of Near Miss Reporting,” in van der Schaaf T.W. Lucas D.A. Hale A.R. , eds., Near Miss Reporting as a Safety Tool (Oxford: Butterworth-Heinemann, 1991).

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 545;.

Leape , supra note 6, at 1851–52;.

Hilfiker D. , “Facing Our Mistakes,” N. Engl. J. Med., 310 (1984): 118–22;.

Christensen J.F. Levinson W. Dunn P.M. ., “The Heart of Darkness: The Impact of Perceived Mistakes on Physicians,” Journal of General Internal Medicine, 7 (1992): 424–31;.

Wu A.W. , “Do House Officers Learn from Their Mistakes?,” JAMA, 265 (1991): 2089–94.

Anesthesia is the exception to this lack of a systems focus in health-care delivery. Through simulation and systems analysis, anesthesia has reduced errors and associated injuries by at least an order of magnitude. See, e.g., Cullen D.J. , “Effect of Pulse Oximetry, Age, and ASA Physical Status on the Frequency of Patients Admitted Unexpectedly to a Postoperative Care Unit,” Anesthesia Analgesia, 74 (1992): 181–88;.

Cooper J.B. Newbower R.S. Kitz R.J. , “An Analysis of Major Errors and Equipment Failures in Anesthesia Management: Considerations for Prevention and Detection,” Anesthesiology, 60 (1984): 34–42;.

Gaba D.M. , “Human Errors in Anesthetic Mishaps,” International Anesthesiology Clinics, 27 (1989): 137–47;.

Gaba D.M. DeAnda A. , “A Comprehensive Anesthesia Simulation Environment: Recreating the Operating Room for Research and Training,” Anesthesiology, 69 (1988): 387–94.

See Liang B.A. , “The Effectiveness of Physician Risk Management: Potential Problems for Patient Safety,” Risk Decision and Policy, 5 (2000): 183–202.

See. id at;.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 546–47.

See Liang , supra note 22;.

Frisch P.R. , “Role of Previous Claims and Specialty on the Effectiveness of Risk-Management Education for Office-Based Physicians,” Western Journal of Medicine, 163 (1995): 346–50;.

Walshe K. Dineen M. , Clinical Risk Management in the NHS: Making a Difference? (Birmingham, United Kingdom: NHS Confederation, 1998).

See Liang , supra note 22;.

Frisch , supra note 24.

See JCAHO, Facts about the Sentinel Event Policy, at <http://www.jcaho.org/sentinel/se_fact.html> (last visited December 1, 2000).

Although there are claims by representatives of JCAHO that adherence to the Sentinel Event Policy is merely “voluntary,” accreditation — and thus the ability to provide services to at least Medicare and Medicaid patients — hinges on adherence to the policy. See, e.g., Liang B.A. , “Comment: Other People's Money: A Reply to the Joint Commission,” Journal of Health Law, 33 (2000): 657–64.

See JCAHO, Facts about the Sentinel Event Policy, supra note 26.

See infra notes 32–149 and accompanying text (discussing the legal holes that prevent medical error and patient safety activities).

Note that although JCAHO indicated that the information required under the Sentinel Event Policy would not be subject to discovery and disclosure, see Bressler H. , “Sentinel Events and the JCAHO: The Genesis of Patient Safety” (presentation to the “Medical, Legal, and Ethical Dilemmas in Modern Healthcare,” 39th Annual Conference of the American College of Legal Medicine, New Orleans, March 11–13, 1999);.

Crane M. , “Peer Review: Breaking the Code of Silence,” Medical Economics, 76 (1999): 158–60;.

Bressler H. , “The Sentinel Event Policy: A Response by the Joint Commission,” Journal of Health Law, 33 (2000): 519–25.

Recently, a court has ordered production of this very information in a patient injury lawsuit. See Becker C. , “Root-Cause Trouble: Court Ruling in N.J. Could Set Precedent for Making JCAHO Reports Public,” Modern Healthcare, June 18, 2001, at 11.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 118.

Liang , supra note 27.

IOM Report, supra note 1.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 549–50.

There may also be a significant conflict of interest in the Sentinel Event Policy itself. JCAHO not only decides the acceptability of the root cause analysis and, critically, accreditation status, but also offers consulting services to perform this analysis. This situation presents providers subject to the Sentinel Event Policy with difficult choices. See id. at 550;.

Liang , supra note 27. In addition, beginning July 2001, JCAHO requires physicians under its hospital accreditation standards to disclose “unanticipated outcomes” to patients, which is seen as requiring physicians to “tell patients when they received substandard care.”.

Lovern B. , “JCAHO's New Tell-All; Standards Require That Patients Know about Below-Par Care,” Modern Healthcare, January 1, 2001, at 2.

See JCAHO, Revisions to Joint Commission Standards in Support of Patient Safety and Medical/Health Care Error Reduction, at <http://jcprdwl.jcaho.org/standard/fr_ptsafety.html> (last visited January 10, 2001). Providers have expressed concerns regarding provider liability for this new policy, e.g., every admission has unanticipated outcomes, the standard will create awkwardness between hospitals and medical staffs, and “the hospital, by definition, is now intruding into the patient-physician relationship if there is a [JCAHO] documentation process required” for these disclosures.

Lovern , supra.

See Liang B.A. , Health Law & Policy (Boston: Butterworth-Heinemann, 2000): at 15–27.

See also Liang B.A. , “Medical Malpractice: Do Physicians Have Knowledge of Legal Standards and Assess Cases as Juries Do?,” University of Chicago Law School Roundtable, 3 (1996): 59–110, at 59–60 (describing negligence rule as standard economic incentive theory);.

Liang B.A. , “Assessing Medical Malpractice Jury Verdicts: A Case Study of an Anesthesiology Department,” Cornell Journal of Law and Public Policy, 7 (1997): 121–64, at 121–23 (describing malpractice tort system as a possible efficient deterrence structure under standard theory and a possible effective, but not efficient deterrence structure under alternate theory).

See Liang , Health Law & Policy, supra note 32, at 15.

As applied in practice, see, e.g., Liang B.A. , “Legal Issues in Transfusing a Jehovah's Witness Patient Following Cesarean Section,” Journal of Clinical Anesthesia, 7 (1995): 522–24;.

Liang B.A. , “Blood, Bone, and Dura: Anesthesia Responsibility and Pediatric Neurosurgery,” Journal of Clinical Anesthesia, 9 (1997): 597–601;.

Liang B.A. , “A Case of Resident Malpractice Administering Spinal Anesthesia,” Journal of Clinical Anesthesia, 9 (1997): 341–44;.

Liang B.A. , “Efforts at Intubation: Cervical Injury in an Emergency Circumstance?,” Journal of Clinical Anesthesia, 11 (1999): 349–52.

See Liang , Health Law & Policy, supra note 32.

See Liang , “Medical Malpractice,” supra note 32.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32. Good Samaritan statutes may change the standard and incentives.

see generally Liang , Health Law & Policy, supra note 32, at 19.

See, e.g., Liang , “Medical Malpractice,” supra note 32 (radiologists).

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32 (anesthesiologists).

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4 (internal medicine/family practice physicians).

See Liang , “Medical Malpractice,” supra note 32, at 65;.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32, at 131;.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 551.

See Liang , supra note 13, at 33.

See Liang , supra note 22.

See Liang , “Medical Malpractice,” supra note 32;.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32;.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4.

See also Cheney F.W. , “Standard of Care and Anesthesia Liability,” JAMA, 261 (1989): 1599–603 (more than 40 percent of patients receiving appropriate care assessed by neutral anesthesiologists received malpractice payments);.

Brennan T.A. , “Relation Between Negligent Adverse Events and the Outcomes of Medical Malpractice Litigation,” N. Engl. J. Med., 335 (1996): 1963–67 (malpractice payments related to severity of injury, not negligence as defined by physician review);.

Edbril S.D. Lagasse R.S. , “The Relationship Between Malpractice Litigation and Human Errors,” Anesthesiology, 91 (1999): 848–55 (reporting no relationship between care deemed below the standard of care and medical malpractice suits).

There may be an argument that malpractice awards under circumstances when the care was in fact appropriate might be the cost of a compensation system; however, a 40-percent error rate would seem a high price indeed.

See Liang , supra note 13, at 35. For a discussion of the debate as to the effectiveness of the malpractice system as well as a discussion of some of the important literature,

see generally Liang , id.

See Liang , “Medical Malpractice,” supra note 32.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32;.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4;.

Liang B.A. , “Clinical Assessment of Malpractice Case Scenarios in an Anesthesiology Department,” Journal of Clinical Anesthesia, 11 (1999): 267–79.

See, e.g., Liang , “Medical Malpractice,” supra note 32 (radiology: 21–50 percent disagreement);.

Liang , “Clinical Assessment of Malpractice Case Scenarios in an Anesthesiology Department,” supra note 41 (anesthesiology: 30–46 percent disagreement);.

Liang B.A. , “Physician Assessment of Jury Verdict Case Scenarios: Does the Legal System Promote an Effective Deterrence Structure and Patient Safety?” (unpublished manuscript on file with author) (internal medicine/family practice: 20–50 percent disagreement). It has been reported that identification of care that is deemed lower than the prevailing standard by physician peer review is independent of cases that are at risk of or adjudicated in the malpractice system. See Edbril and Lagasse, supra note 40.

See also Studdert D.M. , “Negligent Care and Malpractice Claiming Behavior in Utah and Colorado,” Medical Care, 38 (2000): 250–60 (noting when a physician is sued, a high probability exists that it is for non-negligent care).

See Liang , supra note 22.

See Liang , “Medical Malpractice,” supra note 32;.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32;.

Liang B.A. , “Layperson Assessment of Malpractice Case Scenarios: Comparison with Physician Evaluations” (unpublished manuscript on file with author).

See Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32.

See Liang , “Medical Malpractice,” supra note 32;.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32;.

Liang , “Layperson Assessment of Malpractice Case Scenarios,” supra note 44. Some studies suggest that the agents of the legal system evaluate cases appropriately as defined by ex post physician assessment.

See Vidmar N. , Medical Malpractice and the American Jury (Ann Arbor: University of Michigan Press, 1995). However, these studies relied on only one or two physician reviewers and were limited to a single medical specialty, whereas the studies cited at the outset of this note used between 11 and 138 physician reviewers for each case in three different specialties.

This conclusion is exacerbated by significant hindsight bias and the potential that experts reviewing malpractice cases assess physician activities using subjective standards. See Liang B.A. Cullen D. J. , “The Legal System and Patient Safety: Charting a Divergent Course” (editorial), Anesthesiology, 91 (1999): 609–11;.

Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32;.

Liang , supra note 22.

See, e.g., Liang , “Assessing Medical Malpractice Jury Verdicts,” supra note 32.

Liang Cullen , supra note 47;.

Liang , “Clinical Assessment of Malpractice Case Scenarios in an Anesthesiology Department,” supra note 41;.

Liang , supra note 13.

See id.

See generally Liang B.A. , “Deselection under Harper v. Healthsource: A Blow for Maintaining Patient-Physician Relationships in the Era of Managed Care?,” Notre Dame Law Review, 72 (1997): 799–861;.

Liang B.A. , “An Overview and Analysis of Challenges to Medical Exclusive Contracts,” Journal of Legal Medicine, 18 (1997): 1–45;.

Liang B.A. , “Patient Injury Incentives in Law,” Yale Law & Policy Review, 17 (1998): 1–93;.

Shum C.W. Liang B.A. , “Tax Treatment of a New Animal: Health Care Providers Who Are Neither Employees Nor Independent Contractors,” Virginia Tax Review, 18 (1998): 301–61.

For an overview of independent contractor versus employee status, see Liang , Health Law & Policy, supra note 32, at 135–48.

See id.

See id.

See also U.S. General Accounting Office, Practice Guidelines: The Experience of Medical Specialty Societies, Pub. No. GAO/PEMD-91-11 (Washington, D.C.: U.S. General Accounting Office, 1991).

U.S. General Accounting Office, Practice Guidelines: Managed Care Plans Customize Guidelines to Meet Local Interests, Pub. No. GAO/HEHS-96-95 (Washington, D.C.: U.S. General Accounting Office, 1996).

See, e.g., Liang , “An Overview and Analysis of Challenges to Medical Exclusive Contracts,” supra note 50, at 1–3.

See Liang , “Deselection under Harper v. Healthsource,” supra note 50, at 810–25;.

Liang , “Patient Injury Incentives in Law,” supra note 50, at 50.

This characteristic of the legal system is important since a large majority of patients are now in some form of managed care, requiring physicians to obtain some managed care contract in order to practice. See Liang , “Deselection under Harper v. Healthsource,” supra note 50, at 799 n.1 (noting 190 million U.S. citizens in managed care plans).

See, e.g., Liang , “Deselection under Harper v. Healthsource,” supra note 50, at 810–25;.

Liang , “Patient Injury Incentives in Law,” supra note 50, at 50.

This is reflected by the various clinical practice guidelines that conflict and the use of consensus rather than double-blind studies to support these guidelines. See, e.g., U.S. General Accounting Office, Practice Guidelines: The Experience of Medical Specialty Societies, supra note 52.

U.S. General Accounting Office, Practice Guidelines: Managed Care Plans Customize Guidelines to Meet Local Interests, supra note 52.

Liang Cullen , supra note 47.

See Liang , supra note 13, at 39–43;.

Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 113–17.

See infra notes 65–96 and accompanying text (discussing privilege-based barriers to reporting).

See Liang , supra note 13, at 45. Note that contract law as it pertains to independent contractors also gives highly negative incentives to fully communicate with patients due to the inherent threat of deselection.

See Liang B.A. , “The Practical Utility of Gag Clause Legislation,” Journal of General Internal Medicine, 13 (1998): 419–21.

See, e.g., Liang , “Patient Injury Incentives in Law,” supra note 50, at 50–51;.

Keeton Page W. , Prosser and Keeton on the Law of Torts, 5th ed. (St. Paul: West Publishers, 1984): § 71, 509–10.

See Liang , “Deselection under Harper v. Healthsource,” supra note 50;.

Liang , “Patient Injury Incentives in Law,” supra note 50.

Shum Liang , supra note 50.

See Liang , supra note 22;.

Passineau T. , “When the Law Gets in the Way. Litigation, Mediation, and Healthcare Quality” (in published proceedings of the annual meeting of the American Bar Association Section on Dispute Resolution, San Francisco, April 6–8, 2000).

It should be noted that other aspects of the medical liability system in practice make litigation a poor vehicle for quality improvement. For example, the Employee Retirement Income Security Act of 1974, 29 U.S.C.A. §§ 1001–1461 (West 1985 & Supp. 1998, is one area of the law that has been roundly criticized for its negative effect on quality in the world of managed care. Anti-managed care forces believe that the ERISA managed care legacy — indeed, managed care itself — could be brought down by the U.S. Supreme Court in a recent managed care case, namely, Pegram v. Herdrich, 530 U.S. 211 (2000). However, this case is not broadly applicable to the entire managed care industry based upon its facts (e.g., physician incentives as a possible breach of ERISA fiduciary duty in the context of a physician-owned health maintenance organization, hardly a common type of managed care arrangement). Second, an astounding number of courts appear to make significant errors themselves as to basic questions of jurisdiction in these ERISA cases; indeed, many federal district courts and virtually all federal courts of appeals that have addressed the issue of managed care liability in the context of ERISA have made completely erroneous jurisdictional assessments, making all of the cases so decided void.

See Liang , “Patient Injury Incentives in Law,” supra note 50, at 35–49. Note, however, that there may be a movement toward expanding agency theories of liability to managed care organizations.

This situation is exacerbated by the ease of hiding medical error as well as the medical and legal cultures of shame and blame. See Leape , supra note 6, at 1852.

This observation is not merely theory, based on the anecdotal experience of investigators and health-care entities, these incentives have chilled safety work and publication.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 112, 114.

Fed. R. Civ. P. 26(b). Note that most discovery rules are state-based; however, states have adopted federal privilege rules to a great extent.

Fed. R. Civ. P. 26(b)(1).

See, e.g., University of Pennsylvania v. EEOC, 493 U.S. 192 (1990).

Trammel v. U.S., 445 U.S. 40 (1980).

U.S. v. Nixon, 418 U.S. 683 (1974).

Fed. R. Civ. P. 37.

Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 112.

infra note 79.

Scheutzow S.O. , “State Medical Peer Review: High Cost But No Benefit — Is It Time for a Change?,” American Journal of Law & Medicine, 25 (1999): 7–60.

Liang B.A. Storti K. , “Creating Problems as Part of the ‘Solution’: The JCAHO Sentinel Event Policy, Legal Issues, and Patient Safety” Journal of Health Law, 33 (2000): 263–85, at 272–73.

Cepelewicz B.B. , “Recent Developments in Medicine and Law,” Tort & Insurance Law Journal, 33 (1998): 580–603, at 583. This trend has recently been extended to Medicare Peer Review Organizations.

a federal court has ruled that reviews made by these organizations regarding quality of care initiated by patients and/or their representatives, previously confidential, now must be reported to these individuals within twenty days of completion. See Public Citizen, Inc. v. Department of Health and Human Services, 2001 WL 800013 (D.D.C. July 9, 2001). Such requests need not emanate from an actual adverse event, simply a complaint from a Medicare beneficiary or his or her representative. This holding has significant potential to encourage legal maneuvering by plaintiffs' attorneys to obtain sensitive information from providers that might otherwise be unavailable.

Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 115.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 555–57;.

Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 115–16;.

Liang Storti , supra note 74, at 272–73.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 557.

See, e.g., American Society for Healthcare Risk Management, Position Statement and Recommendations: JCAHO Sentinel Event Reporting Program (February 13, 1998), at <http://205.243.101.143/news/jcaho/jcahopos.html> (last visited April 3, 2000) (warning hospitals of high discoverability risk of collecting and performing JCAHO Sentinel Event Policy information).

Medical Risk Management Associates, Conducting a Cost-Effective Root Cause Analysis, at <http://www.sentinel-event.com/costeffective.htm> (last visited March 22, 1999) (also warning hospitals of high discoverability risk of collecting and performing JCAHO Sentinel Event Policy information).

See also Becker , supra note 29 (discussing case that held Sentinel Event Policy information discoverable).

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 116.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 117.

Liang Storti , supra note 74, at 273–74.

It should also be noted that there are risks of discovery on the basis of both the state and federal versions of the Freedom of Information Act if information on medical errors and safety is within any government boundaries.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 116.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 117.

See id. at 116.

Courts may grant discovery even when a privilege applies if a balancing test by the judge indicates that the plaintiff legitimately needs the information and cannot sustain a claim without this relevant information. See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 115;.

Liang , supra note 13, at 39.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 116–17.

Note that an entity cannot simply deem any and all professional staff members with some role in quality as part of a peer review or quality assurance committee in order to obtain privilege protections. Further, this privilege extends only to a body that actually performs peer review or quality assurance activities as its primary function. The extensive and qualitatively different activities involved in error and safety analysis seem to go beyond traditional peer review and quality assurance activities, and thus may be outside the privilege. See id. at 115.

See id. at 117.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 557.

See IOM Report, supra note 1, at 78–80, 210–17.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 557–58 n.59.

See Liang , supra note 13, at 41.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 558, n.60.

See id. at 558–59 n.61.

The related concept of attorney work product also does not shield error and safety information. See id. at n.61.

Rozovsky F.A. Roosevelt J. Jr. Chaurette K.A. , “The JCAHO Sentinel Event Policy,” Health Law Digest, May 1998, at 3–11.

See Liang , supra note 13, at 28–29.

See also Reason, supra note 8;.

Maurino Reason Johnston Lee , supra note 9;.

Moray N. , “Error Reduction as a Systems Problem,” in Bogner M.S. , ed., Human Error in Medicine (Hillsdale: Lawrence Erlbaum Associates, 1994).

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 560;.

Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 117.

Pub. L. 104–191. The statute required that federal privacy legislation be enacted by Congress by August 21, 1999, with the Secretary of the Department of Health and Human Services (DHHS) to issue proposed privacy rules in the event of Congressional inaction.

Congress did miss the deadline and thus DHHS issued proposed regulations, 45 C.F.R. pts. 160, 164, at 64 Fed. Reg. 59,917 (Nov. 3, 1999).

Final regulations were issued at 65 Fed. Reg. 82,461 (Dec. 28, 2000).

See 45 C.F.R. §§ 160.102, 160.103, 164.500, 164.501 (2000).

See 45 C.F.R. §§ 160.102, 160.103, 164.104, 164.500 (2000).

See id., 45 C.F.R. § 164.530 (2000).

For health plans and health-care clearinghouses, the date is February 26, 2003.

See 45 C.F.R. § 164.534 (2000). Small health plans (but not other small businesses) have thirty-six months to comply with the rule.

compliance reviews by DHHS, covered entities' responsibilities under these reviews, and potential government actions for noncompliance are indicated in 45 C.F.R. §§ 160.308, 164.310, 164.312 (2000). Note, however, that final does not always mean final.

because the regulations were not delivered to Congress on December 28, 2000 — their date of issuance — but instead were delayed until February 13, 2001, Congress did not have its 60-day period to review the agency rule. Thus, the effective date was 60 days after the actual delivery date, or April 14, 2001. This administrative glitch provided the Bush administration with an opportunity to reopen public comment on the regulations. See McQueen A. , “HHS to Review Privacy Rules,” AP Online, available on Westlaw, 2001 WL 13676231 (Feb. 23, 2001).

See 45 C.F.R. §§ 164.524, 164.526, 164.528 (2000).

Note that for non-treatment, payment, and health-care operations disclosures or disclosures to the patient or DHHS, covered entities must note in the electronic or paper record when, to whom, and what information was disclosed, the purpose of disclosure or a copy of the patient's written authorization/request for a disclosure for the past six years or as requested, but exclude disclosures in the accounting that were made to a health oversight agency or law enforcement official. See 45 C.F.R. § 164.528 (2000).

See also Liang B.A. , Killing Patient Safety—Privately: HIPAA and Impediments to Community Patient Safety Work (unpublished manuscript on file with author).

See, e.g., 45 C.F.R. §§ 164.504(c), 164.514(a), 164.530 (2000);

65 Fed. Reg. at 82,502, 82,761–82,762;.

Liang , supra note 102.

Pub. L. 104–191, § 262. Note, however, that the enforcement rule regarding these penalties has not yet been issued. 65 Fed. Reg. at 82,487.

See 45 C.F.R. §§ 160.201, 164.202, 164.203 (2000).

Exceptions to the federal rule may be requested under 45 C.F.R. § 164.204 (2000).

See, e.g., 65 Fed. Reg. at 82,482–82,487. Such extensive interaction may also increase implementation costs.

See 45 C.F.R. § 164.506 (2000).

Health-care operations include activities that are related to the covered entity's functions as a provider, health plan, or health-care clearinghouse, also known as the entity's “covered functions.” 45 C.F.R. §§ 164.501, 164.504 (2000).

See 45 C.F.R. §§ 164.506, 164.508 (2000). Providers that have direct treatment relationships with patients, i.e., those who see patients directly (as opposed to those, such as radiologists, who see patients indirectly), must obtain consent for treatment, payment, and health-care operations as well as provide specific notice of privacy practices and procedures written in “plain language.”

See 45 C.F.R. §§ 164.506(b)(5), 164.508(b)(5), 164.508(c)(2), 164.520 (2000).

Fed. Reg. at 82,770. Other uses or disclosures require fulfilling extensive requirements for authorization.

See 45 C.F.R. §§ 164.508(c)—(d) (2000).

See 45 C.F.R. § 164.506(b)(5).

Liang , supra note 102.

See 45 C.F.R. § 164.512 (2000). For activities not specifically listed in the regulations, determinations of whether they meet an exception may be requested under the provisions of 45 C.F.R. §§ 160.204, 160.205 (2000).

See 45 C.F.R. §§ 164.506(a)(2)-(3), 164.512(j) (2000).

For example, disclosure of patient information in a hospital's patient directory or to those individuals assisting in a patient's care requires only informal verbal agreement, which may be implied by the circumstances. See 45 C.F.R. § 164.510 (2000).

Neither disclosure by a covered entity's worker who is a crime victim nor a covered entity's disclosure of protected health information related to evidence of criminal conduct is in violation of the rule. See 45 C.F.R. §§ 164.512(f) (2000).

As well, no patient authorization is required for the release of information in a judicial or administrative proceeding if the request is from a court order or administrative tribunal. Patient notice of the request or assurance of confidentiality by the requester is required for the covered entity to release the patient's information in response to a subpoena or discovery request from a party in litigation, and covered entities may also disclose protected health information for law enforcement purposes as required by law. See 45 C.F.R. §§ 164.512(e), 164.512(f) (2000).

Disclosure for research has specified requirements under 45 C.F.R. § 164.512(i). Note, however, that websites are not bound by HIPAA rules unless they fall within some other health-care provider, clearinghouse, or other covered entity definition.

See 45 C.F.R. § 164.522 (2000).

Covered entities must provide patients with the opportunity to request restrictions on the uses or disclosures of protected health information for treatment, payment, or health-care operations and accommodate requests for confidential communications in certain specific situations. Id.

See 45 C.F.R. §§ 164.524(b), 164.526(b) (2000).

Note that if the covered entity does not maintain the information requested by the patient, the entity must direct the patient to the appropriate entity for access.

See 45 C.F.R. § 164.524(d)(3) (2000). If patient requests are denied in whole or in part, the patient has the right to have the covered entity provide him or her with a written statement describing the basis of the denial and the complaint mechanism to access the entity's procedures or the procedures of the Department of Health and Human Services.

See 45 C.F.R. §§ 164.524, 164.526, 164.530 (2000).

In some circumstances, the covered entity must provide the patient with a second health-care provider to review the denial. See 45 C.F.R. § 164.524(a)(4) (2000).

See 45 C.F.R. §§ 164.502(b), 164.514(d) (2000).

Prior to any disclosures under this section, a covered entity must verify the identity as well as authority of the person who is requesting the protected health information if this is not known to the covered entity, as well as obtain relevant documentation, statements, or representations from the person as a condition of disclosure. See 65 Fed. Reg. at 82, 719; 45 C.F.R. § 164.54(h).

A health-care clearinghouse is defined as a “public or private entity that … [p]rocesses or facilitates the processing of nonstandard data elements of health information received from another entity in a nonstandard format … into standard data elements or a standard transaction … [or] [r]eceives a standard transaction … and processes or facilitates the processing of health information into nonstandard format. …” 45 C.F.R. § 164.103 (2000).

See 45 C.F.R. § 164.530 (2000).

See 45 C.F.R. §§ 160.103, 164.502(e), 164.504(e) (2000).

In these situations, the covered entity and the business associate must execute an agreement providing assurances that the business associate will fulfill the requirements of the rule. A violation of the rule by the business associate requires the covered entity, in specified circumstances, to investigate and act against the associate, including terminating the contract. All contractors and subcontractors of the business associate are similarly bound by these terms. See id.

See 45 C.F.R. § 164.504(e) (2000).

45 C.F.R. § 504(e)(ii) (2000);

65 Fed. Reg. at 82,476. See also Hearing on Proposed Rule on the Privacy of Individually Identifiable Health Information Before Senate Committee on Health, Education, Labor, and Pensions, 106th Cong., 1st Sess. (April 26, 2000)

(testimony of Heinrich Janet Dr. , associate director of health financing and public health issues at the General Accounting Office), available at <http://labor.senate.gov/Hearings/apr00hrg/042600wt/042600jmj/042600emk/heinric1/heinric1.htm>. It is interesting to note that the policies, procedures, and sanctions relating to entity noncompliance with the rule seem not to be followed by the Department of Health and Human Services itself in similar circumstances. The Department's Office of Inspector General found that contrary to departmental policy, several divisions collected personally identifiable information through websites and did not warn the user that such information was being collected. Twenty-one of the Department's websites designed for children did not contain a privacy statement or link to a privacy statement as mandated by federal law. No report of sanctions for these violations appears forthcoming.

See U.S. Office of Inspector General, Department of Health and Human Services, Monitoring of Personally Identifiable Information on Users of Departmental Internet Sites, Pub. No. A-01-01-03000 (Washington, D.C.: U.S. Department of Health and Human Services, April 16, 2001).

The highly complex statutory efforts at simplification have come under significant fire. See, e.g., Withrow S.C. , “The Next Compliance Crunch: Administrative Simplification,’” Health Care Fraud & Abuse Newsletter, February 2000, at 1: “Rather than promoting ‘administrative simplification,’ the proposed regulations establish reporting requirements that are simply stupefying. The regulations describe roughly 500 separate data elements that support a single health care claim. Embedded in these 500 data elements are dozens of code sets for both medical and nonmedical data requiring the provider to convert commonly understood words and terms into literally thousands of possible alphanumeric codes.”.

Pub. L. 104–191.

See, e.g., 65 Fed. Reg. at 82,511 (no model for consent);

65 Fed. Reg. at 82, 548 (no model for privacy notice);.

Liang , supra note 102.

See, e.g., Page S.L. , “Proposed Federal Privacy Rules: Locking the Electronic File Cabinet,” Health Lawyer, December 1999, at 2.

See also Withrow , supra note 121 (discussing highly complex coding requirements).

See 65 Fed. Reg. at 82,761, Table 1.

64 Fed. Reg. at 60,037; 65 Fed. Reg. at 82,780. Roughly half of all hospitals and more than 90 percent of physician offices are small businesses. See id.

Note that these percentages would have been even higher if the Health Care Financing Administration had used the more current Small Business Association definition of health-care small business released prior to the final medical privacy regulations. See Liang , supra note 102.

Page, supra note 124, at 3. Indeed, additional concerns with compliance include the uncertainty by which providers and others can protect sensitive proprietary information in the context of the virtually unchallengeable subpoena power granted by HIPAA to the Department of Justice. The Department of Justice is not required to describe the activities upon which its investigation is based, not required to disclose the actual target of the investigation, has no statutory limitation by which a recipient of the subpoena can challenge it, has no limits on the scope of the documents requested, has no confidentiality requirements for the information obtained, and has continuing power to use the HIPAA subpoena in an ongoing investigation.

18 U.S.C. § 3486 (1999).

See also Feldman W.L. O'Callaghan E.C. , “HIPAA Subpoenas: What Protections for Companies Served?,” Corporate Counselor, September 1998, at 1.

See 45 C.F.R. § 164.508(b)(3) (2000). “We prohibit the use of broad or blanket authorizations requesting the use or disclosure of protected health information for a wide range of unspecified purposes. Both the information that is to be used or disclosed and the specific purpose(s) for such uses or disclosures must be stated in the authorization.” 65 Fed. Reg. at 82,518. Such a standard also requires only the minimum necessary information be disclosed.

See 45 C.F.R. § 164.514(d)(4) (2000);.

Liang , supra note 102.

45 C.F.R. §164.508(c)-(d) (2000). Note that there appear to be substantive differences between those patients who give researchers consent to use their personal identifiable health-care information and those who do not. This finding, apparently unrecognized by the Department of Health and Human Services, will create significant selection bias and limit the conclusions from patient safety and medical error work.

See Woolf S.H. , “Selection Bias from Requiring Patients to Give Consent to Examine Data for Health Services Research,” Archives of Family Medicine, 9 (2000): 1111–18.

See, e.g., van der Goes P.H.W. Jr. , “Comment: Opportunity Lost: Why and How to Improve the HHS-Proposed Legislation Governing Law Enforcement Access to Medical Records,” University of Pennsylvania Law Review, 147 (1999): 1009–67. This omission is particularly noteworthy because former Secretary Shalala indicated that, with regard to HIPAA, “Individuals' claims to privacy must be balanced by their public responsibility to contribute to the common good, through use of their information for important, socially useful purposes, with the understanding that their information will be used with respect and care and will be legally protected.”.

Shalala D. , 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, submitted to the Senate Committee on Labor and Human Resources, the Senate Committee on Finance, the House Committee on Commerce, and the House Committee on Ways & Means, § I(D) (September 11, 1997), available at <http://aspe.os.dhhs.gov/admnsimp/pvcrec0.htm> (last visited October 5, 2001). Surely patient safety and medical error activities are as important as marketing, lawsuit, and law enforcement activities “to contribute to the common good.”.

See 65 Fed. Reg. at 82,490. Note that “treatment” also refers to individual patients and, thus, treatment activities cannot be easily used to justify using patient data for safety work.

See 65 Fed. Reg. at 82,497.

See 45 C.F.R. § 164.512(d) (2000).

See 65 Fed. Reg. at 82,491–82,942; 45 C.F.R. § 512(d) (2000).

See 45 C.F.R. §§ 164.501, 164.512(b) (2000);

65 Fed. Reg. at 82,497.

See 45 C.F.R. § 164.512(b)(iii) (2000). Other disclosures require authorization.

See 45 C.F.R. §§ 164.506, 164.512(b)(v) (2000).

See Liang , supra note 13;.

Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4;.

Liang , “Risks of Reporting Sentinel Events,” supra note 4;.

Liang Storti , supra note 74.

See 45 C.F.R. § 512(i) (2000).

See, e.g., 65 Fed. Reg. at 82,516 (“We clarify the proposed research exception … for the purpose of research that includes treatment of the individual, including clinical trials. …”);

65 Fed. Reg. at 82,518 (“except for [research] authorizations requested for clinical trials …”);

65 Fed. Reg. at 82,520 (“research that includes treatment … including clinical trials”; “prior to the individual's enrollment in a clinical trial, but that is now providing [the] research-related treatment. …”);.

Liang , supra note 102.

Consent issues also arise here. Consent for treatment, payment, and health-care operations generally cannot be combined with other consents or authorizations. See supra note 128. However, consent and authorization for research may be necessary if a patient receives treatment for research and non-research purposes.

45 C.F.R. §§ 164.506(b)(4)(ii), 164.508(b)(3), 164.508(f) (2000). Unfortunately, because patient safety research does not generally include “treatment” as in clinical trials, this exception does not apply and authorization is mandated.

To fund this broad-based type of research, covered entities may consider fundraising. Authorization is not required when a covered entity uses or discloses demographic information regarding itself to raise funds or conduct marketing. 45 C.F.R. § 164.514(e)—(f) (2000). However, a covered entity must have the patient's authorization to use protected health information to solicit funds for a non-profit organization that engages in research, education, and awareness efforts regarding a particular disease state

(see 65 Fed. Reg. at 82,534), once again stymying patient safety research efforts.

See 45 C.F.R. § 164.512(i)(1)(i)(A) (2000).

See 45 C.F.R. § 164.512(i)(1)(i)(B) (2000).

See 45 C.F.R. § 164.514(d) (2000);

65 Fed. Reg. at 82,536–82,537.

See 65 Fed. Reg. at 82,534; 45 C.F.R. § 164.512(h) (2000). In addition, although covered entities may deny an individual access to protected health information that is obtained by a provider during the course of research that includes treatment, this is limited to the period while research is in progress.

See 45 C.F.R. § 164.524(a)(2)(iii) (2000). At the end of the research, the patient has the right to inspect and copy the information. If this information relates to medical error, it will likely contain sensitive information regarding the health-care system and it may be used in a lawsuit against the provider. This potential provides additional reasons to avoid performing this kind of work. A covered entity can deny an individual access to protected health information if the source was given a promise of confidentiality.

See 45 C.F.R. § 164.524(a)(2)(v) (2000). This might serve as a method to keep sensitive patient safety data confidential; however, this provision is not applicable if the source is a health-care provider. Id. Unfortunately, the implication is that one of the most valuable sources of information regarding health-care systems is limited in its communications due to the provisions of the rule.

See 45 C.F.R. § 164.514 (2000). The rule contemplates use of deidentified information in preparation for research rather than for primary research work, and limits this review to the site where the information is located.

See 65 Fed. Reg. at 82,537.

See 45 C.F.R. §§ 164.502(d), 164.514 (2000).

See 65 Fed. Reg. at 82,542; 45 C.F.R. § 164.514(b)(2)(ii) (2000).

Note that any non-routine disclosures, including research, which seems to be what patient safety requests would fall under, are subject to the minimal necessary standard, and require covered entity procedures for requests to be reviewed individually. See 45 C.F.R. § 164.514(d) (2000). Indeed, this is true “in order to obtain information that will subsequently be disclosed to a third party, for example, … for quality assessment purposes.”

65 Fed. Reg. at 82,545. See Liang , supra note 102.

See 45 C.F.R. § 164.514(a)—(c) (2000).

The rule expressly adopts the statutory standard for deidentification. See also 65 Fed. Reg. at 82,543 (discussing 45 C.F.R. § 164.514(a)—(c)).

45 C.F.R. § 164.514(b)(2)(i)(r) (2000) (emphasis supplied).

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 561–68.

See id. at 561–62;.

Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 119.

See Liang , “Risks of Reporting Sentinel Events,” supra note 4, at 118–19.

See id. at 118.

See Liang , supra note 13, at 29–30.

See id. at 29.

See id. at 30.

See IOM Report, supra note 1. Note that similar concerns attend in aviation, although the aviation industry has gleaned significant lessons by taking these concerns into account.

See, e.g., Helmreich R.L. , “On Error Management: Lessons from Aviation,” British Medical Journal, 320 (2000): 781–85.

See, e.g., National Patient Safety Foundation, A Tale of Two Stories: Contrasting Views of Patient Safety (Chicago: National Patient Safety Foundation, 2000).

National Patient Safety Foundation, Current Research on Patient Safety in the United States: A Report to the Agency for Healthcare Research and Quality (Chicago: National Patient Safety Foundation, 2000).

See Leape , supra note 6, at 1857;.

Barach P. Small S. , “How the NHS Can Improve Safety and Learning: By Free Lessons from Near Misses,” British Medical Journal, 320 (2000):1683–84;.

Liang , supra note 27.

See, e.g., Weick K.E. , “Organizational Culture as a Source of High Reliability,” California Management Review, 29 (1987):112–27;.

Weick K.E. , “Organizing for High Reliability: Processes of Collective Mindfulness,” Research in Organizational Behavior, 21 (1999): 23–81;.

Reason J. , “Human Error: Models and Management,” British Medical Journal, 768 (2000): 768–70. Note, however, that some attorneys may attempt to use near-miss data in lawsuits to show a pattern of error in health care; this potential indicates that there may even be negative incentives to collecting and analyzing near-miss data, emphasizing the overall need to protect safety data from discovery and evidentiary use.

See Liang , supra note 27.

See id.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 562–63. Beyond continuing medical education, medical students and residents must be provided with education and the means to address medical error and improve patient safety. This is beginning to be done.

See, e.g., Wu A. , “A Major Medical Error,” American Family Physician, 63 (2001): 985–86;.

Battles J.B. Shea C.E. , “A System of Analyzing Medical Errors to Improve GME Curricula and Programs,” Academic Medicine, 76 (2001): 125–33;.

Wu A. , “Handling Hospital Errors: Is Disclosure the Best Defense?,” Annals of Internal Medicine, 131 (1999): 970–72;.

Casarett D. Helms C. , “Systems Errors Versus Physicians' Errors: Finding the Balance in Medical Education,” Academic Medicine, 74 (1999): 19–22;.

Finkelstein D. ., “When a Physician Harms a Patient by a Medical Error: Ethical, Legal, and Risk Management Considerations,” Journal of Clinical Ethics, 8 (1997): 330–35. However, efforts by others with purported patient safety knowledge may stymie these efforts due to their shame-and-blame approach and imposition of legal risk.

See, e.g., Liang , supra note 27.

Liang Storti , supra note 74.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 563;.

Liang , “Patient Injury Incentives in Law,” supra note 50, at 91–93.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 563–64.

Voluntary reporting is the preferable method of encouraging providers to report errors due to its cooperative nature; however, politically, there may be calls for mandatory reporting. It is hoped that the poor experience with mandatory reporting will be instructive for those who pin their hopes on requiring errors and associated adverse events to be reported for patient safety. Further, within the infrastructure outlined above, supra notes 151–66 and accompanying text, much more information will be obtained through the use of the significantly more frequent near-miss reports.

See Liang , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 564.

See also Rosenthal J. , Current State Programs Addressing Medical Errors: An Analysis of Mandatory Reporting and Other Initiatives (Portland, Maine: National Academy for State Health Policy, 2001) (describing underreporting as the norm in mandatory error-reporting states).

See Weiler P.C. , A Measure of Malpractice (Cambridge: Harvard University Press, 1993): at 75.

See Weiler P.C. , Medical Malpractice on Trial (Cambridge: Harvard University Press, 1991).

See Brennan T.A. , “Medical Malpractice Reform — The Long View” (editorial), Journal of Clinical Anesthesia, 11 (1999): 265–66, at 265. Note that injuries that are caused by the health delivery system are not equivalent to injuries caused by “negligence.” Under the standard rule, one can cause injury and not be negligent.

further, in health care, providers may act completely appropriately yet a patient may still suffer an injury due to patient variation effects. See Liang Cullen , supra note 47, at 610–11.

See Brennan , supra note 170. Recent analysis suggests that a no-fault system similar to the Swedish system could compensate all patients who suffer a preventable adverse event for the same amount of money spent on malpractice premiums.

See Studdert D.M. Brennan T.A. , “No-Fault Compensation for Medical Injuries: The Prospect for Error Prevention,” JAMA, 286 (2001): 217–23;.

Studdert D.M. Brennan T.A. , “Toward a Workable Model of ‘No-Fault’ Compensation for Medical Injury in the United States,” American Journal of Law & Medicine, 27 (2001): 225–52;.

Studdert D.M. Brennan T.A. Thomas E.J. , “Beyond Dead Reckoning: Measures of Medical Injury Burden, Malpractice Litigation, and Alternative Compensation Models from Utah and Colorado,” Indiana Law Review, 33 (2000): 1643–86;.

Studdert D.M. , “Costs of Alternative Approaches to Compensation of Medical Injuries in Colorado and Utah,” Law & Contemporary Problems, 60 (1997): 1–33. These analyses may illustrate a feasible approach to no-fault at least on a demonstration level.

See Liang B.A. , “ADR in Health Care: An Overview of the ADR Landscape,” in Dauer E.A. , eds., Health Care Dispute Resolution Manual (New York: Aspen Press, 2000);.

Liang B.A. , “An Understanding and Applying Alternative Dispute Resolution Methods in Modern Medical Conflicts,” Journal of Legal Medicine, 19 (1998): 397–430;.

Liang B.A. , “The Perils of Law and Medicine: Avoiding Litigation to Promote Patient Safety,” Preventive Law Reporter, 19, no. 4 (2001): 10–12.

See, e.g., Bartholomew L.A. , “The Realities of Medical Malpractice Mediation” (in published proceedings of the 39th Annual Meeting of the American College of Legal Medicine, New Orleans, March 11–13, 1999): 393–408;.

Dauer Marcus Payne , supra note 4.

See Liang Cullen , supra note 47, at 610–11.

See Liang , supra note 102.