Sunday, April 26, 2026

Law in Failure: Medical Malpractice. Mass Preventable Death, Massive Injury, Suffering, and Trillion-Dollar Rent Seeking

 Why the medical-malpractice and defensive-medicine system deserves condemnation as a policy crime against humanity

Prepared April 26, 2026

The medical-malpractice field appears, as a public policy system, to be a scam and an utter failure. It is worse than wasteful. It helps perpetuate death and serious injury by making candid error investigation dangerous to the survival of doctors, hospitals, nursing homes, pharmacies, and other health entities, thereby forcing concealment where learning should occur. The central legal question should not be how many malpractice cases can be filed. It should be how many future patients can be saved by immediate, protected investigation and public learning.

This treatise advocates a statute mandating immediate full investigation of all factors converging to cause any serious medical error. Serious should mean death or any injury requiring medical treatment. The facts, interviews, internal analyses, causal maps, and safety recommendations generated by that mandatory investigation should be immunized from discovery in future tort litigation. The de-identified lessons should then be published on a public medical-error website for other health entities, clinicians, patients, regulators, and researchers to learn from.

The statute should not protect a cover-up. It should do the opposite. Ordinary medical error should trigger mandatory investigation, protected candor, corrective action, and public learning. Concealment, falsification, destruction of evidence, retaliation, refusal to investigate, refusal to publish, or knowing repetition of an identified serious hazard should forfeit protection and open the door to tort litigation, punitive sanctions, professional discipline, and institutional penalties.

The policy premise is simple: a serious medical error is a public safety signal, not merely a private lawsuit. The current malpractice system turns too many safety signals into silence.

1. The central failure: malpractice validates lawsuits, not safety

Medical-malpractice litigation is a poor validation system for medical error. It sometimes sorts strong from weak claims after a claim is filed, but it fails as a public safety system because most injured patients never sue, most filed claims produce no payment, plaintiffs rarely win at trial, and the process is slow, expensive, adversarial, and hostile to disclosure.

The Harvard Medical Practice Study III found that only 1.53% of patients with adverse events filed malpractice claims, and that adverse events caused by negligence outnumbered malpractice claims 7.6 to 1. That is not an error-detection system. It is a narrow litigation filter that misses far more negligent injury than it processes. [10]

Once claims are filed, most fail by outcome. A RAND summary of the Jena, Seabury, Lakdawalla, and Chandra study reports that 7.4% of physicians annually had a malpractice claim, while only 1.6% had a claim leading to an indemnity payment. That implies that roughly 78% of claims did not produce a payment. [11] The AMA report on medical-liability claim frequency states that 72% of claims do not involve indemnity payment. [12] At trial, the Bureau of Justice Statistics reported that medical-malpractice plaintiffs won about 23% of 2005 state-court trials, the lowest plaintiff win rate among the tort categories reported. [13]

The strongest defensible statement is therefore this: the vast majority of medical-malpractice claims fail. No-payment outcomes do not always prove that a claim was factually wrong; some valid claims fail because of causation, proof, expert availability, cost, delay, damages limits, or settlement economics. But the outcome data do show that the malpractice system is a high-failure adversarial process. It is not a precision safety instrument.

The malpractice system also drains resources. Studdert, Mello, Gawande, and colleagues found substantial litigation overhead, long resolution times, and imperfect alignment between payment and medical merit. They concluded that outcomes were often, but not perfectly, concordant with merit; claims involving error that received no payment were more common than non-error claims that were paid. [14]

2. The scale of medical harm

The need for a learning statute is not theoretical. The Institute of Medicine estimated in To Err Is Human that at least 44,000 and perhaps as many as 98,000 people died in U.S. hospitals each year from preventable medical errors. The report emphasized that many errors arise from unsafe systems, not simply bad individuals. [1]

Deaths are only the visible tip of the pyramid. In the Utah and Colorado adverse-event study, death occurred in 6.6% of adverse events. The policy shorthand used here — roughly fourteen nonfatal serious adverse events for every death — is derived from that percentage: if 6.6% of adverse events are fatal, then approximately 93.4% are nonfatal, and 93.4 divided by 6.6 is about 14.2. This is not a perfect epidemiological equivalence to every statutorily defined serious injury, but it is a reasonable injury-pyramid estimate for policy discussion. [2]

Recent evidence confirms that preventable harm remains a major problem. A 2023 New England Journal of Medicine study of inpatient safety found adverse events in nearly one in four admissions; approximately one fourth of those events were preventable; 6.8% of admissions had a preventable adverse event; and 1.0% had a preventable adverse event of serious severity or higher. [3] The World Health Organization reports that around 1 in every 10 patients is harmed in health care, that more than half of such harm is preventable, and that unsafe care causes more than 3 million deaths annually worldwide. [4]

The system also fails to capture harm. In 2022, HHS-OIG found that 25% of hospitalized Medicare patients experienced patient harm in October 2018 and that 43% of harm events were preventable. [6] In 2025, HHS-OIG reported that hospitals did not capture about half of patient-harm events among hospitalized Medicare patients; of the events hospitals did capture, few were investigated and fewer led to safety improvements. [5] That finding is a direct indictment of voluntary reporting and ordinary institutional risk management.

The economic stakes are enormous. OECD reported that the economic cost of medical error in the United States was estimated at almost USD 1 trillion in 2008 when flow-on and indirect costs were considered. [7] OECD later estimated that, in developed countries, the direct cost of unsafe care approaches 13% of health spending and that the full global economic cost is over USD 1 trillion annually using a willingness-to-pay approach. [8] These figures do not fully price pain, suffering, grief, loss of trust, or the moral injury inflicted on patients, families, and clinicians.

3. The reverse comparison: failed med-mal claims versus serious medical failure

A useful comparison is the reverse of the usual litigation argument. Instead of asking how often patients sue after error, ask how often filed malpractice claims fail compared with the fatal-or-serious medical-error rate across the total universe of patients seen.

Using the Institute of Medicine death range of 44,000 to 98,000 deaths and the derived fourteen nonfatal serious adverse events per death, the estimated fatal-plus-serious-error numerator is 660,000 to 1,470,000 events annually. [1][2]

For a broad patient-year denominator, CDC reports that 85.2% of adults and 95.1% of children had a visit with a doctor or other health care professional in 2024. [21] The Census Bureau estimated the U.S. population at 340,110,988 in 2024, with 21.5% under age 18. [23] Weighting adult and child visit rates gives approximately 297 million people seen by a health professional in a year. Using that denominator, the fatal-or-serious medical-error rate is approximately 0.22% to 0.49% per patient seen, or about 2.2 to 4.9 fatal-or-serious events per 1,000 patients seen.

MeasureApproximate rateInterpretation
Filed med-mal claims with no indemnity payment72% to 78.4%Most filed claims fail by outcome. [11][12]
Fatal-or-serious medical-error rate per patient seen0.22% to 0.49%Small in percentage terms, devastating in human and economic terms. [1][2][21][23]
Failed-claim fraction divided by patient-seen error rateAbout 150 to 350 times largerThe failed-claim fraction is vastly larger than the serious/fatal error rate across all patients seen.

On an encounter basis, the comparison is even more dramatic. CDC reports about 1.0 billion physician office visits and 155.4 million emergency-department visits. [21][22] Using only those two categories gives about 1.155 billion encounters, before counting hospital admissions, outpatient surgery, imaging, labs, pharmacy interactions, nursing-home care, home health, and other settings. With that limited denominator, the fatal-or-serious error rate is approximately 0.057% to 0.127%, and the failed-claim fraction is roughly 570 to 1,370 times larger than that encounter-based error rate.

This does not mean serious medical error is acceptable. It means the opposite: because fatal and serious error is small as a percentage of total care but enormous in human and economic cost, the law should focus on prevention, not on a litigation model that largely fails after the harm has already occurred.

4. The proposed statute

The statute should create a mandatory public-safety process for every serious medical error. Serious should mean death or injury requiring medical treatment. The trigger should be broad enough to include error, delayed care, omitted care, medication error, diagnostic error, procedure error, equipment failure, communication breakdown, health information technology failure, inadequate staffing, supervision failure, unsafe policy, unsafe environment, or any convergence of health-care factors that may have caused or contributed to serious harm.

DutyStatutory requirement
Duty to investigateEvery death or injury requiring medical treatment that may involve medical error triggers immediate mandatory investigation.
Duty to preserveRelevant medical records, EHR audit trails, device data, medication-dispensing data, staffing records, messages, policies, and physical evidence must be preserved at once.
Duty to examine convergenceThe investigation must identify human, technical, organizational, environmental, diagnostic, medication, staffing, policy, communication, and economic factors.
Duty to protect candorInvestigation-generated facts, interviews, deliberations, analyses, causal maps, and recommendations are immune from tort discovery and evidentiary use.
Duty to actThe health entity must adopt corrective actions, assign responsibility, and track completion.
Duty to teachDe-identified findings must be published on a medical-error learning website.
Duty to punish cover-upConcealment, falsification, retaliation, refusal to investigate, refusal to publish, or knowing repetition after notice forfeits protection.

The investigation should begin within twenty-four hours. Patients and families should be invited to provide their observations. A preliminary safety alert should issue quickly if an ongoing hazard remains. A final de-identified report should be completed and published on a defined schedule. The report should state what happened, what factors converged, what safeguards failed, what corrective actions were ordered, who is accountable for implementation, and how completion will be verified.

The investigation must not stop at the last clinician in the chain. Serious medical error usually emerges from convergence: fatigue, understaffing, unclear orders, weak handoffs, confusing medication labels, EHR alerts buried in noise, missing diagnostic information, equipment design, production pressure, lack of supervision, patient complexity, inadequate language support, prior unaddressed near misses, or reimbursement systems that reward volume over safety. WHO emphasizes that patient harm often arises from multiple interacting factors and that most mistakes leading to harm are rooted in system or process failures rather than isolated individual fault. [4]

5. Why the investigation must be protected

Without legal protection, the investigation becomes litigation preparation. Every interview becomes deposition rehearsal. Every timeline is drafted for cross-examination. Every candid statement becomes a potential exhibit. Lawyers then fight over documents while the safety lesson remains buried. The next patient inherits the same hazard.

Federal law already recognizes the need for protected safety learning. The Patient Safety and Quality Improvement Act provides privilege and confidentiality protections for patient safety work product, including information collected or created during the reporting and analysis of patient safety events. HHS explains that these protections encourage reporting and analysis of medical errors. [19] The regulations at 42 C.F.R. Part 3, Subpart C provide that patient safety work product is generally privileged, not subject to subpoena or discovery, not subject to FOIA-type disclosure, and not admissible as evidence, subject to listed exceptions. [20]

The flaw is that the current framework is not enough. It is too voluntary, too fragmented, and too easy for serious harm to remain inside private institutional systems. A death or medically treated injury should trigger mandatory learning. The law should make serious harm impossible to bury.

The protection should apply only to the safety investigation itself. Original medical records, billing records, independently existing documents, regulatory reports, and ordinary witness testimony can remain available under ordinary law. The statute should protect the special investigation created for candor, convergence analysis, correction, and public learning. Tort litigation can assign compensation in exceptional cases. The safety investigation must prevent recurrence. Those are different public purposes.

6. Publication: every serious error becomes a public lesson

The statute should require publication of de-identified reports on a public medical-error learning website. Publication must not reveal patient identity, protected health information, or unnecessary clinician identifiers. It should publish what matters for prevention: the setting, hazard, contributing factors, failed safeguards, corrective actions, implementation status, and lessons for similar institutions.

The website should be searchable by specialty, setting, diagnosis, medication, device, workflow, EHR issue, staffing factor, communication failure, patient population, and corrective action. A rural emergency department should learn from a medication error at an academic center. A nursing home should learn from a fall investigation in another state. A surgical center should learn from a retained-object case elsewhere. A pediatric unit should identify an EHR default before a child is harmed.

This is not secrecy. It is structured transparency. The current system already produces secrecy through guarded peer review, closed settlements, defensive documentation, incomplete reporting, and lessons trapped inside institutions. A mandatory learning statute would trade defensive silence for protected disclosure and national learning.

7. Compensation without destructive litigation

A protected investigation does not require abandoning injured patients. Patients and families should receive prompt disclosure, medical-record access, explanation of known facts, apology where appropriate, and practical compensation for economic loss through an administrative mechanism. Economic loss can include additional medical care, rehabilitation, disability-related needs, lost income, and funeral expense. But ordinary negligence litigation should not be the default remedy for ordinary error. It should be reserved for cover-up, intentional misconduct, reckless disregard, or knowing failure to correct a serious identified hazard.

That structure reverses the present incentive. Today, silence protects institutions. Under the proposed statute, candor earns protection and concealment earns litigation. The legal trigger should not be merely “Was there an error?” The trigger should be “Was there a cover-up?”

8. Why would such a system be allowed to continue?

The blunt answer is that the system continues because it is a stable political-economic cartel of incentives, even if no one formally coordinates it. The tort plaintiff bar, defense bar, insurers, hospitals, physicians, labs, imaging centers, device suppliers, expert witnesses, consultants, risk managers, and administrators all have different motives, but the present system lets each of them survive or profit while the public pays the bill.

The direct malpractice industry is expensive, but the larger scandal is defensive medicine. If defensive medicine is even close to 10% of U.S. health spending, then it is a roughly USD 530 billion annual burden in a USD 5.3 trillion health system. [9] That dwarfs malpractice premiums, malpractice payouts, plaintiff-lawyer fees, defense-lawyer fees, and insurer claims-handling costs. It also explains why medicine has not truly destroyed the malpractice system: the same liability fear that feeds the lawyers also feeds a huge volume of medical revenue.

There are several cost layers. AM Best reported that the U.S. medical professional liability market reached USD 13.02 billion in 2024 direct premiums written. [15] The Insurance Information Institute reported USD 1.833 billion in 2024 medical professional liability defense and cost-containment expenses; because that amount was 28.8% of incurred losses, incurred losses were roughly USD 6.37 billion by calculation. [16] Mello, Chandra, Gawande, and Studdert estimated the overall medical-liability system, including defensive medicine, at USD 55.6 billion in 2008 dollars, or 2.4% of total health spending, with defensive medicine the largest component. [17] If the same 2.4% share were applied to 2024 national health spending of USD 5.3 trillion, the figure would be about USD 127 billion. If one uses a high-end 10% defensive-medicine theory, the figure is about USD 530 billion. [9]

Cost categoryApproximate amountMeaning
Direct MPL premiumsUSD 13.02 billion in 2024Premiums paid into the medical professional liability insurance market. [15]
Defense and cost containmentUSD 1.833 billion in 2024Defense lawyers, experts, claims investigation, litigation management, and related expenses. [16]
Insured incurred losses proxyAbout USD 6.37 billion in 2024Derived from DCCE of USD 1.833 billion equaling 28.8% of incurred losses. [16]
Mello total liability-system estimateUSD 55.6 billion in 2008 dollarsIncludes indemnity, administrative/legal/insurance overhead, clinician time, and defensive medicine. [17]
2.4% scaled to 2024 NHEAbout USD 127 billion2.4% of USD 5.3 trillion national health spending. [9][17]
10% defensive-medicine theoryAbout USD 530 billionHigh-end advocacy estimate; far above CBO and Mello estimates. [9][18]

Who gets the money? Plaintiffs and families receive indemnity payments, but only in a minority of filed claims and often after years of conflict. Plaintiff lawyers usually receive contingency fees from recoveries. Defense lawyers, experts, and claim vendors are paid to resist claims, whether claims are valid or weak. Insurers receive premiums, invest reserves, pay claims and defense costs, pay reinsurance and brokers, and may earn underwriting or investment profit. [11][12][14][15][16]

But doctors, hospitals, imaging centers, laboratories, consultants, and other health entities may receive the much larger stream: revenue from defensive tests, referrals, admissions, imaging, consultations, procedures, monitoring, and documentation-heavy care. A CT scan ordered partly for legal protection is still a billed CT scan. A consult ordered to protect the chart is still a billed consult. A hospital admission ordered “to be safe” is still revenue. Defensive medicine can be economically irrational for the country while economically rational for the provider.

That is why doctors and hospitals do not stop the system. Their incentives are conflicted. They dislike lawsuits, premiums, depositions, reputational attack, and litigation stress. But fee-for-service medicine often pays them for doing more. Health entities attack payouts and premiums, but they do not always attack the deeper engine of overutilization. They want less liability risk, but not necessarily less reimbursed volume. That contradiction helps the system continue.

Defensive medicine is medical care that is legally useful but not medically necessary. If a procedure is truly not medically necessary and is knowingly billed to Medicare or Medicaid as medically necessary, that can become a False Claims Act problem. HHS-OIG states that it is illegal to submit Medicare or Medicaid claims that a provider knows or should know are false or fraudulent. [24] The Justice Department has brought False Claims Act cases involving allegedly medically unnecessary services. [25]

Not every defensive order is legal fraud. Many defensive tests have some arguable clinical basis. A clinician may say the test was ordered to rule out a dangerous condition. That may be debatable, wasteful, or liability-driven without being fraudulent. But defensive medicine exposes a fraud-like contradiction in the system: the law pressures clinicians to order care they may not believe is medically necessary, and the payment system reimburses that care as if it were medically necessary.

Unnecessary care is not merely financial waste. It can physically injure patients. The AMA Journal of Ethics has described tests or procedures ordered out of fear of litigation as unnecessary and potentially iatrogenic. [26] The ABIM Foundation’s Choosing Wisely campaign was designed to help physicians and patients discuss overuse, and it involved more than 80 specialty societies producing hundreds of recommendations on overused tests and treatments. [27]

Extra imaging creates radiation exposure and false positives. Extra testing creates cascades. Extra procedures create complications. Extra hospitalization creates infection, delirium, falls, and medication exposure. Extra charting and legal ritual consume clinician attention. If the system rewards unnecessary intervention, it does not merely waste money. It creates physical risk.

Why is the system allowed to continue? Because the costs are diffuse and the benefits are concentrated. Patients, taxpayers, employers, and premium payers absorb the total cost. But the beneficiaries are organized and immediate: plaintiff lawyers get fees, defense lawyers get hourly work, insurers get premiums and float, experts get paid, hospitals get reimbursed, physicians get paid, vendors get volume, and politicians avoid the charge that they are taking away an injured patient’s day in court.

The public experiences it as theft-like legalized extraction. The tort side monetizes injury after the fact. The medical side monetizes fear before the fact. The public pays both bills, financially and physically. Patients are harmed by errors that are concealed, by lessons that are not learned, and by unnecessary care that exposes them to risk without medical need.

9. The rule that should replace malpractice default litigation

The statute should create a clean public bargain:

Every serious medical error must be reported immediately.

Every serious medical error must be investigated fully.

Every converging factor must be identified.

Every safety lesson must be published in de-identified form.

Every investigation-generated fact, interview, deliberation, and recommendation must be immune from tort discovery.

Every identified hazard must be corrected, with implementation tracked.

Every cover-up forfeits protection and triggers litigation exposure, punitive sanctions, and regulatory consequences.

The statute should also include anti-retaliation protections for staff, patients, and family members who report harm or cooperate with investigations. It should require the public website to de-identify reports while retaining enough factual detail to allow practical learning. It should create audit authority to ensure that hospitals and other health entities do not underreport serious harm. It should impose escalating penalties for failure to report, failure to investigate, failure to correct, or failure to publish.

10. Conclusion

Every serious medical error contains a lesson. Some contain many. The tragedy is not only that harm occurred. The deeper tragedy is when the same harm happens again because the first lesson was hidden, privileged only for defense, settled into silence, or never investigated at all.

Medical malpractice litigation is not a patient-safety system. It is a high-failure, high-cost, adversarial process that induces silence. If every serious medical error were litigated as a default, no health entity could function openly. If serious errors are hidden to avoid litigation, patients die from repeated hazards. The answer is not ordinary immunity. The answer is mandatory investigation, protected candor, public learning, practical compensation, and zero tolerance for cover-up.

The law should stop litigating medical error into secrecy. It should make every death and every medically treated injury a mandatory public lesson. It should protect truth-telling and punish concealment. It should put prevention ahead of professional enrichment. It should make the next patient safer than the last.

11. The moral indictment: annual mass death, massive injury, suffering, and economic rent seeking

The yearly toll makes this more than an inefficient compensation system. Using the Institute of Medicine death range of 44,000 to 98,000 preventable hospital deaths and the derived injury-pyramid estimate of roughly fourteen nonfatal serious adverse events for every death, the United States faces approximately 660,000 to 1,470,000 fatal-or-serious medical-error events every year. [1][2] This is not a sporadic accident pattern. It is annual mass death and massive injury, repeated year after year, with disability, suffering, grief, lost work, family disruption, and loss of trust layered on top of the visible statistics.

The economic cost is correspondingly massive. OECD estimated that the economic cost of medical error in the United States was almost USD 1 trillion in 2008 when indirect and flow-on costs were included, and later framed unsafe care as a trillion-dollar global economic burden. [7][8] In a USD 5.3 trillion U.S. health system, a 10% defensive-medicine burden would be roughly USD 530 billion annually. [9] Even if lower estimates are used, the recurring burden is large enough to dwarf the direct malpractice industry and to justify treating the problem as a national human-safety emergency rather than ordinary professional friction.

In moral and policy terms, a rent-seeking system that predictably permits this annual toll to continue deserves condemnation as a crime against humanity. This treatise uses that phrase as a moral indictment, not as a claim that any court has adjudicated the malpractice-defensive-medicine system under the technical international-law definition. The Rome Statute defines crimes against humanity as certain acts committed as part of a widespread or systematic attack directed against a civilian population, with knowledge of the attack. [28] The point here is that the scale of preventable death, serious injury, suffering, and economic extraction is so large that public policy should treat it with the urgency normally reserved for atrocities, not with the complacency reserved for a private insurance dispute.

If such harm were inflicted by one visible actor, the public would recognize it as intolerable. Because it is produced by incentives — litigation fear, insurance economics, defensive billing, institutional silence, and political protection of organized interests — it is normalized. That normalization is the moral crime. The cure is not another round of litigation. The cure is mandatory investigation, protected candor, public learning, practical compensation, and severe penalties for cover-up.

References and Source Notes

Citations are placed here at the end of the treatise, as requested. Numbers in brackets in the text refer to the source notes below. Calculations in the treatise are derived from the cited source data and are approximate.

[1] Institute of Medicine, To Err Is Human: Building a Safer Health System, report brief. Source for the 44,000 to 98,000 annual preventable hospital death estimate and the systems-based patient-safety framing. Source link URL: https://nap.nationalacademies.org/resource/9728/To-Err-is-Human-1999--report-brief.pdf

[2] Thomas EJ, Studdert DM, Burstin HR, et al., Incidence and Types of Adverse Events and Negligent Care in Utah and Colorado, Medical Care, 2000. Source for death occurring in 6.6% of adverse events, supporting the derived approximately fourteen nonfatal adverse events per death ratio. Source link URL: https://pubmed.ncbi.nlm.nih.gov/10718351/

[3] Bates DW, Levine DM, Salmasian H, et al., The Safety of Inpatient Health Care, New England Journal of Medicine, 2023. Source for nearly one in four admissions involving adverse events, about one fourth preventable, 6.8% preventable adverse-event admissions, and 1.0% preventable serious-or-higher admissions. Source link URL: https://www.nejm.org/doi/full/10.1056/NEJMsa2206117

[4] World Health Organization, Patient Safety fact sheet. Source for global patient-safety facts, preventability, system factors, and the need for systems rather than blame-focused approaches. Source link URL: https://www.who.int/news-room/fact-sheets/detail/patient-safety

[5] HHS Office of Inspector General, Hospitals Did Not Capture Half of Patient Harm Events, 2025. Source for the finding that hospitals did not capture about half of patient harm events and that captured events were rarely investigated or converted into improvements. Source link URL: https://oig.hhs.gov/reports/all/2025/hospitals-did-not-capture-half-of-patient-harm-events-limiting-information-needed-to-make-care-safer/

[6] HHS Office of Inspector General, Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018, 2022. Source for 25% of hospitalized Medicare patients experiencing harm and 43% of harm events being preventable in the OIG review. Source link URL: https://oig.hhs.gov/reports/all/2022/adverse-events-in-hospitals-a-quarter-of-medicare-patients-experienced-harm-in-october-2018/

[7] OECD, The Economics of Patient Safety, 2017. Source for the estimate that the economic cost of medical error in the United States was almost USD 1 trillion in 2008 when indirect and flow-on costs were included. Source link URL: https://www.oecd.org/content/dam/oecd/en/publications/reports/2017/06/the-economics-of-patient-safety_258f9682/5a9858cd-en.pdf

[8] OECD, The Economics of Patient Safety: From Analysis to Action, 2022. Source for the broader economic framing: direct cost of unsafe care in developed countries approaching 13% of health spending and global economic cost exceeding USD 1 trillion annually. Source link URL: https://www.oecd.org/en/publications/the-economics-of-patient-safety_761f2da8-en.html

[9] Centers for Medicare & Medicaid Services, National Health Expenditure Fact Sheet. Source for U.S. national health expenditures of USD 5.3 trillion in 2024, or 18.0% of GDP. Source link URL: https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet

[10] AHRQ PSNet summary of Localio et al., Relation Between Malpractice Claims and Adverse Events Due to Negligence. Source for 1.53% of patients with adverse events filing claims and the 7.6-to-1 ratio of negligent adverse events to malpractice claims. Source link URL: https://psnet.ahrq.gov/issue/relation-between-malpractice-claims-and-adverse-events-due-negligence-results-harvard-medical

[11] RAND Research Brief, Malpractice Risk, by Physician Specialty, summarizing Jena et al. Source for 7.4% annual physician claim rate and 1.6% annual claim-with-payment rate, implying about 78% of claims did not lead to payment. Source link URL: https://www.rand.org/pubs/research_briefs/RB9610.html

[12] American Medical Association, Medical Liability Claim Frequency Among U.S. Physicians, Guardado, 2016–2022. Source for the statement that 72% of claims do not involve indemnity payments. Source link URL: https://www.ama-assn.org/system/files/policy-research-perspective-medical-liability-claim-frequency.pdf

[13] Bureau of Justice Statistics, Civil Bench and Jury Trials in State Courts, 2005. Source for medical-malpractice plaintiff win rates at trial of about 23%. Source link URL: https://bjs.ojp.gov/content/pub/pdf/cbjtsc05.pdf

[14] Studdert DM, Mello MM, Gawande AA, et al., Claims, Errors, and Compensation Payments in Medical Malpractice Litigation, New England Journal of Medicine, 2006. Source for closed-claim analysis, payment/error concordance, litigation overhead, and limitations of malpractice as a sorting mechanism. Source link URL: https://www.nejm.org/doi/full/10.1056/NEJMsa054479

[15] AM Best, Best’s Rankings: U.S. Medical Professional Liability 2024 DPW Rose 5.4%. Source for 2024 direct premiums written of USD 13.02 billion in the U.S. medical professional liability market. Source link URL: https://news.ambest.com/newscontent.aspx?altsrc=9&refnum=266815

[16] Insurance Information Institute, Facts + Statistics: Product Liability. Source for medical professional liability defense and cost-containment expense of USD 1.833 billion in 2024 and the 28.8% relationship to incurred losses. Source link URL: https://www.iii.org/fact-statistic/facts-statistics-product-liability

[17] Mello MM, Chandra A, Gawande AA, Studdert DM, National Costs of the Medical Liability System, Health Affairs, 2010. Source for the USD 55.6 billion 2008 estimate and 2.4% of health spending estimate for the medical-liability system, including defensive medicine. Source link URL: https://pubmed.ncbi.nlm.nih.gov/20820010/

[18] Congressional Research Service, Medical Malpractice Insurance and Health Reform, 2011. Source for CBO-related discussion that federal tort reforms were estimated to reduce national health spending by about 0.5% and for the statement that defensive-medicine estimates are contested. Source link URL: https://www.everycrsreport.com/files/20110208_R40862_5998ebb1387385eb97f64dba73b9854de0ec2289.pdf

[19] HHS Office for Civil Rights, Understanding Confidentiality of Patient Safety Work Product. Source for the federal Patient Safety and Quality Improvement Act framework and privilege/confidentiality protections for patient safety work product. Source link URL: https://www.hhs.gov/hipaa/for-professionals/patient-safety/index.html

[20] eCFR, 42 C.F.R. Part 3, Subpart C — Confidentiality and Privilege Protections of Patient Safety Work Product. Legal source for privilege, confidentiality, non-discovery, non-subpoena, and non-admissibility protections, subject to exceptions. Source link URL: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-3/subpart-C

[21] CDC/NCHS FastStats, Ambulatory Care Use and Physician Office Visits. Source for 2024 adult and child percentages with a doctor or other health professional visit and approximately 1.0 billion physician office visits. Source link URL: https://www.cdc.gov/nchs/fastats/physician-visits.htm

[22] CDC/NCHS FastStats, Emergency Department Visits. Source for 155.4 million emergency department visits. Source link URL: https://www.cdc.gov/nchs/fastats/emergency-department.htm

[23] U.S. Census Bureau QuickFacts, United States. Source for 2024 U.S. population estimate of 340,110,988 and 21.5% under age 18. Source link URL: https://www.census.gov/quickfacts/fact/table/US/PST045224

[24] HHS Office of Inspector General, Fraud & Abuse Laws. Source for the rule that it is illegal to submit Medicare or Medicaid claims a provider knows or should know are false or fraudulent. Source link URL: https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/

[25] U.S. Department of Justice, Florida Physician to Pay $26.1 Million to Resolve False Claims Allegations, 2013. Example of a False Claims Act resolution involving allegations of billing Medicare for medically unnecessary services. Source link URL: https://www.justice.gov/archives/opa/pr/florida-physician-pay-261-million-resolve-false-claims-allegations

[26] AMA Journal of Ethics, Choosing Unwisely, 2020. Source for the proposition that diagnostic tests or procedures ordered out of fear of litigation can be unnecessary and potential sources of iatrogenic harm. Source link URL: https://journalofethics.ama-assn.org/article/choosing-unwisely/2020-09

[27] ABIM Foundation, Choosing Wisely Initiative. Source for the Choosing Wisely campaign and specialty-society recommendations addressing overused tests and treatments. Source link URL: https://abimfoundation.org/what-we-do/choosing-wisely

[28] Rome Statute of the International Criminal Court, Article 7 — Crimes against humanity. Source for the technical international-law definition of crimes against humanity, used here to distinguish the treatise’s moral and policy condemnation from a formal adjudicated legal charge. Source link URL: https://www.ohchr.org/en/instruments-mechanisms/instruments/rome-statute-international-criminal-court

Calculation note

The patient-seen denominator is calculated as 340,110,988 multiplied by a weighted visit-rate estimate: 78.5% adults times 85.2% adult visit rate, plus 21.5% children times 95.1% child visit rate, yielding approximately 297,013,824 people seen by a doctor or other health professional. The fatal-plus-serious numerator is calculated as the IOM death estimate multiplied by fifteen: one fatal event plus fourteen nonfatal serious adverse events per death, yielding 660,000 to 1,470,000 events. The resulting patient-seen error rate is approximately 0.22% to 0.49%. The encounter-based denominator uses 1.0 billion physician office visits plus 155.4 million emergency-department visits, yielding approximately 0.057% to 0.127%.

TEACH STATES Act Transparent Error Analysis, Candor, and Healthcare Standards to Encourage Adoption by the States Act

 

The TEACH STATES Act

Transparent Error Analysis, Candor, and Healthcare Standards to Encourage Adoption by the States Act

A Model Federal Medical Error Public Reporting Incentive and Patient Safety Protection Act


Section 1. Short Title

This Act may be cited as the Transparent Error Analysis, Candor, and Healthcare Standards to Encourage Adoption by the States Act, or the TEACH STATES Act.


Section 2. Congressional Findings and Constitutional Basis

Congress finds that:

  1. Serious medical errors resulting in death or injury requiring medical treatment are matters of national public health, patient safety, health care quality, and fiscal integrity.
  2. Federal health care programs, including Medicare, Medicaid, the Children’s Health Insurance Program, federally supported public health programs, health information technology programs, hospital preparedness programs, and quality-improvement programs, have a direct interest in reducing preventable patient harm.
  3. The federal government expends substantial funds to support state health care systems, public health infrastructure, hospital preparedness, Medicaid and CHIP administration, patient safety, and health care quality.
  4. A national floor for serious medical-error reporting, investigation, public learning, and protected safety analysis will improve patient safety and reduce preventable death, injury, waste, defensive medical practice, and avoidable public expense.
  5. Existing federal law recognizes that patient-safety information should receive privilege and confidentiality protections in order to encourage reporting and analysis of medical errors. The Patient Safety and Quality Improvement Act protects patient safety work product and encourages reporting, but the existing federal framework remains largely voluntary.
  6. Serious medical error should not remain a voluntary reporting matter when the consequence is death or injury requiring medical treatment.
  7. The purpose of this Act is to encourage, but not commandeer, States to adopt a serious medical-error public reporting and protected investigation system.
  8. Congress does not command any State legislature to enact or administer a federal regulatory program. Instead, Congress establishes clear, prospective, related, and limited conditions on certain federal health-system assistance.
  9. The conditions imposed by this Act are intended to satisfy the constitutional requirements for Spending Clause legislation: they promote the general welfare, are stated unambiguously, relate to the federal interest in health care quality and patient safety, do not require unconstitutional state action, and are limited so that the financial inducement remains encouragement rather than coercion.
  10. Congress intends this Act to follow the constitutional principles recognized in South Dakota v. Dole, while avoiding the coercion concerns identified in National Federation of Independent Business v. Sebelius.

Section 3. Definitions

For purposes of this Act:

3.1 “Secretary”

“Secretary” means the Secretary of Health and Human Services.

3.2 “State”

“State” means any State of the United States, the District of Columbia, Puerto Rico, Guam, American Samoa, the United States Virgin Islands, and the Northern Mariana Islands.

3.3 “Compliant State Medical Error Law”

“Compliant State Medical Error Law” means a State statute, regulation, or enforceable legal framework certified by the Secretary as substantially satisfying Section 5 of this Act.

3.4 “TEACH Act”

“TEACH Act” means a State law substantially equivalent to the Transparent Error Analysis, Candor, and Healthcare Learning Act, requiring immediate reporting, full investigation, public de-identified learning reports, discovery immunity for protected safety investigation material, preservation of original evidence, and loss of protection for cover-up.

3.5 “Covered Federal Health-System Assistance”

“Covered Federal Health-System Assistance” means federal funds payable to a State government, or to a State agency, for health care quality, health care administration, patient safety, public health infrastructure, health information technology, hospital preparedness, health-system oversight, Medicaid administration, CHIP administration, health care workforce safety programs, or health-system improvement.

Covered Federal Health-System Assistance includes, to the extent determined by the Secretary by regulation:

  1. Federal public health infrastructure grants;
  2. Federal hospital preparedness and health-system readiness grants;
  3. Federal patient-safety and health care quality grants;
  4. Federal health information technology grants payable to States;
  5. Federal Medicaid administrative matching funds;
  6. Federal CHIP administrative matching funds;
  7. Federal quality-improvement, oversight, and program-integrity grants payable to States; and
  8. Any other federal health-system assistance to States that the Secretary determines is directly related to patient safety, health care quality, public health reporting, or health-system oversight.

3.6 Funds Excluded from Covered Federal Health-System Assistance

Covered Federal Health-System Assistance does not include:

  1. Medicare benefit payments;
  2. Medicare payments to providers, suppliers, plans, or beneficiaries;
  3. Medicaid medical-assistance payments for covered services;
  4. CHIP child-health-assistance payments for covered services;
  5. Veterans Health Administration benefit payments;
  6. Indian Health Service direct care funds;
  7. Social Security benefits;
  8. Direct patient benefits;
  9. Direct provider reimbursement for patient care; or
  10. Any funds whose withholding would directly reduce a patient’s eligibility for, or receipt of, medically necessary care.

3.7 “Reportable Serious Medical Error”

“Reportable Serious Medical Error” means any known or reasonably suspected medical error, adverse medical event, preventable harm event, system failure, diagnostic failure, medication failure, procedural failure, device failure, communication failure, staffing failure, monitoring failure, discharge failure, or other health care-related event that results in:

  1. Death;
  2. Injury requiring medical treatment;
  3. Unplanned transfer to a higher level of care;
  4. Prolonged hospitalization;
  5. Emergency medical treatment caused by the event;
  6. Permanent or temporary loss of bodily function requiring medical treatment;
  7. Unplanned surgery, procedure, medication, transfusion, device intervention, or therapeutic intervention; or
  8. Any other event designated by the Secretary as reportable because of severity, preventability, recurrence risk, or public safety importance.

3.8 “Protected Patient Safety Investigation Material”

“Protected Patient Safety Investigation Material” means all analyses, findings, conclusions, interview statements, root-cause analyses, apparent-cause analyses, safety recommendations, drafts, deliberations, causal maps, internal memoranda, corrective-action deliberations, preventability assessments, and other materials created, assembled, obtained, or used primarily for a patient safety investigation required under a Compliant State Medical Error Law or under the federal default reporting program established by this Act.

3.9 “Original Medical Record or Independently Existing Evidence”

“Original Medical Record or Independently Existing Evidence” means medical records, billing records, discharge records, orders, medication administration records, laboratory records, imaging records, device logs, electronic health record audit trails, staffing records, policies, communications, physical evidence, and other information that exists independently of a patient safety investigation.

3.10 “Public Learning Report”

“Public Learning Report” means a de-identified public report describing a reportable serious medical error, its contributing factors, safety lessons, and corrective actions, without identifying patients, individual clinicians, reporters, witnesses, reviewers, or other natural persons.

3.11 “Cover-Up”

“Cover-up” means any knowing, reckless, or intentional act or omission designed to conceal, falsify, alter, destroy, suppress, delay, mischaracterize, or prevent reporting or investigation of a reportable serious medical error.

Cover-up includes, but is not limited to:

  1. Falsifying, altering, backdating, or destroying records;
  2. Directing or inducing any person to provide false or misleading information;
  3. Retaliating against a person for reporting a medical error or participating in an investigation;
  4. Failing to report a serious medical error as required by State or federal law;
  5. Knowingly submitting a materially false or misleading report;
  6. Concealing an ongoing hazard after actual or constructive notice of that hazard;
  7. Preventing patient or family participation required by law; or
  8. Failing to conduct or complete a required patient safety investigation.

Section 4. Federal Policy

It is the policy of the United States that:

  1. Every reportable serious medical error should be reported promptly;
  2. Every such event should be investigated fully and immediately;
  3. Every investigation should identify all converging human, technical, organizational, environmental, diagnostic, medication, device, staffing, communication, supervision, training, policy, and financial-pressure factors;
  4. De-identified safety lessons should be published for public learning;
  5. Protected patient safety investigation materials should be immune from civil discovery and evidentiary use;
  6. Original medical records and independently existing evidence should remain available under otherwise applicable law;
  7. Candor should be protected;
  8. Cover-up should be punished; and
  9. Federal funding should support States that adopt and enforce this patient-safety framework.

Section 5. Requirements for a Compliant State Medical Error Law

To receive full Covered Federal Health-System Assistance under this Act, a State shall adopt and enforce a Compliant State Medical Error Law.

A State law shall be certified as compliant if the Secretary determines that it substantially contains each of the following elements.

5.1 Mandatory Reporting

The State law shall require health care entities and health care personnel to report known or reasonably suspected reportable serious medical errors.

The State law shall require:

  1. Internal reporting within 24 hours after discovery;
  2. Reporting to the State health agency within 72 hours after discovery;
  3. Supplemental reporting when material new information becomes known; and
  4. Immediate notification to the State health agency if an ongoing hazard presents substantial risk to other patients.

5.2 Mandatory Preservation of Evidence

The State law shall require immediate preservation of original medical records and independently existing evidence, including medical records, device data, audit trails, medication records, staffing records, policies, communications, and physical evidence.

5.3 Mandatory Patient Safety Investigation

The State law shall require a prompt and complete patient safety investigation of each reportable serious medical error.

The investigation shall identify all contributing factors, including clinical, diagnostic, medication, communication, equipment, device, staffing, training, supervision, policy, workflow, electronic health record, environmental, leadership, production-pressure, and financial-pressure factors.

5.4 Patient and Family Participation

The State law shall require a health care entity to offer the patient, patient representative, or family a reasonable opportunity to provide information relevant to the investigation.

5.5 Disclosure to Patient or Patient Representative

The State law shall require plain-language disclosure to the patient or patient representative that:

  1. A serious adverse event or suspected medical error occurred;
  2. An investigation has begun;
  3. The patient or patient representative may provide information;
  4. Corrective steps are being considered or taken; and
  5. A de-identified public learning report will be published when complete.

5.6 Public Medical Error Learning Registry

The State law shall require a publicly accessible online medical-error learning registry.

The registry shall publish de-identified public learning reports searchable by event type, care setting, specialty, medication, device, diagnosis, procedure, workflow, contributing factor, and corrective action.

5.7 Required Contents of Public Learning Reports

The State law shall require each public learning report to include, in de-identified form:

  1. General care setting;
  2. General event type;
  3. General nature of the harm;
  4. Plain-language description of what happened;
  5. Contributing factors identified;
  6. Safeguards that failed or were absent;
  7. Corrective actions taken or planned;
  8. Schedule for corrective action;
  9. Method for verifying completion and effectiveness; and
  10. Broader safety lessons for other health care entities.

5.8 Privilege and Immunity from Discovery

The State law shall provide that Protected Patient Safety Investigation Material is privileged, confidential, immune from discovery, immune from subpoena, inadmissible in evidence, and unavailable for use in civil litigation, administrative proceedings, arbitration, professional disciplinary proceedings, credentialing disputes, employment proceedings, or public-records requests.

5.9 Protection of Findings

The State law shall specifically immunize from discovery and evidentiary use all findings, conclusions, causal analyses, root-cause analyses, preventability assessments, safety recommendations, corrective-action analyses, witness statements made for the investigation, drafts, deliberations, and internal communications created for the patient safety investigation.

5.10 Preservation of Original Evidence

The State law shall provide that original medical records and independently existing evidence do not become privileged merely because they are reviewed, copied, preserved, discussed, or analyzed during a protected patient safety investigation.

5.11 No Waiver

The State law shall provide that privilege and confidentiality are not waived by:

  1. Reporting to a State agency;
  2. Reporting to a federal agency;
  3. Reporting to a patient safety organization;
  4. Disclosing information to the patient or patient representative;
  5. Publishing a de-identified public learning report;
  6. Disclosing protected material to contractors, consultants, experts, insurers, reinsurers, attorneys, auditors, accrediting bodies, or quality-improvement organizations for patient safety purposes; or
  7. Using protected material for internal education, quality improvement, credentialing, peer review, or corrective action.

5.12 Cover-Up Exception

The State law shall provide that cover-up is not protected.

A health care entity or person who engages in cover-up shall be subject to civil penalties, regulatory sanctions, referral to licensing authorities, and loss of privilege to the limited extent necessary to prove the cover-up after in camera judicial review.

5.13 Anti-Retaliation Protection

The State law shall prohibit retaliation against any person who reports a medical error, participates in an investigation, refuses to participate in cover-up, discloses an ongoing substantial patient-safety risk, or assists a patient or family in providing information.

5.14 Enforcement

The State law shall authorize meaningful civil penalties, corrective-action orders, audits, compliance reviews, referral to licensing boards, and public aggregate reporting.

5.15 Annual Statewide Patient Safety Report

The State law shall require the State health agency to publish an annual aggregate report summarizing:

  1. Number and type of reportable serious medical errors;
  2. Care settings involved;
  3. Common contributing factors;
  4. Recurrent hazards;
  5. Corrective-action categories;
  6. Compliance trends;
  7. Enforcement actions; and
  8. Recommendations for statewide patient-safety improvement.

Section 6. State Certification

6.1 Submission

Each State seeking full Covered Federal Health-System Assistance shall submit to the Secretary a certification that the State has enacted and is enforcing a Compliant State Medical Error Law.

6.2 Contents of Certification

The certification shall include:

  1. The text of the State law and implementing regulations;
  2. Description of the State reporting system;
  3. Description of the State medical-error learning registry;
  4. Description of enforcement procedures;
  5. Description of privilege and discovery protections;
  6. Description of patient and family disclosure procedures;
  7. Description of anti-retaliation protections;
  8. Data on implementation, reporting, and publication; and
  9. Any additional information required by the Secretary.

6.3 Review

The Secretary shall approve, conditionally approve, or disapprove a State certification within 180 days after submission.

6.4 Substantial Compliance

The Secretary may certify a State law that is substantially equivalent to the requirements of this Act, even if the State uses different terminology, procedures, agencies, or enforcement mechanisms.

6.5 Conditional Approval

The Secretary may conditionally approve a State for up to two fiscal years if the State has enacted a substantially compliant law and is making good-faith progress toward implementation.


Section 7. Funding Condition and Withholding

7.1 Condition on Federal Funds

Beginning with the first fiscal year that begins at least two years after enactment of this Act, a State shall not receive 5% of its otherwise payable Covered Federal Health-System Assistance unless the Secretary certifies that the State has adopted and is enforcing a Compliant State Medical Error Law.

7.2 Scope of Withholding

The withholding under this section shall apply only to Covered Federal Health-System Assistance.

The withholding shall not apply to:

  1. Direct patient benefits;
  2. Medicaid medical-assistance payments for covered services;
  3. CHIP child-health-assistance payments for covered services;
  4. Medicare payments;
  5. Direct provider reimbursement for patient care;
  6. Veterans Health Administration patient-care payments;
  7. Indian Health Service direct care funds; or
  8. Any amount whose withholding would directly reduce a patient’s eligibility for, or receipt of, medically necessary care.

7.3 Maximum Withholding

The maximum annual withholding under this Act shall be 5% of Covered Federal Health-System Assistance otherwise payable to the State for that fiscal year.

7.4 Notice

Before withholding funds, the Secretary shall provide the State with:

  1. Written notice of noncompliance;
  2. Specific reasons for the determination;
  3. A description of required corrective action;
  4. At least 180 days to cure the noncompliance; and
  5. Opportunity for administrative review.

7.5 Good-Faith Reduction

The Secretary may reduce the withholding to not less than 1% for a fiscal year if the State demonstrates good-faith progress toward compliance.

7.6 Waiver for Extraordinary Circumstances

The Secretary may waive withholding for one fiscal year if extraordinary circumstances prevent compliance and the State submits an acceptable corrective-action plan.

7.7 Restoration of Funds

Withheld funds may be restored to the State if the State achieves certification within the same fiscal year, subject to regulations issued by the Secretary.

7.8 Use of Withheld Funds

Funds withheld under this Act shall remain available to the Secretary for:

  1. Patient safety implementation grants;
  2. Federal default reporting and registry activities;
  3. Grants to health care entities in noncompliant States to implement reporting systems;
  4. Grants to States seeking to become compliant;
  5. Technical assistance;
  6. Research on medical-error prevention; and
  7. Public education on patient safety.

Section 8. Federal Default Reporting Program

8.1 Establishment

The Secretary shall establish a Federal Medical Error Reporting and Learning Program for use in States that are not certified under this Act.

8.2 Voluntary Provider Participation

A health care entity in a noncertified State may participate in the federal default program by reporting reportable serious medical errors to the Secretary or to a federally listed patient safety organization designated by the Secretary.

8.3 Federal Public Learning Registry

The Secretary shall maintain a federal public learning registry for de-identified public learning reports received under the federal default program.

8.4 Federal Privilege

Protected Patient Safety Investigation Material submitted, created, assembled, or analyzed under the federal default program shall receive the privilege and confidentiality protections provided by this Act.

8.5 No Preemption of Stronger State Law

The federal default program shall not preempt a State law that provides equal or greater public reporting, investigation, privilege, confidentiality, anti-retaliation, or enforcement protections.


Section 9. Federal Privilege and Immunity

9.1 General Rule

Protected Patient Safety Investigation Material created, assembled, obtained, maintained, submitted, or analyzed under a Compliant State Medical Error Law or the federal default reporting program is privileged and confidential.

9.2 Discovery and Subpoena Protection

Protected Patient Safety Investigation Material shall not be:

  1. Subject to subpoena;
  2. Subject to discovery;
  3. Subject to civil investigative demand;
  4. Subject to public-records disclosure;
  5. Admitted into evidence;
  6. Used for impeachment;
  7. Used as a basis for expert testimony;
  8. Used to prove negligence, causation, standard of care, liability, damages, notice, foreseeability, recklessness, professional misconduct, or institutional fault; or
  9. Used in any civil, administrative, arbitration, licensing, credentialing, employment, or professional disciplinary proceeding.

9.3 Protection of Findings

All findings, conclusions, contributing-factor analyses, root-cause analyses, preventability assessments, safety recommendations, corrective-action deliberations, and implementation analyses are absolutely privileged and immune from discovery and evidentiary use, except as expressly provided in this Act.

9.4 Protection of Statements

Statements made for purposes of a patient safety investigation by health care personnel, patients, patient representatives, family members, witnesses, reviewers, consultants, or investigators are privileged and immune from discovery and evidentiary use.

9.5 Protection of Public Learning Reports

A de-identified public learning report may be used for public health, research, policy, education, and safety improvement, but shall not be admissible in civil litigation or administrative proceedings to prove negligence, causation, standard of care, liability, damages, notice, foreseeability, recklessness, or professional misconduct.

9.6 Original Evidence Preserved

Nothing in this Act shall prevent discovery or use of original medical records or independently existing evidence, subject to otherwise applicable law.


Section 10. Cover-Up Exception

10.1 No Protection for Cover-Up

Nothing in this Act protects cover-up.

10.2 Motion Required

A party seeking disclosure of Protected Patient Safety Investigation Material to prove cover-up must file a motion supported by specific facts establishing a substantial basis to believe that cover-up occurred.

10.3 In Camera Review

Before ordering disclosure, the court shall conduct an in camera review.

10.4 Standard for Disclosure

The court may order disclosure only if it finds by clear and convincing evidence that:

  1. Cover-up occurred;
  2. The material sought is directly relevant to proving the cover-up;
  3. The information cannot reasonably be obtained from nonprivileged sources;
  4. Disclosure is narrowly tailored; and
  5. A protective order will adequately protect confidentiality.

10.5 Limited Disclosure

Any disclosure ordered under this section shall be limited to the materials directly necessary to prove cover-up and shall not constitute general waiver of privilege.

10.6 Criminal Conduct

Nothing in this Act immunizes criminal conduct, intentional patient harm, intentional falsification, intentional destruction of evidence, fraud, obstruction of justice, or retaliation.


Section 11. Anti-Retaliation

11.1 Prohibited Retaliation

No health care entity, State agency, employer, insurer, contractor, or other person may retaliate against any person because that person:

  1. Reports a serious medical error;
  2. Participates in a patient safety investigation;
  3. Provides information to a State or federal agency;
  4. Refuses to participate in cover-up;
  5. Discloses an ongoing substantial patient-safety risk; or
  6. Assists a patient or family in providing information.

11.2 Remedies

A person subjected to retaliation may bring a civil action for:

  1. Reinstatement;
  2. Restoration of privileges;
  3. Back pay;
  4. Front pay;
  5. Compensatory damages;
  6. Injunctive relief;
  7. Attorney fees and costs; and
  8. Any other appropriate relief.

Section 12. Patient Privacy and De-Identification

12.1 HIPAA Compliance

Nothing in this Act authorizes disclosure of protected health information in violation of HIPAA or other federal privacy law.

12.2 De-Identification

Public learning reports shall be de-identified before publication.

12.3 Prohibition on Re-Identification

No person may knowingly attempt to re-identify a patient, patient representative, family member, clinician, reporter, witness, reviewer, investigator, or other natural person from a public learning report.

12.4 Penalties

The Secretary may impose civil monetary penalties for knowing re-identification or attempted re-identification.


Section 13. Technical Assistance and Grants

13.1 Implementation Grants

The Secretary may award grants to States to support:

  1. Drafting and enactment of compliant laws;
  2. Creation of medical-error learning registries;
  3. Reporting-system technology;
  4. Training of health care personnel;
  5. Patient and family disclosure programs;
  6. Anti-retaliation enforcement;
  7. Investigation workforce development;
  8. Human-factors and systems-safety analysis; and
  9. Publication of de-identified safety lessons.

13.2 Priority

The Secretary shall give priority to States that:

  1. Enact compliant laws early;
  2. Demonstrate high-quality public learning reports;
  3. Protect candor while preserving original evidence;
  4. Enforce anti-retaliation provisions;
  5. Penalize cover-up; and
  6. Share data with federal patient safety databases.

Section 14. Rulemaking

The Secretary shall issue regulations to implement this Act, including regulations governing:

  1. Certification procedures;
  2. Definition of Covered Federal Health-System Assistance;
  3. Withholding calculation;
  4. Notice and cure procedures;
  5. State reporting standards;
  6. Public learning registry standards;
  7. De-identification requirements;
  8. Privilege and confidentiality procedures;
  9. Federal default reporting;
  10. Grant administration;
  11. Data security;
  12. Anti-retaliation enforcement;
  13. Cover-up referral procedures; and
  14. Coordination with the Patient Safety and Quality Improvement Act.

Section 15. Administrative Review

15.1 State Review

A State may seek administrative review of a certification denial, conditional approval, or withholding determination.

15.2 Final Agency Action

A final decision by the Secretary after administrative review shall constitute final agency action for purposes of judicial review.

15.3 Limited Scope

Judicial review shall be limited to whether the Secretary’s decision was arbitrary, capricious, an abuse of discretion, contrary to law, or unsupported by substantial evidence.


Section 16. Relationship to Existing Federal Law

16.1 Patient Safety and Quality Improvement Act

This Act supplements and does not diminish the Patient Safety and Quality Improvement Act, 42 U.S.C. §§ 299b-21 through 299b-26, or 42 C.F.R. Part 3.

16.2 No Reduction of Existing Privilege

Nothing in this Act shall be construed to reduce any privilege, confidentiality, immunity, peer-review protection, quality-improvement protection, or patient-safety protection available under federal or State law.

16.3 Stronger State Laws Preserved

Nothing in this Act preempts a State law that provides stronger medical-error reporting, public learning, investigation, privilege, anti-retaliation, enforcement, or cover-up penalties.

16.4 Federal Floor

This Act establishes a federal floor for States seeking full Covered Federal Health-System Assistance.


Section 17. Non-Commandeering Construction

This Act shall be construed as an exercise of Congress’s power to provide for the general welfare by attaching clear, prospective, related, and limited conditions to federal funds.

Nothing in this Act shall be construed to command a State legislature to enact a law, to command a State executive officer to administer a federal program, or to require a State to participate in any federal program.

A State remains free to decline certification and accept the funding consequences described in this Act.


Section 18. Severability

If any provision of this Act, or the application of any provision to any person, State, entity, or circumstance, is held invalid, the remainder of the Act and the application of the remaining provisions shall not be affected.

If the 5% withholding is held excessive as applied to any State or funding category, the Secretary shall apply the maximum lower percentage permitted by law, not to exceed 5%.


Section 19. Effective Dates

19.1 Rulemaking

The Secretary shall issue proposed regulations within 12 months after enactment and final regulations within 24 months after enactment.

19.2 State Certification

States may submit certifications beginning 18 months after enactment.

19.3 Funding Condition

The funding condition in Section 7 shall apply beginning with the first fiscal year that begins at least 36 months after enactment.

19.4 Federal Default Program

The federal default reporting program shall begin not later than 36 months after enactment.


Section 20. Construction Against Coercion

This Act shall be construed to avoid unconstitutional coercion of the States.

If a court determines that the withholding of 5% of Covered Federal Health-System Assistance is coercive as applied to any State, funding stream, or circumstance, the Secretary shall reduce the withholding to the highest constitutionally permissible percentage.

No provision of this Act shall be construed to authorize withholding of funds in a manner that directly denies medical care, coverage, or benefits to patients.


Section 21. Sense of Congress

It is the sense of Congress that:

  1. Medical error should be treated as a public-safety event before it is treated as a private litigation event;
  2. The public interest is served when serious medical errors are reported immediately, investigated fully, and converted into public de-identified lessons;
  3. Litigation fear should not prevent hospitals, physicians, nurses, pharmacists, and other health care personnel from speaking candidly about the causes of patient harm;
  4. Original medical records and independently existing evidence should remain available under ordinary law;
  5. Safety findings, root-cause analyses, witness statements made for safety investigation, corrective-action deliberations, and public learning reports should not be turned into litigation weapons;
  6. Cover-up, falsification, retaliation, destruction of evidence, and knowing concealment of ongoing hazards should never receive protection; and
  7. Candor should be protected, public learning should be mandatory, and concealment should be punished.

Drafting Note

The most aggressive version would withhold 5% of all federal health care funds to a State. That would be constitutionally riskier after NFIB v. Sebelius. The safer version above withholds 5% only from related state-administered health-system, quality, safety, public-health, and administrative funds, while protecting direct patient benefits and provider reimbursements.

This structure is intended to mirror the Dole model: clear notice, related funds, limited percentage, no direct command to legislate, and no loss of direct patient care benefits.