Sunday, April 26, 2026

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.

The TEACH Act Transparent Error Analysis, Candor, and Healthcare Learning Act

 Every serious medical error must teach. Candor is protected. Cover-up is punished.

The TEACH Act

Transparent Error Analysis, Candor, and Healthcare Learning Act

A Model State Medical Error Public Reporting and Patient Safety Investigation Act


Section 1. Short Title

This Act shall be known and may be cited as the Transparent Error Analysis, Candor, and Healthcare Learning Act, or the TEACH Act.


Section 2. Legislative Findings and Purpose

2.1 Findings

The Legislature finds that:

(a) Serious medical errors resulting in death or injury requiring medical treatment are matters of public health and public safety.

(b) The purpose of a medical-error investigation is to identify every human, technical, organizational, environmental, staffing, communication, diagnostic, medication, equipment, training, supervision, and policy factor that converged to cause or contribute to patient harm.

(c) A serious medical error is rarely caused by one act or one person. It is commonly the result of multiple converging system conditions.

(d) The existing tort litigation system creates incentives for silence, defensive documentation, delay, incomplete investigation, and concealment of lessons that could prevent future patient harm.

(e) Public safety requires immediate investigation, preservation of evidence, candid participation by health care personnel, disclosure of de-identified lessons, and protection of investigative findings from use in adversarial litigation.

(f) The State has a compelling interest in replacing secrecy after serious medical error with mandatory learning, mandatory reporting, and public dissemination of de-identified safety lessons.

(g) The purpose of this Act is not to conceal ordinary medical records or independently existing facts. The purpose is to protect the special safety investigation so that health care entities and personnel can identify causes candidly and prevent recurrence.

2.2 Purpose

The purposes of this Act are to:

(a) Require immediate reporting of serious medical errors;

(b) Require a complete patient safety investigation of each serious medical error;

(c) Require publication of de-identified safety findings on a public medical error learning registry;

(d) Protect patient safety investigation materials and findings from discovery, subpoena, public-records requests, and evidentiary use in civil litigation;

(e) Preserve access to original medical records and independently existing evidence;

(f) Create penalties for failure to report, failure to investigate, false reporting, concealment, retaliation, and cover-up; and

(g) Establish a legal structure in which candor is protected and concealment is punished.


Section 3. Definitions

For purposes of this Act:

3.1 “Adverse medical event”

“Adverse medical event” means an injury, complication, death, or other negative patient outcome that occurs during or after medical care, whether or not the event is ultimately determined to have been preventable.

3.2 “Agency”

“Agency” means the State Department of Health, or such other state agency designated by law to administer this Act.

3.3 “Contributing factor”

“Contributing factor” means any condition, act, omission, decision, process, equipment feature, communication failure, staffing condition, policy, training issue, supervision issue, organizational practice, environmental condition, diagnostic factor, medication factor, handoff failure, documentation failure, technology issue, human-factors issue, financial pressure, production pressure, or other circumstance that caused, increased the risk of, or failed to prevent a serious medical error.

3.4 “Cover-up”

“Cover-up” means any knowing, reckless, or intentional act or omission designed to conceal, distort, delay, falsify, suppress, destroy, alter, mischaracterize, or prevent discovery of a serious medical error or its contributing factors. Cover-up includes, but is not limited to:

(a) Falsifying, altering, backdating, or destroying records;

(b) Directing, pressuring, or inducing any person to provide false or misleading information;

(c) Retaliating against a person for reporting a medical error or participating in an investigation;

(d) Failing to report a serious medical error as required by this Act;

(e) Knowingly submitting a materially false or misleading report;

(f) Preventing a patient, patient representative, or family member from receiving information required by this Act;

(g) Concealing an ongoing hazard after the health care entity has actual or constructive notice of the hazard; or

(h) Failing to conduct or complete a required patient safety investigation.

3.5 “De-identified”

“De-identified” means that information has been removed, redacted, generalized, coded, aggregated, or otherwise modified so that the identity of a patient, patient representative, family member, individual clinician, individual employee, or other natural person is not reasonably ascertainable.

3.6 “Finding”

“Finding” means any conclusion, determination, causal statement, contributing-factor identification, root-cause analysis, safety recommendation, corrective-action recommendation, hazard classification, preventability assessment, risk assessment, timeline interpretation, credibility assessment, deliberation, analysis, judgment, or evaluative statement created, obtained, assembled, or used in a patient safety investigation under this Act.

3.7 “Health care entity”

“Health care entity” means any hospital, health system, clinic, physician practice, ambulatory surgical center, nursing facility, rehabilitation facility, hospice, home health agency, laboratory, imaging center, pharmacy, emergency medical service, behavioral health facility, birthing center, telehealth provider, accountable care organization, managed care entity, or other person or organization licensed, certified, registered, authorized, or paid to provide health care services in this State.

3.8 “Health care personnel”

“Health care personnel” means any physician, nurse, pharmacist, therapist, technician, aide, resident, fellow, student, contractor, employee, agent, administrator, executive, board member, or other person involved in the delivery, supervision, management, financing, documentation, or support of health care services.

3.9 “Medical error”

“Medical error” means an act, omission, failure, delay, system condition, process failure, diagnostic failure, medication failure, device failure, communication failure, staffing failure, supervision failure, or other health care-related event that caused or contributed to patient harm or created an unreasonable risk of patient harm, regardless of whether the error would constitute negligence under tort law.

3.10 “Patient representative”

“Patient representative” means a person authorized by law to act for the patient, including a parent, guardian, health care proxy, personal representative, executor, administrator, next of kin, or other legally authorized representative.

3.11 “Patient safety investigation”

“Patient safety investigation” means the mandatory investigation required by this Act after a reportable serious medical error, including preservation of evidence, interviews, analysis, root-cause or systems analysis, contributing-factor analysis, corrective-action planning, follow-up, and creation of a public learning report.

3.12 “Protected investigation material”

“Protected investigation material” means all materials created, collected, received, maintained, assembled, analyzed, generated, or used primarily for a patient safety investigation under this Act, including:

(a) Interview notes, transcripts, statements, memoranda, and summaries;

(b) Internal communications concerning the investigation;

(c) Root-cause analyses, apparent-cause analyses, failure-mode analyses, timelines, diagrams, causal maps, and contributing-factor analyses;

(d) Findings, recommendations, conclusions, drafts, deliberations, opinions, and evaluative judgments;

(e) Safety committee materials;

(f) Corrective-action deliberations and implementation analyses;

(g) Reports submitted to the Agency under this Act, except as otherwise expressly provided;

(h) Materials prepared for publication in the public medical error learning registry; and

(i) Any metadata, audit notes, or analytical work product created for the investigation.

3.13 “Public learning report”

“Public learning report” means the de-identified report required by this Act for publication in the State Medical Error Learning Registry.

3.14 “Reportable serious medical error”

“Reportable serious medical error” means any medical error, suspected medical error, or adverse medical event occurring in whole or in part in the course of health care that results in:

(a) Death;

(b) Injury requiring medical treatment;

(c) Permanent or temporary loss of bodily function requiring medical treatment;

(d) Unplanned transfer to a higher level of care;

(e) Unplanned surgical, procedural, medication, blood-product, device, or other therapeutic intervention;

(f) Prolonged hospitalization;

(g) Emergency department evaluation or treatment caused by the event;

(h) Birth injury requiring medical treatment;

(i) Hospital-acquired infection or complication requiring medical treatment;

(j) Medication, diagnostic, surgical, anesthesia, monitoring, laboratory, imaging, device, transfusion, handoff, or discharge error requiring medical treatment; or

(k) Any other event designated by Agency regulation as reportable because of its severity or preventability.


Section 4. Duty to Report Serious Medical Errors

4.1 Mandatory internal report

A health care entity shall require health care personnel to report any known or reasonably suspected reportable serious medical error to the entity’s patient safety officer or designated reporting system as soon as practicable, and in no event later than twenty-four hours after discovery.

4.2 Mandatory report to Agency

A health care entity shall report any known or reasonably suspected reportable serious medical error to the Agency no later than seventy-two hours after discovery.

4.3 Preliminary report

The preliminary report to the Agency shall include, to the extent known:

(a) The date, time, and location of the event;

(b) The type of care involved;

(c) The general nature of the harm;

(d) Whether death or injury requiring medical treatment occurred;

(e) Whether an ongoing risk to other patients may exist;

(f) Immediate steps taken to protect the patient and other patients;

(g) Confirmation that a patient safety investigation has begun; and

(h) Such other nonprivileged administrative information as the Agency may require.

4.4 No admission of liability

A report made under this Act shall not constitute an admission of negligence, causation, liability, standard-of-care violation, professional misconduct, or legal fault.

4.5 Continuing duty

A health care entity has a continuing duty to supplement its report when additional material information becomes known.


Section 5. Immediate Preservation of Evidence

5.1 Preservation duty

Upon discovery of a reportable serious medical error, the health care entity shall immediately preserve all relevant original records and physical, electronic, and digital evidence.

5.2 Materials to be preserved

Preserved materials shall include, as applicable:

(a) The medical record;

(b) Orders, notes, medication administration records, flowsheets, operative records, anesthesia records, discharge records, nursing records, pharmacy records, laboratory records, imaging records, and billing records;

(c) Device data, alarm data, monitor data, pump data, ventilator data, implant data, and machine logs;

(d) Electronic health record audit trails;

(e) Medication dispensing records;

(f) Staffing schedules, assignments, acuity data, and supervision records;

(g) Policies, protocols, guidelines, checklists, and training materials in effect at the time;

(h) Relevant communications, including secure messages, pages, calls, texts, emails, and handoff documents;

(i) Photographs, videos, physical objects, medication containers, devices, implants, instruments, and specimens; and

(j) Any other material reasonably likely to contain relevant information.

5.3 Preservation period

Evidence preserved under this section shall be maintained for the longer of:

(a) Ten years;

(b) The applicable statute of limitations and repose;

(c) The period required by federal or state law;

(d) The period required by the Agency; or

(e) The period required by court order.

5.4 Original records not privileged merely because preserved

Original records and independently existing evidence do not become privileged merely because they are preserved, reviewed, copied, referenced, or analyzed in a patient safety investigation.


Section 6. Mandatory Patient Safety Investigation

6.1 Commencement

A health care entity shall commence a patient safety investigation immediately upon discovery of a reportable serious medical error.

6.2 Investigation team

The investigation shall be conducted by a qualified patient safety investigation team. The team shall include individuals with appropriate clinical, operational, human-factors, risk-management, quality-improvement, and subject-matter expertise.

6.3 Independence

The investigation team shall have authority to obtain information, interview personnel, review records, inspect equipment, examine policies, and recommend corrective action without interference by any person whose primary interest is litigation defense, financial protection, public relations, or avoidance of regulatory consequences.

6.4 Required scope

The patient safety investigation shall identify all contributing factors, including, where relevant:

(a) Diagnostic factors;

(b) Medication factors;

(c) Surgical or procedural factors;

(d) Communication and handoff factors;

(e) Staffing, workload, fatigue, and supervision factors;

(f) Equipment, device, alarm, interface, maintenance, and design factors;

(g) Electronic health record and health information technology factors;

(h) Training, credentialing, privileging, and competency factors;

(i) Policy, protocol, checklist, and workflow factors;

(j) Environmental and facility factors;

(k) Leadership, governance, production pressure, and financial incentive factors;

(l) Prior similar events or near misses;

(m) Reporting culture and retaliation risk;

(n) Patient-specific factors relevant to prevention, without blaming the patient; and

(o) Any other factor necessary to understand how the harm occurred and how recurrence may be prevented.

6.5 Required investigative questions

The investigation shall answer, to the extent reasonably possible:

(a) What happened?

(b) What harm occurred?

(c) What care was required because of the event?

(d) What conditions made the event possible?

(e) What safeguards failed?

(f) What safeguards were missing?

(g) Whether similar hazards exist for other patients;

(h) Whether the event was reasonably preventable;

(i) What corrective actions are required;

(j) Who is responsible for implementing each corrective action;

(k) When each corrective action will be completed; and

(l) How completion and effectiveness will be verified.

6.6 Patient and family participation

The health care entity shall offer the patient or patient representative a reasonable opportunity to provide information for the investigation, including observations, questions, concerns, and relevant records.

6.7 Time for completion

The health care entity shall complete the patient safety investigation and submit a final report to the Agency within sixty days after discovery of the reportable serious medical error, unless the Agency grants an extension for good cause.

6.8 Immediate hazard notice

If the investigation identifies an ongoing substantial risk to other patients, the health care entity shall notify the Agency within twenty-four hours and immediately implement interim protective measures.


Section 7. Disclosure to Patient or Patient Representative

7.1 Initial disclosure

Within seven days after discovery of a reportable serious medical error, the health care entity shall disclose to the patient or patient representative:

(a) That a serious adverse event or suspected medical error occurred;

(b) The known general nature of the event;

(c) The known general nature of the harm;

(d) The care being provided to address the harm;

(e) That a patient safety investigation has begun;

(f) How the patient or patient representative may provide information; and

(g) The expected schedule for further communication.

7.2 Follow-up disclosure

Upon completion of the investigation, the health care entity shall disclose to the patient or patient representative, in plain language:

(a) What is known about what happened;

(b) The general contributing factors identified;

(c) The steps taken or planned to reduce the risk of recurrence; and

(d) The location of the public learning report when published.

7.3 Apology and expression of sympathy

An apology, expression of sympathy, expression of responsibility, explanation, or disclosure made under this section shall not be admissible to prove negligence, causation, liability, standard of care, professional misconduct, or legal fault.

7.4 No waiver

Disclosure to a patient or patient representative under this section does not waive any privilege, confidentiality, immunity, or protection under this Act.


Section 8. State Medical Error Learning Registry

8.1 Creation

The Agency shall establish and maintain a publicly accessible online registry known as the State Medical Error Learning Registry.

8.2 Purpose

The purpose of the Registry is to allow patients, families, clinicians, health care entities, regulators, researchers, policymakers, and the public to learn from serious medical errors without revealing protected identities or creating litigation evidence.

8.3 Public learning report required

For each reportable serious medical error, the health care entity shall submit a public learning report to the Agency.

8.4 Contents of public learning report

The public learning report shall include, in de-identified form:

(a) The general care setting;

(b) The general type of event;

(c) The general nature of the harm;

(d) The relevant clinical process involved;

(e) A plain-language description of what happened;

(f) The contributing factors identified;

(g) The safeguards that failed or were absent;

(h) The corrective actions taken or planned;

(i) The schedule for corrective action;

(j) The method for verifying corrective action;

(k) Any broader safety lesson for other health care entities; and

(l) Such additional de-identified safety information as the Agency may require.

8.5 De-identification

The public learning report shall not identify:

(a) The patient;

(b) A patient representative;

(c) A family member;

(d) Individual health care personnel;

(e) A witness;

(f) A reporter;

(g) A reviewer; or

(h) Any other natural person whose identity is not necessary for public safety learning.

8.6 Identification of health care entity

The Legislature may choose one of the following alternatives:

Alternative A — Named entity reporting.
The public learning report shall identify the health care entity where the event occurred.

Alternative B — De-identified entity reporting.
The public learning report shall not identify the health care entity, but the Agency shall maintain confidential entity-identifying information for enforcement, trend analysis, and corrective-action monitoring.

Alternative C — Tiered reporting.
The public learning report shall not identify the health care entity for the first event of a substantially similar type, but the Agency shall identify the entity publicly if the entity fails to complete corrective action, repeats a substantially similar preventable event, submits a false report, or engages in cover-up.

8.7 Publication deadline

The Agency shall publish the public learning report within thirty days after receipt of the final investigation report, unless the Agency determines that additional de-identification, clarification, or corrective-action information is required.

8.8 Searchability

The Registry shall be searchable by event type, care setting, specialty, medication, device, diagnosis, procedure, workflow, contributing factor, corrective action, and other patient-safety categories.

8.9 Public report not admissible

A public learning report is created solely for public safety learning and shall not be admissible in any civil action to prove negligence, causation, standard of care, liability, damages, professional misconduct, notice, defect, recklessness, or any other element of a civil claim.


Section 9. Privilege, Confidentiality, and Immunity from Discovery

9.1 General privilege

Protected investigation material is privileged and confidential.

9.2 Immunity from discovery and subpoena

Protected investigation material shall not be:

(a) Subject to subpoena;

(b) Subject to discovery;

(c) Subject to a civil investigative demand;

(d) Subject to a public-records or freedom-of-information request;

(e) Subject to compulsory disclosure in any civil, administrative, arbitration, licensing, credentialing, employment, or professional disciplinary proceeding;

(f) Admitted into evidence;

(g) Used for impeachment;

(h) Used to establish negligence, causation, liability, standard of care, damages, notice, foreseeability, recklessness, or professional misconduct; or

(i) Used as the basis for expert opinion testimony in any civil action.

9.3 Protection of findings

All findings of a patient safety investigation are absolutely privileged and immune from discovery and evidentiary use, except as expressly provided in this Act.

9.4 Protection of interviews and statements

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

9.5 Protection of drafts and deliberations

Drafts, comments, notes, deliberations, mental impressions, disagreements, recommendations, rejected recommendations, and internal communications created for a patient safety investigation are privileged and immune from discovery and evidentiary use.

9.6 Protection of corrective-action analysis

Corrective-action deliberations, risk-ranking, preventability assessments, implementation analysis, and effectiveness analysis are privileged and immune from discovery and evidentiary use.

9.7 No waiver

Privilege and confidentiality under this Act are not waived by:

(a) Reporting to the Agency;

(b) Submitting material to a patient safety organization;

(c) Disclosure to a patient or patient representative;

(d) Publication of a de-identified public learning report;

(e) Disclosure to a regulator under confidentiality protection;

(f) Disclosure to a contractor, consultant, expert, insurer, reinsurer, attorney, auditor, accrediting organization, or quality-improvement organization for patient safety purposes;

(g) Use in internal education, quality improvement, credentialing, or peer review; or

(h) Any other disclosure made for patient safety, compliance, or corrective-action purposes under this Act.

9.8 Construction with federal law

This Act shall be construed to supplement, and not reduce, any privilege, confidentiality, or protection available under the Patient Safety and Quality Improvement Act, 42 U.S.C. §§ 299b-21 through 299b-26, 42 C.F.R. Part 3, or any other federal or state law.


Section 10. Materials Not Protected

10.1 Original records

The following are not protected investigation material merely because they are reviewed, copied, preserved, referenced, or analyzed in a patient safety investigation:

(a) Medical records;

(b) Billing records;

(c) Discharge records;

(d) Consent forms;

(e) Orders;

(f) Medication administration records;

(g) Laboratory records;

(h) Imaging records;

(i) Device logs existing before the investigation;

(j) Electronic health record audit trails existing before the investigation;

(k) Policies and procedures existing before the investigation;

(l) Staffing records existing before the investigation;

(m) Communications existing before the investigation;

(n) Physical evidence; and

(o) Any other original patient or provider information that exists independently of the patient safety investigation.

10.2 Independent facts

A fact does not become privileged merely because it is learned, discussed, analyzed, or included in protected investigation material.

10.3 Independent testimony

A person with independent knowledge of facts may be required to testify to those facts, but may not be required to disclose:

(a) Statements made for purposes of the patient safety investigation;

(b) Questions asked during the patient safety investigation;

(c) Opinions formed solely because of participation in the investigation;

(d) Findings of the investigation;

(e) Deliberations of the investigation team; or

(f) The contents of protected investigation material.

10.4 Required records

A health care entity may not shield records required to be maintained or reported by state or federal law by placing them in a patient safety investigation file.


Section 11. Cover-Up Exception and Forfeiture

11.1 No protection for cover-up

This Act does not protect cover-up.

11.2 Loss of protection

A health care entity that engages in cover-up forfeits the protections of this Act with respect to materials directly relevant to proving the cover-up, subject to the procedures in this section.

11.3 Motion and showing

A party seeking disclosure under this section must file a motion supported by specific facts establishing a substantial basis to believe that cover-up occurred.

11.4 In camera review

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

11.5 Standard

The court may order disclosure only upon finding by clear and convincing evidence that:

(a) Cover-up occurred;

(b) The requested material is directly relevant to proving the cover-up or its consequences;

(c) The information cannot reasonably be obtained from nonprivileged sources; and

(d) Disclosure is narrowly tailored to the demonstrated need.

11.6 Protective order

Any disclosure ordered under this section shall be subject to a protective order limiting use, reproduction, dissemination, and public filing.

11.7 Punitive consequence

A health care entity that engages in cover-up shall be subject to:

(a) Civil penalties under this Act;

(b) Loss of statutory privilege to the extent provided in this section;

(c) Referral to licensing, accreditation, or law enforcement authorities;

(d) Enhanced administrative sanctions;

(e) Ineligibility for safe-harbor protections under this Act; and

(f) Any other remedy authorized by law.


Section 12. Protection Against Retaliation

12.1 Prohibited retaliation

A health care entity shall not discharge, demote, suspend, threaten, harass, discipline, discriminate against, report in bad faith, reduce privileges, reduce compensation, or otherwise retaliate against any person because the person:

(a) Reports a serious medical error;

(b) Participates in a patient safety investigation;

(c) Provides information to the Agency;

(d) Refuses to participate in cover-up;

(e) Discloses an ongoing substantial risk to patient safety; or

(f) Assists a patient, patient representative, or family member in providing information.

12.2 Remedies

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

(a) Reinstatement;

(b) Restoration of privileges;

(c) Back pay;

(d) Front pay;

(e) Compensatory damages;

(f) Reasonable attorney fees and costs;

(g) Injunctive relief; and

(h) Any other relief necessary to make the person whole.

12.3 Burden of proof

If protected activity was a contributing factor in the adverse action, the burden shifts to the health care entity to prove by clear and convincing evidence that it would have taken the same action absent the protected activity.


Section 13. Agency Oversight and Enforcement

13.1 Agency authority

The Agency shall administer and enforce this Act.

13.2 Powers

The Agency may:

(a) Receive reports;

(b) Require supplemental information;

(c) Audit compliance;

(d) Require corrective action;

(e) Monitor implementation;

(f) Publish public learning reports;

(g) Issue regulations;

(h) Impose civil penalties;

(i) Refer matters to licensing boards, accrediting bodies, payors, or law enforcement; and

(j) Take any action reasonably necessary to carry out this Act.

13.3 Confidential Agency file

The Agency shall maintain confidential files sufficient to identify health care entities, monitor recurring hazards, enforce corrective action, and detect failure to report.

13.4 Trend reports

The Agency shall publish at least annually an aggregate statewide patient-safety report identifying:

(a) Number and type of serious medical errors reported;

(b) Care settings involved;

(c) Common contributing factors;

(d) Recurrent hazards;

(e) Corrective-action categories;

(f) Compliance trends;

(g) Enforcement actions;

(h) Recommendations for statewide safety improvement; and

(i) Legislative or regulatory recommendations.

13.5 Agency use of protected material

The Agency may use protected investigation material for oversight, enforcement, public health, and patient safety purposes, but shall not disclose protected investigation material except as expressly authorized by this Act.


Section 14. Civil Penalties

14.1 Failure to report

A health care entity that fails to report a reportable serious medical error as required by this Act shall be subject to a civil penalty of not less than $25,000 and not more than $250,000 per event.

14.2 Failure to investigate

A health care entity that fails to conduct or complete a patient safety investigation as required by this Act shall be subject to a civil penalty of not less than $50,000 and not more than $500,000 per event.

14.3 Failure to publish or submit public learning report

A health care entity that fails to submit a public learning report as required by this Act shall be subject to a civil penalty of not less than $25,000 and not more than $250,000 per event.

14.4 False or misleading report

A health care entity that knowingly submits a materially false or misleading report shall be subject to a civil penalty of not less than $100,000 and not more than $1,000,000 per event.

14.5 Cover-up

A health care entity that engages in cover-up shall be subject to a civil penalty of not less than $250,000 and not more than $5,000,000 per event.

14.6 Retaliation

A health care entity that retaliates against a person protected by this Act shall be subject to a civil penalty of not less than $50,000 and not more than $500,000 per violation.

14.7 Factors

In setting penalties, the Agency shall consider:

(a) Severity of harm;

(b) Duration of noncompliance;

(c) Whether the violation was intentional, reckless, or negligent;

(d) Prior violations;

(e) Size and resources of the health care entity;

(f) Cooperation with the Agency;

(g) Corrective action taken;

(h) Whether patients remained at risk; and

(i) Whether cover-up or retaliation occurred.


Section 15. Safe Harbor for Full Compliance

15.1 Safe harbor

A health care entity that timely reports, fully investigates, preserves evidence, discloses to the patient or patient representative, submits a public learning report, implements corrective action, and does not engage in cover-up shall receive the protections of this Act.

15.2 No punitive damages based on protected investigation

No punitive, exemplary, or enhanced damages may be based on protected investigation material, findings, public learning reports, disclosures required by this Act, or corrective actions taken under this Act.

15.3 Corrective action not admission

Corrective action taken after a reportable serious medical error shall not be admissible to prove negligence, culpability, standard of care, defect, causation, liability, or damages.


Section 16. Interaction with Civil Litigation

16.1 No discovery of protected material

In any civil action, arbitration, or administrative proceeding, no party may obtain protected investigation material.

16.2 No adverse inference

No adverse inference may be drawn from a health care entity’s assertion of privilege under this Act.

16.3 Discovery of original evidence preserved

Nothing in this Act prevents discovery of original records, independently existing evidence, or testimony based on independent personal knowledge, subject to otherwise applicable law.

16.4 Expert testimony

An expert witness may not rely on protected investigation material, findings, or public learning reports as a basis for an opinion in civil litigation.

16.5 Public learning report

A public learning report may be used for public health, research, policy, education, and safety improvement, but shall not be admissible in civil litigation.


Section 17. Criminal Conduct

17.1 Criminal conduct not protected

This Act does not immunize criminal conduct.

17.2 Referral

If a patient safety investigation identifies evidence of intentional falsification, intentional destruction of evidence, intentional patient harm, criminal neglect, fraud, or other criminal conduct, the health care entity shall report the matter to the appropriate law enforcement authority and the Agency.

17.3 Limited disclosure

Protected investigation material may be disclosed to law enforcement only as expressly required by court order after in camera review and only to the extent necessary to investigate or prosecute criminal conduct.


Section 18. Regulatory and Licensing Proceedings

18.1 General protection

Protected investigation material shall not be used in professional licensing, credentialing, privileging, employment, or disciplinary proceedings except as expressly authorized in this Act.

18.2 Original evidence available

Licensing boards and regulators may obtain original records and independently existing evidence.

18.3 Cover-up and intentional misconduct

Upon a finding after in camera review that cover-up or intentional misconduct occurred, the court may authorize limited disclosure of protected investigation material directly relevant to such cover-up or intentional misconduct.


Section 19. Data Use, Research, and Public Health

19.1 De-identified use

The Agency may use de-identified information from reports and public learning reports for research, public health, education, and patient-safety improvement.

19.2 Research access

The Agency may permit qualified researchers to access de-identified or limited data sets under data-use agreements that protect confidentiality and prohibit re-identification.

19.3 Prohibition on re-identification

No person may attempt to re-identify any patient, clinician, reporter, reviewer, witness, family member, or health care personnel from information published under this Act.

19.4 Penalty for re-identification

A person who knowingly re-identifies or attempts to re-identify protected information shall be subject to civil penalties and injunctive relief.


Section 20. Rulemaking

The Agency shall promulgate regulations to implement this Act, including rules governing:

(a) Report forms;

(b) Reporting deadlines;

(c) Public learning report format;

(d) De-identification standards;

(e) Investigation standards;

(f) Corrective-action tracking;

(g) Registry design;

(h) Agency audits;

(i) Enforcement procedures;

(j) Civil penalties;

(k) Patient and family disclosure;

(l) Protection of confidential information; and

(m) Coordination with federal patient safety organizations and federal reporting systems.


Section 21. Annual Legislative Review

The Agency shall submit an annual report to the Governor and Legislature containing:

(a) Aggregate serious medical error data;

(b) Trends in death and serious injury;

(c) Common contributing factors;

(d) Corrective actions taken statewide;

(e) Rates of reporting by health care entity type;

(f) Enforcement actions;

(g) Barriers to reporting and investigation;

(h) Recommendations for statutory or regulatory amendment; and

(i) Assessment of whether the Act is improving patient safety.


Section 22. Private Right of Action for Retaliation and Cover-Up

22.1 Retaliation

A person injured by retaliation prohibited by this Act may bring a civil action as provided in Section 12.

22.2 Cover-up injury

A patient or patient representative injured by cover-up may bring a civil action for damages caused by the cover-up.

22.3 Remedies

In an action for cover-up, the court may award:

(a) Actual damages caused by the cover-up;

(b) Reasonable attorney fees and costs;

(c) Injunctive relief;

(d) Punitive damages where authorized by law;

(e) Civil penalties payable to the State; and

(f) Any other appropriate relief.

22.4 Protected investigation material

Discovery in an action for cover-up shall be governed by Section 11.


Section 23. Severability

If any provision of this Act or its application to any person or circumstance is held invalid, the invalidity shall not affect other provisions or applications of the Act that can be given effect without the invalid provision or application. The provisions of this Act are severable.


Section 24. Effective Date

This Act shall take effect one year after enactment.


Section 25. Transition

25.1 Agency preparation

Within six months after enactment, the Agency shall establish reporting forms, de-identification standards, investigation standards, and the initial design of the State Medical Error Learning Registry.

25.2 Health care entity preparation

Within nine months after enactment, each health care entity shall:

(a) Designate a patient safety officer;

(b) Establish a reporting process;

(c) Train health care personnel;

(d) Adopt evidence-preservation procedures;

(e) Adopt investigation procedures;

(f) Adopt patient and family disclosure procedures;

(g) Adopt anti-retaliation procedures; and

(h) Certify readiness to the Agency.

25.3 Initial implementation

For the first year after the effective date, the Agency may reduce civil penalties for good-faith first violations that do not involve death, intentional misconduct, retaliation, false reporting, or cover-up.


Optional Stronger Version: Tort-Limiting Addendum

The following optional section would go beyond reporting and privilege. It would move the statute closer to the position that ordinary medical error should be handled through mandatory investigation and public learning, while litigation should be reserved for cover-up, intentional misconduct, reckless disregard, or refusal to comply.

Optional Section 26. Limitation on Civil Actions Where Full Compliance Occurs

26.1 Administrative remedy

Where a health care entity fully complies with this Act and does not engage in cover-up, intentional misconduct, reckless disregard, or knowing repetition of a previously identified hazard, the patient’s remedy for ordinary medical error shall be limited to an administrative compensation process established by separate statute.

26.2 Preservation of action for cover-up and intentional misconduct

Nothing in this section bars a civil action for:

(a) Cover-up;

(b) Intentional harm;

(c) Fraud;

(d) Falsification or destruction of records;

(e) Retaliation;

(f) Knowing failure to correct a previously identified serious hazard;

(g) Reckless disregard of a known and substantial risk; or

(h) Failure to comply materially with this Act.

26.3 No use of protected findings

Even where a civil action is permitted under this section, protected investigation material and findings remain privileged except as provided in the cover-up exception.


Optional Constitutional Guardrail

Optional Section 27. Preservation of Due Process

This Act shall not be construed to deny any person access to original medical records, independently existing evidence, eyewitness testimony based on independent knowledge, or any remedy required by the State Constitution or the Constitution of the United States. The privilege created by this Act applies only to protected investigation material created or assembled for patient safety investigation, learning, reporting, corrective action, and prevention.

Tuesday, April 21, 2026

Test the Remedy Before You Buy the Cure

Every society is flooded with remedies. New drugs. New policies. New weapons systems. New software platforms. New consulting frameworks. New “solutions” to education, housing, inflation, cybersecurity, public safety, and public health. Everyone has a fix. Everyone claims urgency. Everyone says their remedy must be adopted now.

That is exactly why empirical testing in pilot studies should be mandatory before remedies are rolled out at scale.

A remedy is not good because it sounds intelligent, morally urgent, technically impressive, or politically fashionable. A remedy is good only if it works. And in most cases, whether it works depends on finding the sweet spot. Too little intervention does nothing. Too much creates damage. Too narrow misses the problem. Too broad causes collateral harm. The right answer is usually not maximal force, maximal spending, or maximal complexity. It is calibrated action.

Medicine understands this better than most fields. A drug can be ineffective at one dose and toxic at another. But the same principle applies everywhere. Too little economic stimulus may fail to revive demand; too much may fuel inflation and dependency. Too little cybersecurity hardening leaves systems exposed; too much can cripple usability and productivity. Too little military deterrence may invite aggression; too much force may trigger escalation, backlash, and long-term instability. In every domain, the question is the same: what level, timing, duration, and target actually works?

You cannot answer that question with slogans. You cannot answer it with expert status alone. And you definitely cannot answer it with lobbying.

That is where the problem gets uglier. Remedies are rarely abstract ideas. They usually involve buying something: products, services, contracts, systems, consultants, vendors, professional staff, agencies, or programs. Once money enters the picture, organized interests appear. Small groups with a lot to gain from a particular remedy will lobby for it, market it, dramatize the crisis, and pressure decision-makers to approve it. They have every incentive to get the remedy purchased whether it works or not.

When an ineffective remedy is pushed primarily because it generates profit, budget growth, prestige, or political advantage, that is classic rent-seeking. In some cases it may remain technically legal. In worse cases it can slide toward corruption, fraud, procurement abuse, or influence-peddling. Either way, the public pays for failure while the sellers cash the checks.

Pilot testing is one of the best defenses against this.

A pilot study forces advocates to prove results before demanding large-scale adoption. It shifts the argument from promises to evidence. It gives decision-makers a chance to observe real-world effects, unintended consequences, costs, compliance problems, and measurable outcomes before locking themselves into expensive commitments. It also makes it harder for self-interested actors to hide behind hype, fear, or political theater.

Just as importantly, pilot testing creates intellectual honesty. Sometimes the pilot shows the remedy works, but only for a narrow group or under strict conditions. Sometimes it shows the dose needs adjustment. Sometimes it reveals that the proposed cure is worse than the disease. That is not failure. That is learning before the damage becomes national, permanent, or irreversible.

We should stop treating remedies as virtuous simply because they are proposed in response to a real problem. Problems are real. But so are bad fixes. Before we spend billions, mobilize institutions, or hand power to vendors and bureaucracies, we should ask one question: where is the evidence from the pilot?

The rule should be simple: no large remedy without small-scale empirical proof. Test first. Purchase later. That is how you find the sweet spot—and how you protect the public from both honest error and organized rent-seeking.

Tuesday, January 13, 2026

Reply to the Montgomery County Medical Society Call for More Physician Particiaption in Policy Making

 Subject: Barriers to Physician Engagement and Patient Safety Advocacy

Thank you for the invitation to become more involved in the Pennsylvania Medical Society. I believe it is important to explain candidly why many physicians remain disengaged.

The Society is widely perceived as politically unbalanced. Many Pennsylvania physicians hold conservative or nonpartisan views, yet Society positions and public advocacy consistently align with one ideological framework. This discourages participation and contributes to low membership penetration.

Equally problematic is the Society’s limited defense of clinical care against external pressures from the legal profession and insurance industry. Defensive medicine, insurer interference, and post-hoc liability distort patient care daily, yet the Society rarely confronts these forces directly or forcefully.

The internal resolution process compounds the problem. Requiring sponsorship by senior leadership before consideration ensures that dissenting or minority viewpoints—particularly from frontline clinicians—rarely reach debate. This structure suppresses meaningful discussion and policy innovation.

Most concerning is the absence of serious leadership on patient safety reform. Pennsylvania experiences an estimated ~2,000 deaths annually associated with medical error. Yet the current system prioritizes liability avoidance over learning. Immunizing internal root-cause investigations from civil discovery would encourage honest analysis, reduce repeat errors, and improve outcomes.

Finally, the Society has not adequately challenged licensing practices that disproportionately penalize physicians—often ethnic or immigrant doctors—for being labeled “disruptive” when advocating strongly for patient care, while systemic failures remain unaddressed.

Physicians need a Society that defends clinical judgment, welcomes ideological diversity, and places patient safety above institutional risk management.

Respectfully,

David Behar, MD

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Here is a resolution you will never allow to come up for discussion, and that will find no sponsor from your hierarchy. Please, explain why your hierarchy is qualified to select resolutions anyway.

Formal Resolution Proposal — 

Resolution: Protection of Patient-Safety Root Cause Analyses

WHEREAS, Pennsylvania experiences an estimated ~2,000 deaths annually associated with medical error; and

WHEREAS, effective patient-safety improvement requires candid, multidisciplinary root-cause analysis of adverse events; and

WHEREAS, the discoverability of internal safety investigations in civil litigation discourages honest analysis and perpetuates repeat errors;

THEREFORE, BE IT RESOLVED, that the Pennsylvania Medical Society advocate for legislation granting privilege and immunity from civil discovery to bona fide patient-safety root-cause investigations, while preserving accountability for willful misconduct and gross negligence; and

BE IT FURTHER RESOLVED, that the Society opposes the use of professional discipline based solely on speech or tone when a physician is advocating in good faith for patient safety or care quality. Harassment of physicians by the Licensing Board is intended to drive them out of the profession. Drive a doctor out, save $6 million a year in medical costs.