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Legislation of Links LandOfficial statute book

Title XLV

Patient Safety and Candour Act 2026 (PSC)

The official text of the Patient Safety and Candour Act 2026 (PSC)

Article P

Preamble

To improve patient safety, candour, learning from clinical incidents and access to fair administrative redress, while respecting the common law, constitutional rights, professional independence and the right to bring civil proceedings. This Act works in conjunction with the Common Law Act 2025, the Consumer Fairness Act, the Child Safety and Protection Act 2025, the Senior Dignity and Welfare Act 2025, the Ethics and Anti-Corruption Act 2025, the Unity and Equality Act 2025, the Digital Liberty and Algorithmic Rights Act 2025, the Public Health Preparedness Act 2025 and other applicable health, information and public-service law. It is read alongside those Acts and does not alter their legal effect.

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Article 1

Purpose, Scope and Preservation of Rights

Section 1A - Purpose

(a) This Act establishes minimum duties and institutions for patient safety, openness, investigation and accessible complaints concerning publicly funded or publicly regulated clinical care.

(b) The duties in this Act apply to a health organisation, professional or contractor to the extent that person or organisation provides or manages clinical care in Links Land.

Section 1B - Preservation of law and remedies

(a) Nothing in this Act determines whether negligence, breach of duty, causation or damages have been established.

(b) A patient retains every right to bring or continue civil, criminal, professional, equality, data-protection or other lawful proceedings.

(c) An apology, explanation, safety report or finding under this Act is not, by itself, an admission of negligence or civil liability.

(d) This Act is read alongside, and does not amend, repeal or displace, any existing Act or common-law rule.

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Article 2

Duty of Candour

Section 2A - Notification of unexpected harm

(a) Where a health organisation reasonably believes that a patient has suffered unexpected death, serious harm or material harm in connection with clinical care, it must notify the patient or lawful representative as soon as reasonably practicable.

(b) The notification must provide the known facts, identify that the investigation is ongoing where applicable, give a named contact and explain available complaint and support routes.

(c) The organisation must provide a truthful apology, keep the patient or representative reasonably informed, and explain measures taken to reduce recurrence.

(d) The duty applies without waiting for a finding of negligence and does not require disclosure of information lawfully withheld to protect another person or an investigation.

Section 2B - Records of candour

(a) The organisation must keep a record of the notification, response and material information provided.

(b) A patient may obtain the patient’s own medical record subject to applicable law protecting another person’s confidential information.

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Article 3

Safety Reporting and Learning

Section 3A - Reporting system

(a) The Linkslandic Health Service shall maintain or designate a confidential patient-safety reporting system for errors, hazards and near misses.

(b) A report may be made by a patient, representative, worker, contractor or other person with relevant information.

(c) The system shall accept reports concerning clinical software, automated decisions and algorithm-related errors or near misses.

Section 3B - Use and limits of protection

(a) Reports shall be access-controlled and used for stated patient-safety, prevention and learning purposes.

(b) This protection does not prevent disclosure required by law, court order, safeguarding duty, or an investigation of deliberate harm, gross misconduct or crime.

(c) The system shall not prevent a patient, court, regulator or lawful investigator from obtaining a relevant patient record or other evidence through lawful process.

(d) A worker shall not suffer detriment solely for making a good-faith safety report.

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Article 4

Health Ombudsman

Section 4A - Establishment and independence

(a) There is established an independent Health Ombudsman for complaints about clinical care and the administration of patient-safety duties.

(b) The Ombudsman shall be appointed following public advertisement and a recommendation of a Commons committee approved by a supermajority prescribed by Standing Orders.

(c) The Ombudsman has security of tenure and may be removed only for incapacity, serious misconduct or other specified lawful cause following a fair process.

(d) The Ombudsman shall have sufficient staff, accessible offices and arrangements for free assistance without requiring a lawyer.

Section 4B - Complaints and powers

(a) A person may complain after giving the relevant health organisation a reasonable opportunity to resolve the matter, unless the Ombudsman considers direct acceptance necessary because of urgency, vulnerability or risk to safety.

(b) The Ombudsman may investigate, require information subject to lawful privilege and confidentiality, make findings, recommend corrective action and publish anonymised decisions.

(c) The Ombudsman shall not award damages, determine civil negligence conclusively, or prevent a claimant from bringing court proceedings.

(d) The Ombudsman shall refer or signpost matters within the specialist competence of an equality, digital-rights, data-protection, health-information, safeguarding, professional or other lawful regulator.

(e) The Ombudsman may exercise any additional complaint or review function expressly conferred by a later Act, subject to the limits of that Act.

Section 4C - Reporting and accountability

(a) The Ombudsman shall publish an annual report stating complaint numbers, outcomes, referrals, waiting times, expenditure, equality impacts and recommendations.

(b) The annual report and audited accounts shall be laid before the Commons.

(c) The Ombudsman shall maintain a public register of interests and an accessible policy for handling conflicts of interest.

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Article 5

Safety Investigation Branch

Section 5A - Independent investigations

(a) The Health Ombudsman shall establish a Safety Investigation Branch operationally separate from the complaints team.

(b) The Branch may investigate a patient death or serious harm where an independent investigation is likely to improve safety or reveal systemic risk.

(c) The Branch shall not determine civil liability or replace a criminal, professional, safeguarding or coroner-type investigation.

Section 5B - Reports and cooperation

(a) The Branch shall complete and publish a report within 180 days of opening an investigation, unless it records reasons for an extension of no more than 90 further days.

(b) Reports shall remove patient-identifying information unless disclosure is lawful, necessary and proportionate.

(c) Before publication of an adverse factual finding, an affected person or organisation shall receive notice and a fair opportunity to correct material factual error.

(d) The Branch shall share safety findings with the competent inspectorate or regulator where necessary to prevent recurrence, subject to lawfully protected information.

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Article 6

Protection for Safety Reporters

Section 6A - Protection from retaliation

(a) An employer or contracting organisation shall not dismiss, demote, penalise, intimidate or otherwise disadvantage a person because the person made a good-faith patient-safety report, assisted an investigation or declined to conceal a safety concern.

(b) A person alleging retaliation may seek an employment remedy, compensation or other relief under applicable law and may complain to the Ombudsman.

(c) Protection does not immunise a person from liability for deliberate harm, gross misconduct, bad-faith fabrication or a criminal act.

Section 6B - Overlapping wrongdoing

(a) Where a report also concerns procurement wrongdoing, the person may seek the protection available under this Act and any stronger protection available under applicable procurement or anti-corruption law.

(b) Authorities shall cooperate to prevent contradictory retaliation assessments and shall not require a reporter to make repeated disclosures unnecessarily.

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Article 7

Indemnity and Rapid Redress

Section 7A - Clinical indemnity

(a) The Linkslandic Health Service may establish a centrally administered indemnity arrangement for clinicians providing LHS care.

(b) The arrangement shall provide clear coverage terms, claims assistance and safeguards against personal financial exposure for good-faith clinical work, without preventing recovery from deliberate wrongdoing or gross misconduct.

(c) The responsible Minister shall publish an estimate of expected cost, funding source and risk controls before the arrangement begins.

Section 7B - Optional compensation scheme

(a) The responsible Minister may establish an optional scheme for prompt compensation for avoidable clinical harm below a prescribed maximum value.

(b) Regulations establishing the scheme must specify eligible harm, the maximum payment, application and limitation periods, independent assessment, reasons for decisions, review rights and information about legal assistance.

(c) Accepting payment under the scheme does not waive a right to bring or continue a court claim unless the claimant gives a separate, informed and express waiver after receiving clear advice about its effect.

(d) The scheme shall not make a final finding of negligence binding on a court or prevent referral of suspected criminal, safeguarding or professional misconduct.

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Article 8

Administration, Review and Finance

Section 8A - Regulations and safeguards

(a) Regulations under this Act are subject to affirmative approval by the Commons and must be published in accessible form.

(b) Regulations shall include reasonable accommodations for disabled persons, language access, protection of children and vulnerable adults, and safeguards for personal data.

(c) No power under this Act authorises arbitrary disclosure, surveillance or interference with privileged legal communications.

Section 8B - Three-year review

(a) The responsible Minister shall arrange an independent review beginning no later than three years after this Act comes into force.

(b) The review shall assess patient outcomes, candour compliance, complaint resolution, investigation quality, reporter protection, equality effects, data protection, staffing and total public cost.

(c) The report shall be laid before the Commons and made publicly accessible, with recommendations for continuation, improvement or replacement.

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Article C

Constitutional Compliance

Section C1 - Rights and legality

(a) This Act shall be interpreted consistently with the Constitution of Links Land, including dignity, equality, privacy, due process, access to justice and freedom of expression.

(b) Any restriction on confidentiality, privacy or professional rights must be lawful, necessary and proportionate to patient safety or another recognised public interest.

(c) Nothing in this Act removes the jurisdiction of the courts or the constitutional authority of competent oversight bodies.

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