Following its formal commencement, Ireland’s Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 transformed open disclosure from a voluntary hospital policy into a mandatory legal duty across all public and private health services. Designed to dismantle the culture of secrecy that historically surrounded adverse medical events, the Act establishes strict legal requirements for disclosing serious safety incidents directly to patients and their families.
Key Mandates of the Patient Safety Act 2023
The Act introduces a statutory list of 13 mandatory notifiable incidents, predominantly involving unexpected deaths or severe, permanent injuries, that health service providers are legally required to disclose.
Key statutory features include:
Statutory Requirement | Legal and Operational Impact |
Mandatory Notification | Providers must formally report notifiable incidents to relevant regulators (such as HIQA or the Mental Health Commission) generally within 7 days. Failure to disclose without reasonable excuse constitutes a criminal offence. |
Formal Disclosure Meetings | Health bodies must offer an in-person open disclosure meeting with the patient or family, followed by a signed written statement within 5 days. |
Maternity & Neonatal Protection | Mandatory disclosure explicitly covers serious birth-related harm, including unexpected stillbirths, maternal deaths, and infants requiring therapeutic hypothermia. |
Legal Status of Apologies | The Act clarifies that an apology made during open disclosure does not constitute a legal admission of fault or liability, encouraging open, honest communication from clinicians. |
Why Statutory Candour Matters
The importance of mandatory candour is underscored by high-profile Irish medical negligence jurisprudence, where families faced prolonged court battles simply to uncover the factual sequence of events surrounding a birth injury or diagnostic failure.
Historically, when an adverse outcome occurred, families were frequently left in the dark, forced to institute legal proceedings merely to obtain medical records and understand what happened behind closed doors.
Under the Patient Safety Act 2023, the statutory written statement provided after an open disclosure meeting establishes a clear factual baseline. It helps patients establish their date of knowledge regarding whether an injury was linked to clinical management, significantly reducing the emotional distress caused by institutional stonewalling.
Transparency Is Not the End of the Process
While statutory open disclosure is a major victory for patient rights in Ireland, receiving an open disclosure statement or an apology from a hospital is only the beginning of understanding your legal options.
An open disclosure meeting explains what happened, but it rarely determines whether the incident constituted a breach of the legal standard of care. Independent expert medical opinion remains required to evaluate whether an adverse outcome was an unavoidable complication or the result of actionable clinical negligence.
Have you received an open disclosure notification or experienced an unaddressed adverse event in care?
Contact Whelan Law today to speak with our specialist medical negligence solicitors. We will review your open disclosure documentation and medical records to ensure your family gets complete clarity and justice.