Gary Gannon (Dublin Central, Social Democrats)
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431. To ask the Minister for Health if she has any plans to establish a Patient Safety Commissioner role in Ireland, modelled on the UK and Scottish systems, to provide independent advocacy and accountability following serious failings in care; and if she will make a statement on the matter. [23034/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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There are currently no plans to establish a Patient Safety Commissioner role in Ireland. The Government established the National Patient Safety Office (NPSO) in December 2016 to strengthen the patient safety role of the Department and to provide national leadership for patient safety in support of the Minister. The Office was tasked with promoting policy and planning with regard to patient safety and quality in health care through embedding a national framework for clinical effectiveness and clinical audit, developing patient safety policy and legislation and progressing patient safety priorities and initiatives through the use of data and health information and evidence-based policy making.

Gary Gannon (Dublin Central, Social Democrats)
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432. To ask the Minister for Health to detail how the new Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 will ensure families like that of a person (details supplied) receive full, timely disclosure of risks, adverse events, and post-treatment concerns; if the Act will apply retrospectively in any way; and if she will make a statement on the matter. [23035/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides a legislative framework for a number of important patient safety issues, including the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to the patient and/or their family. The Act was passed by both Houses of the Oireachtas and signed into law by the President on 2nd May 2023. It was commenced (other than Section 68) on 26 September 2024.

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 is an important piece of patient safety legislation. A key intention of the Patient Safety Act is to ensure that patients and their families have access to comprehensive and timely information. This is achieved by the open disclosure mechanism in the Act and it contributes to embedding a culture whereby clinicians, and the health service as a whole, engage openly, transparently and compassionately with patients and their families when things go wrong.

These requirements of the Act apply to all healthcare bodies including:

• HSE (including all Section 38 organisations)

• Section 39 organisations

• Private Hospitals

• Private health and social care providers such as GPs, Dentists, Pharmacists, etc.

The Patient Safety Act 2023 provides for the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to the patient and/or their family. The Act contains a provision by which the Minister can add to this list via regulation. Patients and their families must have access to comprehensive and timely information, including an apology where appropriate, in relation to these serious patient safety incidents.

Section 18 (3) & (4) of the Act sets out what the notifiable incident disclosure meeting should include. This information includes:

• The names of the people present at the meeting.

• A description of the notifiable incident concerned.

• The date on which the notifiable incident occurred (if known) and the date it came to the notice of the health services provider.

• The manner in which the notifiable incident came to the notice of the health services provider.

• Where, in the opinion of the health services provider, physical or psychological consequences of the notifiable incident (i.e. harm to the patient) which, at the time of the notifiable incident disclosure meeting is held, are present or have developed, information in respect of those consequences.

• Where physical or psychological consequences have not yet presented or developed but the health services provider has such grounds for believing they are likely to present or develop at any time after the notifiable incident disclosure meeting, information in respect of those consequences. The same applies if the health services provider has such grounds for believing they are less likely or unlikely to present or develop at any time after the holding of the notifiable incident disclosure meeting.

• A statement that the health services provider has reasonable grounds for believing that no physical or psychological consequences are likely to present or develop from the notifiable incident if this is the case.

• If at the time of the meeting, physical or psychological consequences have arisen and the patient is under the clinical care of the health services provider concerned, the health services provider shall provide the patient with information in respect of the treatment, and relevant clinical care, that the provider is providing (or proposes to provide) to the patient to address those consequences.

• The actions the health services provider has taken or proposes to take and the procedures or processes to be implemented. This is to allow the health services provider, in so far as it is reasonably open to that provider to do so, to address the knowledge the provider has obtained from its consideration of that incident and the circumstances giving rise to it.

• An apology, if appropriate.

The Act also provides for the mandatory external notification of those same events to the appropriate regulatory body (HIQA, Chief Inspector within HIQA or Mental Health Commission as appropriate).

The Act does not apply retrospectively.