The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was enacted in Ireland to establish a legislative framework for the mandatory open disclosure of certain incidents occurring in the provision of health services. This Act is part of a broader program of legislative and policy initiatives aimed at embedding a culture of open disclosure across the Irish health sector.

Here we look at some of the main implications of this Act and its relevance to medical negligence cases.

Key provisions of the Act

Signed into law on the 2nd of May 2023, this Act brought into the following key changes for healthcare providers.

Mandatory open disclosure

The Act requires healthcare providers to disclose certain serious patient safety incidents to patients and/or their families. These notifiable incidents are of a very serious nature, often related to death, and healthcare providers must provide all relevant information about the incident, its consequences, and any treatment or care provided to address those consequences.

Inadmissibility of evidence in court proceedings

Section 10 of the Act provides protection for health service providers and their insurers by stating that any information provided throughout the open disclosure meeting, including an apology, shall not invalidate insurance, constitute an admission of liability, or be admissible as evidence in court proceedings.

Sanctions for non-compliance

Section 77 of the Act establishes that failure to comply with the open disclosure of a notifiable incident without reasonable excuse will be a criminal offense, emphasising the importance of compliance with the legislation.

Notification to regulatory bodies

Health service providers are obliged to notify the relevant regulatory body, such as the Health Information and Quality Authority (HIQA), the Chief Inspector of Social Services, or the Mental Health Commission, within seven days of a notifiable incident occurring.

Part 5 reviews

Part 5 of the Act focuses on assessing and reviewing incidents that occur during the provision of healthcare services, particularly related to cancer screening services. It allows patients to request a review of the results of a screening, and healthcare providers are obligated to hold an open disclosure meeting if requested.

Guidelines and training

The Act provides for the issue of guidelines to offer practical guidance regarding the operation of and compliance with the Act. The health service is understood to have implemented an open disclosure training policy and communications plan.  

List of notifiable incidents

Schedule 1 of the Act sets out the list of notifiable incidents subject to mandatory open disclosure, which includes various incidents resulting in death or serious harm.

The Act represents a significant step towards prioritising patient safety in Ireland by promoting transparency, accountability, and trust between patients and healthcare providers. It also aims to ensure that openness and transparency are embedded across the health service, fostering a culture of learning from incidents to improve patient care.

How does the Act affect medical negligence cases?

The Act represents a shift from a voluntary to a mandatory regime of open disclosure and is aimed at fostering a culture of open and honest communication following patient safety incidents. It also emphasises the importance of independent expert medical opinion in medical negligence litigation, highlighting the duty of experts to provide truthful, independent, and impartial evidence to the court. Finally, it reinforces the importance of legal practitioners retaining impartial experts who have the relevant expertise to support medical negligence claims.