Mandatory Open Disclosure – the new Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

In a long-anticipated development, Ireland has recently taken significant steps to prioritise patient safety with the introduction of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023. This legislation establishes a comprehensive framework aimed at promoting transparency within healthcare organisations and improving patient outcomes. Its key provisions highlight an extensive approach to enhancing healthcare quality and ‘fostering trust’ between patients and healthcare providers, which will inevitably have implications for healthcare providers and professionals.



Mandatory Open Disclosure

First, at the core of the legislation, is the requirement for mandatory open disclosure: under the Act, healthcare providers are now obliged to disclose to patients and/or their families certain serious patient safety incidents known as a ‘notifiable incident’. They must be provided with all relevant information about the incident, its consequences, and any treatment or care provided to address those consequences. These notifiable incidents are described as those of a “very serious nature (all death related) that mostly fall into the category of preventable events.” Examples include ‘wrong surgery site’ and ‘death due to medication error’.


Requiring ‘open and honest communication’, healthcare professionals must ensure that patients are informed about notifiable incidents and have a clear understanding of what happened. Purporting to foster trust, promote accountability and help patients make educated choices about their care, the Act should ensure that patients and their families have access to comprehensive and timely information including an apology where appropriate, in relation to serious patient safety incidents.


Furthermore, if a health service provider becomes aware of a ‘notifiable incident’ occurring, both in public and private settings, they will be obliged to notify the incident to the relevant regulatory body, such as Health Information and Quality Authority (HIQA), the Chief Inspector of Social Services or the Mental Health Commission within seven days of the incident. This is aimed at preventing harm to patients going forward, and practically, expands HIQAs oversite to include private hospitals, exhibiting a more unified approach to patient safety and monitoring compliance.


Part 5 Review

Part 5 of the Act focuses on assessing and reviewing incidents that occur during the provision of healthcare services known as “Part 5 Review”. More specifically healthcare providers are obligated to make open disclosures related to cancer screening services, providing information about the review process, the incident, its consequences, and any treatment or care provided address those consequences. It allows a patient to request a review of the results of a screening which has been carried out by CervicalCheck, BreastCheck and Bowel Screen in relation to the patient. Every patient undergoing a screening is informed of their right to make a request for Part 5 review, and if requested, the healthcare provider will hold an open disclosure meeting.


What does this mean for healthcare providers and professionals?

It is important to note for healthcare providers that the Act includes a criminal sanction for non-compliance with a fine of up to €5,000. It also applies to both public and private patients. There is however protection from liability – information provided during a notifiable incident disclosure meeting, as well as any apologies made, does not constitute an admission of fault or liability in regulatory or clinical negligence proceedings as long as procedures are followed. Notably, whilst the requirement to disclose a notifiable incident falls to the healthcare provider, such as the hospital or GP practice, its important that all healthcare professionals are familiar with the legislation. Practitioners will be expected to inform the healthcare provider when a notifiable incident has occurred and those in management roles may be responsible for ensuring the disclosure and notification of incidents.


While great care has been taken in the preparation of the content of this article, it does not purport to be a comprehensive statement of the relevant law and full professional advice should be taken before any action is taken in reliance on any item covered.