CURRENT LEGAL ARTICLES

4th November 2024

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was signed into law in May 2023 and enacted on 26th September 2024. 

The  2023 Act significantly improves transparency, accountability, and patient rights within Ireland’s healthcare system.

The Act imposes mandatory open disclosure of severe medical incidents in response to past healthcare scandals and the need for greater oversight. It establishes clear protocols for how healthcare providers must communicate with patients and their families about notifiable incidents.

Mandatory Open Disclosure

One of the Act’s core features is the requirement for open disclosure in severe, often life-threatening or fatal medical incidents. Healthcare providers must inform patients and/or their families of specific notifiable incidents during treatment. These incidents include serious events such as surgical errors, unintended deaths related to medical procedures, or medication errors. This shift towards transparency aims to rebuild trust between patients and healthcare providers by openly acknowledging mistakes or adverse outcomes​.

Notifiable Incidents

The Act provides a detailed list of notifiable incidents that require mandatory reporting. These incidents are primarily focused on events that lead to unintended patient harm, such as surgeries performed on the wrong patient or wrong site, retention of foreign objects after surgery, and death due to medication or transfusion errors. Such incidents must be reported to the patient and the relevant healthcare regulatory bodies, such as the Health Information and Quality Authority (HIQA), within seven days of occurrence​.

Apologies and Legal Protections

A significant aspect of the Act is its focus on providing patients with apologies where appropriate. Notably, the law ensures that any apology or disclosure made by healthcare professionals does not constitute an admission of fault or legal liability. This provision encourages healthcare providers to communicate openly without fear of legal repercussions, fostering a more transparent and compassionate environment for handling patient safety issues​.

Penalties for Non-Compliance

Healthcare providers who fail to comply with the Act’s open disclosure requirements face penalties. This includes fines for not holding disclosure meetings or failing to report notifiable incidents to regulatory bodies. These penalties reinforce the importance of compliance and accountability in the healthcare system​.

Scope and Application

The Act applies to public and private healthcare providers, broadening HIQA’s regulatory oversight to include private hospitals and healthcare services. This ensures that the same transparency and patient safety standards are maintained across all healthcare sectors in Ireland.​

In conclusion, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 is a landmark piece of legislation aimed at embedding a culture of openness in Irish healthcare. By mandating disclosure of severe incidents and providing legal protections for those who apologize, the Act seeks to improve patient safety and restore trust in the healthcare system.