Stephen Donnelly

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 also provides for the mandatory external notification of those same events to the appropriate body.

The Act contains a list of specified patient safety incidents resulting in the main, in death or serious injury, and also provides for the mandatory external notification of those same events to the appropriate body. It also contains a provision by which the minister can add to this list via regulation.

Health minister Stephen Donnelly said: “I am delighted to be commencing this important piece of patient safety legislation.

“It will serve an important role in progressing a cultural change in our health service whereby, together, we create space for openness and transparency in our everyday actions.

“Ireland has made another great stride forward in our suite of patient safety legislation and this will signal a new era for the health service.”

The Act also provides for mandatory open disclosure requirements for completed individual patient requested reviews of their cancer screening by the HSE’s National Screening Service in a dedicated part of the Act. It provides for an obligation for the Cancer Screening Services to inform patients of their right to request a review.

Under the Act, the remit of the Health Information and Quality Authority (HIQA) will be expanded into prescribed private health services and private hospitals.

This will allow HIQA to set standards for the operation of prescribed private health services and private hospitals, to monitor compliance with them and to undertake inspections and investigations as required.

Mr Donnelly said: “This is a landmark piece of patient safety legislation. It will play an important role in ensuring that patients and their families have access to comprehensive and timely information.

“This is achieved by the open disclosure mechanism in the Act which 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.

“Poor communication between patients and health practitioners has been at the heart of many patient safety issues. It is so important that when things go wrong, there is an understanding of what has happened and an assurance that it will not happen again.”

The new law requires a review of its operation to be carried out two years from the date of commencement.