Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, signed into law

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On 2 May 2023, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was signed into law by the President of Ireland.

This is a very important piece of legislation that expands our remit and puts new requirements on providers in order to promote and uphold patient safety and transparency. This is in line with our mission to ensure safer, better care for those using health and social care services in Ireland.

For health service providers, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 will facilitate:

    • Mandatory open disclosure, by health services providers, of certain incidents occurring in the course of the provision, to a person, of a health service.
    • This will 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, any apologies made in the course of such disclosures and the use of any other information relating to the open disclosure provided to make provision for procedures in respect of clinical audit, and the data obtained in clinical audits.

From a HIQA perspective, our statutory responsibilities will be extended by amending the Health Act 2007 and;

    • extending HIQA’s monitoring functions into the private hospitals and other health services as determined by the Minister
    • extending HIQA’s standard-setting function into the private health sector, along with mandatory consultation requirements
    • extending HIQA’s functions in respect of health information (setting of standards and assessment of compliance of such standards), into the private health sector
    • adapting the threshold for Section 9 statutory investigations
    • requiring healthcare service providers to notify HIQA and the Chief Inspector where relevant of statutorily defined notifiable events.

Separately, it also extends the Chief Inspector’s functions to conduct reviews of patient safety incidents arising in nursing homes.

HIQA is preparing for the commencement of the Act as it relates to our extended function and a body of work is underway. We have started an in-depth programme of stakeholder engagement with new and existing service providers in preparation for our new function. Further clarity will be provided when the legislation is commenced.

For more information, see the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.