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The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, which came into effect from 26 September 2024, introduces mandatory open disclosure for specific notifiable incidents in Irish healthcare.
This is the first legal requirement for healthcare providers to disclose such incidents to patients, and it obligates the Health Service Executive’s (“HSE”) cancer screening services to inform patients of their right to request a review of their screening.
Mandatory Open Disclosure
The Patient Safety Act 2023 provides for 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 contains a provision by which the Minister for Health, Mr. Stephen Donnelly, can add to this list via regulation.
Patients and their families must have access to comprehensive and timely information, including an apology where appropriate, in relation to serious patient safety incidents. It also provides for the mandatory external notification of those same events to the appropriate regulatory body (the Health Information and Quality Authority (“HIQA”), the Chief Inspector within HIQA or the Mental Health Commission as appropriate).
For details of the key amendments in the legislation, see our prior article Open Disclosure Requirement in New Patient Safety Act 2023.
New Open Disclosure Training Policy
In addition, to facilitate commencement of the Act, the HSE developed a new open disclosure training policy and communications plan for all staff regarding the new disclosure and notification requirements under the Act. The HSE advise that the new open disclosure training module is now available to all staff.
Health Service Providers and Notifiable Incidents
Under the Act, a health service provide is defined as any entity or individual employing or contracting health practitioners such as doctors, nurses or pharmacists.
The notifiable incidents requiring mandatory disclosure include serious medical errors or adverse events such as surgery on the wrong patient or site, medication errors, deaths related to surgical or medical treatment and stillbirths or perinatal deaths.
Open Disclosure and Notification Process
When a notifiable incident occurs, the health practitioner must inform the health service provider, who must hold a disclosure meeting with the patient or their representative. The meeting should be in person unless otherwise requested, and a written statement documenting the disclosure and any apologies must be provided. Health providers must also notify the relevant external body, such as HIQA or the Mental Health Commission, within seven days.
Consequences of Non-Compliance
Failure to disclose a notifiable incident without reasonable excuse may result in a Class A fine of up to €5,000. However, healthcare providers can defend against penalties if they demonstrate reasonable efforts to comply.
Conclusion
The Act builds on previous voluntary disclosure initiatives, making open disclosure mandatory while maintaining legal protections for healthcare providers.
It aims to foster transparency and trust in the Irish healthcare system by ensuring patients are informed when notifiable incidents occur, promoting accountability and patient safety, which is very much welcome.
Further Information
For further details, see our previous article Open Disclosure Requirement in New Patient Safety Act 2023 while the full text of the Act is available here.
For expert advice about Patient Safety and the Mandatory Open Disclosures, please contact Avril Scally, Partner and Head of our award-winning Medical Negligence & Personal Injury Team.