The Minister for Health has recently confirmed the commencement of the Patient Safety Act. Our Medical Law team examines the scope and the likely impact of this landmark legislation, which implements mandatory open disclosure for the first time in Ireland.
The commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides for mandatory – as opposed to voluntary – open disclosure. This marks a major development for the Irish healthcare sector. Healthcare practitioners are now required under law to make open disclosure regarding a list of patient safety incidents which may occur during the provision of health services. We reviewed the key features of this legislation in a previous article.
In a separate update, we also discussed the launch of the National Open Disclosure Framework in October 2023 as well as the various steps being implemented to prepare for commencement of the Act.
On World Patient Safety Day, 17 September 2024, the Minister for Health announced that all preparatory steps had been completed.
Private health services to be monitored by HIQA
It was also confirmed that the Minister had approved amendments to HIQA’s National Standards for Safer Better Care. The amendments mainly address the expansion of HIQA’s remit to monitor certain private health services and private hospitals. This will enable HIQA to set standards for the operation of these services, to monitor compliance and to undertake inspections and investigations, as required.
Cultural shift
In a press release published on commencement date, 26 September 2024, the Minister stated as follows:
“[The Act] 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.”[1]
What next?
The majority of the Act has been commenced. A further technical amendment is set to be made to Section 68. This will provide the Chief Inspector within HIQA with a discretionary power to carry out a review of certain serious patient safety incidents which may occur in a nursing home. This Section is expected to commence shortly.
Interestingly, Section 80 mandates that a full review of the operation of the Act will take place two years following its commencement date.
Comment
This is an important piece of legislation which will pave the way to ensuring that patients have timely access to information. The aim is that the mandatory open disclosure provisions in the Act will contribute to embedding a culture whereby clinicians, and the health service as a whole, will engage openly, transparently and compassionately with patients and their families when things go wrong.
Healthcare providers should familiarise themselves with their obligations under the Act and have appropriate systems in place to ensure full compliance. While the Act may present challenges for healthcare providers, they should ensure their staff are supported as we move into the new era of mandatory open disclosure.
For more information on this new legislation, please contact a member of our Medical Law team.
People also ask
Who does the Act apply to? |
The Act imposes obligations on healthcare providers, in both the public and private sectors, to make mandatory open disclosure following the occurrence of a ‘notifiable incident’ within the meaning of the Act. |
What constitutes a ‘notifiable incident’? |
Schedule 1 sets out the list of ‘notifiable incidents’ which are subject to mandatory open disclosure. At present, the list refers to incidents which result in unintended or unanticipated death. Section 8 empowers the Minister for Health to prescribe additional incidents to this list in due course. |
How is open disclosure made? |
The health service practitioner who is responsible for the patient’s care must hold a meeting with the patient and/or a family member, so that open disclosure can be made. The following information should be addressed at the meeting: - The date of the incident. - A description of the incident. - Details of when the incident came to the attention of the health service provider. - Any physical/psychological consequences to the patient. - Any actions to be taken in order to address the occurrence of the incident and the circumstances that gave rise to it. |
Is there any guidance for healthcare providers to follow when making open disclosure? |
Yes. In October 2023, the Minister for Health launched the National Open Disclosure Framework which sets out a system-wide approach for healthcare providers to follow, when engaging in open disclosure. The HSE have also rolled out a training policy to all staff. |
Does the Act impose any obligations on cancer screening services to make open disclosure? |
Yes. Part 5 of the Act provides a separate procedure relating to cancer screening services such as CervicalCheck or Bowel Screen. Patients now have a right to request a review of their results from the cancer screening service, and there is an obligation on screening services to inform patients of this right. Once the review is carried out, a meeting will be held with the patient to discuss the results. |
The content of this article is provided for information purposes only and does not constitute legal or other advice.
[1] “Minister for Health announces commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023”, 26 September 2024
