The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides a legislative framework for the mandatory open disclosure of specified serious patient safety incidents that must be disclosed to the patient and/or their family, and notified to HIQA, the chief inspector of Social Services or the Mental Health Commission (MHC) once the Act commences. The Act was signed into law in May 2023 and, at the time of going to press, it was expected to commence on September 26.

Voluntary open disclosure 

Prior to this, open disclosure has been on a voluntary basis. The 2013 HSE Open Disclosure Policy initially laid the groundwork for open disclosure in the Irish health service. This policy only applies to the HSE and HSE-funded organisations.

Part 4 of the Civil Liability (Amendment) Act 2017 (‘the 2017 Act’) introduced the legal framework to support voluntary open disclosure; it applies to all patient safety incidents including near misses and no-harm events. It provides that where a patient safety incident occurred in the provision of healthcare, the health services provider may make an open disclosure of the incident to the patient. The 2017 Act provides that any apology provided cannot then be used in litigation.

The Act 

The Act will introduce what is termed as ‘mandatory open disclosure’ of adverse incidents during the provision of healthcare services. The intention is to 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. It applies to both public and private healthcare providers. 

Another core purpose of the Act is to enable national learning from serious patient safety incidents, and to support health service-wide improvements to prevent harm to other patients. 

This will be achieved through the obligation on health service providers to report notifiable incidents to the relevant regulatory body. In addition to mandatory open disclosure, the Act also provides for the expansion of HIQA’s remit into private hospital services to allow it to set standards for the operation of private hospitals, to monitor compliance with these standards, and to undertake inspections as required. 

Mandatory open disclosure will also apply in respect of a patient-requested review of certain screening programmes, known as ‘Part 5 reviews’. At present these reviews are limited to the CervicalCheck, BreastCheck, and BowelScreen programmes.

What constitutes a notifiable patient safety incident under the Act?

A patient safety incident can be described as an instance of preventable harm or injury which occurs to a patient during their care. Schedule 1 to the Act sets out a list of specific serious patient safety incidents that must be disclosed under the mandatory open disclosure process. These incidents are described as ‘notifiable patient safety incidents’ and include the following:

• Patient death associated with a medication error
• Wrong site surgery or wrong surgery resulting in unintended and unanticipated death 
• Unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery
• Unintended and unanticipated death occurring in any place where a health services provider provides a health service that is directly related to any medical treatment and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient
• Unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight was alive at the onset of care in labour
• Unanticipated death of a woman while pregnant, or within 42 days of the end of the pregnancy
• Unanticipated and unintended stillbirth
• A baby who was considered for, requires, or is referred for therapeutic hypothermia
• A death believed to be caused by the suicide of a patient within a health service setting.

As above, all notifiable incidents currently involve the death of a patient. However, provision has been included under Section 8 of the Act for the Minister for Health to add additional notifiable incidents to the list and widen the potential for GP-related care to be involved. 

Notification to the health service provider

Where one of the notifiable incidents set out in the Act occurs, there is now an obligation on a health practitioner to notify the health services provider that was providing the service to the patient as soon as practicable. The health services provider is obliged to notify the incident to HIQA, the chief inspector of Social Services or the MHC, dependant on the types of health services provider involved, within seven days.

Notification to the patient 

Where a health services provider is satisfied that a notifiable incident has occurred, there is also an obligation to hold a notifiable incident disclosure meeting to disclose the incident to the patient concerned and/or a ‘relevant person’. A ‘relevant person’ may be notified instead of the patient where: 

• Having regard to the patient’s age, capacity or health status, it is appropriate, in the opinion of the principal health practitioner, to disclose the incident to a relevant person. For example, if the patient has significant cognitive impairment 
• The patient has died; or 
• The patient has requested that disclosure be made to the relevant person as well as themselves or alternatively has requested disclosure is made solely to the relevant person. 

Who discloses the information? 

The Act provides that the patient’s principal health practitioner should make the disclosure on behalf of the health service provider, unless they are not available or not otherwise in a position to make the disclosure; or having regard to the circumstances of the notifiable incident, the health service provider or the principal health practitioner is satisfied that open disclosure should be made by another health practitioner. In a GP setting, it is most likely to fall to the patient’s usual treating GP.  

The notifiable incident disclosure meeting

The Act sets out specific requirements about how the notifiable incident disclosure meeting (‘the meeting’) should take place and what information should be provided during and after the meeting. It states that the meeting should generally be held in person unless requested otherwise by the patient or relevant person. 

A description of the incident concerned together with the date on which it occurred, the date it came to the attention of the health services provider and the manner in which it came to the attention of the provider should be disclosed. 

In addition, where, in the opinion of the health services provider, physical or psychological consequences of the notifiable incident are present or have developed, the patient and/or relevant person should be informed in respect of those consequences and of any other physical or psychological consequences the health services provider believes are likely to develop at any time after the meeting. 

If the health services provider has determined that an apology is to be provided, this can also be provided at the meeting together with the details of any actions being taken or proposed to be taken as a result of the notifiable incident. 

There are also specific requirements for the maintenance of records and the provision of statements during and following the meeting within specified timelines. 

Is there any legal protection during the open disclosure process? 

The protections included in both the 2017 and 2023 Acts should allay fears that information provided to patients in open disclosure could be used against them in civil proceedings. Any disclosure and apology made during the open disclosure process shall not: 

• Constitute or be used as evidence of an admission of fault or liability 
• Invalidate any insurance or indemnity
• Constitute an express or implied admission of professional misconduct, poor professional performance or unfitness to practise in any regulatory fitness to practise proceedings; or 
• Be admissible as evidence of professional misconduct, poor professional performance or unfitness to practise.

Consequences of failure to comply

Given its mandatory nature, there are serious consequences for non-compliance with the legislation including the health services provider being charged with an offence and/or being liable to a potential fine of up to €5,000.

Key points for GPs

• GPs, as healthcare providers, will be required to comply with the open disclosure requirements for notifiable incidents that occur in their practice 
• GPs must have processes in place to identify and disclose these incidents to patients and/or relevant persons in a timely manner and to prepare and maintain statements and records
• The HSE has introduced an e-learning programme which can be accessed through the HSEland website which includes a helpful quick reference guide and toolkit 
• GPs may need to notify relevant regulatory bodies of notifiable incidents as per the Act
• GPs should also have reference to Paragraph 4 of the Medical Council’s Guide to Professional Conduct & Ethics for Registered Medical Practitioners (9th Edition 2024)  
• In light of statutory timelines to notify relevant regulatory bodies, it is advisable for GPs to seek advice from their indemnifier as early as possible.