A landmark shift in Irish healthcare has arrived with the commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023. For the first time, 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.
Why this matters
The 2017 Civil Liability Amendment Act provided a discretionary disclosure system, whereby healthcare providers could voluntarily disclose incidents that had occurred in clinical settings, resulting in unanticipated harm or a ‘near miss’.
The introduction of mandatory open disclosure is a direct response to past failures in patient communication, most notably the Cervical Check scandal in which more than 221 women saw their cervical cancer tests return false negatives. This meant that many of them were diagnosed when their cancer was in a much more advanced state and therefore their prognoses were terminal.
Vicky Phelan became the headline campaigner for the introduction of mandatory open disclosure. Her tireless campaigning throughout her illness and treatment shone a spotlight on the consequences of non-disclosure, ultimately driving political and legislative change.
Key provisions of the Act
The Act applies to both public and private patients, including individual practitioners, employer organisations, and partnerships. It mandates that healthcare providers must now proactively inform patients and their families when a 'notifiable incident' has occurred. Such incidents include cases where a patient suffers a permanent impairment of bodily, sensory, motor, physical, or intellectual function, or an impairment lasting 28 days or more.
What healthcare providers need to know:
- Obligation to disclose – Providers must hold a meeting with the affected patient or their representative to openly discuss the incident.
- Annual reporting – Relevant organisations must submit annual reports on open disclosure implementation and compliance with the Framework.
- Legal consequences – Failure to comply with the Act could result in fines of up to €5,000.
Additionally, it was also confirmed that the Minister had approved amendments to HIQA’s National Standards for Safer Better Care which mainly addresses 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, therefore, reinforcing patient safety standards across the sector.
This is an important piece of legislation which will pave the way to ensuring that patients have timely access to information. When mistakes happen, open conversations between clinicians and patients can build trust, facilitate learning, and potentially reduce the number of legal claims arising from miscommunication.
Beyond legal compliance, the Act aims to foster 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.
This is more than just a regulatory shift—it’s a fundamental transformation in how Irish healthcare engages with those it serves
