Transparency and accountability are fundamental pillars of trust in healthcare. To strengthen these principles, Ireland introduced the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, a significant development in the country’s legislative landscape. Signed into law in May 2023 and officially commencing on 26 September 2024, the Act marks a milestone in embedding open disclosure and mandatory reporting within the healthcare system.
This blog seeks to demystify the Act, exploring its provisions, goals, and what it means for patients, advocates, and healthcare practitioners.
What is the Patient Safety Act?
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 is a landmark piece of legislation mandating healthcare providers to openly disclose specific patient safety incidents—labelled notifiable incidents—to patients or their families. It also introduces stringent reporting measures, requiring these incidents to be communicated to relevant regulatory bodies such as the Health Information and Quality Authority (HIQA).
For patients and advocates alike, the Act signifies a commitment to fostering transparency, learning from healthcare errors, and prioritising patient trust—an overdue shift for Ireland’s healthcare system.
Key Provisions of the Act
The Act outlines various obligations and safeguards aimed at ensuring accountability in healthcare operations. Below are the most critical aspects you need to know.
1. Mandatory Open Disclosure
At the heart of the legislation lies mandatory open disclosure, requiring healthcare providers to communicate notifiable incidents honestly, promptly, and with compassion. These incidents include, but are not limited to:
- Surgical errors causing death.
- Wrong-site surgeries causing death.
- Maternal or perinatal deaths.
- Medication errors leading to fatalities.
Open disclosure meetings must provide patients with detailed explanations of incidents, an apology where appropriate, and follow-up actions aimed at addressing the occurrence.
2. Mandatory Notifications to Regulators
Beyond patient conversations, healthcare providers must notify regulatory bodies like HIQA, the Mental Health Commission, or the Chief Inspector of Social Services about notifiable incidents within a seven-day window. This dual reporting ensures both institutional accountability and transparency to patients.
3. Legal Protections for Information Disclosed
The Act protects healthcare providers participating in open disclosure by ensuring that information or apologies shared during these discussions cannot:
- Be used as an admission of fault in legal actions.
- Lead to professional disciplinary actions.
- Void healthcare providers’ indemnities or insurance coverage.
By removing fear of litigation, this provision encourages honest and open communication.
4. Cancer Screening Reviews
The Act highlights cancer screening by requiring the HSE’s National Screening Services to inform patients of their right to request a review of their screening results. Findings from these reviews must also be disclosed according to open disclosure protocols.
5. Expanded Oversight from HIQA
HIQA’s remit now extends beyond public healthcare to prescribed private health services and hospitals. This includes standard setting, inspections, and investigations into private healthcare practices, ensuring equity in accountability across sectors.
6. Clinical Audit Protections
Recognising the importance of quality improvement, the Act safeguards clinical audit data from being admissible in legal proceedings. This measure enables practitioners to focus on enhancing patient safety without fear of repercussions.
Penalties for Non-Compliance
Healthcare providers failing to meet their obligations face fines of up to €5,000 unless they can demonstrate reasonable efforts to comply.
Why this Legislation is Necessary
Historically, poor communication around patient safety incidents has been a recurring issue in Irish healthcare. Previous efforts, such as the Civil Liability (Amendment) Act 2017, advocated for open disclosure but left it as a voluntary practice. By making open disclosure mandatory, the Patient Safety Act aims to bridge the trust gap between healthcare providers and patients.
Goals of the Patient Safety Act
- Building Patient Trust
Transparency fosters trust. By mandating dialogue around incidents, patients receive the clarity and assurance they need during challenging times.
- Better Learning and Systemic Improvement
Open disclosure helps healthcare providers review errors, identify patterns, and adapt their systems to prevent future incidents.
- Uniformity Across Public and Private Healthcare
With HIQA’s expanded oversight, private institutions are held to the same standards of accountability and transparency as public counterparts.
What this Means for Patients and Advocates
For patients, the Act guarantees the right to timely, accurate, and empathetic communication about their care. It empowers them to request and understand detailed explanations of incidents, along with steps taken to rectify the situation.
For patient advocates, the legislation is a tool to amplify their impact. Advocates can use the Act to:
- Educate patients about their rights.
- Ensure healthcare providers fulfil their obligations.
- Provide emotional and psychological support to those navigating the aftermath of safety incidents.
The Act also encourages collaboration between advocates, patients, and designated points of contact in healthcare organisations to simplify the disclosure process.
Challenges Ahead
While the Act’s intentions are clear and commendable, aligning healthcare practice with these legal mandates will take time. Challenges include:
- Implementing organisation-wide open disclosure training for healthcare professionals.
- Addressing provider anxiety around the perceived consequences of transparency.
- Building robust systems for tracking and reporting incidents to avoid non-compliance.
How You Can Take Action
If you are impacted or have concerns regarding healthcare incidents, you don’t need to face it alone. Understanding your rights under the new legislation is essential, and legal advice can be invaluable in navigating complex healthcare interactions. Contact HOMS Assist for expert guidance tailored to your needs.
Get in touch today to ensure your rights are upheld and to gain clarity on your options for recourse.
