The introduction of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 in Ireland marks a significant step forward in enhancing patient rights and promoting transparency in the healthcare system. This legislation aims to ensure that serious medical incidents, known as “notifiable incidents,” are promptly disclosed to patients or their families, fostering a culture of openness. However, despite being signed into law in May 2023, the Act has not yet commenced as several preparatory steps are still in progress. This article explains what the Act covers, why it hasn’t been fully implemented yet, and what it means for both patients and healthcare providers.

What is the Patient Safety Act 2023?

At its core, the Patient Safety Act 2023 is designed to strengthen patient safety by ensuring that healthcare providers are required to disclose serious incidents, known as “notifiable incidents,” that occur during treatment. These incidents include surgical errors, medication mistakes, or unanticipated deaths.

The Act emphasises the importance of open disclosure, which involves transparent communication between healthcare providers and patients when something goes wrong. By mandating that healthcare providers disclose these incidents, the Act aims to build trust between patients and healthcare providers, ensuring that patients are fully informed about their care. However, Section 1(2) of the Act requires a commencement order for it to take full effect​​.

Current Status of the Act – What Has Delayed Commencement?

Though the Act was enacted in May 2023, its full commencement has been delayed as the healthcare system prepares to implement the necessary infrastructure and training. The Minister for Health has outlined several key steps that need to be completed before the Act can officially commence, including:

  • Updates to the National Incident Management System (NIMS) to handle the increased reporting of notifiable incidents.
  • Roll-out of open disclosure training for all HSE staff, ensuring that healthcare providers are equipped to communicate effectively and transparently.
  • Finalisation of procedures for patient-requested cancer screening reviews​.

These steps are crucial to ensuring the successful implementation of the Act’s provisions. Until these preparatory measures are completed, the Act remains unenforced, and it is unclear when it will come into effect.

Open Disclosure Requirements and Notifiable Incidents

One of the key features of the Patient Safety Act is the concept of mandatory open disclosure. Under this provision, healthcare providers are required to inform patients about serious incidents, termed “notifiable incidents,” that occur during treatment. These include:

  • Wrong-site surgeries or incorrect surgical procedures.
  • Unanticipated deaths following surgery or treatment in otherwise healthy patients.
  • Medication errors that result in death.
  • Pregnancy-related incidents, such as unexpected stillbirths or deaths within 42 days of pregnancy​.

However, there is ongoing debate about whether the list of notifiable incidents should be expanded to include serious but non-fatal injuries. Some stakeholders believe that the current scope of the Act is too narrow and leaves out incidents that, while not fatal, have life-altering consequences for patients. Expanding the list could ensure more comprehensive protection for patients​.

Impact on Medical Negligence Cases

The Patient Safety Act 2023 is poised to have a significant impact on medical negligence claims by providing patients with more transparency and access to critical information. Before this legislation, patients often struggled to obtain detailed information about incidents that could form the basis of a negligence claim. By mandating disclosure of serious incidents, the Act empowers patients to be more informed about what happened during their care. This transparency can be essential when pursuing a legal claim for medical negligence.

However, it is important to note that while healthcare providers must disclose these incidents, any apologies or admissions made during these disclosure meetings cannot be used as evidence of liability in court. This provision aims to balance fostering openness with protecting healthcare providers from automatic legal repercussions. Though healthcare providers are shielded in this regard, the factual information revealed can still be crucial in building a strong medical negligence case​​.

Understanding medical negligence in Ireland can be difficult, but consulting with a seasoned solicitor who is aware of these upcoming acts and how they impact legal cases is key. A solicitor can help navigate the complexities of the law and advise you on the best course of action based on the disclosure of notifiable incidents. This also includes considering why mediation could be your best option for resolving medical negligence cases. While the Patient Safety Act provides greater transparency, having the right legal support ensures that your rights are fully protected as these changes take effect.

What Healthcare Providers Need to Know

Healthcare providers have a crucial role in ensuring the success of the Patient Safety Act. While the Act hasn’t commenced, healthcare providers are encouraged to prepare for compliance by:

  • Training staff on how to conduct open disclosure meetings.
  • Setting up systems to record and report notifiable incidents through the updated NIMS system.
  • Establishing internal procedures to ensure incidents are disclosed promptly and transparently to patients.

Providers must also be aware of their obligations to report incidents to regulatory bodies such as HIQA, the Chief Inspector of Social Services, or the Mental Health Commission within seven days of a notifiable incident​.

Conclusion

While the Patient Safety Act 2023 represents a significant step forward in improving patient safety and transparency in healthcare, its full commencement is still pending. The Act introduces mandatory disclosure of serious incidents, providing patients with greater insight into their care and healthcare providers with clear guidelines for reporting and communication. However, until the required infrastructure and training are in place, the Act’s provisions remain inactive.

At McElhinney & Associates, we are closely monitoring the progress of this legislation. Whether you are a patient looking to understand your rights or a healthcare provider preparing for the Act’s commencement, our team is here to assist. Get in touch today for expert legal advice on how the Patient Safety Act 2023 could affect you.

Disclaimer

In contentious business, a Solicitor may not calculate fees or other charges as a percentage or proportion of any award or settlement.

This information is for guidance purposes only. It does not constitute legal or professional advice. Professional or legal advice should be obtained before taking or refraining from any action as a result of the contents of this publication. No liability is accepted by McElhinney & Associates for any action taken in reliance on the information contained herein. Any and all information is subject to change.

About the Author

Jolene McElhinney, BBLS, Principal Solicitor

Jolene McElhinney is the founding principal of McElhinney & Associates, renowned for her expertise in employment law and personal injury claims across the North West of Ireland. With a distinguished academic background and over a decade of experience, Jolene is dedicated to providing personalised, expert support to her clients, ensuring they navigate the complexities of the legal landscape with confidence and clarity.