Open Disclosure

This information has been prepared to support doctors with the recent changes regarding open disclosure. The following sections define open disclosure, outline recent changes, set out the expectations of registered medical practitioners in open disclosure and outlines the role of the Medical Council as a professional regulator.

What is open disclosure?

Healthcare is complex, and sometimes things go wrong, which may result in harm to patients. Open disclosure is an honest, open, compassionate, consistent and timely approach to communicating with patients, and, where appropriate, their family, carers and/or supporters, following patient safety incidents. It includes acknowledging what has happened, expressing regret for what has happened, keeping the patient informed and providing reassurance in relation to ongoing care and treatment, how lessons will be learned from what happened, and the steps being taken by the health services provider to try to prevent a recurrence of the event.

Open disclosure is a feature of high-quality health and social care and is an important contributor to patient safety.

What is a patient safety incident?

A patient safety incident, in relation to the provision of a health service to a patient by a health services provider, means “an incident which occurs during the course of the provision of a health service” which:

a) has caused an unintended or unanticipated injury, or harm, to the patient

b) did not result in actual injury or harm to the patient but was one which the health services provider has reasonable grounds to believe placed the patient at risk of unintended or unanticipated injury or harm or

c) unanticipated or unintended injury or harm to the patient was prevented, either by “timely intervention or by chance”, but the incident was one which the health services provider has reasonable grounds for believing could have resulted in injury or harm, if not prevented (Civil Liability (Amendment) Act 2017).

Therefore, a patient safety incident includes harm events, no harm events, and near miss events.

What is an adverse event?

An adverse event is an incident which resulted in harm that may or may not be the result of an error.

What has changed?

Open disclosure is not a new concept within healthcare. Most doctors are aware of open disclosure, particularly in relation to existing HSE policy. In 2023, a national framework was introduced in this area, followed by new legislation in 2024.

Framework

The National Open Disclosure Framework was launched in September 2023. Driven by the National Patient Safety Office of the Department of Health, the Framework aims to provide a consistent and unified approach to open disclosure across all public and private health and social care providers, health and social care professional regulators, health and social care educators, and other relevant bodies and organisations. Each relevant organisation has specific responsibilities in relation to adopting the Framework and in embedding positive open disclosure cultures and behaviours into practice.

Legislation

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (the Act) was enacted in September 2024 and applies to all public and private health services. The Act places emphasis on open disclosure and introduces a legal requirement for mandatory disclosure of 13 specified incidents, known as notifiable incidents, most of which result in death. The process of open disclosure is specified in the Act. This includes the requirement for mandatory notification of notifiable incidents to the appropriate regulatory body.

The Act also provides protections for staff in relation to clinical audit and permits patients the right to request a review of certain cancer screening results. A snapshot of key changes is presented below:

Recent-changes-regarding-Open-Disclosure-(700-x-350-px)-(1)

The HSE provide a helpful summary of the Act available here.

The Act differs to the Civil Liability (Amendment) Act 2017, which in contrast, applies to all patient safety incidents that are not notifiable incidents, and is considered “voluntary” as healthcare professionals can choose to seek the protections of the Civil Liability (Amendment) Act 2017 for any patient safety incident that is not a notifiable incident. It is important that you familiarise yourself with both pieces of legislation.

Principles of open disclosure

Open disclosure is underpinned by six key principles:
1. Open, honest, compassionate and timely communication.
2. Patient/ service user and support person’s entitlement in open disclosure.
3. Supporting health and social care staff.
4. Promoting a culture of open disclosure.
5. Open disclosure for improving policy and practise in health and social care.
6. Clinical and corporate governance for open disclosure.

Summaries of what these principles look like in practice are available within the National Open Disclosure Framework.

Role of the medical practitioner in open disclosure

The obligation to report a notifiable incident resides with the health service provider. This will typically be a hospital setting, given the nature of the specified notifiable incidents.
Health practitioners are obliged to inform the health service provider, as soon as possible, when they believe a notifiable incident has taken place. This is regardless of whether it is considered to have occurred whilst under the care of another provider.

A registered medical practitioner within the meaning of the Medical Practitioners Act 2007 (as amended) or a medical practitioner practising medicine pursuant to section 50 of that Act, fall under the definition of health practitioner.

The Patient Safety Act defines ‘health service provider’ and ‘health service practitioner’. As a doctor, it is important that you familiarise yourself with these definitions as for some practitioners, they may also be the health service provider, for example a GP operating a GP service.

The National Open Disclosure Framework provides further detail on open disclosure in practice and the requirements of health service providers.

Role of the Medical Council in open disclosure

As a professional regulator, the Medical Council has a key role in the lifecycle of a doctor. The role of professional regulators in this regard has been utilised under the National Open Disclosure Framework, where professional regulators now have specific responsibilities to help support embedding a culture of open disclosure within the Irish healthcare system. For the Medical Council, this involves ensuring that open disclosure is embedded in regulatory guidance and in the activities of the providers and programmes that it regulates. This includes medical schools, intern training providers, postgraduate training bodies and approved clinical training sites.

To ensure this, open disclosure is included in the Medical Council’s quality assurance standards for medical education and training, as well as its guidance for the profession, including the Guide to Professional Conduct and Ethics for Registered Medical Practitioners.

For information on CPD in this area, contact your postgraduate medical training body. Alternatively, the HSE provide an array of resources to support understanding of open disclosure.

Expectations of the profession

The Guide to Professional Conduct and Ethics for Registered Medical Practitioners (the Guide) sets out the expectations of registered medical practitioners and this includes open disclosure. Specifically, the Guide states:
• When a patient safety incident occurs, the response from health service providers, including doctors, must be professional, and empathetic.
• You must practise, promote and support a culture of open disclosure.
• You must comply with any applicable legislation and any national policies regarding open disclosure.

Supports for doctors

Open disclosure is a service-user centred process. When things go wrong in healthcare, it is also important to recognise the impact this has on the health and social care professionals involved or affected by such events or incidents.

The National Open Disclosure Framework specifies that all staff delivering health and social care must be:
• encouraged, facilitated, empowered, and obliged to recognise and report patient safety incidents and adverse events.
• provided with training and education in open disclosure and communication skills (with emphasis on face-to-face skills training).
• provided with debriefing, and critical incident stress management.
• prepared to participate in open disclosure.
• supported through the open disclosure process by the health and social care provider.
• supported in engaging in any audit of open disclosure practice.

Supports for the public

The National Open Disclosure Framework specifies key considerations and entitlements to be reflected in organisational policies to appropriately support patients/ service users and their support person(s). The right to be provided with support services and be advised of the mechanisms to raise concerns or make a complaint about the open disclosure process, patient safety incident or adverse event, are also detailed.

Resources

• Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023
• National Open Disclosure Framework
• HSE resources for staff and organisations
• HIQA guidance on reporting notifiable incidents
• HSE information and resources for the public

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