David Cullinane (Waterford, Sinn Fein)
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820. To ask the Minister for Health his plans to progress legislation on mandatory disclosure; the penalties for non-disclosure; the persons or bodies to which they will and will not apply, respectively; the reason for this disparity; and if he will make a statement on the matter. [9637/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Patient Safety (Notifiable Patient Safety Incidents) Bill provides the legislative framework for a number of important patient safety measures, including: mandatory open disclosure of specified serious patient safety incidents, including a process to designate other patient safety incidents in line with advancements in clinical practice, and the notification of these serious incidents externally to the Health Information Quality Authority (HIQA), the Chief of Inspector of Social Services (CISS) and the Mental Health Commission (MHC) to contribute to national learning and system-wide improvements. Mandatory open disclosure and external notification of notifiable incidents will equally apply to the public and private health services.

A Government Decision on the 3 December 2019 approved the text of the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019, enabling it to be introduced into Dáil Éireann on the 12 December 2019 where it passed the First and Second Stage.

The Bill adopts a dual approach to the designation of notifiable patient safety incidents which are the subject of mandatory open disclosure. Firstly, it lists a small number in Schedule 1 to the Bill and secondly it sets out a process by which the Minister for Health may make regulations expanding the list of notifiable patient safety incidents over time in line with advancements in clinical practice and international developments. The Bill also sets out a process by which the Minister for Health will make regulations expanding the list of notifiable patient safety incidents over time in line with advancement in clinical practice and international developments.

Additionally, the Bill includes a duty of openness and transparency on health service providers. In section 12 of the Bill a specific obligation is placed on health services providers (with an identical one placed on health practitioners) to ensure that all relevant information is provided to the patient and their family in the course of making an open disclosure of a notifiable incident.

The provisions of the Bill will apply to all health services providers and health practitioners. Section 3 of the Bill explains in detail which organisations and individuals fall within the scope of the definition of health services provider. In essence, a health services provider is intended to include public and private organisations and entities involved in providing health services, such as hospitals, clinics, nursing homes, primary care centres etc. For the purposes of this legislation a health practitioner is defined as including registered healthcare professionals such as medical doctors, nurses, midwives, dentists, pharmacists, health and social care professionals and ambulance personnel.

Section 49 of the Bill sets out that a health services provider who fails to comply with the obligations to make an open disclosure of a notifiable patient safety incident (section 5(1), 19(9), 20(5)) to a patient and /or their relevant person, without reasonable excuse, shall be liable on summary conviction to a class A fine. It is open to an individual to take a case against a health services provider who they believe has failed to comply with the obligation to ensure that open disclosure took place as required by the legislation.

If a health practitioner does not engage in open disclosure as they are required to do under this legislation, then this would be a matter for the relevant health professional regulatory body ( such as the Medical Council, the Nursing and Midwifery Board, the Dental Council and other regulatory bodies).

The Bill is part of the current Programme for Government and due to go to Dáil Committee Stage at the earliest opportunity.