Róisín Shortall (Dublin North West, Social Democrats)
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320. To ask the Minister for Health the timeline that he is working towards in progressing the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 through all stages of Dáil and Seanad Éireann; and if he will make a statement on the matter. [58625/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 (Patient Safety Bill) builds on the foundations provided for by the Houses of the Oireachtas in relation to open disclosure as set out in the Civil Liability (Amendment) Act 2017 and Regulations 2018. The development of the Patient Safety Bill arose out of the Government’s Decision of 8 May 2018, which directed that the patient safety elements of the Health Information and Patient Safety Bill dealing with:

- Mandatory external notification of patient safety incidents;- Clinical audit; and - The extension of HIQA's remit to private hospital services

be incorporated into a new Patient Safety Bill. In addition, in accordance with the Government decision, it was agreed that provision should also be made for mandatory open disclosure in the Bill in respect of serious patient safety incidents, further to the undertakings provided by the Minister for Health to the Oireachtas during the passage of the Civil Liability (Amendment) Act 2017. The Patient Safety Bill has been developed in line with this direction.

The Bill was introduced to the Dáil and passed Second Stage on 12 December 2019.

The Bill, including three additional amendments mandated by the Government Decision of December 2019, passed Committee Stage in the Dáil on 10 March 2022.

A key provision of the Patient Safety Bill is to ensure that patients and their families have access to comprehensive and timely information, including an apology where appropriate, in relation to serious patient safety incidents. This contributes to embedding a culture whereby clinicians, and the health service as a whole, engage openly, transparently and compassionately with patients and their families when things go wrong.

The Patient Safety Bill provides for mandatory open disclosure to patients and/or their families/caregivers of specified serious patient safety incidents and also provides for the mandatory external notification of those same events to the appropriate body. The Bill contains a Schedule listing a number of the most serious notifiable patient safety incidents, including maternity related incidents, which are subject to mandatory open disclosure. The incidents listed are of a very serious nature, resulting in the main in unintended or unanticipated death.

The Bill also 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 advancement in clinical practice and international developments.

It is intended to bring the Bill to Report and Final Stages during this Dáil Session. The Bill will then progress through the Seanad.