The general scheme of the Patient Safety Bill (“the Bill’) was brought to Cabinet on 5 July 2018 by the Minister for Health, Simon Harris.

The Bill aims to address the issue of patient safety by providing for the mandatory open disclosure of serious patient safety incidents to those who have been harmed by them. It is hoped that this will promote and create a culture of patient safety in the wake of several recent high profile and tragic incidents which have served to undermine public confidence in the Irish health system. It is intended that Ministerial regulations will be used to prescribe what constitutes a serious patient safety incident that would be subject to mandatory open disclosure under the Bill.

The Bill provides for a similar system to the UK where the Duty of Candour operates. This statutory Duty applies to NHS Bodies (Trusts, Foundation Trusts and Special Health Authorities) from November 2014 and is contained within section 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It was extended in April 2015 to cover all other care providers registered with the Care Quality Commission (“the CQC”). It is of particular interest that the Duty of Candour places the onus of mandatory open disclosure on health services providers but not on individual health practitioners. It remains unclear whether the Bill will place the onus of mandatory open disclosure on both health services providers and individual health practitioners. If so, the obligation of mandatory open disclosure may go further in Ireland than in the UK.

The Bill is intended to compliment Part IV of the Civil Liability (Amendment) Act 2017 (“the 2017 Act”) which provides for the open disclosure of patient safety issues. These provisions of the 2017 Act are designed to give legal protection to the information and apology given to a patient when made in line with this legislation.

A further issue which the Bill seeks to address is the current lack of regulation in the private sector by extending the powers and responsibilities that the Health, Information and Quality Authority (“HIQA”) currently exercises in relation to public hospitals to private hospitals as well. This will allow HIQA to set standards for the operation of private hospitals, to monitor compliance with them and to undertake inspections and investigations as required.

The Bill will now go before the Oireachtas Health Committee. The general scheme of the Patient Safety Bill can be viewed here.