On 5th July 2018, the government approved the general scheme of the Patient Safety Bill. This Bill provides for mandatory open disclosure, mandatory external notification of patient safety incidents, clinical audit guidance and the extension of remit of the Health Information and Quality Authority (HIQA) to private hospitals.
The Patient Safety Bill will now be referred to the Health Committee.
The Civil Liability Amendment Act, 2017, provides the legal framework to support voluntary open disclosure. The Act applies to all patient safety incidents including near misses and no-harm events. It provides for an open and consistent approach to communicating with patients and their families and providing an apology, as appropriate, when things go wrong in healthcare.
The provisions are designed to give legal protection for the information and apology made to a patient during open disclosure when made in line with the legislation. The apology cannot be used in litigation against the provider. The approach is intended to create a positive voluntary climate for open disclosure.
The Minister signed the commencement order on 3rd July 2018 for this legislation and signed the regulations to accompany the Act on 4th July 2018. These came into effect on 23rd September 2018.
The provisions are an enhancement of one part of the open disclosure procedure and are in addition to the current open disclosure policies and procedures in place with the health service. The next step will be mandatory open disclosure which forms of the Patient Safety Bill as outlined above.
Report on the Pre-Legislative Scrutiny on the ‘Open Disclosure’ provisions, to be included in the Civil Liability (Amendment) Bill – February 2017
CMO Opening Statement on Open Disclosure to the Joint Committee on Health – 13 October 2016
Information Note on Open Disclosure to the Joint Committee on Health – 28 July 2016