As the Deputy will be aware, both the Department of Health and the HSE are absolutely committed to upholding the principles of open disclosure, and a variety of policy and legislative measures to support its operation are in place, with further developments being planned.
Open disclosure is an integral element of patient safety incident management and learning. It is about an open, honest and consistent approach to communicating with patients and their families when things go wrong in healthcare. The background to the legislative provisions to support open disclosure lies in the Commission on Patient Safety and Quality Assurance (July 2008) which recommended that legislation be enacted to provide legal protection/privilege for open disclosure of adverse events to patients.
The Civil Liability (Amendment) Act 2017 which was passed by the Oireachtas in November 2017 provides the legal framework to support voluntary open disclosure. Part 4 of the Act applies to all patient safety incidents, including near misses and no-harm events, and provides provisions to create a safe space for staff to be open and transparent with patients in order that they can be given as much information as possible, as early as possible, including an apology where appropriate. The Act of 2017 provides legal protection for the information given following a serious patient safety incident, and ensures that any apology cannot be interpreted as an admission of liability or used in litigation against the provider. Of course, a patient subject to harm will still have the right to seek redress under the law, based upon the circumstances of the case and their medical records. Part 4 of the Act of 2017 and the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018 came into effect on 23 September 2018.
This legislation is an additional support to health professionals undertaking an open disclosure, and it is important that they in turn engage compassionately with patients, listen to the patient’s experience and their individual requirements, and respond in a meaningful and proactive way.
During the Report Stage debate of these provisions, I also committed to examining how legislation could be expedited to provide for mandatory open disclosure to patients of serious incidents. The general scheme for the Patient Safety Bill, approved by Government on 5 July 2018, provides the legislative framework for a number of important patient safety issues, including mandatory open disclosure of a list of serious patient safety incidents and the notification of same externally to the Health Information Quality Authority and the Mental Health Commission to contribute to national learning and system wide improvements. The Bill will also contain provisions in relation to clinical audit and the extension of the Health Information and Quality Authority's remit to private hospitals.
The Bill is part of the broader programme of legislative changes and policy initiatives being taken by the Department so as to improve the ability of the health service to anticipate, identify, respond to and manage patient safety issues. Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making services safer.
The general scheme of the Patient Safety Bill underwent pre-legislative scrutiny at the Oireachtas Joint Committee on Health on 26 September 2018. The Bill will build 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. Officials of my Department and the Office of the Parliamentary Counsel are continuing to progress this legislation. It is intended that the Patient Safety Bill will be introduced in the Autumn Dáil session.