Three important regulatory developments occurred during 2017 which may be of significant benefit to patients, families, practitioners and indemnifiers alike. We examine the scope of these developments and their likely impact on the provision of healthcare in Ireland.

Statutory process of open disclosure

The Civil Liability (Amendment) Bill 2017 provides for open disclosure of patient safety incidents. Once commenced, it will provide, for the first time in Ireland, a statutory mechanism by which disclosures can be made to patients while providing a degree of legal protection and legal privilege over the content of the disclosure. The key legal protection is that information provided and any apology made during this statutory process shall not constitute an admission of fault or liability in any later civil or professional disciplinary proceedings. It shall not be admissible as evidence, nor shall it invalidate an insurance or an indemnity.

The process is an entirely voluntary one, and the procedures involved are quite laborious. However, insurers, hospitals and practitioners should have a genuine interest in these procedures being used as the advantages are potentially significant.

These new statutory protections and privileges for practitioners and institutions are a very significant and welcome step. They should encourage openness whilst allaying the fears of practitioners that such disclosures might be held against them in later civil and disciplinary proceedings.

Implications of the Health Information and Patient Safety Bill

While not yet commenced, this far-reaching Bill includes significant patient safety measures.

Mandatory notifications

Mandatory notifications by health services providers of "reportable incidents" to a variety of public bodies and regulators. These include the Health Information and Quality Authority or HIQA, the Irish Mental Health Commission and the State Claims Agency. Reportable incidents include "events of a serious nature" and "no harm events that potentially could have been serious". While the precise response to each notification is not prescribed by the Bill, it seems inevitable that investigation of notifications made will become more common and intensive. This may well result in a sizeable increase in workload on regulators, hospitals and healthcare practitioners.

Limited Protection for Practitioners

Limited protection for practitioners when making disclosures is a concept which is also introduced in the Bill. Notifications are not subject to Freedom of Information (FOI) requests, nor are they admissible in subsequent civil proceedings. However, any documents created in the course of investigating or reviewing an incident that underpinned the notification is not exempt from FOI. They will also be deemed admissible in proceedings. The aim is that this protection will guarantee a culture of openness and disclosure. However, the impact this will have on the risk management process remains to be seen.

Extension of HIQA Powers

Finally, the Bill proposes the extension of HIQA’s remit to private hospitals and certain prescribed private health services and providers.

Assisted Decision Making Capacity Act and Proposed Irish Mental Health Law Reform

October 2017 saw the commencement of a limited number of sections of the Assisted Decision Making Capacity Act 2015 (ADMCA). These included:

  • the appointment of the Director of the Decision Support Service
  • the drafting of regulations and codes of Practice required under the ADMCA, and
  • the development of a national implementation programme.

In addition, the Mental Health (Amendment) Bill has been passed and will hopefully progress through the committee stages swiftly towards commencement. The Bill will resolve the inconsistencies between the ADMCA and the 2001 Mental Health Act, particularly in the approach to addressing capacity. The Bill will bring the Mental Health Act 2001 more in line with the ADMCA which aims to give effect to the “will and preference” of the person.

What’s on the horizon for 2018?

Many of the provisions above, while enacted, have not yet been commenced. Their real test will be in their implementation. If appropriate resources and training are secured, it is far more likely that these new disclosure processes will be used effectively, much to the benefit of patients, families, practitioners and indemnifiers alike. If not, there is a real danger that they will represent a progressive step in the statute book, but will not be reflected in clinical practice.