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The Health Information and Patient Safety Bill (the “Bill”) includes very significant health information proposals. It also contains three key patient safety measures which may pose significant challenges for hospitals, practitioners, regulators and public bodies.

Mandatory notification of incidents

When the Bill is passed, notifications by health services providers of "reportable incidents" to a variety of public bodies and regulators will now be mandatory. Reportable incidents include "events of a serious nature" and "no harm events that potentially could have been serious". The public bodies and regulators to which incidents will be reported include the Health Information and Quality Authority ("HIQA"), the Mental Health Commission (MHC) and the State Claims Agency ("SCA").

Given the diverse nature of healthcare service delivery, a large number and variety of incidents will be deemed reportable. As a result, it is intended that guidelines contained in the Bill will clarify what should and should not be reported. Between 2008 and 2013, 90,000 "clinical incidents and/or near misses" were reported to the SCA on a non-statutory basis. While near misses, which may or may not be serious, are not subject to notification under the new regime, it is expected that significant numbers of notifications will be made following the introduction of a statutory and mandatory scheme. This scheme will be applicable beyond the public system. While the precise response to each notification is not prescribed, 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 disclosures

The Commission on Patient Safety and Quality Assurance helped to shape the patient safety aspects of this Bill. The Commission recommended that in order to guarantee a culture of openness and disclosure, practitioners should be protected when making disclosures. The Bill only partly satisfies the Commission’s recommendation. The notification itself is protected by not being subject to freedom of information (“FOI”) nor is it admissible in subsequent civil proceedings. However, any documents created in the course of investigating or reviewing the incident that underpinned the notification are not exempt from FOI and will be deemed admissible in proceedings. While this provision would seem to incentivise the technical process of notification, it perhaps discourages a thorough risk management investigation by the practitioner or institution making the disclosure.

Extension of the remit of HIQA to private hospitals

The Bill extends HIQA’s remit to private hospitals and certain prescribed private health services and providers. The authority’s remit will not extend to psychiatric hospitals, however, particularly where HIQA’s functions on setting standards, monitoring compliance with standards and undertaking investigations are concerned.


There is significant scope for the patient safety aspects of this new Bill to pose major challenges for hospitals, practitioners, regulators and public bodies. From a political and public perspective, the new mandatory reporting regime will need to show tangible results in the form of an increased level of investigation and recommendations. Only a very limited amount of legal protection is afforded to mandatory notifications under the new Bill. As a result, public and private hospitals and healthcare practitioners need to be aware of and give careful consideration to how these proposed changes impact upon everyday practice.

For more information on how the new provision may affect your practice, please contact a member of our Healthcare Law team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.

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