Home Knowledge Health Information Bill 2023: the Potential to Revolutionise How Healthcare Information is Shared in Ireland

Health Information Bill 2023: the Potential to Revolutionise how Healthcare Information is Shared in Ireland

Ireland could be on the verge of a revolution in the way in which health information is shared, managed and used following the approval of the general scheme of the Health Information Bill 2023 in April this year.

On 22 June 2023, William Fry and the Irish Pharmaceutical Healthcare Association (IPHA) co-hosted a panel discussion on the Bill. David Kirton, a partner in our Life Sciences and Technology groups, chaired the panel. It included key opinion-formers in the health information space, including Muiris O’Connor, Assistant Secretary at the Department of Health, who has been intimately involved in the Bill since its inception, and stakeholders from industry, the clinical research sector and a leading clinician.

The objectives of the proposed Bill

The proposed Health Information Bill aims to implement the legislative framework for a modern, fit-for-purpose national health information system in Ireland. If passed, it will provide a legislative framework for the collection, use and sharing of health information, both for care and treatment and wider health service goals, such as clinical research and public health management.

The proposed Bill provides for the creation of a “summary care record” and introduces a duty on health service providers to share relevant patient-level health information, with the objective of ensuring that health information “follows” the patient throughout their care and treatment.

The Bill also introduces a public interest-led framework whereby that information can be made available to legitimate third parties, for example for use in clinical research.

Protecting patient privacy

The panel agreed on the vital importance of ensuring that patient privacy is protected.

Muiris O’Connor emphasised that, in the development of the Bill, the Department has worked closely with the Data Protection Commission (DPC) and that all recommendations made by the DPC about patient privacy and cybersecurity have been reflected in the proposed draft.

Use of health information for secondary purposes

Research undertaken by IPHA indicates that Ireland lags behind other comparable countries as a venue for clinical trials, and one of the reasons for this is the lack of a centralised source of health information.

To address this gap, as well as providing for the establishment of a centralised national health information management system, one of the key objectives of the proposed Bill is to introduce a framework through which third parties, such as clinical research organisations, can apply to access health information for secondary purposes, for example for use in clinical trials, research or public health planning.  Muiris O’Connor explained that the Bill will apply a “public interest” test to such disclosures.

The panellists highlighted a widespread perception among stakeholders that, at present, the GDPR prevents the use of health information for such secondary purposes.  Eibhlín Mulroe, CEO of Cancer Trials Ireland, argued that, as a result, the GDPR has had a significant chilling effect on clinical trials in Ireland, leading to worse outcomes for cancer patients in particular.

However, there was a consensus amongst the panel that, in general, patients are eager to share their health information and to allow it to be used for secondary purposes.  Professor Frank Sullivan (Medical Director in the Department of Radiation Oncology at the Galway Clinic and Adjunct Professor of Medicine at NUI Galway) argued that, in his experience, transparency is key – provided patients know how their data is being used, they are generally very happy to permit that use.

Therefore, the panel agreed that the Bill’s objective of providing a clear framework for sharing health information and for processing that information for secondary purposes, such as clinical trials, is welcome.

The clinician’s perspective

One of the questions put to the panel was whether the Bill, which imposes a duty on medical practitioners to disclose patient information, alters the relationship between clinicians and their patients.

Professor Sullivan acknowledged the new obligations that are imposed on clinicians but argued that, in practice, clinicians are likely to welcome the provision of guidance on the circumstances in which it is appropriate to disclose information, and again came back to his point that, in his experience, patients are very happy for their information to be processed, provided they have the necessary information to make an informed decision.

Questions remain

The proposed Bill is at a very early stage, and naturally, a number of questions remain open.

Several panel members raised queries about the practical implementation of the system which the Bill seeks to introduce. While the Bill provides a legislative framework, its practical impact will be wholly dependent on whether user-friendly systems which facilitate actual data sharing can be rolled out across the health system.

In this regard, Muiris O’Connor highlighted that international experience has been that it is not realistic to expect all parts of the healthcare system to implement the same system for information-sharing, and it is more realistic to envision a network of different but interoperable systems which can seamlessly share information.  This, in turn, gives rise to questions around the extent to which such different systems will be able to interoperate in a meaningful way.

Killian MacDonald, commercial lead in Ireland for Gilead Sciences and chair of the IPHA clinical research group, pointed out that there are also many practical questions around whether the facility for third parties to access population-level health data for secondary purposes will have a practical impact on the conduct of clinical trials in Ireland.  Much would depend on the quality of data that is available.

The panel also stressed the need for the framework established by the Bill to work in tandem with ongoing developments in this space at the EU level, in particular the European Health Data Space.

Next steps

The Department is currently preparing a draft Bill, which it aims to put before the Oireachtas later this year, with an ambition to have the legislation on the books by the autumn of 2024.


Contributed by Karolina Rozhnova