Ireland’s new Health Information Bill sets out new rules that will mean all healthcare providers will have a ‘duty to share’ patient health data and will establish a right for patients to easily move their health information between providers.

The Bill, which was published late last week, will require healthcare providers to make arrangements for the transfer of patient health records they hold in the event of closure. This will have a particular impact in the event of a GP practice closing down.

Failure to comply with the requirements of the Bill could result in legal action.

The legislation, once enacted, will also provide a legal basis for digital health records (DHR) in Ireland, along with legal provisions on the sharing of patient data for care and treatment.

It will also support Ireland’s obligations under the European Health Data Space (EHDS) Regulation, which will enter into force in autumn 2024.

The categories of health information in digital health records will align with those set out in the EU EHDS Regulation.

Each record will include a patient summary containing a high-level overview of the patient’s health status, including any diagnoses, allergies, and care plan. The DHR will also include information on prescribed medications, medical imaging, laboratory test results, and discharge reports.

The DHR will be accessible to the patient or an ‘appropriate person’ authorised by the patient. It will be available to different health services providers, but only for the purposes of care and treatment. The information will also be available to the HSE for the purpose of record maintenance.

Under the Bill, patients have enhanced rights to access and control their own health information. Not only will patients be able to access their own health record in full, they will also be able to request correction of information they believe to be wrong, and obtain information on who accessed their record and when.

The legislation also grants patients the right to restrict access to information so it cannot be seen by health services providers.

However, a health services provider can over-ride a patient restriction in emergency situations and can also delay or restrict patient access to information, such as diagnoses or lab results, if there are reasonable grounds to believe that such access would cause serious harm to the physical or mental health of the patient concerned.

A health services provider who receives a request for relevant patient information will be required to deliver that information within a month and free of charge, or face legal action.

A healthcare provider who intends to cease providing health services will be required to notify each patient about the arrangements they will be taking to ensure that their personal health data is transferred to another health services provider who will provide such services.

The Bill makes it easier for the HSE to obtain health information for secondary use. The HSE will be able to request relevant information from any organisation it works with, including voluntary and private hospitals as well as GPs. The information requested will have to be provided.

This is a considerable power and hence the Bill places specific obligations on the HSE. The Executive will be required to publish details of the information requested, what it was used for, and a summary of the results. The information can only be retained by the HSE for as long as is necessary for the stated purpose.

Commenting on the Bill, Minister for Health, Stephen Donnelly said: “Integrated care, as envisioned in Sláintecare, needs the right information, in the right place, at the right time.

“The Health Information Bill gives patients greater access to their own information so they can make informed decisions about their health and care options. It also enables health professionals to have a more complete, holistic view of the patients they are treating.

“This will transform how we access and use health information for care and treatment, as well as for important secondary-use purposes such as research and innovation.

“By harnessing digital, and unlocking the power of quality data, we are laying the foundations for an innovative, efficient, and truly modern health service.”

The Health Information Bill 2024 is the first in a package of legal measures required to give effect to the EHDS Regulation. In 2025 there will be secondary legislation on the EHDS and in 2026, the Health Information Act will be expanded to cover secondary use more broadly.

This will include provision for a national health data access body (HDAB) and a permit system for use of health information for a wider range of secondary uses including research and innovation.

The Health Information Bill now needs to be passed by both Houses of the Oireachtas before it can be signed into law.

The Department of Health has been called on to prepare detailed regulations on access arrangements and the HSE will prepare guidelines, which will include details on the digital format, standards and interoperability requirements.