Ireland prepares for EU digital health regulation    

The European Health Data Space Regulation provides a common framework for the use and exchange
of electronic health data across the EU. Niamh Cahill reports

The European Health Data Space (EHDS) Regulation came into force in all 27 EU member states on 26 March.  Under the regulation, every EU member state will have digital health records in place in about five years’ time.

Ireland has a major task in meeting the EU obligations within the designated timeframes. Where digital healthcare records are in place, they are often fragmented and exist within siloed systems. And now with the clock ticking, more urgency and greater investment is required from the HSE and Department of Health to meet targets.

According to the EU, the EHDS Regulation will enhance people’s access to and control over their healthcare data and enable them to share this data with healthcare professionals across borders (primary use of data). Secondly, it will enable certain anonymised data to be reused for public interest, policy support, and scientific research purposes (secondary use of data). Thirdly, it will “foster a single market” for electronic health record (EHR) systems, supporting both primary and secondary use.

A series of transition phases up to 2031 will allow time for the changes to be fully realised. Each member state is required to appoint three supervisory authorities: A digital health authority to support the governance of health data for primary use; a health data access body to support the governance of health data for secondary use; and a market surveillance authority to monitor compliance of EHR systems with the EHDS regulation. 

A Department of Health spokesperson told the Medical Independent (MI) that these supervisory authorities must be appointed by March 2027. 

“Work is currently underway in preparing for these appointments and decisions around resourcing will be made in that context,” the spokesperson said.

The implementation of the EHDS will “provide patients with a number of benefits including access to and more control over their personal health data”, stated the spokesperson. The regulation will also provide healthcare professionals with “faster and easier access to their patients’ health records across different healthcare providers and borders”.

The Health Information Bill

An important component in meeting the EU’s regulatory requirements is the Health Information Bill 2024. It aims to improve the use of health information in Ireland, according to an overview paper by the Department.

“The right information needs to be available in the right place, at the right time, to ensure the best care and treatment for patients. The Health Information Bill helps to achieve this. [It] will also support Ireland’s EU obligations.”

The legislation will support the Department’s Digital for Care – A Digital Health Framework for Ireland 2024-2030, published in May 2024. It will also reflect the HSE’s Digital Health Strategic Implementation Roadmap, published in July 2024.

The Bill cleared the second stage in the Dáil in September 2024 prior to the dissolution of the 33rd Dáil. “The Bill has now been restored to the Dáil order paper and is awaiting committee stage,” the Department spokesperson stated.

The Bill provides for the establishment of digital health records for all patients in Ireland. The contents of the record reflect the priority categories within the EHDS Regulation, including the patient summary; e-prescriptions; e-dispensations; medical imaging studies; medical test results; and discharge reports

It will ensure patients have enhanced access to their own health information. The Bill also introduces a duty on healthcare providers to share health information with each other when it supports the care and treatment of a patient. This information-sharing should be timely, secure, and in a digital format. In keeping with data protection principles, the information-sharing must be ‘necessary, relevant and proportionate’ to the provision of care and treatment.

The Bill strengthens the provision of health information to the HSE for certain secondary purposes relevant to its statutory remit of improving, promoting and protecting the health and welfare of the public, such as the promotion of patient safety and public health, protection against serious health threats, service planning, performance management, and statistics in the health or care sectors. The Bill also sets out the HSE’s obligation to ensure high levels of data protection and cybersecurity to protect patient information.

According to the Department’s paper: “In 2025, there will be a Statutory Instrument (secondary legislation) on the EHDS. In 2026, the future Health Information Act will be expanded to cover secondary use more broadly. This will include provision for a national health data access body and a permit system for use of health information for a wider range of secondary uses, including teaching and training, research, and innovation.”

EHR

The HSE plans to secure Government approval later this year for the EHR business case and to begin procurement. A HSE spokesperson told MI: “The national electronic health record programme, established in 2024, will be progressing a business case for approval and procurement process thereafter ensuring full compliance with GDPR, the Health Information Bill and the EHDS.”

“The launch of the first version of the new HSE Health App in February 2025, allowing people to carry a digital list of self-declared medications represented the next step forward in our digital transformation journey. The procurement of the national shared care record will play a key role in achieving the Sláintecare vision of patient-centred, integrated care by joining up fragmented and siloed digital records.

“Other programmes of focus this year include escalating our medical laboratory system roll-out, progressing a foundational system in our community services, continuing to develop a framework for AI [artificial intelligence] in healthcare, and strengthening our cybersecurity to meet EU directives,” the spokesperson added.

As reported in the previous edition of MI, the HSE has issued a preliminary market consultation on national EHR services. The EHR implementation process will occur on a phased and regional basis. The system is due to be fully embedded by 2032.

Digital for Care

The HSE Digital Health Strategic Implementation Roadmap 2024-2030 provides definitions on key terms in digital healthcare.

An EHR is defined as “a digital version of a patient’s medical record that is designed to be shared between different healthcare organisations, such as hospitals, clinics, and pharmacies. EHRs are designed to improve patient care coordination and communication between healthcare providers.”

A shared care record is “a digital record aggregated from various electronic data sources that provides a holistic view of a patient’s health status across healthcare settings. It can contain information about a patient’s diagnoses, test results, procedures, care plans, and more.”

Finally, a summary care record is “a digital snapshot of a patient’s essential clinical information including medications, and allergies available to healthcare professionals”.

The HSE’s roadmap states how the objectives outlined in Digital for Care will be implemented.

The roadmap is a “business case” for securing the necessary funding and governance required to meet Ireland’s EU and national obligations. It stresses that investment is crucial if plans are to succeed and provides a detailed outline on the type and amount of resources required.

“To achieve the transformation outlined in the roadmap, a balanced investment is crucial, not only in terms of capital, but also in the allocation of whole-time equivalent and non-pay revenue.

“This investment must be distributed across clinical, operational, and technology and transformation both nationally and regionally. The roadmap’s success through to 2030 hinges on the commitment to yearly increases in both capital and revenue funding, accompanied by a corresponding increase in staffing levels.

“The workforce, data, and operational infrastructure are foundational to the initiatives’ success, and as such, they are a primary focus of the investment strategy. An annual digital health budget of between 4 per cent and 6 per cent of the overall healthcare expenditure, which is inclusive of current funding, is being sought to deliver the initiatives outlined in the roadmap and is yet to be approved. The timing of the implementation of the initiatives in the roadmap is dependent on the funding being secured through the annual funding mechanisms.”

It is estimated that over €1 billion a year will be required over the course of seven years based on budgetary estimates in the roadmap. 

Clinicians

According to Dr Conor O’Shea, Coordinator of the National General Practice Information Technology (GPIT) group, it is working with the HSE on what elements of GP records would appropriately populate the shared care record. In particular, the focus is on how this can be done safely and without creating an excessive workload.

“That is early stages and is very much a HSE project,” Dr O’Shea told MI.

“They’re looking at not just GP records, but all sorts of data to populate the shared care record. That is starting to materialise in terms of the new HSE Health App, as the patient-facing part of the shared record.”

Patients need a MyGovID account to log into the app and access personal health information.

The app, in its current format, allows individuals to carry a digital list of self-declared medications and a list of any medicines received through the drugs payment scheme or medical card scheme.

The app can store a digital European health insurance card, medical card, long-term illness card, drugs payment scheme card, and GP visit card.

Patients can also view influenza and Covid-19 vaccination records and find information on HSE services. Maternity patients can view upcoming appointments.

Speaking on its launch, Mr Damien McCallion, HSE Chief Technology and Transformation Officer, explained that the app was an “evolving programme of work” with new services and features planned each year, including expanding the appointment functionality for all public hospital appointments.

“This is a challenging undertaking, but a key priority to deliver for everyone under our care,” he said.

Workload

Some healthcare professionals are concerned that meeting legal obligations to supply health information will demand significant time – which they can ill-afford given already overburdened workloads.

Commenting on the Health Information Bill, Dr O’Shea said: “We will have to comply with the legislation. It’s a question of trying to ensure that our records are constructed in such a way that the right information goes out in the right format and that GPs have knowledge and control of what information may be shared. It should be done ideally without any extra workload.”

He also explained what the EHDS Regulation will mean in practical terms for patients and clinicians. “If you’re on your holidays in Spain, for example, and you get ill while you’re away, there will be a way of identifying medical information and medication history,” Dr O’Shea said.

“In time, that will be increased to include lab results, radiology, that kind of stuff. But there is a basic summary record with information on medication and while the concept is nothing new, the concept of sharing medical information across borders is something that we have been working on for a number of years.

“We’ve been waiting to get that basic information in place in Ireland so that we can allow citizens access to their information were they to become unwell abroad and also from the doctor’s perspective, if we were to see an EU citizen [becoming] unwell in Ireland, then we would have access to some of their records as well.”

Work is ongoing on the development of a shared care record, Dr O’Shea added.

“At a national level, there is a lot of work in getting the shared record up and running because you have to look at all the available data sources to see what information you can obtain, what quality the information is, and how usable it is.”

Dr O’Shea spoke about the difficulties of transferring information from one system to another. He remarked that it can be easier to transfer to another system if information is coded.

“From a GP’s perspective, and I guess from [every clinician’s] perspective, what one wants to ensure is that the process of the information being transferred to a central record is seamless and doesn’t involve any extra work,” he noted.

“GPs and other clinicians need to be confident that the right information is being transferred in the right kind of way and that information is not being sent in an inappropriate format. But we don’t want to be spending a lot of time checking it either, so there is a little bit of balancing those things.

“The other end of it is what does the HSE want from GPs in particular; they may not want everything that is in GPs’ records. The purpose of it is to get a safe and accurate medical record for the patient, which can be shared with the patient or any healthcare professional who is looking after the patient, with appropriate permission.”

According to the HSE, digital health initiatives will bring significant benefits to patients and healthcare staff over the coming years. 

“Patients will have access to, and control over, their personal health data, such as electronic prescriptions, medical test results, and discharge reports; there will be continuity of care through integrated health records, improved safety and reduction in errors,” said the spokesperson. “Healthcare staff can make informed clinical decisions with access to comprehensive patient data and these digital platforms will help facilitate better coordination between departments.”