First introduced by the European Commission in 2022, the European Health Data Space (EHDS) is a data-sharing infrastructure framework designed to put power back into patients’ hands.

The legislation is two-fold. Firstly, every patient and citizen in Europe will have access to, and control over, their own digital health information, including when they travel in Europe. The second part of the EHDS will enable large anonymised datasets to be made available for research, innovation and policymaking.

European Health Data Space implementation

A lengthy legislative process at EU level has now passed, and implementation of the EHDS can begin across Europe. Ireland has until 2030 to introduce an Electronic Health Record (EHR) system nationwide to comply with the framework.

In the short term, data collected under the EHDS will enable faster and more effective development of new drugs and medical technologies, such as AI tools to assist diagnosis. Clinicians will have access to more comprehensive information about a patient’s medical history to prescribe targeted personalised treatments. Patients will be empowered to take control of their health by making data-driven choices.

Enabling a proactive approach

In the long term, we could see a shift from treatment to prediction and prevention. A national EHR is just the start. Under the EHDS, there are 17 different categories for electronic data to enable research, including genomic data.

The establishment of the Genome of Ireland project was recently announced where the genomic dataset of approximately 1,200 people living in Ireland will be captured. This contributes to the wider Genome of Europe initiative, which 500,000 European citizens are set to get involved in. The EHDS will be a key enabler to this pan-European project.

In the long term, we could
see a shift from treatment to
prediction and prevention.

Data-sharing and fostering trust

Research conducted by EIT Health found that patients are generally in favour of sharing their anonymised data, if used securely, with aspirations of helping others. Access to a multitude of diverse datasets, like never before, can accelerate research into life-saving treatments for rare diseases and advance disease prediction, identifying individuals who may be predisposed to certain risk factors.

As EHDS implementation begins, public engagement will be important to build trust and communicate why we need a health data-sharing framework. Actions could include:

• Largescale health and digital literacy campaigns
• Patient advocates communicating the EHDS
• Patient decision-making roles on EHDS governing boards

Interacting with healthcare more efficiently

The EHDS affords us a clear path forward and timeline for implementation of an EHR. This isn’t just another regulation; it’s an opportunity to transform how we interact with healthcare and share learnings with others in Europe on the journey to digitisation.

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For patients with complex illnesses like cancer, autoimmune diseases, genetic disorders and neurodegenerative conditions, advanced therapies offer life-changing potential.

Advanced cellular therapies use living cells or genes to target and even cure diseases. A prime example is CAR-T cell therapy, where a patient’s immune cells are extracted, reengineered to better recognise and attack cancer cells, and then reintroduced into the body. Unlike traditional medicines, these therapies are designed to work with a patient’s unique biology.

Ireland falls short in cell and gene therapy investment

Globally, these therapies are transforming healthcare. In Ireland, however, access to such innovations is still limited. In 2022–2023, only 1.5% of the €2.6 billion invested in Ireland’s biopharma sector was directed toward cell and gene therapies. Without expanded clinical trials, specialised manufacturing facilities and stronger connections between research and clinical care, Ireland risks losing its competitive edge in this rapidly evolving field.

Ultimately, this means that Irish patients could face delayed access to innovative treatments, the financial burden of seeking care abroad or limited or no access to potentially life-saving therapies. There is hope, however, through IMPACT, a new all-Ireland research centre designed to position the country at the forefront of personalised advanced cellular therapeutics.

In 2022–2023, only 1.5% of the €2.6 billion
invested in Ireland’s biopharma sector was
directed toward cell and gene therapies.

Hub aims to advance precision healthcare

Supported by NIBRT, the cornerstone of Ireland’s biopharmaceutical training and research, IMPACT will create a national innovation hub to connect research institutes, hospitals, manufacturing facilities and industry partners. This collaboration will accelerate the clinical translation of new therapies, making them more accessible and affordable for patients. IMPACT’s personalised approach ensures that treatments are tailored to each patient’s individual biological profile.

This initiative aligns with both Ireland’s new Life Sciences Strategy and the European Commission’s push to strengthen biotechnology as a driver of competitiveness and strategic autonomy. With strong national support and partnerships across Europe, Ireland is well-positioned to lead in regenerative medicine and advanced therapeutics.

Strengthen Ireland’s position in advanced medicine

IMPACT’s mission is clear: improve patient access; reduce treatment costs; and strengthen Ireland’s healthcare ecosystem. By addressing these critical needs, Ireland can secure its place as a leader in regenerative medicine and precision healthcare.

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The ‘healthcare transformation era’ involves addressing chronic disease management, workforce shortages, ageing populations and digitisation to enhance productivity and maintain regulations that protect patients while fostering innovation.

Digitisation presents tremendous opportunities. Globally, there is a shift from needs-driven treatment to preventative, planned and patient-centred healthcare.

Healthcare milestones for Ireland

Despite being behind, progress is being made both in government and the HSE. Milestones such as the AI Act, the European Health Data Space and the Health Information Bill will ensure safety and support the capability to deliver solutions. The Digital for Care roadmap and HSE Implementation Plan will provide strategic direction.

With the HSE’s move to six new regions, there is a push for a more integrated, patient-centred approach, improving access, integration and accountability. Recently, the Irish Government announced a record €25.8 billion allocation to the health sector, marking a €2.94 billion increase compared to 2024.

The Digital for Care roadmap
and HSE Implementation Plan
will provide strategic direction.

Advancing digital healthcare together

This is a time of super convergence in healthcare, with rapid integration of advanced technologies such as AI, genomics, robotics and precision medicine. Technologies are converging in new and unexpected ways, leading to significant advancements and benefits to human health and healthcare delivery.

Trusted collaboration is essential to harness the full potential of this super convergence. It requires meaningful collaboration between key stakeholders in government, the healthcare system, industry, academia and patients. It provides the necessary elements for success, including multidisciplinary expertise, resource sharing and an innovation ecosystem where stakeholders thrive together.

Frameworks and agreements enable meaningful action

Patient-centred care is a priority, ensuring needs are met and aligning policies and regulations supports the safe and effective use of new technologies while enabling innovation. The inclusion of a Life Science Strategy in the new programme for government is welcomed as a critical enabler of essential connectivity and alignment across the ecosystem.

HealthTech Ireland, along with its members and the HSE, is driving progress through milestones such as the first public/private centre of excellence for sustainable supply chains. The work began with senior leaders in health and on the recently launched Memorandum of Understanding. By embracing opportunities and addressing challenges, Ireland’s healthcare system is poised to thrive in this ‘era of transformation.’

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A leading healthcare expert highlights the need to break down digital barriers to help deliver better outcomes for patients.

A significant barrier to sharing healthcare data remains the different coding systems and terminologies used for patient records, says Cathy McCartan, Director of Dedalus Healthcare Ireland, a European healthcare software provider supporting clinical decision-making across Ireland. McCartan emphasises that standardising clinical terminology can enhance healthcare delivery and patient outcomes.

Terminology alignment

With Ireland set to introduce its Digital for Care 2030 plan, terminology alignment and standardised data models are going to play a “major role in its success,” says McCartan. McCartan’s company provides technology for scheduling, predicting health outcomes, managing electronic health records (EHR) and handling diagnostics and lab results, all while prioritising the patient at the core of the process.

We strive to be a software company
that keeps the interests of the patient
in mind with everything we do.

Healthcare ecosystem

An important aspect is Dedalus’ Clinical Terminology Services, which provides an effective way of implementing and accessing terminologies and classifications such as SNOMET CT, LOINC and ICD. Clinicians often use a range of terms to describe orthopaedic procedures such as hip replacements, for example, which can be problematic when searching for information on similar topics.

“This solution enables different terminologies and coding systems to be aligned so that all the information can be used in a way that enables the healthcare system to operate as an ecosystem,” explains McCartan.

Predictive clinical models

The company has developed its own AI and machine learning solutions to enhance healthcare outcomes, including 19 predictive clinical models used in 388 departments across European hospitals for conditions such as delirium, sepsis, pneumonia and deep vein thrombosis (DVT). Models also manage the flow of patients via natural language tools, support wound management and prioritise night shift tasks. All advancements are trained using European healthcare data and in line with the European AI Act.

Patient focus

Dedalus also supports the National PAS Programme and works with hospitals lacking digital tools, such as providing ordering solutions for lab and radiology test results. “We support healthcare organisations across the continuum of care with applications that follow patients across every stage,” McCartan concludes. “We strive to be a software company that keeps the interests of the patient in mind with everything we do.”

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Dr Rabah Mouras

Research Centre Manager, PMTC

Biopharma is a cornerstone of Ireland’s economy, establishing the country as the EU’s leading net exporter of medicines.

In 2024, biopharma in Ireland produced approximately €100 billion worth of products, with indigenous companies accounting for approximately €3.0 billion of this total. This economic value highlights biopharma’s critical role in national infrastructure, including employment, facility construction, technology and social development.

Biopharma innovation and collaboration

Manufacturing biopharmaceutical products requires highly specialised techniques and analytical capabilities to keep pace with the evolving characteristics of novel drugs. The sector must also meet numerous stringent regulatory requirements, increasing the need for bespoke technology and data analytics to support drug development, scale-up and lifecycle research.

The Pharmaceutical Manufacturing Technology Centre (PMTC), funded by Enterprise Ireland and IDA Ireland, drives innovation and applied research in the biopharma industry. It fosters collaboration between SMEs and MNCs, providing a platform to introduce, demonstrate and de-risk new technologies and services while showcasing indigenous capabilities and facilitating engagement with local and international partners.

All research projects are designed with
sustainability in mind, incorporating green
processes and waste management solutions.

Sustainability and innovation contributions

Central to the organisation’s success is commitment to biopharma community and industry practices, providing targeted solutions for real world needs. Looking ahead, PMTC’s next phase of development will focus on expanding productivity-oriented research for its growing membership base. This includes enhancing the centre’s capabilities with the delivery of an integrated testbed, including LAB 5.0 for advanced characterisation.

Sustainability is a key focus. All research projects are designed with sustainability in mind, incorporating green processes and waste management solutions while exploring how digitalisation, AI and machine learning can address environmental challenges.

To support the industry’s evolving needs, PMTC has identified priority research areas including digitalisation, advanced data analytics, continuous manufacturing, process optimisation and talent development. In 2025, the centre’s core research will focus on cleaning optimisation; advanced manufacturing with continuous flow reactors; process intensification through digital twin technology; and the expansion of its FoReSight research programme on digitalisation and data analytics.

Digitally driven and research-enabled

As the biopharma sector seeks to integrate digitalisation and data analytics into decision-making, PMTC’s FoReSight research programme plays a pivotal role. A recent white paper, developed in collaboration with a consortium of MNCs and reviewed by the Health Products Regulatory Authority (HPRA), addressed the challenge of improving trust in data analytics for biopharma. Ongoing research aims to publish industry guidelines to harmonise the application of digitalisation and data analytics, paving the way for the adoption of technologies like AI in pharmaceutical manufacturing.

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Raising awareness about human papillomavirus (HPV) is essential to reduce the prevalence and harm of HPV-related cancers and diseases, ensuring a healthier future for everyone.

In Ireland, over 190 people lose their lives annually because of HPV-related cancers.¹ Despite its prevalence, awareness about HPV and its potential to cause various cancers remains low. Research by Ipsos MRBI for MSD Ireland in 2023 showed that a third of Irish people have ‘no awareness’ that vaccines may prevent certain cancers, and three-quarters of people (76%) think it is ‘unlikely’ that they have ever had HPV, despite its commonality.³

Prevalence of HPV-related cancers and diseases

Human papillomavirus (HPV) is a common virus primarily transmitted through intimate skin-to-skin contact, including vaginal, anal or oral sex.⁴ While most HPV infections resolve on their own within two years, some can persist and lead to serious health issues, including cancers of the cervix, vulva, vagina, anus and penis.⁴ In Ireland, HPV-associated cancers account for nearly 3% of all invasive cancers, excluding non-melanoma skin cancer.¹ This figure rises to 7% among young adults aged 20– 49 years.¹ Anogenital warts, caused by HPV types 6 and 11, are another significant concern, with approximately 1,000 cases reported annually in Ireland.²

The impact of HPV on cervical cancer
is particularly significant, with 99%
of cervical cancer cases attributed to HPV.

Cervical cancer elimination

The impact of HPV on cervical cancer is particularly significant, with 99% of cervical cancer cases attributed to HPV.⁵ In Ireland alone, there are an estimated 250 new cases of cervical cancer diagnosed each year, resulting in around 80 deaths.¹ The World Health Organization (WHO) launched a global initiative in 2020 to eliminate cervical cancer by focusing on prevention through HPV vaccination, screening and treatment of pre-cancerous lesions.⁶

Ireland has aligned with this global strategy by launching its Cervical Cancer Elimination Action Plan,⁷ setting a target to eliminate cervical cancer by 2040 by aiming to vaccinate 90% of girls by age 15, screen 80% of eligible individuals with an HPV test every five years and treat 97% of women with cervical disease within one year.⁷

Need to address remaining challenges

This ambitious plan represents a significant milestone, but challenges remain. Even though Ireland’s vaccination rate is relatively high compared to some other countries, 78.4% for the 2022/2023 academic year,⁸ the vaccination rate has been declining for the past three years⁸ and is still far from the 90% target outlined in the plan.⁷ It is crucial to expand HPV education and awareness, particularly among marginalised or harder-to-reach groups. By focusing on these communities, we can reduce the burden and harm of all HPV-related cancers and pave the way for a healthier future for Ireland.

[1] NCRI. 2024. HPV – Associated Cancers. Cancer Trends Report, Key findings.
[2] Ano-genital warts in Ireland 2018 (includes latest trends).pdf (hpsc.ie)
[3] MSD, MSD Data on File 2023. The research was commissioned by MSD Ireland and carried out by Ipsos B&A on a sample population of 1,400 adults in Ireland. 2023.
[4] CDC. 2024. About HPV. https://www.cdc.gov/hpv/about/index.html (Accessed March 2025)
[5] WHO. 2025. Cervical Cancer. https://www.who.int/health-topics/cervical-cancer#tab=tab_1 (Accessed March 2025)
[6] WHO. 2020. Global strategy to accelerate the elimination of cervical cancer as a public health problem.
[7] HSE. Ireland’s Cervical Cancer Elimination Plan – Strategic Vision 2025 – 2040, Action Plan 2025-2030.
[8] HSE. 2024. HSE School Vaccination Programme HPV, Tdap, MenC/MenACWY Uptake Data up to 2022/2023.

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Innovations in patient care, like HPV vaccination, are driving significant reductions in cervical pre-cancer cases, marking a new era in women’s health where cervical cancer can be eliminated as a public health problem.

The introduction of the human papillomavirus (HPV) vaccine in Ireland represents a groundbreaking step in patient-centred care. Launched in 2010, the programme prioritised early prevention by targeting girls before exposure to the HPV virus, which we know causes the majority of cervical cancers. Despite early challenges, such as vaccine hesitancy driven by misinformation, the programme has significantly reduced the burden of high-grade cervical changes, meaning fewer women require treatment for cervical cancer and pre-cancers.

Shift in screening outcomes

Recent data underscores the vaccine’s transformative effect. Between 2019 and 2022, high-grade cytology rates among vaccinated 25-year-old women dropped to 1.5%, compared to 3.7% in prior unvaccinated cohorts. This decline demonstrates how preventive innovations reduce invasive procedures, improving patient experiences and outcomes.

Recent modelling work has
shown that Ireland is on target
to eliminate cervical cancer as
a public health problem by 2040.

Addressing barriers to preventive care

The initial HPV vaccine catch-up campaign had variable vaccine uptake (44%–70%). Later, cohorts of girls in the first year of second-level school achieved over 80%, thanks to targeted public health campaigns. Innovations in outreach, including patient advocacy and education, highlight how addressing misinformation can improve care delivery and public trust. The vaccine programme is now a universal programme offered to both boys and girls in first year, since 2019.

Cervical cancer elimination

Recent modelling work has shown that Ireland is on target to eliminate cervical cancer as a public health problem by 2040. This is due to the combination of high vaccine uptake and cervical screening along with high treatment rates for those identified with cervical pre-cancers and cancers.

Optimising public health strategies

HPV vaccination demonstrates how innovations in preventive care can transform patient outcomes, reducing the need for invasive treatments and optimising public health strategies. Ireland’s success provides a model for integrating vaccination with screening, indicating a future where cervical cancer prevention is more effective and patient-centred. By continuing to innovate, we can ensure that every woman benefits from these advancements, paving the way for a healthier future.

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