As the healthcare industry embraces digital transformation, the convergence of cutting-edge technologies and regulatory frameworks presents both opportunities and challenges. Here we explore the intersection of the EU AI Act and the Department of Health’s “Digital for Care: A Digital Health Framework for Ireland”, shedding light on how these regulations shape the future of patient-centred healthcare.

At the heart of Ireland’s healthcare evolution lies the ‘Digital for Care’ Framework. HealthTech Ireland members, in contributing to this through consolidation of member’s perspectives and input to the Health Service Executive (HSE) and Department of Health, welcomed openness in this engagement.

We are also encouraged that our visions are aligned, to enhance the creation of a patient-centric, sustainable health service by harnessing the power of digital technologies, including AI. By enhancing care quality, improving efficiencies, and increasing accessibility, the framework sets ambitious goals for the years ahead. Critically, the next consideration is implementation and accelerating the scaling of innovation adoption.

Balancing innovation and compliance

Enter the EU AI Act, a landmark legislation designed to foster innovation while ensuring responsible AI deployment. As the HSE explores AI adoption, it, like other jurisdictions, faces the pressing need of balancing technological advancements with compliance obligations.

The Act requires that AI systems in healthcare adhere to safety, transparency, and ethical standards which our members support. Clarity is needed and requested by our members, as part of the MedTech Europe submission to Europe, to ensure healthcare can benefit from the many advantages of adopting AI.

A positive development is the establishment of the AI competent authority giving members full visibility of the standards needed to be achieved for their products, solutions and services. For the HSE importantly, it will provide reassurance and knowledge to drive ahead with scalable innovation adoption. Training and education will also play a key role within this.

The recent publication of the Health Information Bill is also a welcome first step in improving Ireland’s health information landscape. While the focus is understandably on the establishment of digital health records for patients and the primary use of information by the HSE, in order to truly deliver for patients we must await the publication of the expanded Health Information Act covering secondary use more broadly including research, predictive health and population health.

The European Health Data Space (EHDS): a pan-European vision

Further development to drive safe adoption is the EHDS legislation – passed by the European Parliament – which aims to empower individuals with control over their electronic health data. Our member, EIT Health Ireland/UK, gathered national insights which along with their counterparts across Europe, informed the drafting of this legislation. Shona D’arcy from EIT Health stresses its importance and power in creating the capability to leverage health records from more than 360 million people.

For the EHDS to succeed, interoperability is key and standardising electronic health record systems essential. Across Europe, we need interoperable platforms like MyHealth@EU and HealthData@EU. Member states have a two-year window to implement the EHDS, emphasising the urgency of harmonising standards.

While interoperability remains a concern for many countries, Ireland faces a unique opportunity. Our digital maturity is nascent, allowing us to swiftly harmonise data standards and health IT software. By doing so, we avoid the interoperability-associated costs that other nations grapple with.

Again though, clarity and guidance is required on the AI Act, the structures to leverage insights and the right representation of organisations and investment in building confidence and public trust.

Unlocking value for the ecosystem

Ultimately for patients, key actors have a responsibility to ensure we collectively deliver on the potential of new ways to deliver care. A collaborative, effective and accelerated implementation of these legislative changes is key to this. Risk is often cited, slowing down progress and innovation adoption.

With the publication of the HSE’s Digital Health Strategic Implementation Roadmap amongst others, we have a pathway to drive ahead safely with guardrails within our healthcare system. It is critical to consider the risk of doing nothing versus strategically stepping into this new world together.

What we know for sure is the convergence of AI, compliance, and digital transformation holds immense promise for Ireland’s healthcare system in giving richer insights, patient demand and ensure Ireland’s digital maturity and the road ahead.

As industry leaders, we are actively collaborating across the ecosystem supporting navigation of this landscape with foresight, trust, and a commitment to patient well-being. Together, we can build a future where technology enhances care, without compromising safety or ethics.

Susan Treacy is CEO of HealthTech Ireland. This article has been prepared with contributions from HealthTech Ireland members Sean McElligott, Partner and Head of the Technology Practice in Philip Lee Solicitors; Shona D’arcy, EIT Health; and John Bosworth, TEKenable.