Telemedicine and the advanced practice of medicine: an Irish regulatory perspective

Colin Kavanagh
Arthur Cox, Dublin
Colin.Kavanagh@arthurcox.com

Bridget Clinton
Arthur Cox, Dublin
Bridget.Clinton@arthurcox.com

Orla Clayton
Arthur Cox, Dublin
Orla.Clayton@arthurcox.com

Robert Byrne
Arthur Cox, Dublin
Robert.Byrne@arthurcox.com

Aoibhín Ní Dhubháin
Arthur Cox, Dublin
Aoibhin.NiDhubhain@arthurcox.com

Brónach Rafferty
Arthur Cox, Dublin
Bronach.Rafferty@arthurcox.com

Introduction

Digital health solutions are increasingly becoming an integral part of healthcare products and systems. Although there is no definition of digital health under Irish legislation, it is generally accepted as referring to standalone software, health technologies and applications used in the healthcare sector. Telemedicine is a key service offering within the digital health space. Challenges arise from a legal perspective when technology solutions, medical devices, medicinal products and software converge in a product or service. 

Programme for government

Ireland held a general election in late 2024, with a new administration taking office in early 2025. A key focus of the new government is the digitalisation of the health records service, whereby the government has committed to working towards the full digitalisation of Irish healthcare records and information systems, establishing a national system for electronic prescribing and promoting greater use of remote health monitoring and virtual care solutions. The Irish Health Service Executive’s (HSE) 2024 Digital Health Strategic Roadmap cites Regulation (EU) 2025/327 on the European Health Data Space (the ‘EHDS Regulation’) as a key driver for developing Ireland’s digital health framework, aligning Ireland internationally in order to facilitate the joint policy and implementation effort that is required to deliver against the roadmap. This is analysed below in greater detail.

A core component of the Irish government’s digitalisation strategy in this regard is the launch of a digital national patient application. The HSE Health app will give patients secure personalised access to their health information, hospital appointments, medical cards and more.

The development of the telehealth/virtual ward model of care is also a cornerstone of the government’s health digitalisation focus. The government intends to provide a comprehensive platform through which to deliver virtual care for patients in Ireland, including audio and video-based consultations, remote monitoring and more online support and therapies, and to develop and enhance the remote health monitoring capacity to support the delivery of community and acute health services. This second aspect is being progressed by the National Digital Health Clinical Office.

The EHDS Regulation

The EHDS Regulation was published in the Official Journal of the EU on 5 March 2025. It serves to implement the European Commission’s proposal in its 2020 communication on a European strategy for data and creates the first sector-specific common data space in the form of the EHDS. It is intended to specify and complement the rights laid down in the General Data Protection Regulation (GDPR).

Echoing GDPR provisions, the Health Data Regulation aims to improve individuals’ access to and control over their electronic health data (EHD) contained within their electronic health record (EHR).  The definition of ‘primary use’ of EHD is broad and includes healthcare provision and assessment, and the provision of medicinal products and devices. The EHDS Regulation grants rights to immediate access to one’s personal, priority-category EHD, such as patient summaries, electronic prescriptions and medical test results, and to cross-border data portability. The EHDS Regulation also establishes a governance framework for the ‘secondary use’ of EHD in areas including research, innovation and policymaking.

Key points for industry regarding the EHDS as provided for under the Health Data Regulation are as follows:

• limited processing. Companies considered to be ‘health data users’ under the Health Data Regulation will only be permitted to access anonymised or pseudonymised EHD for secondary use. The processing of that data must be for specific purposes, including scientific research that contributes to public health or ensures the high quality and safety levels of healthcare and medicinal products, aiming to benefit end users;
• EHD sharing. Companies may have to adhere to data sharing obligations;
• intellectual property (IP) concerns. EHD protected by IP rights, trade secrets or regulatory data protection rights, must be available for secondary use.  Health data holders must justify the need for protection to the health data access body (HDAB) established by the relevant EU Member State
• interoperability. Manufacturers of EHR systems must meet specific requirements before placing such systems on the market, including creating and updating technical documentation, securing an EU declaration of conformity and CE marking; an
• enforcement. HDABs have enforcement powers against health data users and holders, including the ability to revoke data permits and cease processing operations. Possible fines range from €10m or two per cent of the firm’s total worldwide annual turnover up to €20m or four per cent. In addition to a HDAB, EU Member States are required to designate both a digital health authority and a market surveillance authority, to act in accordance with the EHDS Regulation.

While the EHDS Regulation is in effect 20 days from publication, parts of it will start to apply by March 2027, with some aspects not applying until 2029, 2031 and 2035. Given that there is a particularly technical element to the preparation phase, we can expect to see further guidance from the European Commission and EU Member States as to the associated practical measures, by way of implementing acts and domestic regulation. The Health Data Bill, which is making its way through the legislative process, is an initial step at the Irish level, in preparing for the new regime.

Telemedicine and ePrescribing

Telemedicine is generally defined broadly as ‘the delivery of healthcare services through information and communication technologies’ and entails services such as opinions, consultations and diagnosis, which is delivered by registered healthcare practitioners to patients using online platforms or healthcare applications.

Moreover, eHealth Ireland has recently published the HSE Telehealth Roadmap 2024-2027 to improve population health outcomes through facilitating increased accessibility to and quality of digital health support and services. The Telehealth Roadmap identified the following three methods through which telehealth delivers virtual care to patients in Ireland:

• remote consultations and care;remote health monitoring; and
• online support and therapies.

The introduction of electronic prescriptions (‘ePrescribing’) in Ireland also represents a significant development in the provision of telemedicine services in this jurisdiction. A change in legislation in 2020 in response to the Covid-19 pandemic allowed the secure emailing of prescriptions.

Wearables and software as medical devices

The convergence of medical devices, medicinal products and software requires that product classification is carefully considered to ensure regulatory compliance. Software and applications hosted on connected wearables and mobile devices that monitor or influence a person’s health and wellbeing may be classified as medical devices under Regulation (EU) 2017/745 on medical devices (the ‘EU MDR’). Failure to register software and wearables appropriately can result in criminal sanctions. As a result, companies that are traditionally outside of the healthcare industry face several challenges when endeavouring to enter the market and navigate a complex regulatory framework, which they may be unfamiliar with.

The EU MDR provides for categorisation of medical devices into four risk classes (Class I, Class IIa, Class IIb and Class III). A different conformity assessment procedure applies prior to being granted market access, depending on the class of risk of the product. Devices identified as being higher risk will undergo increased scrutiny as compared to those which are lower risk.

Even where wellness and fitness applications and wearables are not subject to the EU MDR, any personal user data collected will fall under the GDPR. This requires that consideration be given to privacy and data security.

Many EU Member States are designing assessment frameworks for digital health technologies individually. In the context of the EU Common Market, standardised product classification and assessment is preferable. Steps towards this have been taken through Regulation (EU) 2021/2282 on Health Technology Assessment (the ‘HTAR’), which became applicable as of 12 January 2025. The HTAR provides for joint clinical assessments and joint scientific consultations using a common framework of procedures and methodologies across the EU. However, it will only cover the clinical aspects of the assessment and will not make any economic assessment or conclusion on pricing and reimbursement. The roll out of the application of the HTAR will be staggered, with all new medicines being subject to joint assessment by 2030.

Conclusion

The introduction of the EHDS Regulation marks a significant step towards harmonising health data management across the EU, enhancing patient rights and fostering a collaborative environment for research and innovation. This regulatory framework, alongside the EU MDR and HTAR, provides a robust foundation for the safe and effective deployment of digital health technologies and the advanced practice of medicine.

However, the successful adoption of these technologies will require careful navigation of the regulatory landscape, particularly concerning data protection, interoperability and IP rights. Companies entering this space must be vigilant in ensuring compliance with these regulations to avoid potential legal and financial repercussions.

The digital transformation of healthcare is a policy focus of the new Irish government. As the new Irish government takes the mantle, and preparations for the application of the EHDS Regulation get underway, it seems as though both Ireland and the EU look set to usher in a new digital health era. The Irish government’s commitment to digitalising healthcare services, as evidenced by the Programme for Government^[1] and the HSE’s Digital Health Strategic Roadmap, underscores the importance of these innovations for improving patient care and accessibility.

Note