Nuala Downes

Achieving Interoperability in Digitalised Healthcare in the European Union

Research Stream: Social Technologies

Author: Matthew McKenna, PhD Researcher at Maynooth University’s Assisting Living and Learning (ALL) Institute, Research Funded through the Science Foundation of Ireland (SFI) Centre for Research Training in Advanced Networks for Sustainable Societies (ADVANCE CRT)

In October 2021, MedTec Europe released a white paper in collaboration with the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) titled, ‘Interoperability Standards in Digital Health: A White Paper from the Medical Technology Industry’. It defines interoperability in digital healthcare as “the ability of different information systems, devices and applications (systems) to access, exchange, integrate and cooperatively use data in a coordinated manner, within and across organisational, regional and national boundaries, to provide timely and seamless portability of information and optimise the health of individuals and populations globally”. It also underscores the fundamental importance of interoperability, stating that, “Lack of interoperability is widely acknowledged to be a critical barrier for the adoption and deployment of digital health technologies and for the digital transformation of healthcare”. To this end, interoperability in digital healthcare represents an indispensable systems component and critical necessity for the provision of modern healthcare in the European Union (EU).

To date however, the digitalisation of healthcare in the EU has encountered a complex web of bureaucratic, social and legal challenges due to a fragmented digital health technology market and poor inter-agency cooperation resulting from insufficient interoperability between structures and stakeholders on a national and international level. This has greatly slowed the pace at which potential benefits of digital technology can be translated into tangible improvements in healthcare and quality of life for people in the EU. The European Commission (hereinafter referred to as the ‘Commission’) has arguably been slow to take decisive measures to enhance cross-sectoral coordination by reforming regulatory frameworks governing digital healthcare technologies. As such, data sharing, procurement and administration of digital technologies in the care environment has been governed by customary national laws of individual EU member states. Discordant legal rules and standards across the EU limit the ability of businesses developing and marketing digital health technologies such as robots and connected devices and services to operate effectively in the single market. Deficits of strategic cross-sectoral interoperability in the digitalisation of healthcare infrastructure and a lack of interagency communication and cooperation has discernibly contributed to the longevity of traditional, non-digital and wardship models of care provision, particularly for vulnerable individuals including older people and persons with disabilities.

Perhaps understandably, the Commission has approached the emergence of digital health technologies with a significant degree of apparent caution. In the absence of measures to promote wide-scale uniformity in procurement and implementation processes for connected devices and services in the care environment, the cohesive integration of these modern capabilities represents a slow and costly challenge for a siloed and fragmented European healthcare sector. In its approach to digital health technology, the Commission has assumed an unhurried and deliberate process of supporting research initiatives funded through programmes such as Horizon 2020 and Horizon Europe. The logical reasoning here is to assess, trial and identify examples of best practice in digitalisation within the care sector through the professional utility and implementation of digital technologies by clinicians and care workers. In this way, a trial-and-error process through practice and research can be established, with the experiences of the carer playing an important role in determining the practical challenges of ensuring effective implementation of digital health technologies in the care environment.

The digital healthcare technology industry in the EU is splintered and disorganised, even within the context of the single market. The following Commission Communication document from April 2018 titled ‘Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Enabling the Digital Transformation of Health and Care in the Digital Single Market; Empowering Citizens and Building a Healthier Society’, announced the following strategic initiatives:

“To date, the uptake of digital solutions for health and care remains slow and varies greatly across Member States and regions. Further action at EU level is crucial to accelerate the meaningful use of digital solutions in public health and healthcare in Europe. In its mid-term review on the implementation of the Digital Single Market (DSM) 2014 – 2019 strategy the Commission set out its intention to take further action in three areas:

citizens’ secure access to their health data, including across borders, enabling citizens to access their health data across the EU;
personalised medicine through shared European data infrastructure, allowing researchers and other professionals to pool resources (data, expertise, computing processing and storage capacities) across the EU;
citizen empowerment with digital tools for user feedback and person-centred care using digital tools to empower people to look after their health, stimulate prevention and enable feedback and interaction between users and healthcare providers” (European Commission, 2018).

To this end, in 2022, the Commission put forward a proposal for a regulatory framework for the sharing of health data within the EU called the ‘European Health Data Space’ (EHDS) (European Union, 2022). According to the Commission, it will function as “a common EU data space for health data that empowers individuals and fosters a single market for electronic health records”. Further to this, “in 2024, the European Parliament and Council reached a political agreement on the Commission Proposal for the EHDS”. The EHDS is an important pillar in the construction of the European Health Union which aims to create a more unified, harmonised and effective healthcare system throughout the EU and to ensure the availability of medical supplies. These measures also address significant aspects of the three areas outlined above in the 2018 Commission Communication on the Digital Transformation of Health and Care.

In April 2024, the Interoperable Europe Act entered into force in the EU, representing an important step towards the harmonisation of “key” public services as part of the broader Digital Decade strategy. However, extending broader strategic digital interoperability across healthcare systems in the EU arguably requires dedicated and sector-specific legislative overhaul. Interoperable digitalised systems that empower caregiver engagement with stakeholders in policymaking and identification of good practice is necessary to facilitate smooth delivery of high standards in modern care. Digitalised interoperable healthcare systems with seamless transmission of patient health data, alongside appropriately scalable, cost-effective and rapid procurement mechanisms in the implementation of digital technology for effective service provision can maximise the efficiency and expertise of an invaluable care workforce.

Although certain long-anticipated initiatives are underway to harmonise digital healthcare systems in the EU through enhanced interoperability and an easing of some inhibitory regulatory barriers to the smooth functioning of health technology companies in the single market, change is happening at an often-lethargic pace. Unfortunately, this puts an unwelcome delay on the latent potential benefits that could be felt by carers and patients at an individual level given the current state of digitalised technological innovation. Furthermore, carers note that interoperability and scalability challenges often become apparent when trialling digital technologies in the care environment. As such, the involvement of healthcare workers in the creation of policy and best practice for the interoperable digitalisation of the care environment is critically important. Caregiver engagement mechanisms in Commission policymaking and communication with industry represent essential components in the development of digital interoperability frameworks that function smoothly and effectively, delivering versatile person-centred digitalised healthcare at an EU-wide level.

My Experience as Project Manager of DANCING… Some Personal Reflections on the First Four Years

Research Stream: Social Lives

Author: Hilary Hooks, Project Manager, Protecting the Right to Culture of Persons with Disabilities and Enhancing Cultural Diversity in EU Law: Exploring New Paths (DANCING) Project

As the Project Manager for the ERC-funded DANCING Project, led by PI, Prof. Delia Ferri, my role has been to manage the project’s administrative and operational aspects and supporting the PI in ensuring that the project stayed on track with its key milestones.

I have endeavoured to create a robust project management framework. This involved developing a suite of tools, including a spreadsheet to track finances, another to track project activities and deliverables and another to record meetings—ensuring that we met all milestones efficiently. With a project of this scale, managing a €2 million budget requires close attention, and by working closely with other university offices, I ensured compliance with all relevant regulations. The administrative side of the project is complex and involves coordinating with multiple university offices, as well as external entities like graphic designers, filmmakers, and dance companies, the latter two through a tendering process. By managing these details, I freed up our researchers to focus on their work without worrying about the operational hurdles.

Can Lifestyle Changes Inform New Human-Rights Based Approaches to Dementia Management, Treatment and Care?

Research Stream: Social Lives

Authors: Maria Gialama, PhD scholar and Graduate Teaching Assistant at Maynooth University’s Department of Psychology, Joanne McVeigh, Assistant Professor of Psychology, Maynooth University, Mac MacLachlan, Professor of Psychology & Social Inclusion, and Co-Director of the ALL Institute, Maynooth University and Georgios Hadjigeorgiou, Professor of Neurology, Medical School, University of Cyprus.

Dementia is an extremely common, progressive neurodegenerative condition which affects almost 55 million people worldwide. Every year, almost 10 million new cases are reported (WHO, 2024). Today, dementia is the seventh leading cause of death and a major cause of disability and dependency among the elderly. Unsurprisingly, the World Health Organization (WHO, 2019), declared dementia a public health priority, not only because of its global prevalence, but also due to its significant impact on families and health service providers. In Ireland, there are 55,000 ‘people living with dementia’ (PwD) and almost 60,000 people who provide care for someone diagnosed with the condition. Long before COVID-19, dementia emerged as a pandemic due to ageing populations and the relationship between age and the incidence of the condition (Fox & Petersen, 2013).

Competition Law Enforcement in the EU and Access to Health Technologies: An Overview of the EU 2024 Competition Law Report on Pharmaceuticals and Medical Technologies – Update on Competition Enforcement in the Pharmaceutical Sector (2018-2022)

Author: Dr. Opeyemi Kolawole Post-doctoral Researcher, PatentsInHumans Project, ALL Insittute and Department of Law and Crimonology

Research Stream: Social Technologies

Competition law is pivotal in maintaining market equilibrium and safeguarding consumer welfare. In the European Union, competition law principles are enshrined in Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU). While Article 101 prohibits the formation and enforcement of agreements that have the object or effect of distorting competition, Article 102 prevents a dominant firm from abusing its dominant market position.

Competition in healthcare services is critical to providing access to affordable medicines and medical technologies, ensuring expensive pharmaceutical and medical technologies do not significantly strain public and private finances. With their proactive enforcement of competition rules, the EU Commission and the 27 National Competition Authorities (NCAs) have been instrumental in this regard. In the recent Report on Competition Enforcement in the Pharmaceutical Sector, published in January 2024, the EU Commission provides an overview of how EU competition rules have been enforced to prevent and rectify business practices which may harm competition in the common market and consumer welfare. This article examines some of the key decisions reached by the Commission and some of the NCAs and highlights potential improvement opportunities to maximise consumer welfare.

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