European Digital Health in Brief: Background, Landscape, Stakeholders

by Leo Petersen-Khmelnitski, Emilie Balk-Møller, Cecilia Price

This article presents brief results of extensive research. It provides a brief introduction to the European understanding of digital healthcare, touches upon its history, the current status, and expected developments. Further, we focus on major European stakeholders in digital healthcare, policy makers, organisations, the industry, startups. Links to further reading are provided.

European understanding of digital healthcare

In Europe, the consensus is behind the definition of digital healthcare by the European Commission: ‘Digital health and care refers to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health-related issues and to monitor and manage lifestyle-habits that impact health’.
In the European academic discourse and in broader discussions, the term ‘digital healthcare’ usually refers to such areas as EHRs, telemedicine, wearables, AR, VR, AI and ML adoptions to diagnostics and treatments of diseases, digital therapeutics, assistive technologies, rehabilitation robotics, medical computational simulations, and health systems engineering.

Brief history: major phases in development of European digital health

By the 1990s most European university healthcare providers established their own databases, the next major effort was to connect them. These interconnected hubs made health data analysis possible. New opportunities in data management followed to allow new medical services, new organisational and business models. The next two decades introduced robotics, AI, and telemedicine, the latter has received a serious impetus in the COVID lockdown. Application of the above technologies accompanied by wearables provided new opportunities in monitoring, diagnostics, and treatment, by the existing market players, but also gave rise to numerous startups.

Regulations: look back, current status, expected development

The European regulations on digital healthcare have policy roots in ‘e-Europe – an information society for all’ initiative of 1999. This e-Europe Action Plan identified ten areas where action at a European level would add value, one of them notably the Health Online Action. By 2004, a new Action Plan for a European E-health Area was adopted to deal with a new generation of computerised clinical systems, advanced telemedicine services and health network applications. Currently, the European digital health is an area that enjoys the increased activities, inter alia due to the introduction of Covid passports. In the last year only, as was noted at the recent Digital Health Summit in Portugal, the research and innovation programme Horizon Europe was launched with the budget of EUR95B, the EU flagship Connecting Europe, Digital Europe Programme (EUR 7,5B to AI, supercomputing and cybersecurity), the EU4Health Programme (EUR 5,1B to tackle cross border health threats). In April 2021, the new European Health and Digital Executive Agency (HaDEA) was announced.

The creation of a European Data Space is one of the priorities of the Commission 2019-2025, including the health sector. A common European Health Data Space will promote better exchange and access to different types of health data (electronic health records, genomics data, data from patient registries etc.), not only to support healthcare delivery (primary use of data) but also for health research and health policy making purposes (secondary use of data).

One of the most anticipated developments is the proposal by the European Commission to regulate AI adoptions. As the draft suggests highrisking most AI adoptions, including applications in healthcare, this development, if adopted, may impede the development of AI based medical image recognitions as well as AI based mental health services in Europe.

Stakeholders in the European digital health

The following groups of stakeholders are involved with digital healthcare in Europe:

Policy makers: European Parliament, European Commission and the European Council (specifically the Deputy Director General for Health responsible for Directorates B and C (Health systems, medical products and innovation), country level central and local governments, regulators (financial, quality and professional regulators, other other government agencies)

Workforce: Doctors, nurses, allied health professionals, executives and managers, technical IT staff, data scientists and analysts

Health and Social Care: National health and social care organisations, local health and care providers and founders of startups

Industry: Technology, pharmaceutical and medtech companies, digital technology start-ups

Researchers: Universities and hospitals based researchers

Major organisations active in the European digital health

European Connected Health Alliance (ECHAlliance) unites 16,500 experts from 78 countries around the globe.
Healthcare Information and Management Systems Society (HIMSS) is the oldest global health organisation on digital transformation, has a network of 80,000 individual experts, 480 provider organisations, 470 non-profit partners and 650 health services organisations.
Digital Therapeutics Alliance (DTA) exists to broaden the understanding, adoption, and integration of clinically-evaluated digital therapeutics into healthcare through education, advocacy, and research. It has HQ in the USA but is active in Europe.
European Institute of Innovation and Technology (EIT Health) is a network of health innovators backed by the EU, partners with 150 organisations.
DigitalHealthEurope consortium (17 partners from 10 European countries) provides support to the Digital Health and Care Innovation initiative in the context of the Digital Single Market Strategy.

Major corporate players in the European digital health

The European digital health market is currently dominated by large players. Most major European telecoms are involved, from the UK based Vodaphone (telehealth, Digital Angels) to Deutche Telecom (Clinical IT) and the Spanish Telefónica (partnerships with Teladoc Health and Tunstall Healthcare). Also, major pharmaceuticals (Roche, Bayer, Servier, Astra Zeneca, Pfizer, and Novartis) and medtech (Fresenius, Essilor, Coloplast, Smith and Nephew, Sonova, Getinge, William Demant) corporations are active in this field.

Most market analysts agree to the valuation of EUR38-40B of the total digital health market in Europe with annual growth around 20%. In contrast to many other industries, the Covid pandemics provided a further impetus to the development of this market, especially telemedicine.

Various national and cross-border frameworks were established to promote growth in this area. Virtually every European country has one or several trade associations who represent firms engaged with digital health (e.g. Asociación Salud Digital in Spain, Société Française de Santé Digitale in France, Società Italiana di Salute Digitale e Telemedicina in Italy, Spitzenverband Digitale Gesundheitsversorgung in Germany).

The European landscape of digital health startups

Currently, by conservative estimates, 600 to 800 startups operate (more in development and funding) in the area of digital health in Europe. Almost 20% of them enable technologies to established healthcare providers (horisontal, back-end and business process tools), another 20% are engaged with screening and diagnostics (home testing, AI medical imaging, ML to radiological output), yet another large number of startups focus on consumer health (lifestyle, fitness, nutrition). Small but yet a significant number of startups are involved with hardware (usually proprietary), digital therapeutics (mostly mobile apps), and patient engagement (e.g. motivations tokens for a healthier lifestyle). Fewer European digital health startups provide on-demand generalist care (telemedicine) and mental health related services, much more developed in the USA.

The underrepresented areas in the European health startups are women’s (menopause, contraception, fertility) and men’s (erectile dysfunctions, hair-loss) health, sexual and family health. Most median funding varies between EUR 1-2 million. Currently, the best funded are startups in on-demand telehealth, patient engagement, drug discovery and specialised virtual care. Early leaders in women’s health hardware have raised large rounds. Health focused AR/VR solutions have attracted significant capital.

Various and own research shows that many new ideas come from outside the hubs. Also, consumer health and B2C mental health apps are the only two densely populated areas in European digital health. More startups are expected in other areas. Though chronic care or specialised virtual care represent a huge share of public and private wallets in the offline world, a surprisingly small number of companies are taking on these areas and are also far more mature in the US, then in Europe. Mental health and elderly care are expected to become more prominent focus areas, a trend resulting from the aging population and the pandemic-induced mental health crisis.