Digital Health is on the rise, and strong political focus, policy and regulatory frameworks are required to shape the future of Digital Health and healthcare systems. This module should familiarise the learner with the Digital Health field and improve their knowledge on this topic, equipping them to demand, discuss and help implementing key elements they want to see as a part of the healthcare system.

In 2018, the European Commission (here in after EC) concluded that health and care systems1 in the European Union (EU) require reforms and innovative solutions to keep the quality of care and improve accessibility. Health systems promoting health and providing patient-centred care in the EU face severe challenges in delivering health care services1  [1]. These challenges include an ageing population, human resource shortage- particularly doctors and nurses, limitations in managing “big data” (see box below), rapidly growing medical knowledge, innovative technologies, and a limited budget (in member states responsible for financing healthcare). The EC in their 2018 Communication considers modernising health systems by digitalisation to address these challenges and:

  • Promote health,
  • Prevent and control disease,
  • Help address patients' unmet needs
  • Make it easier for citizens to have equal access to high quality care
  • and also strengthen the resilience and sustainability of Europe’s health and care systems [1]

'Big data' is a widely-used term without a commonly-accepted definition. The HMA/EMA Big Data Task Force defined big data as ‘extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends, and associations. In general, big data sets require advanced or specialised methods to provide an answer within reliable constraints.

A single dataset may not strictly meet the definition of big data but, when pooled or linked with other datasets, they become sufficiently large or complex to analyse to assume the characteristics of big data. Sources include real-world data (such as electronic health records, insurance claims data and data from patient registries), genomics, clinical trials, spontaneous adverse drug reaction reports, social media and wearable devices.

Medicines regulators will increasingly use insights derived from big data to assess the benefit-risk of medicines across their lifecycle.

Digital Health is a term which, as often happens in fast evolving areas with a number of different stakeholders, has multiple definitions. The two following definitions give a fairly concise description:

  • The European Commission definition: “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 addition, ‘Digital health and care’ is innovative and can improve access to care and the quality of that care, as well as to increase the overall efficiency of the health sector”  [2].
  • The WHO definition: “a broad umbrella term encompassing *ehealth (which includes *mHealth), as well as emerging areas such as the use of advanced computing sciences in “big data2”, genomics and artificial intelligence”  [3].

*The term Digital Health has its roots in eHealth, which is defined by the WHO as “the cost-effective and secure use of information communication technologies (ICT) in support of health and health-related fields, including healthcare services (e.g. telehealth), health surveillance, health literature, and health education, knowledge and research” 3

To note: so-called mobile Health (mHealth) is an integral part of eHealth and is defined as “the use of mobile wireless technologies for public health” [4].

The Organisation for Economic Co-operation and Development (OECD) in a Working Paper says: Digital Health Technologies (DHT) contain “electronic tools, devices, systems, and resources that generate, store, process, and/or transmit data“ [5]. As such, DHTs, in the form of hardware or software, are used to collect and analyse data, and assisting patients, caregivers, and HCPs. Various digital technologies combined with data and services form different classes of digital health to support healthcare transformation.

For example, electronic health records can support clinical trials and provide large-scale observational data. These approaches have underpinned several high-profile research findings during the COVID-19 pandemic. Sequencing and genomics have been used to understand SARS-CoV-2 transmission and evolution [6].

Note 1 : The term "health and care systems" implies a broader notion than "health systems" or "healthcare systems", notably encompassing public health and social care.

Note 2: Definition and description under Legal, Regulatory and HTA concepts


[1] European Commission. Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society | Shaping Europe’s digital future. Published 2018. Accessed May 22, 2022.
[2] European Commission definition of Digital Health               
[3] WHO guideline: recommendations on digital interventions for health system strengtheningGeneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO                                   
[4] SEVENTY-FIRST WORLD HEALTH ASSEMBLY A71/20 Provisional agenda item 12.4 26 March 2018.                                                                                                           
[5] Organisation for Economic Co-operation and Development: OECD Health Working Paper No. 129 Empowering the health workforce to make the most of the digital revolution, 2021.                                                          
[6] The Lancet Editorial: Can digital technologies improve health? Published Online October 24, 2021. Volume 398, ISSUE 10312, P1663