The overview below compares the definitions of digital health in various countries, to identify international and national priorities set by these definitions. Research by Leo Petersen-Khmelnitski, www.cifs.health Editor, and Gergana Krasovska, Institute for Medical Research.
The classic definition adopted by the WHO points to the general scope of the term “digital health”. The WHO considers digital health to be “a broad umbrella term”. Is singles out since e-health as a main area that digital health encompasses, but points to other “developing areas as well”. The WHO definition provides only one example of such a developing area, “the use of advanced computer sciences”, but specifies further examples for such use:
- big data
- artificial intelligence
The definition of digital health by the WHO points to the following major roles for digital health:
- Strengthening health systems and public health
- Increasing equity in access to health services
- Working towards universal health coverage
The European Union
The definition of “digital health” adopted by the European Union refers to use of information and communication technologies (ICTs) by tools and services. According to the EU definition, to be qualified as digital health, such use has to target:
- Improvement of “prevention, diagnosis, treatment”
- Improvement of “monitoring and management of health-related issue”
- To monitor and manage “lifestyle-habits that impact health”
The United States
The Food and Drugs Administration Guide of Dec 2021 defines digital health technologies as “a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.” Hence, we have four various formats singled out: platforms, connectivity, software, sensors. The rest of the definition is very wide, the use area is defined as “healthcare and related uses”. However, in practice FDA defines the following formats to belong to digital health: mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.
The German definition of digital health refers explicitly to applications but leans on the concept of ICTs employed in the definition of the European Union. According to the German lawmakers, such applications should support treatment and care for patients. Further, it provides examples: the communication of medical data, telehealth. The German law employs the concept of e-health as well, it is defined as “the use of health apps which can be used to treat illnesses and compensate for disabilities (digital health applications) or in prevention.” These three target areas are employed throughout the German regulations related to digital health: 1) treat illness 2) compensate for disabilities 3) prevention.
Similar to the EU definition, the French term ‘l’e-santé, or santé numérique, encompasses e-health, that is defined in France as ‘health-related information, resources and services delivered electronically. It is perhaps the most concise definition of digital health up-to-date.
However, the French definition leans upon the EU approach further, it includes ‘developing areas as well’, one of them being advanced computing referred to in the EU definition. In contrast to the EU definition, it is does not include genomics in the list of the developing areas, only big data and AI.
Another major French contribution is in the definitions provided to big data (“large amounts of data from different sources that can provide valuable information on the health of the population”) and to artificial intelligence (“allows computer systems to perform tasks normally requiring human, such as the ability to make decisions”).
The United Kindgom
In the UK, the term “digital health” covers “apps, programmes and software” (please note the use of the generic terms software, but specified invertedly into programmes (desktop?) and apps. The latter may be referred to mobile apps, while desktop apps may belong to programmes). The United Kindgom then applies the same wide approach as the FDA of the United States, “used in the health and care system”. However, it specifies that such software may be used alone or combined with other products. Two examples of such products are provided, medical devices and diagnostic tests.
By digital health services, Norway means digital services for health personnel, for citizens, and for collaboration within the health service. The Danish Health Data Authority translates policy objectives within healthcare into digital solutions for national IT infrastructure that promote a healthier Denmark. There is no general definition of digital health in Swedish law. However, the Swedish Association of Local Authorities and Regions (Salar) in cooperation with the National Board of Welfare, and the E-Health Agency, defined e-health as the use of digital tools and digital exchange of information to achieve and to maintain health. Similar definitions are developed in Finland. With reference to health, the Scandinavian countries follow the definition by the WHO, “physical, psychological and social well-being”.
In 2021, the Chinese National Bureau of Statistics issued the Statistical Classification of the Digital Economy and its Core Industries, which defines the basic scope of the digital economy in terms of “digital industrialization” and “digitalization of industries”, and explicitly covers “intelligent medical care” (i.e. medical examination, testing and imaging advantage of digital technology and IT platforms), as well as online medical treatment and telemedicine services.
China has also developed regulations and policies in remote diagnosis and treatment, drug sales online, personal health data protection, collection, storage and application of health big data. These regulations and policies are being continuously improved
In Singapore, digital health refers to the usage of connected devices, wearables, software including mobile applications (apps) and artificial intelligence (AI) to address various health needs via information and communications technologies, see the same reference to ICTs in the EU and the French definitions. It is interesting that apps and AI are singled out in software. Otherwise, connected and wearable devices with their software is the target area of the Singaporean definition.
There is no definition of digital health in Israeli law. However, the definition can be derived from the government’s “National Digital Health Plan as a Growth Engine” approved in 2018, which defines digital health as follows: “The vision of the digital health strategy as published by the Ministry of Health is to enable a leap in the healthcare system so that it will be sustainable, advanced, innovative, renewable, constantly improving health system, by leveraging the best available information and communication technologies”. The latter reference to ICTs ties this definition to the definitions by the EU, France and Singapore. What makes the Israeli definition unique is the description of ties and the vision of the national health system, where the role of digital health as defined as leveraging information.
The Brazilian definition is based on the EU model, where digital health is defined as an area that uses information and communication technologies (ICTs) to treat patients, conduct research, promote learning and training, and to monitor illness.