Digital Health in Switzerland
8.7M
population in December 2021
11.8%
of GDP spent on health care in 2022
26
counties responsible for providing health care
The Federalist Structure of the Swiss Healthcare System
Since 1996, Switzerland has guaranteed access to health care for all residents through mandatory health insurance (AOS). The Swiss health care system is highly decentralized. The federal government sets the regulatory framework for the public health care system and oversees compulsory health insurance, the control of communicable diseases, medically assisted reproduction, and transplants. Cantonal governments are responsible for providing health care and implementing federal policies.
Financial flows are distributed among the various levels of government and social insurance schemes. Revenue is primarily collected through taxes and AOS premiums, with a significant portion allocated to social insurance schemes, particularly to subsidize AOS premiums for low-income households.
Switzerland is making progress in digitizing its healthcare system
By international standards, the digitization of the Swiss healthcare system remains fragmented and has not yet been harmonized, a fact that became evident during the COVID-19 pandemic. For example, collected data often has to be re-entered and cannot be used for other purposes. Switzerland aims to implement the “once-only principle,” which allows patients to provide their data only once while enabling its multiple uses. To this end, the country is working to transparently coordinate digital processes and ensure that interfaces function properly, particularly through the implementation of a common strategy involving all stakeholders (healthcare professionals, e-health innovators, etc.).
The ongoing “DigiSanté” government program aims to close Switzerland’s gap in the digitization of the healthcare system between 2025 and 2034. One of the program’s main objectives is to coordinate and align all partners in their responsibilities to pursue this shared ambition. At the same time, efforts to develop the DEP are being stepped up, with a view to widespread adoption among residents and healthcare providers.
How can you enter the Swiss digital health market?
1. Obtain classification of the product as a medical device
Switzerland has thoroughly revised its medical device legislation to bring it into line with EU regulations.
Apps or software considered to be medical devices must obtain the European CE mark or the Swiss medical device label to be legally marketed in Switzerland.
The procedure for obtaining the Swiss label is virtually identical to that of the EU. For example, the classification criteria for medical devices are the same as those of the EU. However, obtaining the Swiss label involves a few additional requirements, such as:
- The requirement for foreign manufacturers to appoint an authorized representative in Switzerland (“CH-REP”).
- The mandatory registration of economic operators with Swissmedic in order to legally place products on the Swiss market.
2. Obtain reimbursement from health insurance companies
To obtain reimbursement from health insurance companies, the manufacturer must demonstrate that its device is effective, suitable for its intended purpose, and cost-effective by following the procedure for reimbursement of digital health applications under the AOS.
Sources regarding the qualification and classification of medical devices
The definitions of medical devices, in vitro diagnostic medical devices, and their accessories are set forth in Article 3 of the Medical Devices Ordinance (MedDO) and in Article 3 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO).
Products are classified into classes I, IIa, IIb, and III pursuant to Article 15 of the MedDO or into classes A, B, C, and D pursuant to Article 14 of the IvDO, taking into account their intended use and the associated risks.
It is the manufacturer’s responsibility to classify its devices correctly. Article 15 of the MedDO and Article 14 of the IvDO specify that, for classification purposes, Annex VIII of the EU-MDR and the EU-IVDR, respectively, applies.
More information on accessing the digital health market
Guidance Documents on Classification from the Medical Device Coordination Group (MDCG)
Government authorities
Responsible for the evaluation and regulation of health products.
Hubs and Innovation Clusters
They bring together and facilitate the incubation of new technologies.
Organizations
Here are a few examples of organizations that bring companies together and facilitate their incubation.
Courses and Training Programs
Here are a few examples of Swiss universities and organizations that offer training and support for innovations in the field of digital health.
Backed by a healthcare system renowned for its quality and organizational rigor, Switzerland stands out for its integrated approach to healthcare innovation, in which e-health is playing an increasingly important role. The country relies on a federal governance structure that encourages local initiatives while gradually establishing national frameworks, particularly around the electronic health record and the interoperability of systems. This structure fosters the emergence of a particularly robust healthcare innovation ecosystem, fueled by collaboration among healthcare facilities, universities, research institutes, and technology companies. Added to this is a robust economic fabric, with numerous startups and industrial players focused on digital health and data solutions, which help make Switzerland a testing ground and deployment site for innovative projects.
Regional roots play a decisive role in this dynamic. Centers of excellence are taking shape around major cities such as Zurich, Lausanne, and Basel, where collaborations between academia and the private sector foster technology transfer and accelerate innovation. This network-based approach, characteristic of the Swiss ecosystem, facilitates synergies among national stakeholders and strengthens the capacity to support project leaders. Incubators, accelerators, and innovation platforms help shape the sector while facilitating access to funding, whether from public funds, private investments, or industrial partnerships. This extensive network enables initiatives to evolve rapidly while operating within a rigorous regulatory framework, which ensures trust and quality.
In this context, G_NIUS offers strategic support to innovators seeking to understand and enter the Swiss e-health market. By centralizing key resources on the healthcare system, relevant authorities, funding opportunities, and support mechanisms, the platform helps guide projects through every stage of their development. It also provides insights into regulatory specifics, the expectations of local stakeholders, and best practices for establishing a presence in a competitive yet innovation-friendly environment. This provision of structured information helps ensure a smooth process and maximize the chances of success for the initiatives undertaken.
For a healthcare provider, a company, or a project leader, Switzerland thus represents a concrete opportunity to develop innovative solutions in an environment that is demanding yet conducive to experimentation. The quality of the infrastructure, the maturity of digital practices, and the willingness of various stakeholders to cooperate create a favorable framework for the emergence of high-impact projects. By drawing on the resources offered by G_NIUS, it becomes possible to accurately understand the levers for action, identify relevant partners, and establish a lasting presence within this constantly evolving ecosystem.