4. Digital Health Services

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Digital Health Services 

(adapted from: In brief: digital healthcare in European Union) [1]

Digital Health Services are not as such governed by a specific EU regulatory legislation. They could, however, fall within the scope of Directive (EU) 2019/770 [2] concerning contracts for the supply of digital content and digital services (DCSD).
In the context of digital health, the DCSD:

Does not apply:

  • To ‘healthcare’ as defined in Directive 2011/24/EU [3].
  • To any digital content or digital service that constitutes a medical device, that is prescribed or provided by a health professional as defined in Directive 2011/24/EU.

Does apply:

  • To any digital content or digital service that constitutes a medical device, such as health applications (health apps), that can be obtained by the consumer without being prescribed or provided by a health professional.

The DCSD governs the conformity of digital content or service with contracts between traders and consumers, remedies in the case of lack of conformity or failure to supply and the modification of digital content or service.

The DCSD prevents member states from imposing more or less stringent provisions at national level. Its provisions are mandatory and they are intended to offer the highest possible standards of consumer safeguards.

References

[1] In brief: digital healthcare in European Union (2021). https://www.lexology.com/library/detail.aspx?g=2498a288-818f-44d5-a542-308d932c9786
[2] Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32019L0770
[3] Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32011L0024