Schalast | Digital Health

Digitalisation is transforming the healthcare sector into what is now known as the era of “digital health” or “new health”. Key themes in this revolution include wearables, personalised medicine, mobile/connected health, and Health 2.0, with robotics and artificial intelligence becoming increasingly significant in digital health. This evolution represents the interdisciplinary fusion of health and medicine with digital and innovative technologies.

We assist our clients across all facets of this new era, from the development and authorisation to the marketing and utilisation of e-health or digital health applications. Tailoring our services to meet our clients’ specific needs, we engage in the legal structuring of new digital health concepts and applications, address specific legal queries, ensure data protection compliance for applications and draft associated distribution agreements and terms of use.

We also provide our clients with support in the realm of cybersecurity, especially for medical devices where standards and regulations impose a unique duty on manufacturers to evaluate and ensure their products’ cybersecurity throughout their entire lifecycle. Additionally, we offer our clients efficient and pragmatic strategies and solutions for managing cyber risks and legally compliant incident response.


  • Is your health app merely software, or does it qualify as a medical device?
  • If it qualifies, to which risk class should it be assigned and what specific requirements should be imposed on the software/hardware and IT security?
  • What obligations does the NIS2 “The Network and Information Security Directive” impose on the healthcare sector?
  • How should your e-health application be structured to ensure compliance with data protection laws?
  • What specific agreements are necessary between the manufacturer and the user of the digital health application?
  • Following a cyberattack, what legal steps must be taken right away to mitigate the risk of damage?
  • What are the legal standards for safeguarding health data?
  • How should a contemporary legal framework for IT support in healthcare be structured?
  • What legal considerations are essential when incorporating AI in healthcare?