Medical devices

​MD6: The importance of digital health – Digital Health Applications (DiGA) and the Digital Mental Health Technology Project

By 2025-11-18T10:06:00

Wolfgang Lauer, Henrik Emmert and Holly Coole_MD6

 Key points: 

  • Germany’s DIGA system (Digitale GesundheitsAnwendungen, or Digital Health Applications) provides structured reimbursement pathways for CE-marked digital health applications, including provisional and permanent listings
  • Evidence generation is a central consideration, with provisional listings supporting early access while final evidence is developed 

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