Conquering the German Market: DiGA “Fast Track” Kit for Digital Health Innovators

#1 What you need to know to successfully scale-up your digital health innovation in Germany

The German Healthcare Market — Overview

The Digital Healthcare Act — What’s new?

  • Full digital transformation of the healthcare system;
  • Telemedicine becoming the new normal;
  • Doctors prescribing Apps as a Treatment.

Pioneering Health Data — Laws to follow?

  • EU Regulations: mostly GDPR and MDR, ensuring data protection and product safety.
  • German Data Protection laws: specifying data protection over GDPR.
  • Laws deriving from the DHA itself: like the Patient Data Protection Law that is in motion or the DiGA Ordinance if you were targeting to prescribe a Digital Health App (DiGA).
  • Medical Professional Secrecy.

#2 How to ensure that your Digital Health Innovation gets adopted and reimbursed in Germany

Software as a Treatment — New opportunities?

Your Digital Health Solution — Eligible under DHA?

  • being patient-centric.
  • classified as a class I or IIa medical-grade solution under MDR.
  • rely on eTech.
  • allow for specific medical functionalities as listed in the law.

Insurance Reimbursement — The Fast Track Process

  • Requests for listing in the DiGA directory are reviewed in a 3-months approximate period, enabling rapid startup evolution if things go well!
  • Pre-listing is allowed during a one year testing period, so that companies have time to prove positive medical efficiency while having their products on the market.
  • Price negotiations are also in order if the testing period is proven to be successful.

#3 Be the first among equals: conquer the new German digital Healthcare market in a heartbeat

Being first to last — requirements

German Healthcare 4.0 — issues to address — DiGA starting kit



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