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Germany Digital Act (DigiG) & DiGA Framework - Digital Health Applications (2026)

The Digital Act (DigiG) and Digital Healthcare Act (DVG) expand reimbursement for Digital Health Applications (DiGA) under statutory health insurance.…

What Germany Digital Act (DigiG) & DiGA Framework - Digital Health Applications (2026) requires

The Digital Act (DigiG) and Digital Healthcare Act (DVG) expand reimbursement for Digital Health Applications (DiGA) under statutory health insurance. Manufacturers must demonstrate safety, performance, and quality; conduct accompanying success measurement (AbEM) with quarterly data reporting from Q3 2026; and comply with performance-linked pricing (at least 20% variable component).

Pillar: Medical & Healthcare · Authority: Federal Institute for Drugs and Medical Devices (BfArM) · Version: 1.0.0 · Last updated:

Primary source: https://www.bfarm.de/EN/Medical-devices/DiGA/_node.html

SHA-256 integrity: 7ab4792f9bfff2e2079e2bc6b7a3595a4b87932c247ba869d25b54944436c0b3

Primary Citations — 5 traced to source

  • Digital Healthcare Act (DVG) - Section 33
  • Digital Act (DigiG) - Article 2

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