#BGBl. 2026 I Nr. 22Second Regulation Amending the Digital Health Applications Ordinance
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This regulation, published in the Federal Law Gazette on 29 January 2026, introduces the second set of amendments to Germany's Digital Health Applications Ordinance (DiGA-Verordnung). It was issued by the Federal Ministry of Health on 27 January 2026. The ordinance refines the regulatory framework for digital health applications that can be prescribed by physicians and reimbursed by statutory health insurance funds in Germany. Changes focus on updating requirements for evidence of medical benefit, data protection standards, interoperability with the German telematics infrastructure, and the approval and listing process for DiGA manufacturers.
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Key Changes
- Updates requirements for demonstrating medical benefit of digital health applications
- Strengthens data protection and cybersecurity standards for listed DiGAs
- Improves interoperability rules with the German telematics infrastructure
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