Germany Adopts GeDIG Government Draft, Reshaping Digital Health

On July 15, 2026, Germany's federal cabinet (Bundeskabinett) adopted the government draft (Regierungsentwurf) of the Gesetz fuer Daten und digitale Innovation im Gesundheitswesen (GeDIG), moving the bill from the ministerial draft of May 5, 2026 into formal parliamentary procedure. Issued by the Federal Ministry of Health (BMG), the GeDIG is a single federal statute that rewrites Germany's digital-health and health-data regime, spanning DiGA and DiPA reimbursement, the electronic patient record (ePA), the secondary use of health data, and AI medical devices.

The cabinet adoption is a procedural milestone, not the finish line: the Regierungsentwurf now passes to the Bundestag for a first reading, then committee review, before a Bundesrat second reading and eventual promulgation in the Bundesgesetzblatt. No provision is binding yet. But the draft is the concrete vehicle through which the next cycle of German digital-health obligations will take shape, and more than 20 industry associations have already positioned on it during the Verbaendeanhoerung.

What does the GeDIG reform, and who is exposed?

The GeDIG consolidates and amends the existing DiGA and DiPA fast-track reimbursement regime created by the Digital-Versorgung-Gesetz (DVG, 2019) under Sections 33a and 139e SGB V, and reaches well beyond it. According to the BMG and the stakeholder record, four areas carry the bulk of the change: the reimbursement pathway and pricing for digital health applications (DiGA) and digital patient applications (DiPA); the electronic patient record (ePA) architecture; the rules for secondary use of health data for research and innovation; and the interface with AI medical devices under the EU AI Act and the MDR and IVDR.

The exposed actors are correspondingly broad. During the association consultation on the Referentenentwurf in May 2026, statements came from pharma (Pharma Deutschland, BPI), medtech and industry (SPECTARIS, ZVEI), health-IT (bvitg), statutory payers and providers (vdek, KBV), medical associations (BVKJ, BPtK), public health bodies (BVOEGD, DHS) and research institutions (DNVF, DGfN, DZNE, DKFZ). That spread signals that the reform touches reimbursement economics, data infrastructure, clinical practice and research access simultaneously, rather than imposing a single narrow obligation.

Where does the GeDIG sit in the legislative process, and what is the timeline?

Germany's federal legislative procedure runs from Referentenentwurf through Kabinettsbeschluss to Bundestag readings, Bundesrat consent, presidential Ausfertigung and publication in the Bundesgesetzblatt. The GeDIG has now cleared the Kabinettsbeschluss stage. The realistic path is a first Bundestag reading in the autumn 2026 session, committee referral, then a second and third reading before the Bundesrat second Durchgang.

Because the GeDIG touches statutory health insurance, it is a Zustimmungsgesetz: the Bundesrat's consent is required, which gives the 16 Laender a formal veto. Entry into force will be fixed in the adopted statute, or default to the 14th day after promulgation under Article 82(2) of the Basic Law (Grundgesetz).

What should DiGA, medtech and health-data teams do now?

Treat the Referentenentwurf as the working text for impact assessment, not a final rule. Three actions are time-sensitive. First, map the draft's DiGA, DiPA and ePA provisions against current product roadmaps and SGB V reimbursement assumptions, since the GeDIG will amend the same Sections 33a and 139e that govern today's fast-track. Second, review the secondary-data-use rules against existing and planned data partnerships, particularly where they intersect the EU European Health Data Space (EHDS), which applies from March 2027. Third, track the AI medical device interface against AI Act high-risk obligations applicable from August 2026 and the MDR and IVDR conformity pathway.

The more than 20 Stellungnahmen already on the BMG record are a ready-made map of the contested provisions; reading the position of the closest peer association is the fastest way to identify which changes will shift commercial assumptions. The BMG information and FAQ page summarizes the law's objectives, and the GeDIG detail page carries the draft, the cabinet dates and the full set of statements.

Continuous, per-jurisdiction monitoring surfaces a cabinet adoption like this the day it publishes, before the parliamentary text is finalized, and Obsidian tracks the GeDIG through each subsequent stage automatically.

Take advantage of this real-time watch

Next steps: confirm whether your products or data flows sit in the DiGA, ePA, secondary-data or AI medical device perimeter of the draft; diarize the Bundestag first reading and the Bundesrat second reading; and brief reimbursement, regulatory and data-privacy leads on the Sections 33a and 139e SGB V amendments now in motion.