What is the timeline?

The Pilot Project diGItal started in August 2024 and is scheduled to run until the end of 2026. Registrations have been open since the beginning of July 2024, and ACS PharmaProtect GmbH, as the project sponsor, is conducting initial legitimation checks of pharmaceutical companies.

In 2025 and 2026, data will be continuously collected and evaluated in accordance with data protection regulations. This will ensure that important findings can be taken into account at an early stage and adjustments can be made if necessary.

Early registration is recommended, as a longer evaluation period will yield clearer findings and companies will be able to benefit from favourable terms offered by ACS.

Depending on the progress of the project, the aim is to transition to regular operation in 2027. The pilot project is intended to enable a smooth transition to regular operation for all stakeholders and contribute data-based experience to the regulatory debate.

December 2026 / January 2027

End of pilot phase and transition to regular operations

October 2026

Start of technical qualification phase for eAAPI and eCAPI clients for regular operations

September 2026

Event: 2nd diGItal Forum 2026

July 2026

Significant FHIR data schema change for improved usability and technical simplification (eAAPI and eCAPI)

June 2026

First hospital pilot products expected on the market

June 2026

Merging of existing GI data from digital and GI4.0 on the digital platform

June 2026

Contribution to ADKA Conference „Package Insert 2.0: Digitalization of Patient

June 2026

Information – Healthcare Policy Background and Implementation of the Pilot Project „e-leaflet" in Hospitals"

April 2026

EEAPI Go Live FHIR input interface eAAPI

April 2026

Event: EPI Summit

February 2026

diGItal - ePIL Editor provided

January 2026

+60 participating companies

December 2025

Sub-project „Hospital Pilot" becomes possible

December 2025

Digital package insert becomes mandatory - Agreement on EU Pharmaceutical Package

December 2025

diGItal pilot project live - „AOK Mein Leben" app introduces digital package inserts

December 2025

diGItal pilot project live - BARMER eCare with digital package inserts

November 2025

+50 participating companies

October 2025

Event: 1st diGItal Forum 2025

September 2025

European Commission expresses its support for the sub-project „Hospital Pilot"

Q3 2025

First FHIR upload via portal possible

June 2025

Successful participation in EMA – FHIR Upload User Acceptance Test

Q2 2025

Start with Showcase GKV retrieval

Q2 2025

First FHIR upload via API possible

March 2025

IKK Classic becomes project partner

February 2025

Development of a FHIR Implementation Guide

January 2025

Start of development of GKV interfaces and conceptualization with health insurance funds. Bertelsmann BKK won as project partner

January 2025

User management and PDF upload in the portal available

December 2024

+30 marketing authorization holders are official project participants

November 2024

Go-live of the first expansion stage of the diGItal platform

October 2024

Announcement of Barmer as first project partner

July 2024

Registration possible & start of development

June 2024

Information events on the project concept and planning

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