Analysis of Germany’s Federal Ministry of Health Digitalisation Strategy for Health and Care 2026

Nelson Advisors
13 minutes ago
10 min read

The strategic landscape of German healthcare in early 2026 is defined by a rigorous transition from foundational digitalisation to an era of operational maturity and data-driven clinical utility. Under the leadership of Federal Health Minister Nina Warken, the updated strategy, titled "GEMEINSAM DIGITAL 2026," represents a sophisticated evolutionary step from the initial 2023 roadmap, focusing on the practical integration of digital tools into the daily workflows of nearly 73 million insured citizens and hundreds of thousands of healthcare providers.

This strategy is not merely a technical upgrade but a fundamental restructuring of the German healthcare ecosystem, moving away from fragmented data silos and toward a unified, person centred digital companion. The framework is anchored in three primary action fields: the creation of digitally supported, cross-sectoral care processes; the systematic generation and utilisation of high-quality health data for research; and the implementation of benefit-oriented technologies such as Artificial Intelligence (AI) and the second-generation Telematics Infrastructure (TI 2.0).

The Evolution of the Electronic Patient Record: From Storage to Navigation

The centerpiece of the 2026 strategy is the electronic patient record (ePA), which has undergone a conceptual metamorphosis. Following the "ePA for all" rollout in early 2025, the focus in 2026 has shifted toward enhancing the ePA’s functionality as a "digital companion" rather than a passive document repository. The transition from an "opt-in" to an "opt-out" system was a decisive policy shift that addressed the historical failure of voluntary adoption, which had left participation rates stagnating at approximately 1% for years. By early 2026, the success of this shift is evident, with nearly 60% of Germans reporting awareness and an intention to actively manage their digital health identities.

The ePA 3.0 iteration, as defined in the 2026 strategy, integrates several critical navigation tools. These include a digitally supported medication process that provides a real-time overview of current prescriptions, automated interaction checks to prevent adverse drug events, and digital appointment brokering.

Furthermore, the introduction of a "digital first assessment" (digitale Ersteinschätzung) allows patients to input symptoms into the ePA application to receive triage recommendations, potentially diverting uncritical cases from overburdened emergency departments. This move signifies a broader trend toward "patient sovereignty," where the citizen is empowered with structured data to make better-informed health decisions.

ePA Implementation Milestone	Target Date / Status (as of Feb 2026)	Strategic Objective
Opt-out Migration	Completed Jan 2025	Universal establishment of digital records
Active User Base	4 Million (Current) to 20 Million (2030)	Critical mass for population health management
Digital Medication Check	80% of users by end of 2025	Reduction in polypharmacy risks
Electronic Arztbriefe	100% transmission by end of 2027	Elimination of paper-based physician letters
Research Data Export	Scheduled for late 2026	Automated pseudonymized data flow to FDZ

The narrative of the ePA in 2026 is increasingly one of "structured data" over "unstructured PDFs." Previously, the ePA was criticized by medical professionals as a "data dump" of non-searchable documents, which hindered rather than helped clinical efficiency. The current strategy mandates the use of Medical Information Objects (MIOs) for vaccinations, maternity records, and dental health, ensuring that these data points are machine-readable and capable of being integrated into clinical decision support systems. This structural integrity is essential for the ePA to fulfil its role as the "central anchor point" of the treatment process.

Data Utilisation and the Health Research Data Center (FDZ)

The second pillar of the 2026 strategy addresses the chronic "data hunger" of the German research landscape. For decades, German pharmaceutical and medical researchers were hampered by strict data protection interpretations and the fragmentation of information across 95 different statutory health insurers and thousands of hospitals. The Health Data Use Act (GDNG) and its 2026 follow-up legislation have sought to dissolve these silos by empowering the Health Research Data Center (FDZ) as a central coordinating body.

The FDZ is tasked with providing a "networked, sovereign health data infrastructure" that allows for the linkage of diverse data sources, including ePA records, billing data from health insurers, and disease registries. A major objective for 2026 is the initiation of at least 300 research projects using data from this centralized laboratory. This goal is viewed as a critical "stress test" for the new data-sharing norms, where the implicit consent provided by the opt-out model is leveraged to drive medical innovation.

The international dimension of this data strategy is equally significant. The BMG has prioritised the alignment of the FDZ with the European Health Data Space (EHDS), ensuring that German research data is interoperable with European partners through the "MyHealth@EU" infrastructure. This enables cross-border care, such as a German patient’s summary being accessible to an emergency physician in Spain, and facilitates large-scale European research cohorts that would be impossible within national borders alone.

Artificial Intelligence: From Theoretical Potential to Administrative Standard

Artificial Intelligence (AI) occupies a prominent position in the 2026 strategy, particularly as a solution to the acute shortage of skilled workers in the healthcare sector. The BMG has moved beyond the hype cycle of AI, setting concrete targets for its operational deployment. Specifically, the strategy aims for AI-supported documentation to become the standard in more than 70% of health and care facilities by 2028.

The mechanism for this deployment involves the creation of "secure test environments" where AI applications can be validated for clinical efficacy and data security. In clinical practice, AI is being deployed in several high-impact areas:

Administrative Relief: Automated transcription and coding of medical consultations into structured ePA entries to reduce the 90% of nurses and doctors who report feeling overburdened by bureaucracy.
Diagnostic Precision: AI-driven analysis of imaging data (e.g., MRI, X-ray) and dermatological scans to assist in earlier and more accurate disease detection.
Predictive Analytics: Utilising population-level data to create personalised prevention programs, such as identifying early indicators of kidney damage in patients with gestational diabetes.

However, the strategy maintains a firm "human in the loop" principle, asserting that while AI provides decision support, the final medical or nursing judgment remains with the professional. This ethical boundary is balanced against the "Digital Omnibus" initiative at the EU level, which seeks to streamline AI regulations to ensure European competitiveness against the United States and China.

Infrastructure Crisis and the Cryptographic Transition

The technical success of the 2026 strategy is currently contingent on a massive and high-stakes migration of the Telematics Infrastructure (TI). The transition from the legacy RSA 2048 encryption to Elliptic Curve Cryptography (ECC) represents one of the most significant technical challenges in the history of the German healthcare system. This migration is driven by updated security requirements from the Federal Office for Information Security (BSI), which determined that RSA-based encryption is no longer sufficiently resilient against emerging threats.

As of early 2026, the migration has reached a critical phase. "RSA-only" connectors, which were the standard for over a decade, became dysfunctional on December 31, 2025, forcing thousands of practices to either replace their hardware or migrate to the "TI-Gateway"—a cloud-based access point. The operational consequences of failing to migrate are severe, as systems that are not ECC-compliant cannot generate E-prescriptions, transmit electronic sick notes (eAU), or access the ePA.

TI Component Migration	RSA Expiry / ECC Mandatory Date	Migration Status & Implications
Hardware Connectors	Dec 31, 2025	Compulsory replacement; failure leads to "digital lockout"
Primary Systems / KIM	Dec 31, 2025	Software updates required to support ECC handshakes
HBA (Physician Card)	June 30, 2026	Transition from G2.0 to G2.1 cards; essential for QES
SMC-B (Institution Card)	June 30, 2026	Mandatory card swap for practice/pharmacy identity
gSMC-KT (Terminal Card)	Dec 31, 2026	Final phase of cryptographic hardware modernization

The BMG has leveraged this infrastructure crisis to accelerate the adoption of "TI 2.0," which envisions a "connector-less" environment. By promoting TI-Gateways and digital identities (GesundheitsID), the strategy aims to enable mobile access to the TI, allowing physicians and nurses to use digital tools during home visits or in telemedical scenarios without being tethered to physical card terminals.

Digitalisation in Long Term Care: The BEEP Reform

A significant achievement of the 2026 strategy is the formal integration of the long-term care sector into the digital health ecosystem. The "Gesetz zur Befugniserweiterung und Entbürokratisierung in der Pflege" (BEEP - Act for the Expansion of Competencies and Reduction of Bureaucracy in Care), effective January 1, 2026, addresses the unique challenges of nursing, which was previously treated as a secondary priority to medical care.

The BEEP reform revitalizes the concept of Digital Care Applications (DiPA) by simplifying the reimbursement pathway. After years of no DiPAs being available due to excessive bureaucratic hurdles, the new framework introduces an "experimental regulation" (Erprobungsregelung) that allows manufacturers to receive preliminary reimbursement while they collect evidence of "pflegerischer Nutzen" (care benefit).

The financial structure for DiPAs in 2026 follows a "40+30" model:

Core Application: Up to 40 EUR per month for the digital application itself (e.g., fall prevention apps, cognitive training).
Professional Support: Up to 30 EUR per month for outpatient nursing services to provide instruction and setup assistance to the patient, ensuring that the technology is effectively integrated into the care routine.
Expanded Scope: For the first time, digital applications that provide relief exclusively to "family caregivers" (e.g., stress management, coordination tools) are eligible for reimbursement, acknowledging the critical role of the approximately 4 million informal caregivers in Germany.

Furthermore, the "Pflege-Cockpit" initiative aims to provide a unified digital portal for insured persons to manage all care-related applications, from applying for care grades to searching for available nursing beds.

Hospital Interoperability and the ISiK Roadmap

The 2026 strategy recognizes that the seamless flow of data across the "patient journey" is only possible if hospital information systems (KIS) speak the same technical language. To this end, the "Informationstechnische Systeme in Krankenhäusern" (ISiK) framework, based on the international FHIR standard, has become the mandatory baseline for hospital digitalisation.

By 2026, German hospitals have transitioned through several critical ISiK development stages:

Stufe 1 & 2: Established the basics of patient demographics, diagnoses, and encounter data exchange

Stufe 3: Mandatory as of July 2025, focusing on structured document exchange, medication lists, and appointment scheduling
Stufe 4 & 5: Rolling out in 2026, these stages enhance the exchange of vital parameters (e.g., heart rate, blood pressure) and integration of third-party web applications within the KIS environment.

ISiK Module / Development Stage	Mandatory Date	Clinical Utility in 2026
Basis Stufe 3	July 1, 2025	Cross-sectoral access to hospital discharge letters
Dokumentenaustausch	July 1, 2025	Eliminating the need for physical CD-ROMs for medical images
Medikation Stufe 3	July 1, 2025	Structured transfer of medication plans to outpatient care
Vitalparameter Stufe 4	Early 2026	Real-time monitoring data for AI early warning systems

The enforcement of these standards is tied to the Hospital Future Act (KHZG) funding. Hospitals that fail to implement ISiK-compliant interfaces risk significant financial penalties, as these standards are now viewed as a prerequisite for patient safety and clinical efficiency.

Stakeholder Resistance and Socio Technical Critique

Despite the strategic clarity of the "GEMEINSAM DIGITAL 2026" roadmap, the rollout has been met with significant resistance from several quarters. The most vocal critics are the medical professional associations (KBV and BÄK), who argue that the digitalisation strategy prioritises "industrial health economics" over "patient care".

The Burden of Digital Duty

Physicians have expressed frustration with the "sanction culture" inherent in the 2026 strategy. From January 1, 2026, physicians who do not use "ePA-ready" systems or fail to populate the record with mandatory data face a reduction in their "TI-Pauschale" (infrastructure lump sum) or even their broader service billing. The KBV has labeled these sanctions as "counterproductive," arguing that they alienate the very professionals who are supposed to champion the digital transition. There is a growing concern that the administrative time required to fill the ePA with structured data will simply replace the administrative time previously spent on paper, failing to deliver the promised "net relief".

Data Protection and Public Trust

The Chaos Computer Club (CCC) and several patient advocacy groups have remained highly critical of the ePA’s security architecture. The report of a successful hack on "improved" ePA protections in May 2025 significantly damaged public trust. Critics argue that the central storage of health data is "inherently insecure" and represents a lucrative target for state-sponsored and criminal actors.

Furthermore, the Federal Commissioner for Data Protection (BfDI) has pointed out that while the "opt-out" system increases participation, it may undermine "informed consent." Surveys from 2025 indicate that 40% of patients erroneously believe their ePA is only created after they install the app, suggesting a significant "information deficit" regarding the automated creation of records for all 73 million GKV members.

Stakeholder Group	Primary Concern in 2026	Proposed Solution / Counter-Position
Physicians (KBV/BÄK)	Administrative burden and sanctions	Moratorium on sanctions; focus on usability
Data Protectors (BfDI)	Lack of granular control and informality of consent	Enhanced education campaigns; user-friendly permission management
Tech Critics (CCC)	Centralized data storage vulnerabilities	Decentralized storage; end-to-end encryption by default
Health Insurers (GKV)	High infrastructure costs and fraud detection	Use of AI for billing transparency; insurers as "digital pilots"

Strategic Synthesis: Navigating Toward 2030

The "GEMEINSAM DIGITAL 2026" strategy is best understood as a bridge to the "Vision 2030." By 2030, the BMG envisions a healthcare system where digital and analogue processes are seamlessly integrated, and the "digital companion" is a ubiquitous part of German life.

The path forward involves several second-order implications:

Industrial Competitiveness: By establishing one of the world's most comprehensive health data infrastructures, Germany is positioning itself as a hub for "Spitzenforschung" (top-tier research). This is viewed as a geopolitical necessity to prevent the exodus of pharmaceutical innovation to the United States or Asia.
Sovereignty in AI: The strategy’s focus on "legal certainty" for AI and secure test environments is an attempt to foster a domestic "AI-Med" sector that is not entirely dependent on non-European technology providers.
The Shift in Care Delivery: The BEEP reform and the rise of tele-monitoring for chronic conditions (e.g., heart failure, diabetes) signal a shift in care delivery from the hospital to the home, necessitated by both cost pressures and patient preference.

In conclusion, the 2026 Digitalisation Strategy represents a high-stakes bet on the transformative power of data. The technical hurdles of the RSA-ECC migration and the socio-political friction with the medical profession are the friction points of a system finally moving at "digital speed." The BMG’s success will be measured not by the number of files created, but by whether these digital tools actually deliver the promised improvements in care quality, patient safety, and professional relief by the turn of the decade.

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