Digital Health in Germany: ePA, E-Rezept and GeDIG

≈73mElectronic patient records (ePA) created for statutory insured peopleApr 2026 · gematik

>100mDocuments stored in ePAs after one year of “ePA für alle”Apr 2026 · gematik

>21mViews of the electronic medication list per weekApr 2026 · gematik

582mE-prescriptions redeemed in pharmacies2025 · ABDA, Zahlen Daten Fakten 2026 (secondary report)

01 / Roll-out

From pilot regions to obligation

The building blocks of German digital health were legislated mostly between 2019 and 2024. Linnemann inherited a system in operation, not a plan.

1 Jan 2024
E-prescription becomes mandatory
Prescriptions for prescription-only medicines in statutory insurance must be issued electronically. Patients redeem them with their health card, the app or a printed code.
26 Mar 2024
Health Data Use Act in force
The GDNG sets the rules for research use of health data, including data from the electronic patient record. See health data.
15 Jan 2025
“ePA für alle” starts in model regions
Insurers create an ePA for every insured person who does not object (opt-out). Testing begins in model regions.
29 Apr 2025
Nationwide roll-out
All practices, hospitals and pharmacies may use the ePA; use is voluntary for providers at first.
1 Oct 2025
Use becomes mandatory for providers
Doctors, hospitals and pharmacies must fill and use the ePA within the legal framework.
15 Jul 2026
Cabinet adopts the GeDIG
Under Nina Warken, the cabinet adopts the draft Gesetz für Daten und digitale Innovation im Gesundheitswesen.
8 Oct 2026
First reading in the Bundestag
The government bill (Drucksache 21/8279) is debated for the first time and referred to the Health Committee — now under Minister Linnemann.

02 / Method

Four lenses for every tool

Digital health policy is often presented as a story of progress. This page uses a stricter frame. Each tool is examined through four lenses: the opportunity it offers, the risk it creates, the regulation that governs it, and the state of implementation in practices, hospitals and pharmacies. A tool can be well regulated and still fail in daily use; it can be popular and still raise legitimate privacy concerns.

The institutional map matters too. The Federal Ministry of Health sets the legal framework in the Social Code (SGB V). gematik, the national agency for digital health in which the federal government holds the majority, specifies and approves the telematics infrastructure (TI) that connects providers. Statutory health insurers operate the ePA apps for their members. The BfArM assesses digital health applications. Data protection is supervised by the Federal Commissioner for Data Protection (BfDI) and the Länder authorities. The Länder are responsible for hospital investment, including IT.

Linnemann has not made digital health the subject of a separate programme speech. In his budget speech of 10 September 2026 he said a digital bill would be discussed in October, and in the Health Committee on 23 September he listed digitalisation among his themes, alongside prevention, patient steering and stable contributions (hib 733/2026). The bill now before the Bundestag was drafted and adopted by the cabinet under his predecessor; it is therefore labelled inherited here.

Inherited
Under review
Proposed
In implementation
In force

Digitalisation is judged by minutes returned to care — and by whether patients trust where their data go.

Editorial noteThe statement above is this site’s analytical framing, not a quotation from the minister.

03 / Tool by tool

Opportunity · Risk · Regulation · Implementation

Six areas of German digital health, each read through the same four cells.

01

ePA für alle

In force · in implementation

Opportunity

A shared medication list and documents available across practices, hospitals and pharmacies can reduce duplicate tests and help detect interactions. More than 21 million medication-list views per week (April 2026) show that the list is being used.

Risk

Central access raises the stakes of security failures. In December 2024, before the national launch, security researchers from the Chaos Computer Club publicly demonstrated weaknesses in the access concept; gematik and the ministry said fixes were in place before the nationwide roll-out. Incomplete records can also create false confidence.

Regulation

Opt-out: every statutory insured person receives an ePA unless they object. Patients may object to the whole record, to specific uses, or hide individual documents; access by providers is time-limited after the health card is read.

Implementation

About 73 million ePAs and more than 100 million documents by April 2026; up to 93,000 practices accessed records weekly. Only 5.1 million people had registered a GesundheitsID to use the app themselves — patient use lags far behind provider use.

02

E-Rezept

In force since 2024

Opportunity

No paper slips, repeat prescriptions without a practice visit, data that flow directly into the medication list.

Risk

System outages stop dispensing; pharmacies have reported time lost to failed transactions. Market effects — for example on mail-order versus local pharmacies — are politically contested (see pharmaceutical policy).

Regulation

Mandatory for prescription-only medicines in statutory insurance since 1 January 2024. The GeDIG would extend e-prescriptions to medical aids and therapeutic services.

Implementation

582 million e-prescriptions were redeemed in pharmacies in 2025 and the cumulative total passed one billion on 17 October 2025 (gematik via press reports).

03

DiGA — apps on prescription

In force · inherited

Opportunity

Certified digital health applications (DiGA) can be prescribed and reimbursed, giving evidence-based apps a route into routine care.

Risk

The GKV-Spitzenverband reported in April 2025 that 861,000 DiGA had been used between September 2020 and December 2024 at a cost of €234 million, and criticised high first-year prices and benefits often not proven at listing. Manufacturers’ associations dispute this assessment.

Regulation

The BfArM assesses safety, data protection and a positive care effect; apps may be listed provisionally while evidence is gathered. Price rules and evidence requirements have been tightened in successive laws.

Implementation

Use is rising but remains small relative to 74.6 million insured people. Whether the GeDIG changes DiGA rules materially is not yet clear from the published summaries.

04

Telemedicine

Inherited

Opportunity

Video consultations and telemonitoring can bridge distance in rural areas and support follow-up care without travel.

Risk

Remote consultations cannot replace examinations in every case, and access requires devices and digital skills that not every patient has.

Regulation

The medical profession relaxed its ban on exclusive remote treatment in 2018; remuneration of video consultations is set in the fee schedules negotiated by self-administration.

Implementation

The GeDIG would build a digital access path for the planned primary-care system — initial assessment, electronic referral and appointment booking through the ePA app — and phase in e-referrals by 1 September 2029.

05

Artificial intelligence

Open question

Opportunity

Decision support in imaging, documentation assistants and summaries of long records could reduce workload. The GeDIG would let insurers offer additional ePA features, including AI-generated summaries.

Risk

Errors, bias in training data, opaque reasoning and unclear liability. A summary that omits a relevant finding is a clinical risk, not just a technical one.

Regulation

AI used for medical purposes is regulated as a medical device under EU law and, in addition, by the EU AI Act (Regulation (EU) 2024/1689, in force since 1 August 2024), whose obligations for high-risk systems apply in stages.

Implementation

Early and fragmented. The ministry has not published a dedicated AI strategy for care since July 2026. See health innovation.

06

Cybersecurity and stability

Under review · GeDIG

Opportunity

A stable, secure telematics infrastructure is the precondition for every other tool. Secure messaging (KIM, TI-Messenger) could replace fax and paper.

Risk

Hospitals and practices are attractive targets for ransomware; outages interrupt care. The ministry counted an average of 25 TI disruptions per month in 2025.

Regulation

Large hospitals fall under critical-infrastructure rules; practices must follow an IT-security directive under the Social Code. The GeDIG would give gematik direct procurement powers for core services and stronger oversight, including withdrawal of approvals.

Implementation

Pending the parliamentary procedure that began on 8 October 2026.

04 / The bill

What the GeDIG would change

Summary based on the ministry’s cabinet release of 15 July 2026 and the Bundestag’s description of the first reading.

Inherited · 1st reading 8 Oct 2026

ePA as a care tool for everyone

A digital medication plan; a digital vaccination overview with reminders (planned for mid-2027); full-text search in the ePA (planned early 2027); optional additional services by insurers. Pharmacies and insurers’ ombudspersons would be allowed to help people set up and use their ePA.

Inherited · in parliament

Primary-care infrastructure

Electronic referral, initial assessment and a digital appointment platform; practices would have to report free appointments through standard interfaces to the regional physicians’ associations. These are the technical foundations for the primary-care system that Linnemann has promised as a bill for November 2026.

Inherited · in parliament

Telematics stability

gematik would procure essential services directly instead of approving many competing products, aiming to reduce complexity and disruptions; its supervisory powers would be strengthened.

Inherited · in parliament

Data use and EHDS

The bill implements parts of the European Health Data Space in German law and widens research use of health data. Details are on the health data page.

Open question

Costs and relief

The ministry estimated annual relief of about €445 million. Whether the relief materialises in practices depends on implementation — a point that professional bodies are likely to test in the committee hearing.

Status correctionThe bill was announced in Linnemann’s budget speech of 10 September 2026 as a digital law for October. Because the cabinet had already adopted it on 15 July 2026, under Nina Warken, it is labelled inherited here rather than as a new announcement.

05 / Privacy and control

Opt-out is a choice architecture, not a verdict

Germany switched the ePA from opt-in to opt-out because few people had actively requested a record. The change moved the default; it did not remove the choice. Insured people can object to the record as a whole, to particular uses such as the medication list, or to the use of their data for research, and they can hide individual documents.

Supporters argue that opt-out is the only way to reach a useful coverage level, and that a record that exists for everyone protects people who would never have opted in — often those with complex medication. Critics, including data-protection advocates and some patient organisations, argue that a default is not informed consent, that objection routes must be equally simple for people without smartphones, and that sensitive information (for example on mental health) needs special protection.

The gap between 73 million records and 5.1 million GesundheitsIDs shows the practical issue: most people have a record they have never opened. Patient control exists in law; whether it exists in daily life depends on accessible apps, help in pharmacies and offline routes.

Record created
The insurer creates the ePA unless the person has objected.
Card read in practice
A practice, hospital or pharmacy gains time-limited access when the health card is read.
Patient settings
Via app or ombudsperson: hide documents, restrict access, object to specific uses.
Research use
Pseudonymised data may flow to the research data centre unless the person objects (see health data).

06 / Debate

Is faster digitalisation the answer?

Arguments documented in professional and public debate. Neither side is endorsed here.

Argument for acceleration

Paper, fax and repeated data entry consume clinical time that Linnemann wants returned to patients.
Germany started later than several European neighbours; delay keeps costs of parallel systems high.
Primary-care steering and appointment platforms are hard to run without digital referral.
Research and prevention depend on structured, interoperable data.

Risks and objections

Unstable systems shift work onto practices and pharmacies rather than removing it.
Security incidents in health care have severe consequences and erode trust.
Opt-out defaults can disadvantage people with low digital literacy.
Each new legal deadline adds pressure on software vendors and smaller providers.

Interoperability — the ability of systems to exchange data in common standards — is the hinge between both positions. Without it, more digital tools can mean more fragmentation.

Sources & further reading

Continue reading

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Digital health: infrastructure, not magic

Digital health in figures

E-prescription becomes mandatory

Health Data Use Act in force

“ePA für alle” starts in model regions

Nationwide roll-out

Use becomes mandatory for providers

Cabinet adopts the GeDIG

First reading in the Bundestag

Four lenses for every tool

ePA für alle

Opportunity

Risk

Regulation

Implementation

E-Rezept

Opportunity

Risk

Regulation

Implementation

DiGA — apps on prescription

Opportunity

Risk

Regulation

Implementation

Telemedicine

Opportunity

Risk

Regulation

Implementation

Artificial intelligence

Opportunity

Risk

Regulation

Implementation

Cybersecurity and stability

Opportunity

Risk

Regulation

Implementation

ePA as a care tool for everyone

Primary-care infrastructure

Telematics stability

Data use and EHDS

Costs and relief

Opt-out is a choice architecture, not a verdict

Record created

Card read in practice

Patient settings

Research use

Argument for acceleration

Risks and objections

Sources & further reading

Continue reading