ePrescription specification in Germany: Is the digital signature a viable alternative to the gematik solution?

The introduction of the ePrescription in Germany marks another important step in the digitalization of the healthcare system. Digitalization facilitates interprofessional collaboration as well as communication with patients and other stakeholders such as pharmacies. ePrescription, electronic certificate of incapacity for work (eAU), eID, and electronic health record (ePA) are now legally mandated, paving the way toward digital normality.

The electronic prescription offers numerous benefits for patients, doctors, and pharmacists:

  • Simplified redemption process
  • Improved security
  • Reduced risk of manipulation and forgery
  • Seamless integration into IT infrastructure

What is the ePrescription?

The ePrescription, officially referred to as the electronic prescription, is the digital alternative to the traditional paper printout. It was introduced to modernize the prescription process for medications in Germany and make pharmaceutical care more efficient. Instead of a printout, patients receive a digital code that can be redeemed at a pharmacy. This code can be transmitted via the gematik app, the electronic health card (eGK), or as a printed QR code. The ePrescription is a core component of the telematics infrastructure (TI) and is organized by gematik.

In addition to the gematik ePrescription, other digital solutions also exist. One such option is the use of digital signatures, which offer a flexible alternative—particularly useful in cases where patients and doctors are not in the same physical location.

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Digitally Sign with QES Remote Signature

Using a qualified electronic signature (QES) via remote signature allows doctors to sign prescriptions for prescription-only medications—or medical leave certificates—digitally and in compliance with legal frameworks (according to eIDAS and GDPR). The remote signature ensures the integrity and authenticity of the ePrescription and is especially advantageous for telemedicine applications.

Technical Implementation

Technically, the remote signature process works by enabling a doctor to generate a qualified electronic signature with just a few clicks using a signature provider like Certifaction. This can be done either through a web app or via API integration into existing software solutions. The process is fully digital and meets the highest security standards, as the signature is uniquely linked to the issuer and tamper-proof.

Zero Document Knowledge

You might be wondering whether a digital signature is as secure as the official gematik solution. At least in the case of Certifaction, the answer is yes. The solution is based on the Zero Document Knowledge principle, which processes documents locally and encrypts them end-to-end. This ensures that the signature provider (Certifaction) has no access to the documents or sensitive medical data. As a result, patient data and prescribed medications remain confidential and are only visible to the involved parties—doctor, patient, and pharmacy.

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eHealth and Telemedicine Providers

Providers of eHealth and telemedicine services can benefit significantly from digital signatures, especially when issuing and managing prescriptions. Key advantages include:

Legal Security and Compliance

Certifaction’s digital signatures meet the requirements of the EU eIDAS regulation and the General Data Protection Regulation (GDPR). For medical documents like prescriptions, a QES is often required, which is legally equivalent to a handwritten signature.

Increased Efficiency

Doctors can sign prescriptions digitally and forward them to patients or pharmacies instantly—no paper involved. Integrated digital signature solutions enable seamless workflows without media disruptions.

Enhanced Patient Experience

Patients receive prescriptions faster and more conveniently via digital channels, reducing the need for physical visits and long waiting times.

Secure and Tamper-Proof Data Exchange

Digital signatures ensure that prescriptions have not been altered after issuance. Only authorized doctors can issue prescriptions, preventing misuse.

Cost Savings

Reduced paper use, printing costs, and physical transportation thanks to fully digital processes. Less administrative effort for reviewing and archiving prescriptions.

Scalability and Interoperability

Digital signatures can be easily integrated into existing eHealth platforms and electronic health records (EHRs). Standards like HL7 and FHIR enable interoperability between different systems and stakeholders (e.g., pharmacies, insurers, hospitals).

Sustainability

Transitioning to digital signatures reduces paper consumption and environmental impact.

Improved Collaboration

Prescriptions can be securely shared in real-time with pharmacies, hospitals, and other healthcare providers, improving coordination between stakeholders.

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Requirements for Using the Electronic Prescription

Doctors and dentists must meet specific technical requirements (also known as specifications) to issue ePrescriptions via the gematik procedure. These include:

  • Electronic Health Professional Card (eHBA): Required for digitally signing prescriptions.
  • Access to TI (Telematics Infrastructure): For secure prescription transmission.
  • Compatible Practice Management System (PMS): Must comply with gematik standards.
  • Connectors and Card Terminals: For securely transmitting patient data.
  • Regular Updates: To meet security requirements and new standards.

If you use an alternative provider like Certifaction to sign prescriptions, you only need:

  • An identification document for verification
  • A mobile phone for two-factor authentication (2FA)
  • (Optional) API integration with your practice software. Alternatively, the web app can be used via browser.
More information about QES signatures from Certification

How an Electronic Prescription Works

gematik Solution

Creating and processing ePrescriptions involves close cooperation between doctors, pharmacies, and the telematics infrastructure (TI). Patients usually visit the doctor in person and may have to wait. Doctors enter prescription data into their PMS and authenticate using their eHBA. Prescriptions are then transmitted via the Insured Master Data Management Service (VSDM) to gematik’s ePrescription specialist service, where they are securely stored and managed.

Patients can access their ePrescriptions via the gematik app, their electronic health card (eGK), or a QR code—on their smartphone, as a printout, or directly via their eGK. Pharmacies retrieve prescriptions using QR codes or NFC-enabled readers. The CardLink procedure requires a Generation 2.1 health card and a PIN if the eGK is used. Technologies like eAEP ensure secure and transparent data transmission.

It is rumored that the nationwide rollout of the gematik ePrescription is progressing more slowly than expected, partly due to usability issues and implementation challenges for doctors. As a result, many are seeking alternative, less error-prone solutions. Digital signatures offer a much leaner workflow—particularly for digital health services.

Digital Signature

A digital signature solution shortens the path to a digital prescription. Typically, this involves an online consultation via video call. The patient registers on a platform and either describes symptoms or requests a specific medication. The doctor enters the prescription data into the PMS and generates a prescription for the patient, which is signed digitally in just a few steps.

Let’s take Certifaction as an example: As mentioned, a QES is required. If the doctor has already completed identification, the QES certificate and a visual signature (e.g., a signature card) are applied to the prescription. The doctor must confirm the signature using their mobile phone as a second factor (usually via passkey). The signed prescription is then sent through a secure digital channel either directly to the patient or to a selected pharmacy, where it can be collected. Alternatively, the prescription can be sent to an online pharmacy that reliably delivers the medication to the patient.

Flexibility in Prescription Redemption

Patients are not required to choose a specific redemption method while still in the doctor’s office. Each electronic prescription can be redeemed flexibly. Patients are always free to choose any pharmacy, including online pharmacies. The gematik telematics infrastructure ensures that each ePrescription can only be redeemed once, preventing misuse. A digital signature alone does not guarantee this protection.
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Legal Obligation to Issue ePrescriptions and Exceptions

As of January 1, 2022, doctors are legally required to issue prescriptions for prescription-only medications electronically if they are connected to the telematics infrastructure, according to the Federal Ministry of Health. Exceptions apply to certain medications, such as narcotics or T-prescriptions, which must still be issued on paper.

Challenges and Perspectives

Despite the many advantages, the ePrescription solution still faces challenges, such as media disruption issues and continued use of paper prescriptions. These are reasons enough to consider alternative, privately developed solutions beyond government offerings.

Many doctors view the ePrescription as an important step toward the digitalization of healthcare, aiming to simplify processes and increase patient satisfaction.

Conclusion

The electronic prescription marks a major milestone in the digitalization of the German healthcare system. It simplifies the prescribing process, reduces media disruptions, and provides patients and doctors with a modern, secure solution. Both the gematik solution and digital signature alternatives offer their own advantages and disadvantages. With continued improvements, more alternative offerings, and broader acceptance, the ePrescription will significantly enhance the efficiency and transparency of pharmaceutical care.

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