The digitalization of the healthcare system represents one of the key challenges, but also a tremendous opportunity for the further development of medical care in Germany. The introduction of e-prescriptions and the electronic patient record (ePA) is intended to make existing processes more efficient and improve patient care. However, this development raises not only organizational but also legal issues.
What real benefits do these innovations bring, and what legal and practical aspects need to be considered?
E-prescription: Simplifying drug supply
The e-prescription revolutionizes the issuing and dispensing of medications. Whereas paper prescriptions were previously prone to loss or misunderstandings, the e-prescription relies on digital solutions. The prescription is fed directly into a central telematics infrastructure and is available to patients via an app or a digital prescription ID.
The advantages at a glance:
- Efficiency: No more paper, administrative effort and error susceptibility are reduced
- Speed: Patients can redeem their prescriptions faster and more easily at the pharmacy.
- Safety: Automatic testing for interactions and contraindications.
Challenges:
- Technical implementation: Not all doctors and pharmacies are yet integrated across the board.
- Acceptance: Some users are skeptical about the digital solution
- Data protection: in order to ensure the security of health data, the requirements of gematik (Society for Telematics) must be met
Legal basis:
The introduction of e-prescriptions is regulated by the Patient Data Protection Act (PDSG), which is a key driver of digitalization. The goal is widespread use of e-prescriptions starting in 2024.
Electronic patient record (ePA): Manage health data centrally and digitally
The ePA offers the possibility of storing health data securely and centrally. Findings, diagnoses, medication plans, maternity records, and vaccination records – everything is stored in a digital health folder that patients and authorized physicians can access.
The advantages at a glance:
- Transparency: Patients have access to their data at any time.
- Optimized care: Doctors can access important information and avoid duplicate examinations.
- Time saving: Documents such as vaccination or maternity records are available at any time.
Challenges:
- Data protection: The security of sensitive health data is a key challenge, especially in light of the requirements of the General Data Protection Regulation (GDPR)
- Technical integration: the comprehensive connection of all healthcare facilities to the telematics infrastructure has not yet been achieved.
- Usage: Currently, only a few insured persons actively use the ePA. This could change with the opt-out procedure starting in 2025.
Legal basis:
The ePA is regulated in Section 291a SGB V and was introduced by the PDSG.
From 2025, all statutory health insurance holders will automatically receive an ePA unless they object (opt-out procedure)
Data protection perspectives
The processing of health data is subject to the strict regulations of the General Data Protection Regulation (GDPR), in particular Article 9 GDPR, which regulates the processing of special categories of personal data. In the context of e-prescriptions and the ePA, the following aspects are important:
- Legal basis: Data processing is carried out on the basis of the PDSG, which provides clear legal legitimacy.
- Purpose limitation: The data may only be processed for the intended purposes, such as medical care and drug supply.
- Transparency: Patients must be fully informed about how their data is processed and they retain control over its use at all times.
- Technical and organizational measures (TOMs): Data security is ensured through encryption, access restrictions, and compliance with gematik requirements.
- Opt-out procedure: The automatic setup of the ePA from 2025 is permissible under data protection law, as insured persons can actively object and retain full control over their data.
Conclusion:
With e-prescriptions and electronic patient records, two central elements of healthcare digitalization are gaining ground. They promise significant benefits for patients, physicians, and the healthcare system as a whole. Despite technical and legal challenges, initial experiences show that digitalization is the right path to making medical care more efficient and patient-friendly. The coming years will be crucial for further increasing the acceptance and benefits of these technologies. Transparency, data protection, and user-friendliness remain the key factors for success.
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