DE Deutschland

Electronic communication in the healthcare sector

Act on the protection of electronic patient data in the telematics infrastructure (Patient Data Protection Act - PDSG [Patientendaten-Schutz-Gesetz])

The notification concerns Sections 325, 342, 358, 360 and 371:

1. § 325 (approval of components and services of the telematics infrastructure)

§ 325(3) contains new regulations for verifying the security of components and services. With the future new regulation on the creation guidelines for security verification by the Gesellschaft für Telematik, these guidelines can be created by the Gesellschaft für Telematik in the future, parallel to the development of specifications for the telematics infrastructure. This makes it possible to create these guidelines more rapidly. Furthermore, in addition to security certifications in the narrower sense, the guidelines for security verifications, may, in the future, also specify other tests and partial verifications which can be combined into overall tests of complex services and partial infrastructures of the telematics infrastructure.

2. § 342 (offer and use of the electronic patient file)

§ 342(2) regulates the requirements for the electronic patient file with regard to the data content it is to provide, the technical access authorisation management by the insured persons and the inspection of the log data by the insured persons.

3. § 358 (electronic medication plan and electronic emergency data)

Paragraphs (1) and (2) stipulate that the electronic health card must be capable of supporting the electronic emergency data and the electronic medication plan.

4. § 360 (transmission of prescriptions issued by doctors under statutory health insurance in electronic form)

The electronic prescription of prescription medicinal products in the telematics infrastructure will be mandatory from 1 January 2022. Medical prescriptions, and thus also the possibility of accessing medical prescriptions, are central elements of the supply of medicinal products in the solidarity-based system of the statutory health insurance. The allocation of tasks to the Gesellschaft für Telematik as a recognised neutral body is intended to ensure that the app is an integral part of the telematics infrastructure.

5. § 371 (integration of open and standardised interfaces in information technology systems)

In order to promote interoperability of electronic documentation and communication for the provision of statutory health insurance services, in particular to ensure the transmission and storage obligations for electronically collected patient data, the information technology systems described are intended to integrate open standardised interfaces that allow unlimited data exchange between the information technology systems of the respective areas of statutory healthcare provision and statutory dental care provision as well as between hospitals.