Recommendation for implemtation:
State of the art – Data exchange / File Service
In order to prove „reasonable precautions to avoid disturbances of information technology systems, components and processes“ according to the “technical standard”, we recommend to consider the following:
With regard to the software used, it is helpful to choose a solution „Made & Hosted in Germany“. German providers are subject to the strict German data protection laws and at the same time ensure that the solution also complies with the EU GDPR. Corresponding certifications and awards, such as ISO27001, further underscore conformity.
Encryption also plays an important role. For example, only client-side data encryption ensures that the data is already encrypted at the end device. This means that not even the manufacturer / provider has the possibility to access stored information. It is also important - not only for the EU-GDPR - that authorized persons can check at any time which data was processed when and by whom. This is the only way to detect and prevent uncontrolled data outflows. A detailed rights system also clearly regulates who can access and process which data.
However, it becomes extremely difficult for KRITIS organizations in the healthcare sector when a so-called ransomware attack occurs: If a malicious program pentrates the internal network, this promptly leads to malfunctions in IT systems. The protection mechanisms of computer networks must be designed to ensure that a successful attack on a single system does not immediately affect the entire network. Ideally, used software should have ransomware protection, which allows damaged data to be restored promptly – best without having to pay the “ransom”.
In general, operators or their associations can specify in „sector-specific safety standards“ (B3S) how the „state of the art“ requirements can be met. Such B3S may be submitted to the BSI to determine suitability. There is no legal obligation to prepare such a B3S. The preparation of a B3S is, however, an opportunity for the industries to formulate their own „state of the art“ specifications based on their own expertise. In addition, it gives legal certainty to operators who have them tested in accordance with such a recognized B3S with regard to the „state of the art“ which is required and checked during an audit.