Are you a hospital, health insurer or provider of healthcare products and services considering the use of cloud services?
We provide expert legal support for health data processing in the cloud, ensuring full compliance and successful implementation.
The complex regulatory landscape and potential obstacles of health data processing in the cloud pose many challenges, requiring a thorough understanding of the requirements and a well-planned strategy.
The use of cloud services for processing health data is possible. The following are the most relevant topics organisations in healthcare should consider when developing and applying cloud services.
There is often uncertainty as to which regulations must be observed at all regarding the data processed. Different rules apply to personal data than to nonpersonal data. Hospitals, health insurance companies and DiGA manufacturers must observe and fulfill different requirements.
One of the central professional duties of physicians is the duty of confidentiality. § Section 203 of the German Criminal Code (StGB) protects patient confidentiality under criminal law. The disclosure of secrets is therefore only permitted to members of the medical profession under special conditions.
With whom must a processing contract be concluded in accordance with the GDPR? Data transfers to third countries without an adequacy decision are also only permitted if appropriate safeguards are in place.
Due to their legal assessment, health and social data are data with a high level of protection. The technical and organizational measures taken when processing this data must reflect this level of protection.
Many state hospital laws restrict the disclosure of patient data collected at the hospital. In many places, these restrictions also apply to the use of processors.
Special regulations apply to social data. One of these is § 80 SGB X. This states, among other things, that no processing may take place in a third country for which no adequacy decision exists pursuant to Art. 45 DGSVO.
Digital health applications (DiGA) are also subject to special requirements regarding the processing of personal data, which are regulated in the DiGAV. The strict interpretation of the legal requirements by the BfArM leads to uncertainty among manufacturers.
Critical infrastructure as defined by BSIG must meet special requirements for security in information technology.
Regulatory authorities often express skepticism and restrictiveness in connection with service providers that have group connections in a third country. This uncertainty needs to be dealt with.
Want to learn more? Take a look at the crucial questions with regard to a privacy-compliant deployment of health data in the cloud.
D+C helps you to come to an informed decision on the use of cloud services. The Quick Check is an initial approach to examine your challenges and develop the roadmap for your cloud transition.
The Quick Check will build on the documents you provide to analyze which data protection framework conditions you must observe when processing your data. Furthermore, it will outline the regulations relevant to attendees, the restrictions they impose, and how cloud providers can be used considering the applicable requirements.
We enable you to implement your roadmap and support you to take all the necessary measures to efficiently move your health data to the cloud.
Starting with the roadmap, we guide you through the requirements of implementing a cloud solution for health data in a 2 day workshop. Knowing your specific needs and challenges, we check off all the boxes on your roadmap and define the necessary checklists and templates together with you.
The workshop includes the following modules:
Let us evaluate your organization and receive a report from us on your fully compliant health data processing implementation in the cloud. Our expertise and reputation can help you in the dialogue with authorities and customers.
Do you need specific on-demand advisory? Let us accompany you in the transition to cloud with confidence.
We provide answers to your specific legal questions that arise during the implementation of cloud services. Our consulting services are tailored to you – be it the preparation of presentations, legal memos or legal opinions. We are solution-oriented and work closely with you – always ensuring full compliance for your results.
With our deep understanding of relevant regulations and industry standards, we empower our clients to make informed decisions and ensure smooth implementation in the cloud.
We combine legal consulting with strategic thinking and political communication
We are well connected with decision makers and stakeholders of the German healthcare system.
Contact us and we will get back to you.