PROCESSING HEALTH DATA: EUROPEAN LEGAL FRAMEWORK AND SELECTED ASPECTS OF THE GERMAN MARKET
In the digital age, all data is valuable, but health data has particular importance. For business leaders in the healthcare sector, understanding the legal framework governing the processing of health data is crucial. This article provides an overview of the applicable European legal framework and explores specific aspects and opportunities presented by the German market.
European legal framework
The General Data Protection Regulation (GDPR) is the cornerstone of data privacy in Europe. It applies to all EU member states and sets stringent rules for processing personal data, including health data. Since health data is classified as ‘special category data’ under the GDPR, it is subject to additional protections and safeguards due to its sensitive nature.
Key principles of the GDPR on data processing include: (i) data must be processed lawfully, fairly and in a manner transparent for the data subjects affected, which requires justifying any data processing under a defined set of legal bases; (ii) data shall only be collected and processed for specified, explicit and legitimate purposes; (iii) only data that is necessary for the intended purpose should be processed; (iv) data, including patient records, must be accurate and kept up to date; (v) data must not be kept longer than necessary for the processing purpose and must be deleted once this purpose no longer applies; and (vi) data must be processed securely to protect against unauthorised access, which includes technical precautions such as IT security concepts.
Data subjects have a right to have their data processed lawfully. They can invoke their rights directly against market participants. Non-compliance with privacy laws may result in claims for damages by data subjects (with the development of litigation strategies in cases of high-volume business models) and significant fines by supervisory authorities.
Apr-Jun 2025 Issue
Hengeler Mueller Partnerschaft von Rechtsanwälten mbB