Background Since the General Data Protection Regulation (GDPR) came into force, the question of concluding a data processing contract (AV contract) became decisive for the practical use of diabetes software in the outpatient and inpatient sector. Material Many of the current diabetes technologies (CGM systems, insulin pumps, blood glucose monitoring systems) allow the local or cloud-based storage of the generated data in the cloud of the respective manufacturers. Cloud-based services are expected to increase in the future to overcome interoperability challenges. A number of questions and issues arise from a data protection law perspective, but also from a supply-related perspective, which need to be clarified. Results In principle, patients are free to choose the read-out software for their diabetes data and the generation of the respective PDF-file. For the initial treatment and long-term care, medical doctors in clinics or practices need the collected data to control the therapy adjustment. In this context, attending physicians in health care facilities often use software based diabetes programs, which allow access to the data stored in the patient's software. It is possible with the physician's software to access the patient data continuously. This form of access allows to read-out, adapt, save and change the data relevant to therapy and constitutes data processing within the meaning of Art. 4 GDPR, which provides for the conclusion of an AV contract. Conclusion In addition to diabetes software solutions, specialist departments in hospitals and medical practices should also deal with the topic of AV contracts in order to be able to guarantee legal certainty for their patients when using such software. A preliminary legal review of the complex contracts by the large diabetes specialist organisations would be desirable.
|Translated title of the contribution
|The contract data processing contract (DP contract): Relevance and practical significance for diabetology
|Diabetologie und Stoffwechsel
|Number of pages
|Published - 01.08.2020
Research Areas and Centers
- Research Area: Center for Population Medicine and Public Health (ZBV)