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Recording medical data in research projects in compliance with data protection law – a practical example (Part 1/2)

11. September 2019

The Preventive Medicine Foundation of the Board of Trustees for Home Dialysis (KfH Foundation) launched a project in 2009 with the aim of improving the prognosis of patients with chronic kidney disease and preventing them from having to undergo dialysis. At the end of 2013, the multi-centre project comprised five individual projects with 14,000 patients. This makes the project one of the largest research efforts in this area in Europe. Five more projects are planned for 2014, which will focus on the care of patients with kidney diseases.
The data collection includes not only medical data but also laboratory data. To protect this sensitive patient data, the generic data protection concept B of the technology and method platform for networked medical research was chosen (in contrast to concept A, which deals with data protection for care-related central databases). The concept describes how medical data is documented separately from patient-identified data in scientifically focused research networks, with the aim of minimizing and controlling the risk of re-identification. This distinguishes the concept from complete anonymization, which is often not desired in the medical research context, as it means that the research results can no longer be reported back to the patient.
Since data protection is subject to state sovereignty, it should be noted here that this theoretical concept has been accepted by data protection officers in all federal states. This makes it applicable nationwide.
As a service provider for the KfH Foundation, MEDEORA GmbH was the first company in Germany to put this data protection concept into practice. You can read how we did it in the second part of this blog, in which we describe the technical infrastructure in this project.

If you would like to find out more about data protection concept B of the TMF, we recommend the following literature:

  1. Dtsch Arztebl 2003; 100: A 2134, 2137 [Heft 33] (http://data.aerzteblatt.org/pdf/100/33/a2134.pdf) <br>
  2. Reng, Debold, Specker, Pommerening. Generische Lösungen zum Datenschutz für die Forschungsnetze in der Medizin. ISBN 978-3-939069-04-1

Part 2

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