The interdisciplinary research network aims at analyzing the normative implications of systems medicine with regard to three key aspects. Core of the project are questions concerning possible new responsibilities of physicians and researchers. Regarding diagnosis and therapy, researchers become more important for analysis and interpretation of patient data. This raises questions about their responsibilities for patients and attending physicians. Furthermore, since approaches in systems medicine deal with huge amounts of patient-related data, questions about the value as well as need for protecting the patients’ privacy arise. The third key aspect deals with the consequences of systems medicine for the patients’ relatives with regard to the handling of genetic information. The project consists of a socio-empirical, an ethical and a legal subproject and works in close collaboration with a local, natural scientific panel of experts from genomic research and clinical practice.
DASYMED: Big Data in Systems Medicine
Normative and Social Issues for Physicians, Patients and Society, Subprojects 1 and 2
University of Heidelberg
Medical Faculty and University Hospital Heidelberg
National Center for Tumor Diseases
Im Neuenheimer Feld 460
Head: PD Dr. med. Dr. phil. Eva Winkler
Phone: +49 6221 56-36049
Funds: 635.969 EUR
Term: 01.08.2014 - 31.07.2017
Wissenschaftlicher Gesamtkoordinator: Dr. phil. Christoph Schickhardt
The subprojects are located at the interface between genomic research and clinical practice as implemented through the collaboration of several central institutions of the Heidelberg University Hospital (e.g. the interdisciplinary tumor board “The individual patient”). Their first task is the empirical description of the current systems medicine practice in Heidelberg as well as the normatively relevant developments in systems medicine and the definition of key terms. This will be the basis for an analysis of normative implications of systems medicine as well as the development of possible solutions. The third task is to transfer the theoretical results into practice.
Legal Analysis of the Impacts of Systems Medicine, Subproject 3
University of Mannheim
Institute for German, European and
International Medical Law,
Public Health Law and Bioethics (IMGB)
The legal subproject consists of two parts, namely “Big Data and Privacy” and “Translational Responsibility”. With regard to “Big Data and Privacy”, a key task of the legal entities is to specify the scope of application of the regulations that apply to research as well as clinical practice, especially concerning genetic data. On the one hand, the potential of systems medicine must be acknowledged in an appropriate manner. On the other hand, the undermining of fundamental rights of the person – which is conceivable in the context of the collection of large amounts of data – must be avoided. This, in turn, will be the basis for “Translational Responsibility”, which analyses legal aspects concerning responsibilities and liability in systems medicine. This is necessary because as a result of huge databases in systems medicine, many non-medical persons are involved and computer programs are of major importance.
Henrike Fleischer*, Christoph Schickhardt*, Jochen Taupitz, Eva C. Winkler
Das Recht von Patienten und Probanden auf Herausgabe ihrer genetischen Rohdaten. Eine rechtliche und ethische Analyse samt einer Empfehlung für die Praxis.
Medizinrecht (MedR) 2016: 34, 481-491. DOI: 10.1007/s00350-016-4319-9
Ausführliche Darstellung einer Empfehlung für ein mehrstufiges Verfahren zum Umgang mit Anfragen von Patienten und Probanden bezüglich einer Herausgabe ihrer genetischen Rohdaten: