Funded by the German Research Foundation (Deutsche Forschungsgemeinschaft)
The project “Learning from Clinical Data. Ethical, Social and Legal Aspects (LinCDat)” investigates the possibility and desirability of a paradigm shift in the usage of clinical data. Systematic usage of clinical data (data derived from patient care) for learning and research purposes has the potential to significantly benefit the delivery of health services for patients, the public health system, and, ultimately, the common welfare.
Several national and international medical research programs, such as the German Medical Informatics Initiatives or the US CancerLinQ enterprise, are designed to systematically collect clinical data for secondary analyses. However, to date, the re-use (or secondary use) of clinical data for learning and research activities is rather the exception than the rule.
Data from clinical routine can contribute to different kinds of data gathering and non-interventional studies or learning activities (DaNIS) that may improve quality, safety and effectiveness of health care and promote scientific knowledge. Also, the set-up of Learning Health Care Systems builds on the systematic use and analysis of clinical data.
As opposed to interventional clinical studies, the secondary use of clinical data for learning and research activities is associated with low risks for patients. At the same time, clinical data are very sensitive data and at the core of patients’ rights to privacy and confidentiality. In addition, the systematic use of clinical data is challenged by serious practical obstacles.
To address ethical, legal and social questions and to elaborate recommendations for data governance and policies, the interdisciplinary LinCDat project aims to address the following research questions:
- What risks and burdens does DaNIS pose for patients, physicians and institutions?
- What are the potential benefits of DaNIS?
- What rights, duties and expectations do physicians and health care institutions, patients, and the public have with respect to DaNIS?
- What recommendations and frameworks should be followed in the governance of DaNIS?