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BackgroundThe secondary use of clinical data in data-gathering, non-interventional research or learning activities (SeConts) has great potential for scientific progress and health care improvement. At the same time, it poses relevant risks for the privacy and informational self-determination of patients whose data are used. ObjectiveSince the current literature lacks a tailored framework for risk assessment in SeConts as well as a clarification of the concept and practical scope of SeConts, we aim to fill this gap. MethodsIn this study, we analyze each element of the concept of SeConts to provide a synthetic definition, investigate the practical relevance and scope of SeConts through a literature review, and operationalize the widespread definition of risk (as a harmful event of a certain magnitude that occurs with a certain probability) to conduct a tailored analysis of privacy risk factors typically implied in SeConts. ResultsWe offer a conceptual clarification and definition of SeConts and provide a list of types of research and learning activities that can be subsumed under the definition of SeConts. We also offer a proposal for the classification of SeConts types into the categories non-interventional (observational) clinical research, quality control and improvement, or public health research. In addition, we provide a list of risk factors that determine the probability or magnitude of harm implied in SeConts. The risk factors provide a framework for assessing the privacy-related risks for patients implied in SeConts. We illustrate the use of risk assessment by applying it to a concrete example. ConclusionsIn the future, research ethics committees and data use and access committees will be able to rely on and apply the framework offered here when reviewing projects of secondary use of clinical data for learning and research purposes.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians' professional ethics to determine whether they include duties that can be considered as good reasons for a physicians' professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts. [ABSTRACT FROM AUTHOR]

Data-sharing among genomic researchers is promoted for its potential to accelerate our understanding of the molecular basis of cancer. However, with genomic data sharing the risks of re-identifying study participants, revealing personal genomic information and data misuse might increase. This study aims at exploring perceptions of patients and physicians in Oncology regarding their assessment of the informational risks resulting from participating in whole genomic research studies in order to improve the informed consent process. For this purpose, we conducted a qualitative focus group study at the National Center for Tumor Diseases (NCT). Patients and oncologists assessed the informational risks either as minimal or as greater than minimal, depending on the context factors of occupational status, age, and patients' prognosis. Interestingly, even patients who assumed a greater risk did not refrain from participating in genomic research, provided that certain informational and institutional safeguards are implemented. Moreover, they expected comprehensive disclosure of the risks resulting from genomic data sharing. These results suggest (1) comprehensive disclosure of the risks of genomic research to potential study participants in genomic research to facilitate risk assessment and sound decision making, (2) establishing independent governance entities in order to minimize the informational risks of genomic research, and (3) implementing data sharing policies which offer guidance for physicians and researchers involved in genomic research., Author(s): Sebastian Schleidgen [sup.1] , Alma Husedzinovic [sup.2] , Dominik Ose [sup.3] , Christoph Schickhardt [sup.2] , Christof von Kalle [sup.4] [sup.5] , Eva C. Winkler [sup.2] Author Affiliations: (Aff1) [...]

BackgroundThe implementation of a personal electronic health record (PHR) is a central objective of digitalization policies in the German health care system. Corresponding legislation was passed with the 2015 Act for Secure Digital Communication and Applications in the Health Sector (eHealth Act). However, compared with other European countries, Germany still lags behind concerning the implementation of a PHR. ObjectiveIn order to explore potential barriers and facilitators for the adoption of a PHR in routine health care in Germany, this paper aims to identify policies, structures, and practices of the German health care system that influence the uptake and use of a PHR. MethodsA total of 33 semistructured interviews were conducted with a purposive sample of experts: 23 interviews with different health care professionals and 10 interviews with key actors of the German health care system who were telematics, eHealth, and information technology experts (eHealth experts). The interviews were transcribed verbatim and subjected to a content analysis. ResultsFrom the expert perspective, a PHR was basically considered desirable and unavoidable. At the same time, a number of challenges for implementation in Germany have been outlined. Three crucial themes emerged: (1) documentation standards: prevailing processes of the analog bureaucratic paper world, (2) interoperability: the plurality of actors and electronic systems, and (3) political structure: the lack of clear political regulations and political incentive structures. ConclusionsWith regard to the implementation of a PHR, an important precondition of a successful digitalization will be the precedent reform of the system to be digitized. Whether the recently passed Act for Faster Appointments and Better Care will be a step in the right direction remains to be seen.