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Background  The  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.    Objective  Since 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.    Methods  In 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 .    Results  We 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.    Conclusions  In 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.

jmir. journal of medical internet research/journal of medical internet research

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment