TMF Publication Series

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This legal opinion provides a comprehensive presentation of the data protection framework for medical research and answers specific questions from the research community collected by the Workgroup Data Protection. In addition to the pure presentation of the legal framework, the aim of the report is to provide information on how a practical concordance can be achieved between the protection of fundamental informational rights and the urgently needed freedom of medical research.

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The University Medical Center Greifswald commissioned this legal opinion, which was prepared by DIERKS+COMPANY. It deals with questions concerning all steps of data processing and provides practical answers to a variety of technical and organizational questions in the field of data protection-compliant processing of research data.

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This volume provides an overview of the current legal framework for scientists and anyone else interested in using social and health data. It also enables the healthcare industry and state institutions to develop solutions and products that improve the quality of care. This publication thus provides stakeholders in the healthcare system with important guidance on the legally compliant use of social and health data.

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This anthology provides suggestions on how to successfully communicate in health research and is a reference work that provides readers with assistance and tips for their own work. The volume is the result of the meetings and workshops of the TMF Science Communication Workgroup, which regularly discusses the latest developments in science and organizational communication in medical research institutions.

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The status of the use of international medical terminologies in German-speaking countries has been examined in a preliminary study funded by the BMG. The first part of the book deals with recommendations developed on the need for and selection of international terminologies and possible cooperations between German-speaking countries. In the second part, experts from science, associations, and industry provide the most important technical background information on individual topics and terminology systems.

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This legal opinion is the first to provide a detailed overview of the specific legal framework conditions for the secondary use of medical data in the individual federal states, which also takes into account the different sponsorship and legal form of the treating institution in each case. The analysis provides researchers and other stakeholders in the healthcare sector with guidance on the legally compliant handling of medical treatment data.

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The TMF has published generic data protection concepts for medical research consortia, consulted with the federal and state data protection officers and made them available to the research community. Based on this, numerous research projects were able to develop and coordinate their data protection concepts more quickly - also with advice through the TMF's Data Protection Workgroup. The insights gained in the process have been compiled in this book.

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In order to better understand, combat, and monitor infectious pathogens that can be transmitted from animals to humans and cause so-called zoonoses, samples are taken from animals for scientific studies. In this context, legal and data protection issues arise that are addressed in this legal expertise. It was created on the initiative of the National Research Platform for Zoonoses.

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Genetic association studies have been carried out relatively successfully for some time using high-throughput methods. This book now provides broadly agreed recommendations for quality assurance of data generated by high-throughput genotyping. The questions addressed range from problems of validity and plausibility to the detection and avoidance of errors and demands for data storage and data transfer.

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This book provides an introduction to the regulatory framework for medical device development and briefly explains the relevant regulatory terms such as clinical evaluation, clinical trials, clinical studies, and health technology assessment. These must be internalized by all stakeholders involved and receive the same attention in the development process as the purely technical-medical product requirements from the perspective of the user or the market.

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Both in patient care and in medical research, knowledge, data, results, services, and products are constantly being generated, but their value is often difficult to assess. This report sheds light on the value creation process, in which added value is created through considerable effort and the use of resources at various stages. The focus here is on questions of exploitation law, while data protection issues are addressed in numerous other TMF publications.

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Biobanks are an internationally sought-after key resource for research into the complex molecular mechanisms of the pathophysiology of diseases with hereditary components. The fifth volume of the TMF publication series provides the research community with an implementation aid that supports users both in the establishment of a new biobank quality management system and in the adaptation of an existing one.

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This guideline contains recommendations for the management of data quality in registries, cohort studies, and data repositories. It provides a set of indicators and describes the application of the indicators as examples for different types of empirical research projects. It is therefore an important component in the diverse range of useful measures for improving and ensuring data quality in medical research.

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Patient consent is an essential basis for the legally compliant collection, processing, and use of pseudonymized patient data in studies and research projects. The third volume of the TMF publication series is a reference work that enables users to create patient information and declarations of consent that meet regulatory demands on the basis of relevant, documented, and annotated sources.

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The establishment and operation of large biomaterial banks is becoming increasingly important: material banks, which make samples available for medical-scientific analyses in the long term, offer great potential for clarifying pressing questions in medical research. The second volume of the TMF publication series examines the legal framework for the establishment and operation of biomaterial banks from a legal perspective.

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The first volume of the TMF publication series helps remove a major obstacle in the field of medical-scientific collaboration. The solutions it contains enable the flow of information from the clinic to science and from science to standard care to be sustainably optimized. Their utilization makes it possible to abstain from expensive "proprietary data protection constructions".