[HTML][HTML] Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio) medical research: Towards a new German …
Background The secondary use of deidentified but not anonymized patient data is a
promising approach for enabling precision medicine and learning health care systems. In …
promising approach for enabling precision medicine and learning health care systems. In …
[HTML][HTML] MAGIC: once upon a time in consent management—a FHIR® tale
M Bialke, T Bahls, L Geidel, H Rau… - Journal of translational …, 2018 - Springer
Background The use of medical data for research purposes requires an informed consent of
the patient that is compliant with the EU General Data Protection Regulation. In the context …
the patient that is compliant with the EU General Data Protection Regulation. In the context …
Strategies for health data exchange for secondary, cross-institutional clinical research
Secondary use of health data has a vital role in improving and advancing medical
knowledge. While digital health records offer scope for facilitating the flow of data to …
knowledge. While digital health records offer scope for facilitating the flow of data to …
[HTML][HTML] Broad consent for biobanks is best–provided it is also deep
RB Mikkelsen, M Gjerris, G Waldemar, P Sandøe - BMC medical ethics, 2019 - Springer
Background As biobank research has become increasingly widespread within biomedical
research, study-specific consent to each study, a model derived from research involving …
research, study-specific consent to each study, a model derived from research involving …
[HTML][HTML] In Defence of informed consent for health record research-why arguments from 'easy rescue','no harm'and 'consent bias' fail
T Ploug - BMC medical ethics, 2020 - Springer
Background Health data holds great potential for improved treatments. Big data research
and machine learning models have been shown to hold great promise for improved …
and machine learning models have been shown to hold great promise for improved …
[HTML][HTML] Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road
E Gefenas, J Lekstutiene, V Lukaseviciene… - Medicine, Health Care …, 2022 - Springer
This paper explores some key discrepancies between two sets of normative requirements
applicable to the research use of personal data and human biological materials:(a) the data …
applicable to the research use of personal data and human biological materials:(a) the data …
Donor's support tool: Enabling informed secondary use of patient's biomaterial and personal data
H Kondylakis, L Koumakis, S Hänold… - International journal of …, 2017 - Elsevier
Purpose Biomedical research is being catalyzed by the vast amount of data rapidly collected
through the application of information technologies (IT). Despite IT advances, the methods …
through the application of information technologies (IT). Despite IT advances, the methods …
[HTML][HTML] Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative
Background The aim of the German Medical Informatics Initiative is to establish a national
infrastructure for integrating and sharing health data. To this, Data Integration Centers are …
infrastructure for integrating and sharing health data. To this, Data Integration Centers are …
Patient views on research use of clinical data without consent: legal, but also acceptable?
G Richter, C Borzikowsky, W Lieb, S Schreiber… - European Journal of …, 2019 - nature.com
The research exemption implemented in the new EU General Data Protection Regulation
(EU-GDPR) gives member states leeway in determining whether patient consent is required …
(EU-GDPR) gives member states leeway in determining whether patient consent is required …
[HTML][HTML] Evaluating models of consent in changing health research environments
S Wiertz, J Boldt - Medicine, Health Care and Philosophy, 2022 - Springer
Abstract While Specific Informed Consent has been the established standard for obtaining
consent for medical research for many years, it does not appear suitable for large-scale …
consent for medical research for many years, it does not appear suitable for large-scale …