Sekundärnutzung von Sozial- und Gesundheitsdaten – Rechtliche Rahmenbedingungen

Viele der im System der Gesetzlichen Krankenversicherung erhobenen Daten sind für die Weiterentwicklung und Verbesserung der Gesundheitsversorgung von hohem Wert. Sozial- und Gesundheitsdaten sind als personenbezogene Daten aber auch datenschutzrechtlich einem engmaschigen Rechtsrahmen unterworfen. Ihre Nutzung in anderen Kontexten bedarf eines tiefgründigen Verständnisses der Regelungen auf europäischer und nationaler Ebene. Dieser Band bietet einen Überblick über den aktuellen Rechtsrahmen und eine wichtige Orientierung zur rechtssicheren Nutzung von Sozial- und Gesundheitsdaten. Das Werk ermöglicht es, Lösungen und Produkte zu entwickeln, die die Qualität der Versorgung verbessern. Im ersten Teil wird der sozialrechtliche Rahmen zur Nutzung von Sozialdaten für die Forschung dargelegt. Im zweiten Teil wird ein Überblick zum Umgang mit Forschungsdaten nach Anwendung der DSGVO und entsprechender nationaler Anpassungen des Rechtsrahmens gegeben

Sekundärnutzung von Sozial- und Gesundheitsdaten

"Much of the data collected in the statutory health insurance system is of great value for the further development and improvement of health care. Social and health data as personal data are also subject to a tight legal framework in terms of data protection law. Their use in other contexts requires a deep understanding of the regulations at European and national level. This volume provides an overview of the current legal framework and an important orientation for the legally secure use of social and health data. The plant makes it possible to develop solutions and products that improve the quality of care. The first part sets out the social law framework for the use of social data for research. The second part provides an overview of how research data is handled after the application of the GDPR and corresponding national adjustments to the legal framework.

Data Privacy in European Medical Research

The European Data Protection Regulation applies since May 25th, 2018. It creates a uniform data protection legal framework within the EU. National and international medical research projects, regardless of whether they were started before or after the introduction of the GDPR, are obliged to follow this new regulation and implement it promptly. This raises various challenges for a large number of medical research projects. The University Medicine Greifswald commissioned this legal report, that was prepared by DIERKS+COMPANY. Two real-world research projects, the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK) provide use cases, questions, and context for this legal report. It addresses questions regarding all steps of data processing. The report provides practical answers to a wide array of technical and organisational questions in the area of data protection-compliant processing of research data. A comprehensive guide to GDPR-compliant data processing has been developed, which both summarises the broad legal environment and provides specific assistance in the design and implementation of GDPR-compliant data management processes, including Informed Consent, Legal Consequences of Withdrawal, and Privacy by Design

Interactions of the Neurotoxin Vipoxin in Solution Studied by Dynamic Light Scattering

AbstractThe neurotoxin vipoxin is the lethal component of the venom of Vipera ammodytes meridionalis. It is a heterodimer of a basic toxic His-48 phospholipase A2 (PLA2) and an acidic nontoxic Gln-48 PLA2. The shape of the neurotoxin and its separated components in solution as well as their interactions with calcium, the brain phospholipid phosphatidylcholine, and two inhibitors, elaidoylamide and vitamin E, were investigated by dynamic light scattering. Calcium binding is connected with a conformational change in vipoxin observed as a change of the hydrodynamic shape from oblate ellipsoid to a shape closer to a sphere. The Ca2+-bound form of vipoxin, which is catalytically active, is more compact and symmetric than the calcium-free heterodimer. Similar changes were observed as a result of the Ca2+-binding to the two separated subunits. In the presence of aggregated phosphatidylcholine, the neurotoxic complex dissociates to subunits. It is supposed that only the toxic component binds to the substrate, and the other subunit, which plays a chaperone function, remains in solution. The inhibition of vipoxin with the synthetic inhibitor elaidoylamide and the natural compound vitamin E changes the shape of the toxin from oblate to prolate ellipsoid. The inhibited toxin is more asymmetric in comparison to the native one. Similar, but not so pronounced, effects were observed after the inhibition of the monomeric and homodimeric forms of the toxic His-48 PLA2. Circular dichroism measurements in the presence of urea, methylurea, and ethylurea indicate a strong hydrophobic stabilization of the neurotoxin. Hydrophobic interactions stabilize not only the folded regions but also the regions of intersubunit contacts

Data Privacy in European Medical Research

The European Data Protection Regulation applies since May 25th, 2018. It creates a uniform data protection legal framework within the EU. National and international medical research projects, regardless of whether they were started before or after the introduction of the GDPR, are obliged to follow this new regulation and implement it promptly. This raises various challenges for a large number of medical research projects. The University Medicine Greifswald commissioned this legal report, that was prepared by DIERKS+COMPANY. Two real-world research projects, the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK) provide use cases, questions, and context for this legal report. It addresses questions regarding all steps of data processing. The report provides practical answers to a wide array of technical and organisational questions in the area of data protection-compliant processing of research data. A comprehensive guide to GDPR-compliant data processing has been developed, which both summarises the broad legal environment and provides specific assistance in the design and implementation of GDPR-compliant data management processes, including Informed Consent, Legal Consequences of Withdrawal, and Privacy by Design

Lung perfusion assessed by SPECT/CT after a minimum of three months anticoagulation therapy in patients with SARS-CoV-2-associated acute pulmonary embolism: a retrospective observational study

Background Anticoagulant treatment is recommended for at least three months after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related acute pulmonary embolism (PE), but the persistent pulmonary clot burden after that time is unknown. Methods Lung perfusion was assessed by ventilation-perfusion (V/Q) SPECT/CT in 20 consecutive patients with SARS-CoV-2-associated acute PE after a minimum of three months anticoagulation therapy in a retrospective observational study. Results Remaining perfusion defects after a median treatment period of six months were observed in only two patients. All patients (13 men, seven women, mean age 55.6 ± 14.5 years) were on non-vitamin K direct oral anticoagulants (DOACs). No recurrent venous thromboembolism or anticoagulant-related bleeding complications were observed. Among patients with partial clinical recovery, high-risk PE and persistent pulmonary infiltrates were significantly more frequent (p < 0.001, respectively). Interpretation Temporary DOAC treatment seems to be safe and efficacious for resolving pulmonary clot burden in SARS-CoV-2-associated acute PE. Partial clinical recovery is more likely caused by prolonged SARS-CoV-2-related parenchymal lung damage rather than by persistent pulmonary perfusion defects

Burnout - das Zusammenspiel von Stress-Symptomen und Stress-Biomarkern

Einleitung Stressbedingte Erkrankungen, wie z.B. Burnout oder mittelgradige depressive Episode, sind geprägt von Symptomen der Erschöpfung, Depression, Angst sowie somatischen Beschwerden. Stressverarbeitungsstörungen zeigen sich zudem durch Veränderungen in unterschiedlichen physiologischen Parametern. Dazu gehören biologische Marker des vegetativen Nervensystems (z.B. Herzratenvariabilität (HRV)) und der neuronalen Plastizität (z.B. brain-derived neurotrophic factor (BDNF)). In dieser Studie ging es darum, zu zeigen, wie eine Verbesserung der subjektiven Stresssymptome nach erfolgreicher Therapie mit einem spezialisierten Behandlungskonzept mit Veränderungen in biologischen Markern von Stress assoziiert ist. Methode Es wurden 74 Patienten mit einer psychiatrischen Diagnose (F32.x (N=42), F33.x (N=29), F4 (N=3)) im Rahmen einer Stressverarbeitungsstörung (Burnout) eingeschlossen, die in stationärer Behandlung mit einem multimodalen Therapieansatz waren. Bei Ein- und Austritt (Dauer des Aufenthalts: 6-8 Wochen) wurden ihnen Fragebögen, z.B. zu Burnout- und Depressionssymptomen, abgegeben sowie die HRV im Schlaf und der BDNF-Spiegel im Blut gemessen. Ergebnisse / Schlussfolgerung Nach dem stationären Aufenthalt zeigte sich bei den Patienten eine signifikante Reduktion der Burnout- und Depressionssymptomatik sowie eine Verbesserung der Schlafqualität. Diese subjektive Verbesserung der Stresssymptome korrelierte deutlich mit einer Erhöhung des BDNF-Spiegels. Die HRV, bzw. die Parasympathikusaktivität im Schlaf zeigte keine signifikante Veränderung. Die Wirkung einer erfolgreichen Therapie scheint sich somit relativ schnell auf der Ebene der neuronalen Plastizität zu zeigen. Es wurde mehrfach belegt, dass eine moderate sportliche Betätigung sich besonders günstig auf den BDNF-Spiegel auswirkt. Das spricht somit für die Wirksamkeit des angewendeten, auf stressbedingte Erkrankungen spezialisierten Therapiekonzepts, das mehrere körperlich aktivierende Elemente integriert, welche die BDNF-Spiegelerhöhung mitunterstützt haben könnten. Dass am Ende des stationären Aufenthaltes bei den Patienten keine Veränderung in der Schlaf-HRV gezeigt werden konnte, weist darauf hin, dass neurovegetative Anpassungen längere Perioden der Erholung und des Stressmanagements beanspruchen könnten

Molecular imaging in multiple myeloma — novel PET radiotracers improve patient management and guide therapy

Due to its proven value in imaging of multiple myeloma (MM), including staging, prognostication, and assessment of therapy response, 2-deoxy-2-[18F]fluoro-D-glucose (FDG) positron emission tomography (PET) is utilized extensively in the clinic. However, its accuracy is hampered by imperfect sensitivity (e.g., so-called FDG-negative MM) as well as specificity (e.g., inflammatory processes), with common pitfalls including fractures and degenerative changes. Novel approaches providing a read-out of increased protein or lipid membrane syntheses, such as [11C]methionine and [11C]choline or the C-X-C motif chemokine receptor 4-targeting radiotracer [68Ga]Pentixafor, have already been shown to be suitable adjuncts or alternatives to FDG. In the present focused review, those imaging agents along with their theranostic potential in the context of MM are highlighted