“Hello ELSA, how are you?” : Legal and Ethical Challenges in RDM, Current and Future Tasks of ELSA Activities Against the Background of AI and Anonymisation

The proposed contribution will shed light on current and future challenges on legal and ethical questions in research data infrastructures. The authors of the proposal will present the work of NFDI’s section on Ethical, Legal and Social Aspects (hereinafter: ELSA), whose aim is to facilitate cross-disciplinary cooperation between the NFDI consortia in the relevant areas of management and re-use of research data

Technology transfer of dynamic IT outsourcing requires security measures in SLAs

For the present efforts in dynamic IT outsourcing environments like Grid or Cloud computing security and trust are ongoing issues. SLAs are a proved remedy to build up trust in outsourcing relations. Therefore, it is necessary to determine whether SLAs can improve trust from the perspective of the outsourcing customer by integration of security measures. The conducted survey indicates that customers see SLAs as an approach to increase their level of trust in IT outsourcing partners. In addition, security measures in SLAs are of high relevance to support trust but not yet integrated appropriately. However, SLAs are very important for the technology transfer of eScience projects in Grid computing. Again, Grid based outsourcing of biomedical IT services requires security measures in SLAs. Thus, the technology transfer process of dynamic IT outsourcing infrastructures requires adequate SLAs in order to be successful

Development of an information platform for new grid users in the biomedical field

Bringing new users into grids is a top priority for all grid initiatives and one of the most challenging tasks. Especially in life sciences it is essential to have a certain amount of users to establish a critical mass for a sustainable grid and give feedback back to the technological middleware layer. Based on the presumable lack of grid IT knowledge it is notably more arduous to satisfy user demands although here the requirements are especially demanding. Therefore, the development of an information- and learning platform could support the efforts of grid experts to guide new users. By providing a platform about grid technology and their feasibilities for users of the community of biomedicine potential, users could be supported using the high potential of their discipline

Development of an information platform for new grid users in the biomedical field

Bringing new users into grids is a top priority for all grid initiatives and one of the most challenging tasks. Especially in life sciences it is essential to have a certain amount of users to establish a critical mass for a sustainable grid and give feedback back to the technological middleware layer. Based on the presumable lack of grid IT knowledge it is notably more arduous to satisfy user demands although here the requirements are especially demanding. Therefore, the development of an information- and learning platform could support the efforts of grid experts to guide new users. By providing a platform about grid technology and their feasibilities for users of the community of biomedicine potential, users could be supported using the high potential of their discipline

Dateninfrastrukturen für die Gesundheitsforschung: ethische Rahmenbedingungen und rechtliche Umsetzung

Die Rolle von Dateninfrastrukturen für die Gesundheitsforschung beschränkt sich nicht allein darauf, als Service oder Schnittstelle für den Datenaustausch zwischen Datenerzeuger:innen und -nutzer:innen zu fungieren. Die Infrastruktur ist vielmehr selbst ein Akteur im Prozess des Datenteilens, der für diesen auch entsprechend Verantwortung trägt. Dies gilt zuallererst für die Rechtmäßigkeit der Verarbeitung personenbezogener Daten. Fußt die Datenverarbeitung auf einer Einwilligung der betroffenen Person, ist auch seitens der Infrastruktur sicherzustellen, dass sämtliche Datenverarbeitungsprozesse von dieser Einwilligung erfasst sind. Stützt sich die Datenverarbeitung auf einen gesetzlichen Erlaubnistatbestand, müssen im Rahmen der Infrastruktur v. a. technische und organisatorische Maßnahmen ergriffen werden, damit ein möglichst hohes Datenschutzniveau sichergestellt ist. Zudem fällt der Infrastruktur eine Verantwortung zu, wenn es um die Umsetzung von Betroffenenrechten wie Auskunft, Berichtigung oder Löschung von Daten geht und um den Umgang mit Zufalls- und Zusatzbefunden. Die Frage, mit welchem Selbstverständnis sich Forscher:innen in Infrastrukturprojekte einbringen und in welcher Form auch privatwirtschaftliche Unternehmen in solcherlei Projekte eingebunden werden sollen, muss sich am Gemeinwohl orientieren. Damit einher geht die Verpflichtung, dass Infrastrukturen so weit wie möglich an den Prinzipien der Partizipation, der Transparenz und der Wissenschaftskommunikation ausgerichtet sind. Die Beachtung all dieser ethischen und rechtlichen Aspekte ist vor allem auch deshalb wichtig, weil nur auf diese Weise das Vertrauen aller Stakeholder gewonnen und damit die zentrale Basis für den erfolgreichen Aufbau und Betrieb einer Dateninfrastruktur geschaffen werden kann

Improving ICD-based semantic similarity by accounting for varying degrees of comorbidity

Finding similar patients is a common objective in precision medicine, facilitating treatment outcome assessment and clinical decision support. Choosing widely-available patient features and appropriate mathematical methods for similarity calculations is crucial. International Statistical Classification of Diseases and Related Health Problems (ICD) codes are used worldwide to encode diseases and are available for nearly all patients. Aggregated as sets consisting of primary and secondary diagnoses they can display a degree of comorbidity and reveal comorbidity patterns. It is possible to compute the similarity of patients based on their ICD codes by using semantic similarity algorithms. These algorithms have been traditionally evaluated using a single-term expert rated data set. However, real-word patient data often display varying degrees of documented comorbidities that might impair algorithm performance. To account for this, we present a scale term that considers documented comorbidity-variance. In this work, we compared the performance of 80 combinations of established algorithms in terms of semantic similarity based on ICD-code sets. The sets have been extracted from patients with a C25.X (pancreatic cancer) primary diagnosis and provide a variety of different combinations of ICD-codes. Using our scale term we yielded the best results with a combination of level-based information content, Leacock & Chodorow concept similarity and bipartite graph matching for the set similarities reaching a correlation of 0.75 with our expert's ground truth. Our results highlight the importance of accounting for comorbidity variance while demonstrating how well current semantic similarity algorithms perform.Comment: 11 pages, 6 figures, 1 tabl

Auf dem Weg zur individualisierten Medizin - Grid-basierte Services für die EPA der Zukunft.

Personalized Medicine is of paramount interest for many areas in Medical Informatics. Therefore genotype data as well a phenotype data about patients have to be available. This data will be stored in Electronic Health Records or – patient controlled - in Personal Health Records. As the amount of (raw) data is rising continuously, methods for a secure data administration have to be found. Grid Services offer data storage, can support data retrieval and the presentation of the data. The basic security services could be provided by the German health professional infrastructure, but there are many security challenges to be faced

Informed consent zum record linkage: best practice und Mustertexte

Ausgangssituation: Die informierte Einwilligung ("Informed Consent") stellt den Königsweg für die Nutzung personenbezogener Daten dar. Gute Beispiele und Orientierungshilfen sind z.B. bei der Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS) bzw. der Medizininformatik Initiative (MII) zu finden. Für die prospektive Verknüpfung eines personenbezogenen Datensatzes mit weiteren personenbezogenen Daten (Record Linkage) – z.B. die Anreicherung von Primärdaten einer epidemiologischen Studie mit Sekundärdaten aus der Krankenversorgung bzw. von Kostenträgern – gestaltet sich das Vorgehen hinsichtlich der Datenschutzanforderungen als sehr komplex. Studien in der Onkologie bzw. der Infektionsforschung, bei meldepflichtigen Erkrankungen bzw. im COVID-19-Umfeld könnten als Erlaubnistatbestand das jeweilige Krebsregistergesetz bzw. das Infektionsschutzgesetz heranziehen. Epidemiologische Studien erfordern i.d.R. diesbezüglich einen Informed Consent zum Record Linkage. Es kann allerdings nicht davon ausgegangen werden, dass alle Betroffenen diesen Informed Consent dazu uneingeschränkt erteilen. Zudem kann eine solche Einwilligung widerrufen werden. Aufgrund der sich daraus ergebenden Anforderungen werden für zukünftige Projekte Mustertexte für die informierte Einwilligung zum Record Linkage als Grundlage für studienspezifische Einwilligungserklärungen – nicht nur für COVID-19 – bereitgestellt. Diese basieren auf erprobten Aufklärungstexten und Formulierungen aus der CoVerlauf-Studie sowie der NAKO Gesundheitsstudie

Prevalence of Nosocomial Infections in Swiss Children's Hospitals

Abstract Objective: To acquire data on pediatric nosocomial infections (NIs), which are associated with substantial morbidity and mortality and for which data are scarce. Design: Prevalence survey and evaluation of a new comorbidity index. Setting: Seven Swiss pediatric hospitals. Patients: Those hospitalized for at least 24 hours in a medical, surgical, intensive care, or intermediate care ward. Results: Thirty-five NIs were observed among 520 patients (6.7%; range per hospital, 1.4% to 11.8%). Bacteremia was most frequent (2.5 per 100 patients), followed by urinary tract infection (1.3 per 100 patients) and surgical-site infection (1.1 per 100 patients; 3.2 per 100 patients undergoing surgery). The median duration until the onset of infection was 19 days. Independent risk factors for NI were age between 1 and 12 months, a comorbidity score of 2 or greater, and a urinary catheter. Among surgical patients, an American Society of Anesthesiologists (ASA) score of 2 or greater was associated with any type of NI (P = .03). Enterobacteriaceae were the most frequent cause of NI, followed by coagulase-negative staphylococci; viruses were rarely the cause. Conclusions: This national prevalence survey yielded valuable information about the rate and risk factors of pediatric NI. A new comorbidity score showed promising performance. ASA score may be a predictor of NI. The season in which a prevalence survey is conducted must be considered, as this determines whether seasonal viral infections are observed. Periodic prevalence surveys are a simple and cost-effective method for assessing NI and comparing rates among pediatric hospital