Rechtliche Aspekte des Einsatzes von KI und Robotik in Medizin und Pflege

Die rasanten Entwicklungen im Bereich der Künstlichen Intelligenz und Robotik stellen nicht nur die Ethik, sondern auch das Recht vor neue Herausforderungen, gerade im Bereich der Medizin und Pflege. Grundsätzlich hat der Einsatz von KI dabei das Potenzial, sowohl die Heilbehandlungen als auch den adäquaten Umgang im Rahmen der Pflege zu erleichtern, wenn nicht sogar zu verbessern. Verwaltungsaufgaben, die Überwachung von Vitalfunktionen und deren Parameter sowie die Untersuchung von Gewebeproben etwa könnten autonom ablaufen. In Diagnostik und Therapie können Systeme die behandelnde Ärztin unterstützen. Intelligente Betten ermöglichen eine Frühmobilisierung der Patient:innen bei gleichzeitig geringerem Personalaufwand. Gleichwohl birgt der Einsatz der Systeme rechtliche Herausforderungen. So besteht das Risiko einer Verletzung der beteiligten Personen. Im Gegensatz zu herkömmlichen Technologien „leidet“ KI unter der „Black-Box-Problematik“: Die von den Systemen generierten Ergebnisse sind nicht mehr vollständig vorhersehbar und nachvollziehbar. Der Einsatz birgt unbekannte und unkalkulierbare Risiken, was sich insbesondere auf die zivilrechtliche Haftung und strafrechtliche Verantwortung auswirkt. Wem die Entscheidungen der Systeme normativ zuzurechnen sind, ist eine Kernfrage des juristischen Diskurses. Die aus praktikabilitätsgründen naheliegende Wahl, dem letztentscheidenden Menschen das Verhalten eines KI-Systems zuzurechnen, überzeugt nicht in allen Fällen, sondern degradiert ihn häufig zum symbolischen Haftungsknecht und legt ihm einseitig die Risiken der Technologien auf. Weiterhin ergeben sich im Bereich der Medizin und Pflege Fragen hinsichtlich der Zulassung von KI-Systemen, da die Maschinen während der Nutzung weiterlernen und so ihren strukturellen Aufbau kontinuierlich verändern. Es ist daher angebracht, sich frühzeitig mit dem Konfliktpotential aus ethischer und rechtlicher Sicht auseinander zu setzen, um einer potenziellen gesellschaftlichen Angst vor derartigen Systemen vorzubeugen und einen praxisgerechten Handlungsrahmen zu schaffen.Definition of the problem: Rapid developments in the field of artificial intelligence (AI) and robotics pose new challenges not only to ethics but also to law, especially in the field of medicine and nursing. In principle, the use of AI has the potential to facilitate, if not improve, both curative treatments and adequate handling in the context of care. Administrative tasks, the monitoring of vital functions and their parameters, and the examination of tissue samples, for example, could run autonomously. In diagnostics and therapy, such systems can support the attending physician. Intelligent beds make it possible to mobilize patients early while at the same time reducing the need for personnel. Nevertheless, the use of these systems poses legal challenges. For example, there is a risk of injury to the people involved. Unlike conventional technologies, AI “suffers” from the “black box problem”: the results generated by the systems are no longer fully predictable and comprehensible. Its use entails unknown and incalculable risks, with particular implications for civil liability and criminal responsibility. Arguments: To whom the decisions of the systems are normatively attributable is a core question of legal discourse. The obvious choice, for reasons of practicability, of attributing the behaviour of an AI system to the human being who makes the final decisions is not convincing in all cases, but often degrades the human being to a symbolic “liability servant” and imposes the risks of the technologies on the human being in a one-sided manner. Furthermore, in the field of medicine and care, questions arise regarding the approval of AI systems, since the machines continue to learn during use and thus continuously change their structural design. Since the systems require any amount of reliable data for training and later use—especially through further learning—adequate handling of personal data is also necessary with regard to data protection law in the area of care and medicine. Conclusions: It is therefore advisable to address the potential for conflict from an ethical and legal perspective at an early stage in order to prevent a potential social fear of such systems and to create a practical framework for action. Orientation towards the guiding principle of “meaningful human control” offers the potential to solve these challenges

Thymidine Metabolism as Confounding Factor of 3'-Deoxy-3'-[18F]Fluorothymidine Uptake after Therapy in a Colorectal Cancer Model.

Non-invasive monitoring of tumor therapy response helps in developing personalized treatment strategies. Here, we performed sequential positron emission tomography (PET) and diffusion-weighted magnetic resonance imaging (DW-MRI) to evaluate changes induced by a FOLFOX-like combination chemotherapy in colorectal cancer (CRC) xenografts, to identify the cellular and molecular determinants of these imaging biomarkers. Methods: Tumor bearing CD1 nude mice, engrafted with FOLFOX-sensitive Colo205 CRC xenografts, were treated with FOLFOX (5 fluorouracil, leucovorin and oxaliplatin) in weekly intervals. On d1, d2, d6, d9 and d13 of therapy, tumors were assessed by in vivo imaging and ex vivo analyses. In addition, HCT116 xenografts, which did not respond to the FOLFOX treatment, were imaged on d1 of therapy. Results: In Colo205 xenografts, FOLFOX induced a profound increase in uptake of the proliferation PET tracer 3'-deoxy-3'-[18F]fluorothymidine ([18F]FLT), which was accompanied by increases in markers for proliferation (Ki67, TK1) and for activated DNA damage response (DDR; γH2AX), whereas the effect on cell death was minimal. As tracer uptake was unaltered in the HCT116 model, these changes appear to be specific for tumor response. Conclusion: We demonstrate that [18F]FLT PET can non-invasively monitor molecular alterations induced by a cancer treatment, including thymidine metabolism and DDR. The cellular or imaging changes may not, however, be directly related to therapy response as assessed by volumetric measurements

Effect of enzyme therapy and prognostic factors in 69 adults with Pompe disease: An open-label single-center study

Abstract. Background: Enzyme replacement therapy (ERT) in adults with Pompe disease, a progressive neuromuscular disorder, is of promising but variable efficacy. We investigated whether it alters the course of disease, and also identified potential prognostic factors. Methods. Patients in this open-label single-center study were treated biweekly with 20 mg/kg alglucosidase alfa. Muscle strength, muscle function, and pulmonary function were assessed every 3-6 months and analyzed using repeated-measures ANOVA. Results: Sixty-nine patients (median age 52.1 years) were followed for a median of 23 months. Muscle strength increased after start of ERT (manual muscle testing 1.4 percentage points per year (pp/y); hand-held dynamometry 4.0 pp/y; both p < 0.001). Forced vital capacity (FVC) remained stable when measured in upright, but declined in supine position (-1.1 pp/y; p = 0.03). Muscle function did not improve in all patients (quick motor function test 0.7 pp/y; p = 0.14), but increased significantly in wheelchair-independent patients and those with mild and moderate muscle weakness.Relative to the pre-treatment period (49 patients with 14 months pre-ERT and 22 months ERT median follow-up), ERT affected muscle strength positively (man

A decade of nutrition research in Africa: Assessment of the evidence base and academic collaboration

Objective: Malnutrition in Africa has not improved compared with other regions in the world. Investment in the build-up of a strong African research workforce is essential to provide contextual solutions to the nutritional problems of Africa. To orientate this process, we reviewed nutrition research carried out in Africa and published during the last decade. Design: We assessed nutrition research from Africa published between 2000 and 2010 from MEDLINE and EMBASE and analysed the study design and type of intervention for studies indexed with major MeSH terms for vitamin A deficiency, protein–energy malnutrition, obesity, breast-feeding, nutritional status and food security. Affiliations of first authors were visualised as a network and power of affiliations was assessed using centrality metrics. Setting: Africa. Subjects: Africans, all age groups. Results: Most research on the topics was conducted in Southern (36 %) and Western Africa (34 %). The intervention studies (9 %; n 95) mainly tested technological and curative approaches to the nutritional problems. Only for papers on protein–energy malnutrition and obesity did lead authorship from Africa exceed that from non-African affiliations. The 10 % most powerfully connected affiliations were situated mainly outside Africa for publications on vitamin A deficiency, breast-feeding, nutritional status and food security. Conclusions: The development of the evidence base for nutrition research in Africa is focused on treatment and the potential for cross-African networks to publish nutrition research from Africa remains grossly underutilised. Efforts to build capacity for effective nutrition action in Africa will require forging a true academic partnership between African and non-African research institutions

Structural and Functional Insights into the Malaria Parasite Moving Junction Complex

Members of the phylum Apicomplexa, which include the malaria parasite Plasmodium, share many features in their invasion mechanism in spite of their diverse host cell specificities and life cycle characteristics. The formation of a moving junction (MJ) between the membranes of the invading apicomplexan parasite and the host cell is common to these intracellular pathogens. The MJ contains two key parasite components: the surface protein Apical Membrane Antigen 1 (AMA1) and its receptor, the Rhoptry Neck Protein (RON) complex, which is targeted to the host cell membrane during invasion. In particular, RON2, a transmembrane component of the RON complex, interacts directly with AMA1. Here, we report the crystal structure of AMA1 from Plasmodium falciparum in complex with a peptide derived from the extracellular region of PfRON2, highlighting clear specificities of the P. falciparum RON2-AMA1 interaction. The receptor-binding site of PfAMA1 comprises the hydrophobic groove and a region that becomes exposed by displacement of the flexible Domain II loop. Mutations of key contact residues of PfRON2 and PfAMA1 abrogate binding between the recombinant proteins. Although PfRON2 contacts some polymorphic residues, binding studies with PfAMA1 from different strains show that these have little effect on affinity. Moreover, we demonstrate that the PfRON2 peptide inhibits erythrocyte invasion by P. falciparum merozoites and that this strong inhibitory potency is not affected by AMA1 polymorphisms. In parallel, we have determined the crystal structure of PfAMA1 in complex with the invasion-inhibitory peptide R1 derived by phage display, revealing an unexpected structural mimicry of the PfRON2 peptide. These results identify the key residues governing the interactions between AMA1 and RON2 in P. falciparum and suggest novel approaches to antimalarial therapeutics

Understanding and using comparative healthcare information; the effect of the amount of information and consumer characteristics and skills

<p>Abstract</p> <p>Background</p> <p>Consumers are increasingly exposed to comparative healthcare information (information about the quality of different healthcare providers). Partly because of its complexity, the use of this information has been limited. The objective of this study was to examine how the amount of presented information influences the comprehension and use of comparative healthcare information when important consumer characteristics and skills are taken into account.</p> <p>Methods</p> <p>In this randomized controlled experiment, comparative information on total hip or knee surgery was used as a test case. An online survey was distributed among 800 members of the NIVEL Insurants Panel and 76 hip- or knee surgery patients. Participants were assigned to one of four subgroups, who were shown 3, 7, 11 or 15 quality aspects of three hospitals. We conducted Kruskall-Wallis tests, Chi-square tests and hierarchical multiple linear regression analyses to examine relationships between the amount of information and consumer characteristics and skills (literacy, numeracy, active choice behaviour) on one hand, and outcome measures related to effectively using information (comprehension, perceived usefulness of information, hospital choice, ease of making a choice) on the other hand.</p> <p>Results</p> <p>414 people (47%) participated. Regression analysis showed that the amount of information slightly influenced the comprehension and the perceived usefulness of comparative healthcare information. It did not affect consumers’ hospital choice and ease of making this choice. Consumer characteristics (especially age) and skills (especially literacy) were the most important factors affecting the comprehension of information and the ease of making a hospital choice. For the perceived usefulness of comparative information, active choice behaviour was the most influencing factor.</p> <p>Conclusion</p> <p>The effects of the amount of information were not unambiguous. It remains unclear what the ideal amount of quality information to be presented would be. Reducing the amount of information will probably not automatically result in more effective use of comparative healthcare information by consumers. More important, consumer characteristics and skills appeared to be more influential factors contributing to information comprehension and use. Consequently, we would suggest that more emphasis on improving consumers’ skills is needed to enhance the use of comparative healthcare information.</p

Different patient subgroup, different ranking? Which quality indicators do patients find important when choosing a hospital for hip- or knee arthroplasty?

<p>Abstract</p> <p>Background</p> <p>Patients are increasingly expected to become active, critical consumers in healthcare. They can use comparative healthcare information presented on websites to make informed choices for healthcare providers. However, the use of this information has been limited so far. An obstacle can be that the information is not perceived as relevant by patients. Presenting only the most important quality indicators might improve the usefulness of this information. The aim of this study was to explore which quality indicators different subgroups of patients find important when choosing a hospital for total hip arthroplasty (THA) or total knee arthroplasty (TKA).</p> <p>Methods</p> <p>In this explorative, cross-sectional study, questionnaires were distributed to 265 patients who underwent or had to undergo THA/TKA. Participants were asked to rank the importance of three types of quality indicators: patient experience indicators, clinical performance indicators, and indicators about hospital services. We used random effects regression analyses to assess the relative importance of the indicators in different subgroups of patients.</p> <p>Results</p> <p>110 patients (response rate 41.5%) who underwent or had to undergo THA/TKA participated. Conduct of doctors, the presence of procedures to prevent adverse effects of thrombosis and information about the specialist area of orthopaedists were the most important patient experience indicator, clinical performance indicator and indicator about hospital services, respectively. We found a few differences between patient subgroups in the importance attached to the quality indicators.</p> <p>Conclusions</p> <p>This study provides a first insight into which quality indicators patients find important when choosing a hospital for THA/TKA, and shows that subgroups of patients differ in the value they attach to these indicators. More extended research is needed to establish the indicators that should at least be presented in succinct overviews of comparative healthcare information for patients choosing a hospital for THA/TKA.</p