How to Best “Sell” the “Best-seller” Clause? A review on whether the Contract adjustment mechanism proposed by the EU draft Digital Single Market Directive can secure fair (additional) remuneration for authors and performers.

PhD thesisThe current - and very relevant - debate about the way authors and performers lose control over exploitation, and more importantly, revenue generated through use of their works and performances in the digital world somewhat overshadows the fact that there are existing scenarios arising from the normal course of dealings in such works where the same occurs and were remedy of any such “injustice” has not been fully enshrined in law. A right to additional fair remuneration is a concept recognised to various degrees in some Member States of the EU but not all, scaling from (seemingly) zero in the UK to quite an elaborate regulation in Germany. Where they are recognised, application and enforcement of relevant provisions also vary. The EU sought to harmonise the issue of author´s and performer´s access to fair share of revenue generated from exploitation of their work or performance (for normal dealings and in digital spheres of copyright exploitation) in its new draft Directive. The Proposal for a Directive on Copyright in the Digital Single Market published in September 2016 dedicates its Chapter 3 of Title IV to Fair remuneration in contracts of authors and performers; contract adjustment mechanism introduced in Article 15 attempts to tackle the issue by proposing a statutory right to additional remuneration being introduced throughout the EU Member States. Or, was the aim of this provision originally even broader? In this work, three main areas are addressed: (i) the background and justification of inclusion of such provisions into the Draft DSM Directive; (ii) current applicable law in Germany, Czech Republic and the UK; three countries each representing different historical and doctrinal approach to copyright law and thus providing unique benchmarks for the analysis, (iii) reconciliation of the first two parts: analysing what – if any – change in the national legislation would be needed for the three Member States to transpose the provision into the national laws. By way of conclusion, recommendations to amend Article 15 of the draft Directive is based on the analysis made in the third part.Herchel Smith Awar

Comprehensive Analysis of the Real Lifestyles of T1D Patients for the Purpose of Designing a Personalized Counselor for Prandial Insulin Dosing

Post-prandial hyperglycemia is still a challenging issue in intensified insulin therapy. Data of 35 T1D patients during a four-week period were analyzed: RT-CGM (real time continuous glucose monitoring) record, insulin doses, diet (including meal photos), energy expenditure, and other relevant conditions. Patients made significant errors in carbohydrate counting (in 56% of cooked and 44% of noncooked meals), which resulted in inadequate insulin doses. Subsequently, a mobile application was programmed to provide individualized advice on prandial insulin dose. When using the application, a patient chooses only the type of categorized situation (e.g., meals with other relevant data) without carbohydrates counting. The application significantly improved postprandial glycemia as normoglycemia was reached in 95/105 testing sessions. Other important findings of the study include: A high intake of saturated fat (median: 162% of recommended intake); a low intake of fiber and vitamin C (median: 42% and 37%, respectively, of recommended intake); an increase in overweight/obesity status (according to body fat measurement), especially in women (median of body fat: 30%); and low physical activity (in 16/35 patients). The proposed individualized approach without carbohydrate counting may help reach postprandial normoglycemia but it is necessary to pay attention to the lifestyle habits of T1D patients too

Personal health data: Privacy policy harmonization and global enforcement

This workshop is jointly organized by EFMI Working Groups Security, Safety and Ethics and Personal Portable Devices in cooperation with IMIA Working Group "Security in Health Information Systems". In contemporary healthcare and personal health management the collection and use of personal health information takes place in different contexts and jurisdictions. Global use of health data is also expanding. The approach taken by different experts, health service providers, data subjects and secondary users in understanding privacy and the privacy expectations others may have is strongly context dependent. To make eHealth, global healthcare, mHealth and personal health management successful and to enable fair secondary use of personal health data, it is necessary to find a practical and functional balance between privacy expectations of stakeholder groups. The workshop will highlight these privacy concerns by presenting different cases and approaches. Workshop participants will analyse stakeholder privacy expectations that take place in different real-life contexts such as portable health devices and personal health records, and develop a mechanism to balance them in such a way that global protection of health data and its meaningful use is realized simultaneously. Based on the results of the workshop, initial requirements for a global healthcare information certification framework will be developed

Personal health data - privacy policy harmonization and global enforcement

This workshop is jointly organized by EFMI Working Groups Security, Safety and Ethics and Personal Portable Devices in cooperation with IMIA Working Group “Security in Health Information Systems”. In contemporary healthcare and personal health management the collection and use of personal health information takes place in different contexts and jurisdictions. Global use of health data is also expanding. The approach taken by different experts, health service providers, data subjects and secondary users in understanding privacy and the privacy expectations others may have is strongly context dependent. To make eHealth, global healthcare, mHealth and personal health management successful and to enable fair secondary use of personal health data, it is necessary to find a practical and functional balance between privacy expectations of stakeholder groups. The workshop will highlight these privacy concerns by presenting different cases and approaches. Workshop participants will analyse stakeholder privacy expectations that take place in different real-life contexts such as portable health devices and personal health records, and develop a mechanism to balance them in such a way that global protection of health data and its meaningful use is realized simultaneously. Based on the results of the workshop, initial requirements for a global healthcare information certification framework will be developed.Peer Reviewe

Sexual Dysfunction in Women Treated for Type 1 Diabetes and the Impact of Coexisting Thyroid Disease

Introduction: More sexual problems are reported among people treated for diabetes; however, this situation is less explored in women than in men. Aim: To analyze the presence and causal links of female sexual dysfunction (FSD) among Czech women treated for type 1 diabetes. Methods: 40 women completed a national version of the Female Sexual Function Index (FSFI), Female Sexual Distress Scale-revised (FSDS-R), and Beck’s Depression Inventory–II (BDI-II). A metabolic and endocrine analysis was done using blood samples. Data were statistically analyzed using SPSS v.24 and the R environment. Main Outcome Measures: Patient details (personal information, diabetes-related data, and sex history), sexual performance (the FSFI and FSDS-R scores), and level of depression (the BDI-II score) were measured. Results: FSD was present in 58% of the participants (based on the FSFI score), and 38% women declared significant sexual distress (according to their FSDS-R score). Even though only 4 women fulfilled the criteria for depression, we observed a strong association between BDI-II and FSFI (for total FSFI score P = .012, ρ = −0.394) resp. FSDS-R scores (P < .001, ρ = 0.552). Although we were not able to establish a clear direct connection between FSD and metabolic control, BDI-II scores were closely correlated with glycosylated hemoglobin (P = .009, ρ = 0.407). The duration of diabetes (based on FSDS-R: P = .046) but neither age nor the presence of chronic diabetic microvascular complications was associated with a higher FSD occurrence. We also observed an association between FSD and the presence of autoimmune hypothyroidism, even when successfully treated (FSDS-R: P = .009; FSFI: P = .067). Conclusion: FSD is more common in women with type 1 diabetes than in healthy women, and coexisting thyroid autoimmune disease seems to exacerbate FSD. Women suffering from type 1 diabetes, and particularly those with additional endocrinopathies, should be actively screened for FSD.Stechova K, Mastikova L, Urbaniec K, et al. Sexual Dysfunction in Women Treated for Type 1 Diabetes and the Impact of Coexisting Thyroid Disease. Sex Med 2019;7:217–226. Key Words: Autoimmune Thyroid Disease, BDI-II, Diabetes, Female Sexual Dysfunction, FSFI, FSDS-R, Insulin, Insulin Pump, Life Quality, Sexarch

The Effect of Diabetes-Associated Autoantigens on Cell Processes in Human PBMCs and Their Relevance to Autoimmune Diabetes Development

Type 1 Diabetes (T1D) is considered to be a T-helper- (Th-) 1 autoimmune disease; however, T1D pathogenesis likely involves many factors, and sufficient tools for autoreactive T cell detection for the study of this disease are currently lacking. In this study, using gene expression microarrays, we analysed the effect of diabetes-associated autoantigens on peripheral blood mononuclear cells (PBMCs) with the purpose of identifying (pre)diabetes-associated cell processes. Twelve patients with recent onset T1D, 18 first-degree relatives of the TD1 patients (DRL; 9/18 autoantibody positive), and 13 healthy controls (DV) were tested. PBMCs from these individuals were stimulated with a cocktail of diabetes-associated autoantigens (proinsulin, IA-2, and GAD65-derived peptides). After 72 hours, gene expression was evaluated by high-density gene microarray. The greatest number of functional differences was observed between relatives and controls (69 pathways), from which 15% of the pathways belonged to “immune response-related” processes. In the T1D versus controls comparison, more pathways (24%) were classified as “immune response-related.” Important pathways that were identified using data from the T1D versus controls comparison were pathways involving antigen presentation by MHCII, the activation of Th17 and Th22 responses, and cytoskeleton rearrangement-related processes. Genes involved in Th17 and TGF-beta cascades may represent novel, promising (pre)diabetes biomarkers

Treated Autoimmune Thyroid Disease Is Associated with a Decreased Quality of Life among Young Persons with Type 1 Diabetes

Type 1 diabetes (T1D) in children and adolescents is relatively often accompanied by other immunopathological diseases, autoimmune thyroid disease (AITD) or celiac disease (CD). Our aim was to assess whether these conditions are associated with changes in the health-related quality of life (HRQOL) in pediatric patients with T1D. In a cross-sectional study we identified eligible 332 patients with T1D aged 8–18 years, of whom 248 (75%) together with their parents responded to the PedsQL Generic and Diabetes Modules. Compared to 143 patients without thyroid autoantibodies, 40 patients with a thyroxine-treated AITD scored lower in the overall generic HRQOL (P=0.014), as well as in the overall diabetes-specific HRQOL (P=0.013). After adjustment for age, gender, duration of diabetes, type of diabetes treatment, and diabetes control, this association remained statistically significant for the generic HRQOL (P=0.023). Celiac disease was not associated with a change in the generic or diabetes-specific HRQOL (P=0.07  and   P=0.63, resp.). Parental scores showed no association with AITD or celiac disease, except a marginally significant decrease in the overall generic HRQOL (P=0.039) in the T1D + AITD compared to T1D group. Our study indicates that, in pediatric patients with T1D, concomitant thyroxine-treated AITD is associated with lower quality of life