Laws governing access to sexual health services and information: contents, protections, and restrictions.

Access to sexual health services and information is critical to achieving the highest attainable standard of sexual health, and enabling legal environments are key to advancing progress in this area. In determining overall alignment with human rights standards to respect, protect, and fulfil sexual health-related rights without discrimination, there are many aspects of laws, including their specificity and content, which impact which sexual health services and information are availed, which are restricted, and for whom. To understand the nature of existing legal provisions surrounding access to sexual health services and information, we analysed the content of 40 laws in English, French, and Spanish from 18 countries for the specific sexual health services and information to which access is ensured or prohibited, and the non-discrimination provisions within these laws. Overall, there was wide variation across countries in the types of laws covering these services and the types and number of services and information ensured. Some countries covered different services through multiple laws, and most of the laws dedicated specifically to sexual health addressed only a narrow aspect of sexual health and covered a small range of services. The protected characteristics in non-discrimination provisions and the specificity of these provisions with regard to sexual health services also varied. Findings may inform national legal and policy dialogues around sexual health to identify opportunities for positive change, as well as to guide further investigation to understand the relationship between such legal provisions, the implementation of these laws within countries, and relevant sexual health outcomes.

Access to sexual health services and information is important to being able to have good sexual health. Laws are relevant because what they include and how specific they are affects what types of sexual health services people can access, what types of services are illegal, and whether or not all people can access services equally. We reviewed 40 laws in English, French, and Spanish from 18 countries to understand how many and which sexual health services and information countries ensure in their laws, which sexual health services are illegal, and which people are protected from discrimination in accessing these services. We found that countries use many different types of laws to ensure access to sexual health services or information, and most countries do not cover the same types or number of sexual health services. There are also differences in which people are specifically protected from discrimination in the laws we reviewed. These findings are important because they may help countries identify ways that access to sexual health services and information could be improved so as to improve people's sexual health. They may also guide future research.

[Health data in France: Abundant but complex]. / Les données de santé en France - Abondantes mais complexes.

TITLE: Les données de santé en France - Abondantes mais complexes. ABSTRACT: Alors que l'application de traçage des contacts (contact tracing) StopCovid (transformée à la mi-octobre 2020 en TousAntiCovid), débattue au Parlement1 en raison des inquiétudes qu'elle suscitait concernant la confidentialité des données personnelles et les libertés individuelles du fait qu'elle permet d'alerter un utilisateur s'il s'est trouvé à proximité d'une personne atteinte de la COVID-19, a été adoptée par près de 12 millions de personnes2, un dispositif concernant les données individuelles de santé, aux conséquences potentiellement beaucoup plus importantes pour les citoyens et leurs données personnelles, a commencé à se mettre en place suite à la Loi du 24 juillet 2019 (Loi n° 2019-774) relative à l'organisation et à la transformation du système de santé3 : la plateforme des données de santé, communément appelée Health Data Hub, constituée sous la forme d'un groupement d'intérêt public (GIP). Il ne s'agit plus de simplement signaler qu'on a croisé une personne anonyme infectée par le SARS-Cov-2, mais de réunir, dans une infrastructure informatique unique, un immense ensemble de données personnelles particulièrement sensibles concernant la totalité de la population française. Ce projet suscite désormais un certain intérêt médiatique et un début d'inquiétude. Mais cette inquiétude ne concerne presque uniquement que le fait que ces données sont déposées et gérées dans un cloud appartenant à une société américaine, un nuage informatique qui tombe sous le coup de la loi américaine de 2018 dite « CLOUD act4 ¼, qui ouvre la possibilité d'un transfert des données personnelles vers les États-Unis, comme s'en est inquiété récemment le Conseil d'État.5 Cet aspect est certes très important, mais il masque également de très nombreux enjeux liés au partage des données de santé, et qui sont largement méconnus de la population. Nous nous proposons de rappeler, tout d'abord, ce que sont les données de santé, ce qu'elles apportent et la nécessité d'en faciliter le partage, mais aussi les difficultés rencontrées pour leur accès et leur utilisation. Nous expliquerons ensuite, dans un deuxième article, en quoi cette plateforme des données de santé, telle qu'elle est conçue et pilotée par les pouvoirs publics pour répondre à ces difficultés et pour promouvoir l'intelligence artificielle en santé, est un projet qui soulève de fortes inquiétudes pour les citoyens et la société dans son ensemble. Même si les problèmes posés se présentent sous une forme différente selon les pays, notre propos concernera spécifiquement la situation en France.

[Susceptibility genetics of common conditions in clinical practice]. / Des tests génétiques pour prédire des maladies communes.

The genetic tests for "non-rare thrombophilias" (TNR) were introduced into clinical setting immediately after the identification of genetic variants in the mid-90s to predict and prevent venous thromboembolism (VTE). Although being a rare example of a genetic test of susceptibility for complex diseases that has been integrated in medical routine, it is the most widespread post-natal genetics inquiry in France nowadays. Yet, determining whom to test and how to use the results is still controversial. This article outlines the trajectory of its clinical regulation and illustrates the importance of the context of use to understand its diffusion. This analysis is intended to feed a more general reflection on the issues raised by the clinical integration of genetic surveys for common diseases, particularly with regard to the clinical utility of a test (statistical vs. biological), the subjects to be tested (the case index and/or her/his relatives), and the criteria underlying access to these tests (modalities of medico-economic assessment).

TITLE: Des tests génétiques pour prédire des maladies communes. ABSTRACT: Introduit au lendemain de l'identification des « thrombophilies non rares ¼ (TNR), au milieu des années 1990 afin de prédire et de prévenir la maladie thromboembolique veineuse (MTEV), le bilan génétique pour ces thrombophilies est un exemple assez rare de test génétique de susceptibilité pour une maladie complexe, à avoir franchi le pas d'un véritable usage de routine en clinique. Bien que ce test soit le plus répandu des tests de génétique post-natale en France, son usage (À qui proposer le test ? Que faire des résultats ?) fait encore l'objet de débats. Cet article analyse la trajectoire de régulation clinique de ce test et illustre l'importance du contexte spécifique d'usage pour comprendre sa diffusion. Cette analyse vise à nourrir une réflexion plus générale sur les enjeux que pose l'intégration clinique des tests génétiques pour les maladies communes, en considérant notamment les modalités de définition de l'utilité clinique d'un test (statistique versus biologique), des sujets du test (le cas index versus ses apparentés), et des critères en sous-tendant l'accès (modalités des calculs médico-économiques).

Transparência da informação pública no Brasil: uma análise da acessibilidade de Big Data para o estudo das interfaces entre mudanças climáticas, mudanças produtivas e saúde / Public information transparency in Brazil: an analysis of the accessibility of Big Data for the study of the interfaces between climate change, productive changes and health / Transparencia de la información pública en Brasil: un análisis de la accesibilidad de Big Data para el estudio de las interfaces entre cambios climáticos, cambios productivos y salud

A informação pública, garantida por lei no Brasil, é base para a geração de conhecimento adaptativo em situações adversas, como a extrema vulnerabilidade socioambiental e seus impactos na saúde humana. O presente artigo avalia a transparência da informação pública nas áreas de saúde humana (com foco no Sistema Único de Saúde ­ SUS), mudanças produtivas (uso do solo) e mudanças climáticas (chuva e temperatura), utilizando dados de 5.570 municípios brasileiros, ao longo dos últimos 20 anos. A experiência da construção de uma base nacional de dados (Data Lake) a partir de informações disponibilizadas em bases públicas (ou público-privadas) ­ DATASUS, MapBiomas, Instituto Nacional de Meteorologia (Inmet) e Hidroweb da Agência Nacional de Águas (ANA) ­ confirmou que, na prática, a acessibilidade da informação pública no Brasil apresenta entraves importantes. Incluímos recomendações sobre como ela pode ser aprimorada para tornar os direitos de acesso à informação uma realidade mais concreta para o cidadão brasileiro.

The transparency of public information, a right that is entitled by law in Brazil, is the basis to generate adaptive knowledge in adverse situations, such as extreme socio-environmental vulnerability and its impacts on human health. This article evaluates the transparency of public information in three areas ­ i) human health, focusing on the Sistema Único de Saúde ­ SUS (Unified Health System); ii) productive changes (land use indicators); and iii) climate changes (rain and temperature indicators) ­ using data from all the 5,570 Brazilian municipalities over the last 20 years. The experience of building a national database (Data Lake) from available information in public (or public-private) databases ­ DATASUS, MapBiomas, Instituto Nacional de Meteorologia ­ Inmet (National Institute of Meteorology), and Hidroweb of the Agência Nacional de Águas ­ ANA (National Water Agency) ­ confirmed that, in practice, the accessibility of public information in Brazil suffers from significant shortcomings. We include some recommendations for and how it could be improved so that the access rights to information becomes a more concrete reality for the Brazilian citizen.

La información pública, garantizada por ley en Brasil, es la base para la generación de conocimiento adaptativo en situaciones adversas, como la extrema vulnerabilidad socioambiental y sus impactos en la salud humana. Este artículo evalúa la transparencia de la información pública en las áreas de salud humana (dirigindo la atención hacia el Sistema Único de Saúde ­ SUS (Sistema Único de Salud), cambios productivos (uso del suelo) y cambios climáticos (lluvia y temperatura), con datos de los 5.570 municipios brasileños, durante los últimos 20 años. La experiencia de la construcción de una base nacional de datos (Data Lake) a partir de informaciones disponibles en bases públicas (o público-privadas) ­ DATASUS, MapBiomas, Instituto Nacional de Meteorología (Inmet) e Hidroweb de la Agência Nacional de Águas ­ ANA (Agencia Nacional de Aguas) ­ confirmó que, en la práctica, la accesibilidad de la información pública en Brasil presenta obstáculos importantes. Incluimos recomendaciones acerca de como la transparencia puede ser perfeccionada para hacer de los derechos de acceso a la información una realidad más concreta para el ciudadano brasileño.

Effects of Public Reporting Legislation of Nurse Staffing: A Trend Analysis.

Public reporting is a tactic that hospitals and other health care facilities use to provide data such as outcomes to clinicians, patients, and payers. Although inadequate registered nurse (RN) staffing has been linked to poor patient outcomes, only eight states in the United States publicly report staffing ratios-five mandated by legislation and the other three electively. We examine nurse staffing trends after the New Jersey (NJ) legislature and governor enacted P.L.1971, c.136 (C.26:2 H-13) on January 24, 2005, mandating that all health care facilities compile, post, and report staffing information. We conduct a secondary analysis of reported data from the State of NJ Department of Health on 73 hospitals in 2008 to 2009 and 72 hospitals in 2010 to 2015. The first aim was to determine if NJ hospitals complied with legislation, and the second was to identify staffing trends postlegislation. On the reports, staffing was operationalized as the number of patients per RN per quarters. We obtained 30 quarterly reports for 2008 through 2015 and cross-checked these reports for data accuracy on the NJ Department of Health website. From these data, we created a longitudinal data set of 13 inpatient units for each hospital (14,158 observations) and merged these data with American Hospital Association Annual Survey data. The number of patients per RN decreased for 10 specialties, and the American Hospital Association data demonstrate a similar trend. Although the number of patients does not account for patient acuity, the decrease in the patients per RN over 7 years indicated the importance of public reporting in improving patient safety.

Secret safety warnings on medicines: A case study of information access requests.

PURPOSE: There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian "direct health professional communications" (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence of harm. DHPCs are not made public by Australia's Therapeutic Goods Administration (TGA). METHODS: We requested all DHPCs sent out in Australia from 2007 to 2016 inclusive for 207 drugs that were subject to safety advisories over this decade in Canada, the United Kingdom, and/or the United States. We contacted 39 manufacturers (February to May 2018), with repeat requests to nonrespondents, and a follow-up freedom-of-information (FOI) request to the TGA. RESULTS: Fifteen companies provided information, either sending DHPCs (n = 4, on five drugs) or affirming none were sent out (n = 11). The remaining 24 of 39 (62%) companies did not provide DHPCs: nine (23%) refused the request, often citing commercial confidentiality; the rest provided no answer despite repeat requests. In total, we had no information for 170 of 207 (82%) of the drugs. Our FOI request to the TGA was unsuccessful. CONCLUSIONS: Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life-threatening harm and guide safer care; full ongoing public access is needed, ideally in searchable online databases.

Judicialization 2.0: Understanding right-to-health litigation in real time.

Over the past two decades, debate over the whys, the hows, and the effects of the ever-expanding phenomenon of right-to-health litigation ('judicialization') throughout Latin America have been marked by polarised arguments and limited information. In contrast to claims of judicialization as a positive or negative trend, less attention has been paid to ways to better understand the phenomenon in real time. In this article, we propose a new approach-Judicialization 2.0-that recognises judicialization as an integral part of democratic life. This approach seeks to expand access to information about litigation on access to medicines (and health care generally) in order to better characterise the complexity of the phenomenon and thus inform new research and more robust public discussions. Drawing from our multi-disciplinary perspectives and field experiences in highly judicialized contexts, we thus describe a new multi-source, multi-stakeholder mixed-method approach designed to capture the patterns and heterogeneity of judicialization and understand its medical and socio-political impact in real time, along with its counterfactuals. By facilitating greater data availability and open access, we can drive advancements towards transparent and participatory priority setting, as well as accountability mechanisms that promote quality universal health coverage.

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate.

Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of research-absent in the GDPR-which can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational self-determination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy.