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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.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

Public health authorities (PHAs), including Tribal nations, have the right and responsibility to protect and promote the health of their citizens. Although Tribal nations have the same need and legal authority to access public health data as any other PHA, significant legal challenges continue to impede Tribal data access.

Crisis motivates people to track news closely, and this increased engagement can expose individuals to politically sensitive information unrelated to the initial crisis. We use the case of the COVID-19 outbreak in China to examine how crisis affects information seeking in countries that normally exert significant control over access to media. The crisis spurred censorship circumvention and access to international news and political content on websites blocked in China. Once individuals circumvented censorship, they not only received more information about the crisis itself but also accessed unrelated information that the regime has long censored. Using comparisons to democratic and other authoritarian countries also affected by early outbreaks, the findings suggest that people blocked from accessing information most of the time might disproportionately and collectively access that long-hidden information during a crisis. Evaluations resulting from this access, negative or positive for a government, might draw on both current events and censored history., Competing Interests: The authors declare no competing interest., (Copyright © 2022 the Author(s). Published by PNAS.)

Background: Companies use brand websites as a promotional tool to engage consumers on the web, which can increase product use. Given that some products are harmful to the health of consumers, it is important for marketing associated with these products to be subject to public health surveillance. However, terms of service (TOS) governing the use of brand website content may impede such important research., Objective: The aim of this study is to explore the TOS for brand websites with public health significance to assess possible legal and ethical challenges for conducting research on consumer product websites., Methods: Using Statista, we purposefully constructed a sample of 15 leading American tobacco, alcohol, psychiatric pharmaceutical, fast-food, and gun brands that have associated websites. We developed and implemented a structured coding system for the TOS on these websites and coded for the presence versus absence of different types of restriction that might impact the ability to conduct research., Results: All TOS stated that by accessing the website, users agreed to abide by the TOS (15/15, 100%). A total of 11 out of 15 (73%) websites had age restrictions in their TOS. All alcohol brand websites (5/15, 33%) required users to enter their age or date of birth before viewing website content. Both websites for tobacco brands (2/15, 13%) further required that users register and verify their age and identity to access any website content and agree that they use tobacco products. Only one website (1/15, 7%) allowed users to display, download, copy, distribute, and translate the website content as long as it was for personal and not commercial use. A total of 33% (5/15) of TOS unconditionally prohibited or put substantial restrictions on all of these activities and/or failed to specify if they were allowed or prohibited. Moreover, 87% (13/15) of TOS indicated that website access could be restricted at any time. A total of 73% (11/15) of websites specified that violating TOS could result in deleting user content from the website, revoking access by having the user's Internet Protocol address blocked, terminating log-in credentials, or enforcing legal action resulting in civil or criminal penalties., Conclusions: TOS create complications for public health surveillance related to e-marketing on brand websites. Recent court opinions have reduced the risk of federal criminal charges for violating TOS on public websites, but this risk remains unclear for private websites. The public health community needs to establish standards to guide and protect researchers from the possibility of legal repercussions related to such efforts., (©Caitlin Weiger, Katherine C Smith, Joanna E Cohen, Mark Dredze, Meghan Bridgid Moran. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 02.12.2020.)

In the United States, the public has a constitutional right to access criminal trial proceedings. In practice, it can be difficult or impossible for the public to exercise this right. We present JUSTFAIR: Judicial System Transparency through Federal Archive Inferred Records, a database of criminal sentencing decisions made in federal district courts. We have compiled this data set from public sources including the United States Sentencing Commission, the Federal Judicial Center, the Public Access to Court Electronic Records system, and Wikipedia. With nearly 600,000 records from the years 2001-2018, JUSTFAIR is the first large scale, free, public database that links information about defendants and their demographic characteristics with information about their federal crimes, their sentences, and, crucially, the identity of the sentencing judge., Competing Interests: The authors have declared that no competing interests exist.

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)., (© 2020 médecine/sciences – Inserm.)

There is a growing body of evidence that supports the view that research participants and the public are concerned about commercial access to health data. Evidence also suggests that attitudes are ameliorated when charity organisations are involved and where research promises to deliver 'public benefit'. To a significant extent, therefore, mechanisms that ensure the public benefit are key to sustaining public and participant support for research access to health data. As a regime founded on the concept of public benefit, charity law provides regulatory and governance mechanisms through which the public benefit of a charity is protected and promoted. This article examines the merits of charity law mechanisms and analyses their significance for governance of commercial access to health data for public benefit, using UK Biobank Ltd, a charitable company limited by guarantee, as an example. The article critically analyses three charity law mechanisms that operate to ensure that an organization providing access to data meets its public benefit requirements: charitable purposes; members' and directors' powers and duties; and accountability via the oversight powers of the Charity Commission and charity proceedings in court. The article concludes that there is potential for the charity model to be the benchmark for governing commercial access to health data for public benefit research, but notes the limitations of the model and recommends the appointment of independent data governance committees to further bolster the charity law framework., (© The Author(s) 2019. Published by Oxford University Press; All rights reserved. For permissions, please email: journals.permissions@oup.com.)

This paper evaluates a method of generating a unique dataset that has been underused-a Freedom of Information (FOI) request. The UK's FOI Act came into force in 2005, allowing the public to make requests of publicly held data. We set out to understand the determinants of the quality responses to FOI requests. We also explain how requests can be made and provide suggestions to construct effective data-driven requests. We applied for data on hate crime from all police forces and on uptake of maternity leave from all universities. We find that observable characteristics of the local area, police force and universities neither determine whether the request was fulfilled, nor the speed of response, suggesting that the data from these FOI requests are representative of the institutions from which they were requested., Competing Interests: The authors have declared that no competing interests exist.

The focus on personal data has merited the EU concerns and attention, resulting in the legislative change regarding privacy and the protection of personal data. The General Data Protection Regulation (GDPR) aims to reform existing measures on the protection of personal data of European Union citizens, with a strong impact on the rights and freedoms of individuals in establishing rules for the processing of personal data. The GDPR considers a special category of personal data, the health data, being these considered as sensitive data and subject to special conditions regarding treatment and access by third parties. This work presents the evolution of the applicability of the Regulation (EU) 2016/679 six months after its application in Portuguese health clinics. The results of the present study are discussed in the light of future literature and work are identified.

One of the goals of the International Code of Nomenclature of Prokaryotes is not only to make nomenclature transparent and predictable, but to also make sure that the biological material on which it is based is available to either verify previous work or to allow further work to be undertaken. The key elements in ensuring the latter two aspects are nomenclatural types (type strains) at the rank of species and subspecies. With increasing regulations controlling access to genetic resources, the limitations put on access are not always evident at the time novel species or subspecies are proposed and corresponding nomenclatural types (type strains) designated. In a number of cases, limitations put on access have been discovered after the fact.

Competing Interests: Competing interests: Shaun Mehta is a part-time medical advisor for Dot Health. No other competing interests were declared.

NHS Resolution provides indemnity cover for legal claims against the NHS, assists the NHS with risk management and aims to share lessons from claims in order to improve safety. The study aimed to investigate the financial costs of litigation against English Health Trusts in otolaryngology over a 10-year period, to see if any lessons have been learned and identify trends that may lead to a potential reduction in costs and improve patient safety. A Freedom of Information request was made to NHS Resolution for information regarding claims made to otolaryngology departments over the last 10 years. There was a total of 612 successful claims in the 10-year period between 2008/2009 and 2017/2018 with costs of nearly £87 million. Overall, the costs of litigation have increased dramatically, and the main areas for these successful claims can be identified, but restrictions in the detail of information released allows too little insight for improvements to be made to avoid them in future. This continues to be a major problem for healthcare funding and practice.

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.

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., (© 2019 John Wiley & Sons, Ltd.)

The authors address the legal void that exists regarding medical student access to clinical records and health information that local healthcare organizations hold under legal and institutional custody. They develop a legal thesis that configures the creation of medical student professional secrecy and its connection with the duty of confidentiality as assumptions that underlie the medical student's right to access and reuse health information. Medical students have the legitimacy to access health information and clinical records, as they bear an unequivocal informational, legitimate, constitutionally protected and sufficiently relevant need. They conclude that the legislature must work together with universities and hospital institutions to legally establish the concept of Medical Student Professional Secrecy, its link to the duty of confidentiality and the right of the medical student to access and reuse health information. Furthermore, it must do so in a specific legal act and in the precise terms of the text approved unanimously by the Council of Portuguese Medical Schools, by the National Council of Medical Ethics and Deontology, by the National Council of the Portuguese Medical Association and by its President.

The term "ag-gag" refers to state laws that intentionally limit public access to information about agricultural production practices, particularly livestock production. Originally created in the 1990s, these laws have recently experienced a resurgence in state legislatures. We discuss the recent history of ag-gag laws in the United States and question whether such ag-gag laws create a "chilling effect" on reporting and investigation of occupational health, community health, and food safety concerns related to industrial food animal production. We conclude with a discussion of the role of environmental and occupational health professionals to encourage critical evaluation of how ag-gag laws might influence the health, safety, and interests of day-to-day agricultural laborers and the public living proximal to industrial food animal production.

In 2016, four US cancer patients legally challenged Myriad by claiming full access to all genomic information produced in the course of Myriad's testing of their risks for a variety of cancers. Asserting that Myriad's refusal to provide them with this information violated the HIPAA Privacy Rule, the patients sought a determination of a right to access all their genetic information from testing laboratories. Such access would not only serve their own care, but also enable them to share their genetic data with the scientific community which they alleged Myriad failed to do. A similar case may be brought in Europe under the novel EU GDPR. Specifically, it would put the GDPR right of access to personal data against Myriad's database right under the EU Database Right Directive. The outcome of this case could impact the fate of personalized medicine, which depends on the one hand on patients' having control over their genetic data, and on the other hand on incentives for genetic testing companies to generate these data. We first address the issue of whether the GDPR applies to medical records. We then analyse how GDPR rights could play out in the context of clinical genetic testing and conclude that the GDPR access right stops short of granting unconditional access to all data generated in the process of testing, to the extent that its exercise would result in the violation of medical-professional norms, expose the testing company to potential liability, or compromise normal exploitation of the database of which the personal data form part.

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.

Competing Interests: Competing interests: None declared.

Objectives: To determine the extent to which National Health Service (NHS) service providers appoint a named Armed Forces veteran lead or champion, and to explore the commissioning of veteran-specific services by Clinical Commissioning Groups., Design: A convergent mixed method design was used to improve understanding obtained from the information provided by respondents on their practice. The study comprised two parts: phase 1 involved NHS Trusts, and phase 2 involved Clinical Commissioning Groups., Setting: All NHS Trusts and Clinical Commissioning Groups in England were contacted using a freedom of information request., Participants: All NHS trusts and Clinical Commissioning Groups across England., Interventions: Initially, existing national websites were searched to gather information within the public domain. An audit was carried out, using the Freedom of Information Act (FOIA) 2000 to gather further information., Primary and Secondary Outcome Measures: The FOIA 2000 applies to UK Government departments and public authorities, including NHS Trusts in England, Wales and Northern Ireland., Results: Responses from the freedom of information requests illustrate inconsistencies in relation to adopting the principles of the Armed Forces Covenant. The inconsistencies extend to the practice of appointing an Armed Forces Veteran Lead or an Armed Forces Veteran Champion. There is also evidence to suggest a lack of commitment to and understanding of policy guidance in relation to Clinical Commissioning Group responsibility for commissioning veteran-specific services., Conclusions: Findings from this study support the case for making improvements to, and improving the consistency of, commissioning practices for veterans., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The use of donated gametes and embryos in assisted reproduction techniques (ART) makes it necessary to examine interests that involve relevant ethical and legal considerations, which include the autonomy and privacy rights of the intended parents, donors' right to privacy and the right of the minors to know their genetic origin. This article presents arguments to consider policies of more openness to obtain information from donors in order to protect the child's best interest in knowing his/her genetic origins. It concludes with the situation in Mexico, where ART has been carried out with donated gametes since several years ago; however, due to the absence of regulations to control these procedures, each establishment imposes its own criteria for the operation of its programs., (Copyright: © 2019 SecretarÍa de Salud.)

We are issuing a final rule to exempt a system of records entitled Social Security Administration Violence Evaluation and Reporting System (SSAvers) from certain provisions of the Privacy Act because this system will contain investigatory material compiled for law enforcement purposes.

The Food and Drug Administration's expanded access program allows patients with serious or immediately life-threatening conditions to seek access to experimental drugs and treatments from their manufacturers. The 21st Century Cures Act of 2016 sought to increase the transparency of manufacturers' approaches to expanded access by requiring public listing of five key pieces of information about their expanded access programs: 1) relevant contact information, 2) procedures for making requests, 3) general criteria used to evaluate requests, 4) length of time anticipated to acknowledge receipt of requests, and 5) a reference to pertinent information on ClinicalTrials.gov. Manufacturers were given 60 days from the Act's enactment, or until February 11, 2017, to post this information. We reviewed a sample of pharmaceutical manufacturers' expanded access policies to determine what information is readily available to patients online, including assessing whether the information described in the Act is available., (© 2017 American Society for Clinical Pharmacology and Therapeutics.)

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., (Copyright © 2018 The Author. Published by Elsevier Ltd.. All rights reserved.)

Background: Anonymity remains the more common practice in gamete donations, but legislation prohibiting anonymity with a goal of protecting donor-conceived children's right to know their genetic origins is becoming more common. However, given the dearth of research investigating the function of anonymity for donors and recipients, it is unclear whether these policies will accomplish their goals. The aim of this study was to explore experiences with anonymity among oocyte donors and recipients who participated in an anonymous donor oocyte program and to understand the ways in which anonymity functions for them., Methods: Semistructured interviews were conducted with 50 women: 28 oocyte donors and 22 recipients who were recruited from an academic center for reproductive medicine in the United States., Results: Donors and recipients view anonymity both as a mechanism to protect the interests of all parties (recipients, donors, and donor-conceived children) and as a point of conflict. Specifically, three key areas were identified where both donors and recipients saw anonymity as having an important role: relieving anxieties about family structures and obligations; protecting their interests and those of donor-conceived children (while acknowledging where interests conflict); and managing the future., Conclusion: As gamete donation increasingly moves away from the practice of anonymity, examining why anonymity matters to stakeholders will be helpful in devising strategies to successfully implement identity-release options.