COVID-19 increased censorship circumvention and access to sensitive topics in China.

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.

When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

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.

Clarification of access regulations to genetic resources that are subject to the sovereign rights of sovereign states and the deposit of nomenclatural types under the International Code of Nomenclature of Prokaryotes.

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.

General Data Protection Regulation in Health Clinics.

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.

Governing Commercial Access to Health Data for Public Benefit: Charity Law Solutions.

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.

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.

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.

[Regulación de la donación de gametos y embriones en las técnicas de reproducción humana asistida: ¿anónima o abierta?]

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.

El uso de gametos y embriones donados en técnicas de reproducción humana asistida hace necesario examinar intereses que implican consideraciones éticas y jurídicas relevantes, y estos incluyen los derechos de autonomía y privacidad de los padres de intención, el derecho a la privacidad de los donantes y el derecho de los menores a conocer su origen genético. En este artículo se exponen argumentos para considerar políticas de mayor apertura para la obtención de información de los donantes en aras de proteger el interés superior del niño y la niña a conocer sus orígenes genéticos. Concluye con la problemática en México, donde desde hace varios años se realizan técnicas de reproducción humana asistida con gametos donados, sin embargo, debido a la ausencia de una normatividad que regule estos procedimientos, cada establecimiento impone sus criterios para el funcionamiento de sus programas.

Pathogens collections, biobanks and related-data in a One Health legal and ethical perspective.

Research on emerging infectious diseases calls for a work on collections of pathogens (including hosts or vectors from which the pathogens were isolated), related to human and animal health, to wildlife or on the environmental material. In this respect, the adoption of a One Health perspective is determined by the need for a common approach to consider the collection, storage and use of pathogens coming from human or non-human sources, and particularly when the same pathogen is taken from different environments. In response to this development, our purpose is to delineate a flexible regulation framework concerning collections of pathogens from various origins or hosts and their associated data in order to facilitate scientific work and research partnerships. The legal and ethical cutting-edge research on Biomedical Big Data is particularly stimulating when it comes to address challenges related to collections or biobanks of pathogens such as prior informed consent and accessibility, Material Transfer Agreement or benefit sharing.

Social Security Administration Violence Evaluation and Reporting System. Final rule.

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.

A Clinician's Guide to Privacy and Communication in the ICU.

OBJECTIVE: To review the legal issues concerning family members' access to information when patients are in the ICU. DATA SOURCES: U.S. Code, U.S. Code of Federal Regulations, and state legislative codes. DATA EXTRACTION: Relevant legal statutes and regulations were identified and reviewed by the two attorney authors (L. F., M. A. V.). STUDY SELECTION: Not applicable. DATA SYNTHESIS: Review by all coauthors. CONCLUSIONS: The Health Insurance Portability and Accountability Act and related laws should not be viewed as barriers to clinicians sharing information with ICU patients and their loved ones. Generally, under Health Insurance Portability and Accountability Act, personal representatives have the same authority to receive information that patients would otherwise have. Persons involved in the patient's care also may be given information relevant to the episode of care unless the patient objects. ICUs should develop policies for handling the issues we identify about such information sharing, including policies for responding to telephone inquiries and methods for giving patients the opportunity to object to sharing information with individuals involved in their care. ICU clinicians also should be knowledgeable of their state's laws about how to identify patients' personal representatives and the authority of those representatives. Finally, ICU clinicians should be aware of any special restrictions their state places on medical information. In aggregate, these strategies should help ICU managers and clinicians facilitate robust communication with patients and their loved ones.