How Internet Contracts Impact Research: Content Analysis of Terms of Service on Consumer Product Websites.

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.

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.

Patients v. Myriad or the GDPR Access Right v. the EU Database Right.

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.

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.

Roundup litigation discovery documents: implications for public health and journal ethics.

This paper reviews the court-released discovery documents obtained from litigation against Monsanto over its herbicide Roundup and through Freedom of Information Act requests (requests to regulatory agencies and public universities in the United States). We sought evidence of corporate malfeasance and undisclosed conflicts of interest with respect to issues of scientific integrity. The findings include evidence of ghostwriting, interference in journal publication, and undue influence of a federal regulatory agency.

Analysis of British American Tobacco's questionable use of privilege and protected document claims at the Guildford Depository.

BACKGROUND: Tobacco companies have a documented history of attempting to hide information from public scrutiny, including inappropriate privilege claims. The 1998 Minnesota Consent Judgement created two depositories to provide public access to discovered documents. Users raised concerns about the access conditions and ongoing integrity of the Guildford Depository collection operated until 2015 by British American Tobacco (BAT). METHODS: A metadata search of the Legacy Tobacco Documents Library identified inconsistent privilege claims, and duplicates of documents withheld by BAT from public visitors. A review of the validity of claims, for documents obtained through these searches, was conducted against recognised legal definitions of privilege. FINDINGS: BAT has asserted inappropriate privilege claims over 49% of the documents reviewed (n=63). The quantity of such claims and consistency of the stated rationale for the privilege claims suggest a concerted effort rather than human error. CONCLUSIONS: There was insufficient attention given to the operation of the Guildford Depository by the original plaintiffs, including to the subsequent use of privilege claims. Appropriate access to these documents, commensurate with the terms of legal settlements creating the collection, was critical given their public interest value for enhancing understanding of industry strategies and activities, informing of policy interventions, and for holding the industry to account. Future legal settlements should prevent defendants from subsequently withholding disclosed documents, aside from those legitimately privileged, from public view. Control of publicly disclosed documents should not be placed back into the hands of defendant tobacco companies. Plaintiffs also need to invest adequate resources into policing claims of legal privilege.

What circumstances lead to non-disclosure of cancer-related information in China? A qualitative study.

BACKGROUND: Withholding information from cancer patients is a common practice in many Asian countries, including China, Japan, and Singapore, as well as in some Western countries, such as Spain, Greece, and Italy. Much research has investigated why doctors withhold information from cancer patients generally, both in the West and the East, but little research has been done on specifically why Chinese doctors withhold such information. METHODS: Three focus group interviews were conducted with a total of 16 oncologists in China. The interviews were recorded, transcribed, and translated. Qualitative data were analyzed using systematic text condensation. RESULTS: The result of this study revealed numerous circumstances that can lead to non-disclosure of cancer-related information. Many of these circumstances have been described in previous studies about non-disclosure in other countries. We found two additional circumstances that have not been described in previous literature and might therefore expand our current knowledge about this phenomenon; they are contradiction between laws and fear for personal safety. CONCLUSION: Numerous circumstances can lead to non-disclosure of cancer-related information. This study found two additional circumstances that might lead to non-disclosure. The findings of this study suggest further assessment and clarification about the laws that govern doctor-patient communication and that action should be taken to ensure safe working environments for Chinese oncologists.

Patient information in orthopedic and trauma surgery. Fundamental knowledge, legal aspects and practical recommendations.

Providing information to surgery patients is a form of health-care governed by clearly defined therapeutic and medicolegal rules, and in particular in France by the Act of March 4, 2002 and the Code of Good Practice. The patient's right to information is implemented in a face-to-face consultation, which should be fully codified, and in a specific clinical examination, followed by information regarding the affected organ, pathology, treatment options, possible surgery, and the preconditions, risks and results associated with the procedure. Information should be personalized and as complete as possible, communicating the state of knowledge as validated by scientific societies and medical institutions. State of the art technology (dedicated website, on-line information suites, etc.) is indispensable but needs to be mastered and to adhere to the guidelines of the Council of the National Order of Medicine. Information traceability, the retraction period and proof of content of the information are essential. A signed document delivered in an informative atmosphere optimizes the exercise. Patient information is an ethical and medicolegal obligation, but above all is the expression and demonstration of the health-care potential of the practitioner and our contribution to reducing the information gap, reinforcing the cement holding our society together.

Responsabilidad social vs. responsabilidad individual en salud / Social responsibility vs. Individual responsibility in Health Care

En el marco general de la actual "Sociedad de la Información" y en el marco específico de la denominada "gobernanza en salud"; reaparece el viejo problema de la atribución de responsabilidad individual en salud. Se presume que el mayor acceso al conocimiento y a la información sanitaria conlleva mayor responsabilidad individual sobre las elecciones de estilos de vida. Mi hipótesis general es que, bajo el discurso ideal de la autodeterminación informativa y la co­responsabilidad individual en salud ­discurso propio de la gobernanza en salud­; se esconde la estrategia (neoliberal o libertariana) de limitación o negación de la atención de la salud pública en la responsabilidad individual ("the argument of desert"). Dicha estrategia justificaría los consiguientes recortes de poder distributivo del Estado en salud pública, reforzando las desigualdades sociales originales. Este discurso ignora que el acceso al conocimiento constituye un determinante social de la salud, y como tal, exige una estricta responsabilidad social en la prevención de la salud comunitaria

Within the general framework of present­day "Information Society" and in the specific context of so­called "governance in health", the old issue of individual attribution of responsibility in health comes back to the fore. It is presumed that wider access to knowledge and information on health­ related matters implies greater individual responsibility on choices concerning life­styles. My overall hypothesis is that, behind the ideal discourse on informational self­determination and individual co­responsibility in health matters ­a usual discourse in health governance­ lies a (neo­liberal or libertarian) strategy of limitation or denial of public health care based on individual responsibility (the argument of desert). Such strategy would justify the corresponding cuts in the distributive power of the State in matters of public health, thus reinforcing original social inequalities. This discourse ignores the fact that access to knowledge is a social determinant of health and, as such, requires strict social responsibility in preventive care in matters of communitarian health

Initial experience with the New York State breast density inform law at a community-based breast center.

OBJECTIVES: The purpose of this study was to review our initial experience with the New York State breast density inform law (New York public health law, S2404-C) at our outpatient breast center. We sought to review the findings in patients returning for screening breast sonography after a screening mammogram revealed heterogeneously dense or extremely dense breast tissue. METHODS: From January 1, 2013, through May 31, 2014, 102,841 patients who underwent screening mammography were seen at our institution. Of these, 35,153 were determined to have heterogeneously dense breast tissue, and 11,864 were determined to have extremely dense breast tissue. Due to the New York State breast density inform law, these 47,017 patients were notified of their breast density, with 935 patients (2%) returning for 971 screening breast sonographic examinations. RESULTS: Heterogeneously dense breast tissue was noted in 66% of the patients (619), and extremely dense breast tissue was noted in 34% (316). Thirty-one percent of the patients (290) reported no additional risk factors; 68% (635) presented with 1 or more additional risk factors; and 1% (10) were adopted, and the risk status could not be assessed. Twenty-five procedures (2.6%) were performed after screening breast sonography, resulting in 22 benign findings, 1 atypical finding, and 2 malignancies. The overall positive predictive value was 8% (2 of 25), and the overall cancer detection rate was 2.1 per 1000 (2 of 935). CONCLUSIONS: Handheld screening breast sonography performed in women with dense breast tissue can aid in the detection of otherwise occult breast cancer, as we found 2 cancers in the study population, with an overall positive predictive value of 8%. The addition of screening sonography in this cohort did lead to an increase in minimally invasive procedures in 2.6%.

Data inconsistencies from states with unconventional oil and gas activity.

The quality and availability of unconventional oil and gas (O&G) data in the United States have never been compared methodically state-to-state. By conducting such an assessment, this study seeks to better understand private and publicly sourced data variability and to identify data availability gaps. We developed an exploratory data-grading tool - Data Accessibility and Usability Index (DAUI) - to guide the review of O&G data quality. Between July and October 2013, we requested, collected, and assessed 5 categories of unconventional O&G data (wells drilled, violations, production, waste, and Class II disposal wells) from 10 states with active drilling activity. We based our assessment on eight data quality parameters (accessibility, usability, point location, completeness, metadata, agency responsiveness, accuracy, and cost). Using the DAUI, two authors graded the 10 states and then averaged their scores. The average score received across all states, data categories, and parameters was 67.1 out of 100, largely insufficient for proper data transparency. By state, Pennsylvania received the highest average ( = 93.5) and ranked first in all but one data category. The lowest scoring state was Texas ( = 44) largely due to its policy of charging for certain data. This article discusses the various reasons for scores received, as well as methodological limitations of the assessment metrics. We argue that the significant variability of unconventional O&G data-and its availability to the public-is a barrier to regulatory and industry transparency. The lack of transparency also impacts public education and broader participation in industry governance. This study supports the need to develop a set of data best management practices (BMPs) for state regulatory agencies and the O&G industry, and suggests potential BMPs for this purpose.

Algunas amenazas actuales a la confidencialidad en medicina / Some current threats to confidentiality in medicine

Social, technical and legal conditions of the current practice of medicine make it necessary to insist on certain actions and circumstances that may jeopardize the confidentiality of information, offered by patients to their health providers. Therefore, some effects of the current Chilean law are analyzed in this respect, regarding access to data from the clinical record of a patient. Also, the risks of putting certain data on social networking sites are analyzed, as well as some of its effects on clinical practice. The reasons because of mandatory reporting of diseases, meaning danger to public health, is allowed, are mentioned. We also discuss the difficulties involved in managing the results of preventative health screenings and its knowledge by third parties, as well as some possible violations of personal privacy, regarding dissemination of some people health information and its further mention or figuration in mass media. We conclude that it is a must for both physicians and other health team members, to safeguard confidentiality of data to which they have had access, as well as the need to know the relevant law, in order to respect human dignity of patients, each one as a person. We address the attention to the possibility that, practicing in a different way, it could endanger the reliability of clinical records, also impairing the quality of people’s health care.

A lei de acesso à informação no Ministério da Saúde: dois anos de implementação / The law on access to information in the Ministry of Health: two years of implementation

Nos últimos anos, vários países aprovaram leis de acesso às informações públicas, visando uma maior transparência governamental e ampliação do processo de democratização da informação, como um direito fundamental do cidadão. No Brasil, a Lei de Acesso à Informação foi sancionada em 16 de maio de 2012 e desde então passa por um processo de implementação no Ministério da Saúde. O objetivo do estudo foi analisar, no período de dois anos de vigência da referida Lei, os dados do Sistema Eletrônico do Serviço de Informação ao Cidadão – e-SIC, referentes a 4.127 pedidos de informação, quanto às respostas fornecidas no prazo, aos recursos e às reclamações apresentados pelos cidadãos. Para tanto, foram analisados dois relatórios: relatório de pedidos de acesso à informação e solicitantes e o relatório de recursos e reclamações, disponibilizados pela Controladoria-Geral da União. Os resultados apresentados fizeram referência ao cumprimento dos prazos, às instâncias de recurso e ao perfil das solicitações. Considerando o curto período de análise e os dados gerados, o órgão vem desempenhando um bom processo de implementação, respeitando os prazos estabelecidos, mantendo a integridade dos estágios de recursos e ampliando o acesso às informações com vários canais de entrada. Merece destaque a disponibilização do canal Disque – Saúde, por meio do telefone 136, que é um serviço gratuito e de acesso nacional para disseminação de informação.

In recent times, several countries have approved acts of access to public informationaimed at attaining greater government transparency and the expansion of the democratization of information, as a fundamental right of citizenship. In Brazil, the Access to Information Act was enacted on 16 May 2012 and since then goes through a process of implementation in the Ministry of Health. The aim of the study was to analyze, during the period of two years of the Act, the Electronic System data from the Citizens Information Service - e-SIC, related to 4,127 requests for information complaints from citizens. Two reports were analyzed: requests for access to information and the appeals and complaints report, provided by the Comptroller General. The results are concerned to meeting deadlines, the Boards of Appeal and the requests profile. Considering the short period of analysis and the data generated, the agency has played a good implementation process, according to the deadlines established, maintaining the integrity of resources stages and expanding access to information with multiple input ports. Noteworthy is the availability of Disque Saude (Dial Health), through the phone 136, which is a free service and a channel for national access to information dissemination.