El ejercicio post mortem de los derechos de protección de datos personales en el ámbito sanitario / [The post-mortem exercise of personal data protection rights in the healthcare field]

La normativa de protección de datos no es clara a la hora de regular la diferencia entre el acceso a los datos personales del fallecido, y el acceso post mortem de cualquier contenido en formato digital de la persona fallecida. De la misma manera, hoy en día no existe ningún instrumento que permita reflejar la voluntad relativa al ejercicio futuro de los derechos del interesado. (AU)

The data protection regulation is not clear when it comes to regulating the difference between access to the personal data of the deceased, and post mortem access to any content in digital format of the deceased person. In the same way, today there is no instrument that allows reflecting the will regarding the future exercise of the rights of the data subject. (AU)

Association between Industry Payments and Published Position on Use of Devices for the Treatment of Lower Urinary Tract Symptoms.

OBJECTIVE: To determine the impact of industry payments to authors of opinion articles on the Urolift and Rezum devices. We also examined the extent to which authors omitted acknowledgements of financial conflicts-of-interest. METHODS: We searched Google Scholar for all articles that cite either of the respective pivotal trials for these devices. 2 blinded urologists coded the articles as favorable or neutral. A separate blinded researcher recorded industry payments from the manufacturers using the Open Payments Program database. RESULTS: We identified 29 articles written by 27 unique authors from an initial screening list of 235 articles. Of these articles, 15 (52%) were coded as positive and 14 (48%) were coded as neutral. 20 (74%) authors have accepted payments from the manufacturer of the device. Since 2014, these authors have collectively received $270,000 from NeoTract and $314,000 from Boston Scientific. Of the 20 authors with payments, 9 (45%) received more than $10,000 from either manufacturer. Of authors with payments, 65% (13/20) contributed to only positive articles. Authors who received payments had more than 4 times the number of article contributions than did authors without payments (42 vs 10). Authors of at least one favorable article were more likely to have received payments from the device manufacturers than authors of neutral articles (P = .014, Chi-squared test). Most (80%, 16/20) authors with payments did not report a relevant conflict-of-interest within any of their articles. CONCLUSION: These data suggest a relationship between payments from a manufacturer and positive published position on that company's device. There may be a critical lack of published editorial pieces by authors without financial conflicts of interest.

Mapping conflict of interests: scoping review.

OBJECTIVE: To identify all known ties between the medical product industry and the healthcare ecosystem. DESIGN: Scoping review. METHODS: From initial literature searches and expert input, a map was created to show the network of medical product industry ties across parties and activities in the healthcare ecosystem. Through a scoping review, the ties were then verified, cataloged, and characterized, with data abstracted on types of industry ties (financial, non-financial), applicable policies for conflict of interests, and publicly available data sources. MAIN OUTCOME MEASURES: Presence and types of medical product industry ties to activities and parties, presence of policies for conflict of interests, and publicly available data. RESULTS: A map derived through synthesis of 538 articles from 37 countries shows an extensive network of medical product industry ties to activities and parties in the healthcare ecosystem. Key activities include research, healthcare education, guideline development, formulary selection, and clinical care. Parties include non-profit entities, the healthcare profession, the market supply chain, and government. The medical product industry has direct ties to all parties and some activities through multiple pathways; direct ties extend through interrelationships among parties and activities. The most frequently identified parties were within the healthcare profession, with individual professionals described in 422 (78%) of the included studies. More than half (303, 56%) of the publications documented medical product industry ties to research, with clinical care (156, 29%), health professional education (145, 27%), guideline development (33, 6%), and formulary selection (8, 1%) appearing less often. Policies for conflict of interests exist for some financial and a few non-financial ties; publicly available data sources seldom describe or quantify these ties. CONCLUSIONS: An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patient care from commercial influence and to ensure public trust.

[Actuality of conflicts of interests in medicine. From financial interests to the run for scientific publication]. / Actualité des conflits d'intérêts en médecine. Des intérêts financiers à la course à la publication scientifique.

Clinical practice and medical research can expose to several situations with risks of conflicts of interests. Such situations can induce attenuations of their primary professional interest in favor of, so-called, secondary interests, and leading to bias in their judgement and actions. In this area, if financial conflicts of interests are consistent and frequently dominant, intellectual conflicts of interests have to be analyzed and considered, like those amplified and even induced by the current tremendous competition for scientific publication. In this article, after a contextual review of conflicts of interests in medicine, we will document and discuss more specifically those frequently induced by leaks of financial interests and those linked by evolutions of the current scientific expansion and competition.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Discrepancies between author- and industry-reported disclosures of financial relationships at an annual gynecologic oncology research meeting.

OBJECTIVE: Trillions of dollars pass to physicians from industry-related businesses annually, leading to many opportunities for financial conflicts of interest. The Open Payments Database (OPD) was created to ensure transparency. We describe the industry relationships as reported in the OPD for presenters at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting and evaluate concordance between author disclosures of their financial interests and information provided by the OPD. METHODS: This is an observational, cross-sectional study. Disclosure data were collected from authors with oral and featured abstract presentations in the 2019 SGO annual conference. These disclosures were compared to data available for each author in the 2018 OPD, which included the amount and nature of industry payments. RESULTS: We examined the disclosures of 301 authors who met inclusion criteria. Of 161 authors who had disclosure statements on their presentations,147 reported "no disclosures," and 14 disclosed industry relationships. The remaining 140 did not list any disclosure information. Sixty percent (184/301) of authors had industry relationships in the 2018 OPD, including 173 of 287 (60.3%) of authors who either reported no disclosures or did not have disclosure data available in their presentations. These transactions totaled over 43 million USD from 122 different companies, with most payments (46%) categorized as "Research or Associated Research." Accurate disclosure reporting was associated with receiving higher payments or research payments, and being a presenting author. CONCLUSIONS: Most authors at the SGO annual conference did not correctly disclose their industry relationships when compared with their entries in the OPD.

El peligroso negocio con la salud (2018) y Salud a la venta (2018): denunciando la corrupción en la investigación biomédica / The dangerous health business (2018) and The Bleeding Edge (2018): exposing corruption in biomedical research

Los documentales El peligroso negocio con la salud (2018) y Salud a la venta (2018) ponen de manifiesto el riesgo de corrupción que puede existir en el proceso de investigación biomédica, específicamente con el desarrollo y posterior aprobación de dispositivos médicos. Esta industria mueve millones de euros al año y por esto puede resultar gobernada por la lógica del lucro a expensas de lesiones, sufrimiento y muerte de pacientes que, con necesidad de utilizar dispositivos, reciben los que son rentables y no necesariamente los más eficaces o seguros. Este material audiovisual recopila casos que obligan a reflexionar sobre el sentido de la invención de dispositivos que debe ser el de mejorar el proceso de salud y enfermedad de las personas y no los bolsillos de los fabricantes. En ese sentido, las denuncias desde los medios de comunicación deben favorecer una autocrítica para que cada individuo sea capaz de reflexionar sobre sus acciones y se desarrolle en un futuro cercano un espíritu colectivo nuevo: sin corrupción

The documentaries The dangerous health business (2018) and The Bleeding Edge (2018) highlight the risk of corruption that may exist in the biomedical research process, specifically in the development and subsequent approval of medical devices. This industry moves millions of euros per year and therefore can be governed by the logic of profit at the expense of injuries, suffering and death of patients who, with the need to use devices, receive those that are profitable but not effective and safe. This audiovisual material collects cases that require a reflection on the sense of devices invention that should be to improve the health-illness process of people and not the pockets of manufacturers. In that sense, complaints from the media should favor a self-criticism for each individual became capable of reflecting on their own actions and, in a near future, a new collective spirit without corruption be developed

Does Health Promotion Harm the Environment?

Health promotion involves social and environmental interventions designed to benefit and protect health. It often harmfully impacts the environment through air and water pollution, medical waste, greenhouse gas emissions, and other externalities. We consider potential conflicts between health promotion and environmental protection and why and how the healthcare industry might promote health while protecting environments. After probing conflicts between promoting health and protecting the environment we highlight the essential role that environmental resources play in health and healthcare to show that environmental protection is a form of health promotion. We then explore relationships between three radical forms of health promotion and the environment: (1) lowering the human birth rate; (2) transforming the food system; and (3) genetically modifying mosquitos. We conclude that healthcare and other industries and their institutions and leaders have responsibilities to re-consider and modify their priorities, policies, and practices.

Human rights mechanisms for anti-corruption, transparency and accountability: enabling the right to health.

Background: The presence of corruption in State institutions and broader society presents a significant obstacle to the right to the enjoyment of the highest attainable standard of health. The Universal Periodic Review, a Member State-led peer review system administered by the Human Rights Council, is a core tool of human rights, including the right to health accountability. This paper builds on existing research to examine processes that support State engagement on the issue of corruption. We identify opportunities for States to use the Universal Periodic Review to support anti-corruption, transparency and accountability to control corruption in the health-care sector.Objectives: This paper focuses on health sector how human rights mechanisms, and particularly the Universal Periodic Review, can be a tool for greater accountability for the right to health for corruption in the health sector.Methods: The research team applied qualitative content analysis methods to analyze all 135 Universal Periodic Review documents produced during 2018 in order to analyze how human rights mechanisms address the impact of corruption on the realization of the right to health.Results: Although health rights violations are often addressed within human rights mechanisms such as the UPR, corruption remains under-addressed, suggesting that there are gaps in understanding how corruption can seriously undermine the right to health.Conclusion: Human rights mechanisms should drive greater attention to the importance of addressing corruption in health. In order to make the UPR more effective, this paper suggests that there is a need to generate more awareness of corruption-based violations of the right to health in order to promote greater health accountabilityPractical tools such as strategic litigation and social audits can also contribute to creating greater transparency and accountability in dealing with corruption.

Baseline, Cross-sectional Survey of Knowledge, Attitudes, and Practices Related to Efficient Use of Government Resources in the Health Sector in Malawi.

Background: Misuse of government resources is a challenge within the health sector that can be addressed by increasing public demand for accountability, reporting suspected misuse of resources, and other client-driven changes. This study was led by the USAID/Health Communication for Life Project to inform the design of social accountability communication messages and interventions. The study also established baseline data on Malawians' knowledge, attitudes, and practices related to efficient use of government resources in the health sector. Methods: This baseline, formative research study used a non-experimental, cross sectional survey design. Sampling for the mobile survey was conducted using the random digit dialing technique. Data were collected via mobile phone using interactive voice response technology. Our sample included 1,425 respondents, 67% of whom were male and 33% were female. Respondents were mostly 35 years old or younger, with more than half of female respondents reporting their age as 18-24 years. Results: Our findings indicate that Malawians believe misuse of government resources is pervasive in Malawi. Seventy percent of men and nearly 60% of women reported having noticed, found, or seen drugs believed to be from a government health facility being sold elsewhere. Few respondents who had observed or experienced misuse of government health sector resources reported the incident. When asked the likelihood that they would report a request for a bribe, gift, or favor in exchange for health services in the future, 68% of respondents said they would report it. Conclusions: Social and behavior change communication could serve a key role in motivating those who are aware of misuse of public sector health resources to report the issues they observe and providing them with the information needed to follow through. Further research is needed to understand the best approaches to mitigate underlying factors that drive misuse of resources and underreporting.

Corruption in Anglophone West Africa health systems: a systematic review of its different variants and the factors that sustain them.

West African countries are ranked especially low in global corruption perception indexes. The health sector is often singled out for particular concern given the role of corruption in hampering access to, and utilization of health services, representing a major barrier to progress to universal health coverage and to achieving the health-related Sustainable Development Goals. The first step in tackling corruption systematically is to understand its scale and nature. We present a systematic review of literature that explores corruption involving front-line healthcare providers, their managers and other stakeholders in health sectors in the five Anglophone West African (AWA) countries: Gambia, Ghana, Liberia, Nigeria and Sierra Leone, identifying motivators and drivers of corrupt practices and interventions that have been adopted or proposed. Boolean operators were adopted to optimize search outputs and identify relevant studies. Both grey and published literature were identified from Research Gate, Yahoo, Google Scholar, Google and PubMed, and reviewed and synthesized around key domains, with 61 publications meeting our inclusion criteria. The top five most prevalent/frequently reported corrupt practices were (1) absenteeism; (2) diversion of patients to private facilities; (3) inappropriate procurement; (4) informal payments; and (5) theft of drugs and supplies. Incentives for corrupt practices and other manifestations of corruption in the AWA health sector were also highlighted, while poor working conditions and low wages fuel malpractice. Primary research on anti-corruption strategies in health sectors in AWA remains scarce, with recommendations to curb corrupt practices often drawn from personal views and experience rather that of rigorous studies. We argue that a nuanced understanding of all types of corruption and their impacts is an important precondition to designing viable contextually appropriate anti-corruption strategies. It is a particular challenge to identify and tackle corruption in settings where formal rules are fluid or insufficiently enforced.