Webinar ética, seguridad y privacidad en tiempos de COVID-19

Conversatorio virtual organizado por la Red Centroamericana de Informática en Salud en colaboración con Central American Healthcare Initiative, el 7 de mayo de 2020.

Cartografando controvérsias na implantação da estratégia e-sus atenção básica a Saúde em Minas Gerais / Cartografía de las controversias en la implementación de la estrategia para la Atención Primaria de Salud en Minas Gerais / Mapping controversies in the implementation of the strategy for Primary Health Care in Minas Gerais

O estudo teve o objetivo de cartografar controvérsias relacionadas à rede de atores na implantação de uma estratégia de informatização da Atenção Básica a Saúde, em Minas Gerais, Brasil. Trata-se de um estudo de abordagem qualitativa fundamentado na Teoria Ator-Rede. Como referencial metodológico utilizou-se a Cartografia de Controvérsias. Entrevistamos 16 porta-vozes (profissionais de saúde, gestores e técnicos de informática) envolvidos com a implantação da estratégia em um município da região oeste de Minas Gerais. Realizamos observação participante e coleta de 43 documentos ao seguir os porta-vozes durante o processo de implantação no período de Janeiro de 2018 a Abril de 2019. Mapeamos como controvérsia central a decisão em utilizar ou não o sistema próprio municipal em detrimento de outra tecnologia. Outros desdobramentos emergiram: controvérsias éticas; controvérsias diante do processo de integração das informações entre o sistema próprio municipal e os sistemas de software governamentais; controvérsias nas unidades básicas durante a implantação da estratégia de informatização relacionadas às fragilidades estruturais e sobrecarga de trabalho dos profissionais. Ainda constatamos traduções relacionadas ao ato de não planejar e não decidir a partir dos dados armazenados nos sistemas, além de incertezas sobre a responsabilização em alimentar os sistemas de software. Conclui-se que há uma controvérsia central (a decisão em implantar a tecnologia) envolvendo uma rede de atores humanos e não-humanos mobilizando decisões, conflitos e acordos, bem como há desdobramentos (outras controvérsias) que acabam por influenciar a informatização(AU)

El estudio tuvo como objetivo mapear controversias relacionadas con la red de actores en la implementación de una estrategia de informatización para la Atención Primaria de Salud, en Minas Gerais, Brasil. Se trata de un estudio cualitativo basado en la Teoría Actor-Red. Como marco metodológico se utilizó la cartografía de controversias. Fueron entrevistados 16 voceros (profesionales de la salud, gerentes y técnicos en computación) involucrados en la implementación de la estrategia en un municipio de la región occidental de Minas Gerais. Se recolectaron 43 documentos durante el proceso de implementación de enero del año 2018 hasta abril de 2019. Como controversia central se mapeó la decisión de usar o no el propio sistema municipal a expensas de otras tecnologías. Surgieron las siguientes controversias: éticas; sobre el proceso de integración de información entre el propio sistema municipal y los sistemas de software del gobierno; y en las unidades básicas durante la implementación de la estrategia de informatización relacionada con las debilidades estructurales y la sobrecarga de trabajo de los profesionales. Aún encontramos traducciones relacionadas con el acto de no planificar y no decidir a partir de los datos almacenados en los sistemas, además de incertidumbres sobre la responsabilidad de alimentar los sistemas de software. Se concluye que existe una controversia central (la decisión de implantar la tecnología) que involucra a una red de actores humanos y no humanos que movilizan decisiones, conflictos y acuerdos, así como también hay desarrollos (otras controversias) que terminan por influir en la informatización(AU)

The study aimed to map controversies related to the network of actors in the implementation of a computerization strategy for Primary Health Care, in Minas Gerais, Brazil. It was a qualitative study based on the Actor-Network Theory. As a methodological framework, Controversy Cartography was used. We interviewed 16 spokespersons (health professionals, managers and computer technicians) involved with the implementation of the strategy in a municipality in the Western region of Minas Gerais. We conducted participant observation and collected 43 documents when following the spokespersons during the implementation process from January 2018 to April 2019. We map as a central controversy the decision to use or not the municipal system itself at the expense of other technology. Other developments have emerged: ethical controversies; controversies regarding the process of integrating information between the municipal system itself and government software systems; controversies in basic units during the implementation of the computerization strategy related to structural weaknesses and work overload of professionals. We still found translations related to the act of not planning and not deciding from the data stored in the systems, in addition to uncertainties about the responsibility to feed the software systems. It is concluded that there is a central controversy (the decision to implant the technology) involving a network of human and non-human actors mobilizing decisions, conflicts and agreements, as well as there are developments (other controversies) that end up influencing computerization(AU)

Health Information Systems in the Digital Health Ecosystem-Problems and Solutions for Ethics, Trust and Privacy.

Digital health information systems (DHIS) are increasingly members of ecosystems, collecting, using and sharing a huge amount of personal health information (PHI), frequently without control and authorization through the data subject. From the data subject's perspective, there is frequently no guarantee and therefore no trust that PHI is processed ethically in Digital Health Ecosystems. This results in new ethical, privacy and trust challenges to be solved. The authors' objective is to find a combination of ethical principles, privacy and trust models, together enabling design, implementation of DHIS acting ethically, being trustworthy, and supporting the user's privacy needs. Research published in journals, conference proceedings, and standards documents is analyzed from the viewpoint of ethics, privacy and trust. In that context, systems theory and systems engineering approaches together with heuristic analysis are deployed. The ethical model proposed is a combination of consequentialism, professional medical ethics and utilitarianism. Privacy enforcement can be facilitated by defining it as health information specific contextual intellectual property right, where a service user can express their own privacy needs using computer-understandable policies. Thereby, privacy as a dynamic, indeterminate concept, and computational trust, deploys linguistic values and fuzzy mathematics. The proposed solution, combining ethical principles, privacy as intellectual property and computational trust models, shows a new way to achieve ethically acceptable, trustworthy and privacy-enabling DHIS and Digital Health Ecosystems.

Información clínica, consentimiento informado y deontología médica. Una relación reciente / Clinical information, informed consent and medical deontology. A recent relationship

El derecho a la información clínica y el consentimiento informado como expresión práctica del principio de autonomía, son conquistas legales en España de finales del siglo XX que se han trasladado a la normativa deontológica médica. Se estudia el ritmo de ese traslado. Revisión histórica de los diferentes códigos de deontología médica desde la Guerra Civil, buscando la presencia de estas ideas en ella. Hasta el código de 1979 la idea de información clínica no aparece en la normativa deontológica vigente y el consentimiento lo hace en casos muy restringidos. A partir de esa fecha su aparición es progresiva en los sucesivos códigos. Actualmente ambas ideas están completamente desarrolladas en la normativa deontológica española. La Deontología médica ha asumido como suyas las ideas de información al paciente y consentimiento in-formado. Este ha sido un proceso largo en el tiempo que ha cambiado en buena medida la orientación deontológica para las relaciones médico-enfermo. En estos aspectos, la Deontología médica pasa, de hacer hincapié en la prudencia del médico, a subrayar el deber de informar y de dar amplio espacio a las decisiones del paciente, al que reconoce como un agente moral autónomo y reflexivo, capaz de tomar sus propias decisiones sobre su salud

In Spain, the right to clinical information and informed consent as a practical expression of the principle of autonomy, are legal conquests achieved in the late twentieth century. From the law they have been transferred to the codes of medical deontology. The aim of this work is to study the pace of this transfer. Historical review of the different codes of medical deontology in Spain since the Civil War, see-king the presence of these ideas in them. Until code of medical deontology of 1979, the idea of clinical information did not appear in the contemporary deontological norm, and the rules on consent did so in very restricted cases. As of that date, their appearance is progressive in the successive codes. Currently, both concepts are fully developed in Spanish deontological regulations. Medical Deontology has take on the ideas of patient information and informed consent. This has been a long process which have brought considerable changes the deontological orientations of the traditional form of doctor-patient relationship. In these aspects, medical deontology has drifted, from emphasizing the prudence of the doctor, to emphasize the duty to inform and give ample space to the patient’s decisions, which he recognizes as an autonomous and reflective moral agent, capable of taking his own decisions about your health

[Gender identity, a factor of inequality forgotten by Spanish health information systems]. / La identidad de género, factor de desigualdad olvidado en los sistemas de información de salud de España.

The Spanish Health Information System (HIS) collects health information. Trans people have poorer health status. This paper aimed to assess the adequacy of the HIS to collect the health data on trans individuals. The HIS sources available in the Statistical Portal of the National Health System were reviewed. The sources containing population health data were selected. The variables "sex" and "gender identity" were searched. Nineteen sources were identified. In all of them the variable "sex" was found, whereas "gender identify" did not appear in any of the 19. In two sources, the variable "sex" allowed values of "transsexual". The SIS contains little information regarding gender identity. This leads to the invisibility of trans people in Spanish health statistics. Obtaining this information would allow for a better understanding of the barriers to health care access, and the health needs of one of the most discriminated groups in our society.

Techno-Anthropological Ethics and Health Information Systems Technologies.

One of the most important Techno-Anthropological intellectual virtues is the ability to make contextualized ethical judgments of new and emerging technologies. This Techno-Anthropological core competence is especially relevant in Health Information Systems Technologies, which is a field characterized by inherent ethical dilemmas such as the pros and cons of regulation of research databases with sensitive information, or storing and application of tissue and blood samples. In this paper we present a method to make 'proper and quick' ethical estimates in Health Information. The method guides its user to make ethical judgments by splitting the judgment process into four steps: (1) Identification of intended beneficial consequences, potential misuse, unintended side effects and long-term consequences for culture and society. (2) Linkage of intended consequences, misuse, side effects and cultural implications to appropriate ethical values. (3) Identification of ethical dilemmas related to a specific use of the Health Information Systems Technology under assessment. (4) Formulation of appropriate technological and institution design criteria that can transcend the identified ethical dilemmas. The methodology will be applied to a the discussions at a hearing on ethical challenges accompanying research involving health data organized by the Danish Council of Ethics and the case of risk reducing breast cancer surgery based on diagnosed genetic predisposition to breast cancer.

When Does FDAMA Section 114 Apply? Ten Case Studies.

BACKGROUND: Section 114 of the Food and Drug Administration Modernization Act of 1997 regulates the promotion of health economic information by pharmaceutical companies to US health plans. Greater clarity is important given demands by payers and other stakeholders for evidence of value. OBJECTIVES: To develop hypothetical case studies of health economic promotions to examine legal and policy implications. METHODS: We constructed for pedagogical purposes 10 categories of potential health economic promotions. We generated hypothetical case studies for each category, including questions about whether each might be allowable under Section 114. The case studies were developed around the following categories: 1) costing out on-label clinical end points; 2) promotion of a costing exercise to physicians working in an accountable care organization setting; 3) burden-of-illness claims; 4) economic analysis of a formulary restriction policy; 5) extrapolations to doses, populations, or settings not covered in trials; 6) adherence claims; 7) "utilization of care" as a secondary end point in randomized clinical trials; 8) costing out a competitor drug's adverse event; 9) economic analysis of comparative effectiveness claims using an indirect treatment comparison; and 10) extrapolating from surrogate to long-term outcomes in an economic model. DISCUSSION: Most cases seem to fall into a gray zone given haziness around what constitutes "competent and reliable evidence" and "directly relate[d]" to an approved indication. In practice, it is difficult to know what the section allows given the imprecision of the statute and lack of guidance about its scope. CONCLUSION: Ideally, future guidance will provide clarity and flexibility.

Ethical aspects of using medical social media in healthcare applications.

The advances in internet and mobile technologies and their increased use in healthcare led to the development of a new research field: health web science. Many research questions are addressed in that field, starting from analysing social-media data, to recruiting participants for clinical studies and monitoring the public health status. The information provided through this channel is unique in a sense that there is no other written source of experiences from patients and health carers. The increased usage and analysis of health web data poses questions on privacy, and ethics. Through a literature review, the current awareness on ethical issues in the context of public health monitoring and research using medical social media data is determined. Further, considerations on the topic were collected from members of the IMIA Social Media Working group.

Pharmaceutical information systems and possible implementations of informed consent -- developing an heuristic.

BACKGROUND: Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. ANALYSIS: The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. RESULTS AND CONCLUSION: Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system.The danger of routinisation of consent is identified.The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent.