Clinical Information Systems - Seen through the Ethics Lens.

OBJECTIVE: The more people there are who use clinical information systems (CIS) beyond their traditional intramural confines, the more promising the benefits are, and the more daunting the risks will be. This review thus explores the areas of ethical debates prompted by CIS conceptualized as smart systems reaching out to patients and citizens. Furthermore, it investigates the ethical competencies and education needed to use these systems appropriately. METHODS: A literature review covering ethics topics in combination with clinical and health information systems, clinical decision support, health information exchange, and various mobile devices and media was performed searching the MEDLINE database for articles from 2016 to 2019 with a focus on 2018 and 2019. A second search combined these keywords with education. RESULTS: By far, most of the discourses were dominated by privacy, confidentiality, and informed consent issues. Intertwined with confidentiality and clear boundaries, the provider-patient relationship has gained much attention. The opacity of algorithms and the lack of explicability of the results pose a further challenge. The necessity of sociotechnical ethics education was underpinned in many studies including advocating education for providers and patients alike. However, only a few publications expanded on ethical competencies. In the publications found, empirical research designs were employed to capture the stakeholders' attitudes, but not to evaluate specific implementations. CONCLUSION: Despite the broad discourses, ethical values have not yet found their firm place in empirically rigorous health technology evaluation studies. Similarly, sociotechnical ethics competencies obviously need detailed specifications. These two gaps set the stage for further research at the junction of clinical information systems and ethics.

Bioethics in the big data era: health care and beyond / La bioética en el época del "big data": la salud y más allá / La bioètica en l’època del 'big data': la salut i més enllà

"Big data" and data-intensive research approaches are rapidly gaining momentum in health and biomedical research, with potential to transform health at all levels from personal to public. The use of "big data" for health research, however, raises a number of ethical challenges. In this paper I discuss ethical aspects of the advent of big data in health. I argue that although public discourse has focused on immediate concerns relating to use of individuals' information, "big health data" requires us to explore alternative conceptual approaches to research ethics, including the "social contract" model. Further, we need to think beyond health research uses of data to the social consequences of big data epistemology and practice, and the moral implications of "datafying" the human

La ciencia de "big data" (o datos masivos) lleva mucho potencial para la investigación biomédica, y promete una transformación en la salud y la asistencia médica. Al mismo tiempo, el uso de datos de salud en investigación presenta varios retos éticos. En este artículo, exploraré aspectos éticos de la llegada del "big data" al ámbito de la salud. Aunque el discurso público y regulatorio se ha focalizado mucho en el uso de datos del individuo, lidiar con los nuevos desafíos de datos masivos requiere considerar enfoques alternativos a la ética de la investigación, tal como el modelo del "contrato social". Hay que pensar más allá del uso de datos para investigaciones en salud y contemplar las consecuencias sociales de la epistemología y la práctica de "big data" y las implicancias morales de la "datificación" del humano

La ciència del "big data" (o dades massives) comporta un enorme potencial per a la recerca biomèdica, i promet ocasionar una gran transformació en l'àmbit de la salut i l'assistència mèdica. Al mateix temps, l'ús de dades de salut en recerca presenta diversos reptes ètics. En aquest article, analitzaré els aspectes ètics de l'arribada del "big data" a l'àmbit de la salut. Encara que el discurs públic i regulador s'ha focalitzat principalment en l'ús de les dades personals, bregar amb els nous desafiaments que comporten la irrupció de les dades massives requereix enfocaments alternatius a l'ètica de la recerca, com ara el model del «contracte social». A més, cal pensar més enllà de l'ús de dades per a recerques en salut i tenir en compte les conseqüències socials de l'epistemologia i la pràctica del "big data" i les implicacions morals de la "datificació" d'allò que és humà

Considerations for use of dental photography and electronic media in dental education and clinical practice.

Photography and electronic media are indispensable tools for dental education and clinical practice. Although previous research has focused on privacy issues and general strategies to protect patient privacy when sharing clinical photographs for educational purposes, there are no published recommendations for developing a functional, privacy-compliant institutional framework for the capture, storage, transfer, and use of clinical photographs and other electronic media. The aims of this study were to research patient rights relating to electronic media and propose a framework for the use of patient media in education and clinical care. After a review of the relevant literature and consultation with the University of Washington's director of privacy and compliance and assistant attorney general, the researchers developed a privacy-compliant framework to ensure appropriate capture, storage, transfer, and use of clinical photography and electronic media. A four-part framework was created to guide the use of patient media that reflects considerations of patient autonomy and privacy, informed consent, capture and storage of media, and its transfer, use, and display. The best practices proposed for capture, storage, transfer, and use of clinical photographs and electronic media adhere to the health care code of ethics (based on patient autonomy, nonmaleficence, beneficence, justice, and veracity), which is most effectively upheld by a practical framework designed to protect patients and limit institutional liability. Educators have the opportunity and duty to convey these principles to students who will become the next generation of dentists, researchers, and educators.

Salami publication: definitions and examples.

Salami publication or segmented publication is a distinct form of redundant publication which is usually characterized by similarity of hypothesis, methodology or results but not text similarity. These aspects of publications are not objectively detected by software applications and therefore present a serious threat to publication ethics. This article presents a practical approach for dealing with manuscripts suspected of salami publication during the submission process and after article publication in Biochemia Medica.

Desenvolvimento de um sistema para gerenciar os processos regulatórios do Laboratório de Pesquisa Clínica em DST e Aids do Instituto de Pesquisa Clínica Evandro Chagas da Fundação Oswaldo Cruz / Development of a system to manage the Regulatory Process the Laboratório de Pesquisa Clínica in DST e Aids at Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz

A atividade regulatória em pesquisa clínica visa o cumprimento de todas as etapas frente às autoridades regulatórias para a condução da pesquisa em conformidade com as Boas Práticas Clínicas. Segundo a International Conference on Harmonization (ICH – Conferência Internacional de Harmonização), as autoridades regulatórias são instâncias dotadas de poder de regulamentação que, conforme as normas de Boas Práticas Clínicas, incluem as autoridades que revisam os dados clínicos e as autoridades que realizam a inspeção. Devido à complexidade do processo regulatório no Brasil é necessário estar atento às modificações na legislação e normas para submissão dos projetos de pesquisa às autoridades reguladoras em um curto prazo de tempo, para cumprir o planejamento dos períodos de duração dos estudos clínicos. O presente trabalho tem o objetivo de desenvolver e disponibilizar um sistema para gerenciar os processos regulatórios do Laboratório de Pesquisa Clínica em DST e Aids do Instituto de Pesquisa Clinica Evandro Chagas, da Fundação Oswaldo Cruz, atendendo à regulamentação nacional e internacional. Uma vez que processo é um conjunto de ações ordenadas e integradas para um fim produtivo específico, ao final do qual serão gerados produtos e/ou serviços e/ou informações, foi realizado o mapeamento das atividades desenvolvidas no dia a dia do setor de assuntos regulatórios do centro para obtenção das aprovações regulatórias das pesquisas em DST e Aids, bem como do processo administrativo para ingresso da equipe de trabalho nos protocolos. Para a representação gráfica dos processos foi usada a notação de modelagem de processos de negócios, Business Process Model Notation (BPMN), que é um padrão definido pelo Governo Federal e já utilizada pela Fundação Oswaldo Cruz. O software BizAgi® foi usado para modelagem dos processos regulatórios...

Regulatory activity in Clinical Research aims at the compliance of all the steps required bythe Regulatory Authorities for the conduction of research in accordance with Good ClinicalPractices. According to the International Conference on Harmonization (ICH), RegulatoryAuthorities are instances endowed with regulatory power that, according to the standards ofGood Clinical Practices, include the authorities who review the clinical data, and theauthorities conducting the inspection. Due to the complexity of the regulatory process inBrazil is crucial to be aware of changes in legislation and regulations for the submission ofresearch projects to regulatory authorities in a short period of time, to comply with the clinicalstudies scheduled time periods. This study aims to develop and make available a database tomanage the regulatory processes of Laboratório de Pesquisa Clínica em DST/Aids at Institutode Pesquisa Evandro Chagas (IPEC), Fundação Oswaldo Cruz (Fiocruz), according tonational and international regulations. As process is a set of coordinated and integratedactions to a specific productive result, which will eventually yieldproducts/services/information, a mapping of the daily activities of the Laboratory RegulatoryAffairs to obtain regulatory approvals for research on STD and Aids, as well as theadministrative procedures for including the study team in the protocols. For the process’graphical representation modeling business processes’ notation was used, the BusinessProcess Model Notation (BPMN), which is a standard defined by the Federal Government,and already used by the Oswaldo Cruz Foundation. The BizAgi ® software was used formodeling of the regulatory processes...

Ethics and the electronic health record in dental school clinics.

Electronic health records (EHRs) are a major development in the practice of dentistry, and dental schools and dental curricula have benefitted from this technology. Patient data entry, storage, retrieval, transmission, and archiving have been streamlined, and the potential for teledentistry and improvement in epidemiological research is beginning to be realized. However, maintaining patient health information in an electronic form has also changed the environment in dental education, setting up potential ethical dilemmas for students and faculty members. The purpose of this article is to explore some of the ethical issues related to EHRs, the advantages and concerns related to the use of computers in the dental operatory, the impact of the EHR on the doctor-patient relationship, the introduction of web-based EHRs, the link between technology and ethics, and potential solutions for the management of ethical concerns related to EHRs in dental schools.

Ética e historia farmacoterapéutica / Ethics and the patient’s pharmacotherapeutic record

El objetivo del presente trabajo es hacer una reflexión ética sobre los datos personales y de salud que están inundando nuestros ordenadores. El respeto a la confidencialidad y a la autonomía del paciente cuando se establece el seguimiento farmacoterapéutico exige un tratamiento ético de los datos que allí se contienen. Conceptos como, por ejemplo, consentimiento informado, confidencialidad, derecho de acceso y derecho de rectificación son términos que acompañan el quehacer clínico y que, poco a poco, hemos de incorporar a nuestra terminología farmacéutica. La obtención y el tratamiento de esta información pueden serlas causas de uno de los principales problemas éticos y legales que se plantean en el seguimiento farmacoterapéutico personalizado. Este trabajo pretende definir el concepto de seguimiento farmacoterapéutico personalizado y abordar diferentes aspectos, entre ellos la finalidad de la historia farmacoterapéutica, su custodia, conservación y confidencialidad, y el consentimiento informado. No se trata simplemente de hacer una extrapolación de la ética médica a la farmacéutica, sino de, basándonos en la normativa legal, abordar el tratamiento de los datos de la historia farmacoterapéutica desde unos principios éticos mínimos, como el respeto a la confidencialidad, la autonomía y la libertad del individuo (AU)

The objective of this study is to consider the ethical aspects of the personal and health data flooding our computers. Respect for confidentiality and the patient's autonomy when establishing the pharmacotherapeutic follow-up requires the ethical treatment of the data contained therein. Concepts like informed consent, confidentiality, right of access and right to correction are terms that go hand in hand with clinical work and which we must slowly incorporate into our pharmaceutical terminology. The collection and handling of this information may be the cause of one of the main ethical and legal problems arising in personalised pharmacotherapeutic follow-up. This study aims to define the concept of personalised pharmacotherapeutic follow-up and approach different aspects, including the purpose of the patient’s pharmacotherapeutic record, its custody, conservation and confidentiality, as well as informed consent. Our aim is not to simply extrapolate pharmaceutical ethics from medical ethics, but rather to approach, on the basis of current regulations, the treatment of data in patients' pharmacotherapeutic records according to certain minimum ethical principles, like respect for the patient's confidentiality, autonomy and freedom (AU)

Privacy impact assessment in the design of transnational public health information systems: the BIRO project.

OBJECTIVES: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. MATERIALS AND METHODS: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. RESULTS: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an "aggregation by group of patients" was finally chosen, based upon the exchange of finely tuned summary tables. CONCLUSIONS: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

Desarrollo y aportaciones del Comité Científico del XXV Congreso de la Sociedad Española de Calidad Asistencial en Barcelona, 2007 / Development and opportunities from de scientific committee of 25 SECA congress held in Barcelona, 2007

Objetivo: Realizar la autoevaluación de la labor del Comité Científico (CC) del XXV Congreso de la Sociedad Española de Calidad Asistencial (SECA), celebrado en Barcelona en octubre de 2007 para aportar líneas de mejora en el desarrollo de la actividad más importante del SECA: el congreso anual. Material y métodos: Diseño: aplicar la metodología de evaluación PDCA (plan, do, check, act ‘planificar, hacer, verificar, actuar’) a las tareas desarrolladas por el CC del XXV Congreso. Plan: descripción de la preparación del congreso según el procedimiento de gestión de comunicaciones del CC del manual de congresos de la SECA. Do: descripción de la implementación de éste. Check: proceso de evaluación de las actividades realizadas. Act: propuestas de mejora para los siguientes congresos. Resultados: El CC (22 personas) desarrolló las labores de gestión de comunicaciones, la edición del libro y la gestión de las actividades científicas en el congreso. La gestión de comunicaciones se organizó en 11 parejas de revisores que evaluaron de forma ciega las comunicaciones recibidas: 348 orales y 457 pósteres, de las que se rechazó el 10,09%. Las comunicaciones se presentaron en 36 mesas orales y 24 sesiones de pósteres. El libro se ha editado con los resúmenes de comunicaciones, las ponencias de las mesas y las conferencias inaugural y de clausura. Premios: las comunicaciones con puntuación por encima de 7,5 optaron a premio y se evaluaron in situ por parte del CC. El congreso en línea también tuvo buena acogida. Conclusiones: La satisfacción de los congresistas con la parte científica del congreso fue buena y se han identificado áreas de mejora (AU)

Objective: To perform a self-assessment of the Scientific Committee of the 25th Conference of the Spanish Society for Quality in Healthcare held in Barcelona on October 2007 in order to identify improvement areas for future Conferences. Material and methods: Design: Applying PDCA methodology to the tasks undertaken by the Scientific Committee (SC) of the Conference. Plan: A description of the preparation of the conference based on the abstract management of the Scientific Committee. Do: description of the implementation. Check: evaluation of activities. A: improvement proposals for the coming conferences. Results: The SC (22 people) worked in the abstracts management, book publishing and development of the scientific aspects of the Conference. Abstracts evaluation was conducted by 11 pairs of blind evaluators who analysed 348 oral communications and 457 posters, and 10.09% were rejected. Oral communications were performed in a total of 36 oral presentations sessions and 24 poster sessions. The book was published with the abstracts, addresses and the Conference opening and closing sessions. Awards: communications graded over 7.5 applied for an award and were reassessed by the SC. The on-line conference was also well received. Conclusions The satisfaction with the Conference regarding the scientific activities was good; however, several areas of improvement were identified (AU)

Managing information: using systematic data collection to estimate process and impact indicators related to harm reduction services in Myanmar.

BACKGROUND: Discussion about coverage has primarily focused on answering the question: what level of coverage is required to reduce the spread of HIV among people who inject drugs? This paper documents the process involved in designing a Monitoring Information System (MIS) that provides a tool to estimate coverage, frequency of contacts as well as provides a mechanism for correlating these data with changes in risk behaviour among the surveyed population. METHODS: The system uses paper and pencil data collection forms to record information about the type and location of a contact. Information about the content of the contact such as the services, equipment or education that is delivered is also collected. This data is then entered into a computer program that manages the information and allows for simple standardised reports to be generated. The reports provide a simple mechanism for analysing process indicators such as the number and frequency of contacts, where the contact occurred as well as what the contact consisted of (i.e. education content or distribution of equipment). The system also allows correlations to be made between exposure to services and changes in behaviour thus providing a mechanism for assessing impact indicators. CONCLUSION AND DISCUSSION: We present a brief description of the Monitoring Information System, its structure and functions and encourage practitioners to consider the importance of adopting standardised monitoring systems to measure coverage. We also explore some potential ethical limitations around using the system.

Ethnicity and the ethics of data linkage.

Linking health data with census data on ethnicity has potential benefits for the health of ethnic minority groups. Ethical objections to linking these data however include concerns about informed consent and the possibility of the findings being misused against the interests of ethnic minority groups. While consent concerns may be allayed by procedures to safeguard anonymity and respect privacy, robust procedures to demonstrate public approval of data linkage also need to be devised. The possibility of findings being misused against the interests of ethnic minority groups may be diminished by informed and open public discussion in mature democracies, but remain a concern in the international context.

Planes de sistemas de información en salud / Information system plan in the health sector

El presente artículo profundiza en la descripción de necesidades de una organización para disponer de una estrategia tecnológica, alineada con la estrategia corporativa y vinculada a los objetivos del “negocio” independiente del sector actividad, algo que viene a llamarse PSI-Plan de Sistemas de Información (AU)

This article gives an in-depth description of the needs of an organisation for a technological strategy, in alignment with the corporative strategy and linked to the “business” objectives, regardless of the activity sector, something which is called ISP- Information Systems Plan (AU)

Converging technologies and human destiny.

The rapid fertility decline in most advanced industrial nations, coupled with secularization and the disintegration of the family, is a sign that Western Civilization is beginning to collapse, even while radical religious movements pose challenges to Western dominance. Under such dire circumstances, it is pointless to be cautious about developing new Converging Technologies. Historical events are undermining the entire basis of ethical decision-making, so it is necessary to seek a new basis for ethics in the intellectual unification of science and the power to do good inherent in the related technological convergence. This article considers the uneasy relations between science and religion, in the context of fertility decline, and the prospects for developing a new and self-sustaining civilization based in a broad convergence of science and technology, coalescing around a core of nanotechnology, biotechnology, information technology, and cognitive technologies. It concludes with the suggestion that the new civilization should become interstellar.

Sistemas de información como instrumento para la gestión en la UCI / Information systems as instrument for ICU management

En este artículo se describen las consideraciones prácticas, los sistemas informáticos para la adquisición de las constantes vitales y la consignación de órdenes médicas en las Unidades de Cuidados Intensivos. Asimismo, se analiza la confección de un cuadro de mandos integral con los indicadores asistenciales con el objeto de facilitar la gestión de la UCI (AU)

This article describes the practical considerations of information systems for obtaining vital signs and the allocation of medical orders in intensive care units. It also analyses the generation of an integral control panel with care indicators with the aim for facilitating ICU management (AU)

M@TIC. Medicine Assisted by Information and Communication Technology: conflicts, responsibility and liability.

The term M@TIC, is that which encompasses all Medicine Assisted by Technology on Information and Communication. The development of these techniques brings up many ethical and legal conflicts, mainly because medical science has developed much faster than the law. Justice cannot be properly served if we do not have the regulations to help mankind to avoid aberrant behavior by medical practitioners in this field. M@TIC is still regarded as an experimental research procedure. Not all that is technically feasible is ethically acceptable. There are many potential risks associated with M@TIC and it is largely considered, and so it is understood by doctors, that any damage to the patient would be the fault of the system, never the responsibility of the doctor. It frightens one to think that this fact may be used, in the future, as a shield to protect negligent medical doctors from malpractice suits.

Progress in governance of converging technologies integrated from the nanoscale.

It is expected that convergence of nanotechnology, modern biology, the digital revolution, and cognitive sciences will bring about tremendous improvements in transformative tools, generate new products and services, enable human personal abilities and social achievements, and in time reshape societal relationships. This article focuses on the progress made in governance of such converging, emerging technologies that are integrated with more traditional technologies. The proposed framework for governance calls for several key functions: supporting the transformative impact; advancing responsible development that includes health, safety, and ethical concerns; encouraging national and global partnerships; and commitment to long-term planning with effects on human development. Principles of good governance include participation of all those involved or affected by the new technologies, transparency, participant responsibility, and effective strategic planning. Introduction and management of converging technologies must be done with respect for immediate concerns (such as information technology privacy, access to medical advancements, and addressing toxicity of new nanomaterials) and longer-term concerns (such as human development and concern for human integrity, dignity, and welfare). Four levels of governance of converging technologies have been identified: (a) adapting existing regulations and organizations; (b) establishing new programs, regulations, and organizations specifically to handle converging technologies; (c) national policies and institutional capacity building; and (d) international agreements and partnerships.

Present and future challenges in medical data management: economics, ethics, and the law.

Electronically-linked knowledge plays an increasingly central role in the delivery of health services worldwide. Medical data collection, archival, and analysis are all increasing in both rate and volume; large, cohesive collections of personal health information are emerging rapidly. Factors driving this integration include value-added methods of diagnosis and therapy, interest in evidence-based practices, safety concerns, and increased consumer demand for personalized, comprehensive medical services. Practitioners, businesses, patients, and the public at large would be well-served to develop and sustain a dialogue addressing these phenomena, including assessments their of economic, ethical, legal implications.

Working IT out in e-Science: experiences of requirements capture in a HealthGrid project.

This paper reports on our experiences of being involved in requirements capture for a HealthGrid project. Large scale, collaborative projects with multiple partners tend to experience numerous problems in the requirements capture phase (and often beyond) and HealthGrid projects are no exception. Projects with highly innovative objectives often have additional sets of problematics, however. In carving out new visions of, for example, clinical research and healthcare service delivery, HealthGrid projects have to reckon with--and work within--existing healthcare policy, legislative frameworks, professional cultures and organisational politics as well as the more common integration problem of dealing with legacy systems. Such factors are not conducive to the achievement in healthcare of the e-Science vision of seamless integration of information and collaborative working across administrative, professional and organisational boundaries. In this paper, we document some of the challenges we encountered in investigating the requirements for eDiaMoND, a flagship pilot UK e-Science project. We discuss what we might learn from these challenges, especially approaches to requirements capture that are appropriate for projects with innovative aims and are also sensitive to representing and addressing what may be complex professional and organisational interests.