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1.
J Clin Ethics ; 35(2): 85-92, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38728697

RESUMO

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.


Assuntos
Confidencialidade , Pais , Humanos , Adolescente , Confidencialidade/legislação & jurisprudência , Confidencialidade/ética , Masculino , Estados Unidos , Revelação/legislação & jurisprudência , Revelação/ética , Autonomia Pessoal , Consentimento dos Pais/legislação & jurisprudência , Consentimento dos Pais/ética , Direitos do Paciente/legislação & jurisprudência , Criança , Privacidade/legislação & jurisprudência , Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/legislação & jurisprudência , Acesso à Informação/legislação & jurisprudência , Acesso à Informação/ética
2.
Pediatrics ; 153(5)2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38646690

RESUMO

Confidentiality is an essential component of high-quality health care for adolescents and young adults and can have an impact on the health care experiences and health outcomes of youth. Federal and state laws, professional guidelines, and ethical standards provide a core framework for guidance in the implementation of confidentiality protections in clinical practice. This policy statement provides recommendations for pediatricians and other pediatric health care professionals, clinics, health systems, payers, and electronic health record developers to optimize confidentiality practices and protections for adolescents and young adults across the spectrum of care.


Assuntos
Confidencialidade , Confidencialidade/ética , Confidencialidade/legislação & jurisprudência , Humanos , Adolescente , Estados Unidos , Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/legislação & jurisprudência , Registros Eletrônicos de Saúde/normas
3.
Eur J Hum Genet ; 32(5): 498-505, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38355959

RESUMO

The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled the health care policy makers to make decisions based on real-time data, it enabled the tracking of the virus, and importantly it enabled the development of vaccines that were crucial to mitigating the impact of the virus. This data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues. If passed, it will create an obligation to share electronic health data for certain secondary purposes. While there is a clear need to address the legal complexities involved with data sharing, it is critical that any proposed reforms are in line with ethical principles and the expectations of the data subjects. In this paper we offer a critique of the EHDS and offer some recommendations for this evolving regulatory space.


Assuntos
COVID-19 , Disseminação de Informação , SARS-CoV-2 , Humanos , COVID-19/epidemiologia , Europa (Continente) , Disseminação de Informação/ética , Disseminação de Informação/legislação & jurisprudência , Pandemias/ética , Segurança Computacional/ética , Segurança Computacional/legislação & jurisprudência , Segurança Computacional/normas , Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/legislação & jurisprudência
4.
Arch Suicide Res ; 27(2): 704-717, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-35446244

RESUMO

OBJECTIVE: Develop a stakeholder-informed ethical framework to provide practical guidance to health systems considering implementation of suicide risk prediction models. METHODS: In this multi-method study, patients and family members participating in formative focus groups (n = 4 focus groups, 23 participants), patient advisors, and a bioethics consultant collectively informed the development of a web-based survey; survey results (n = 1,357 respondents) and themes from interviews with stakeholders (patients, health system administrators, clinicians, suicide risk model developers, and a bioethicist) were used to draft the ethical framework. RESULTS: Clinical, ethical, operational, and technical issues reiterated by multiple stakeholder groups and corresponding questions for risk prediction model adopters to consider prior to and during suicide risk model implementation are organized within six ethical principles in the resulting stakeholder-informed framework. Key themes include: patients' rights to informed consent and choice to conceal or reveal risk (autonomy); appropriate application of risk models, data and model limitations and consequences including ambiguous risk predictors in opaque models (explainability); selecting actionable risk thresholds (beneficence, distributive justice); access to risk information and stigma (privacy); unanticipated harms (non-maleficence); and planning for expertise and resources to continuously audit models, monitor harms, and redress grievances (stewardship). CONCLUSIONS: Enthusiasm for risk prediction in the context of suicide is understandable given the escalating suicide rate in the U.S. Attention to ethical and practical concerns in advance of automated suicide risk prediction model implementation may help avoid unnecessary harms that could thwart the promise of this innovation in suicide prevention. HIGHLIGHTSPatients' desire to consent/opt out of suicide risk prediction models.Recursive ethical questioning should occur throughout risk model implementation.Risk modeling resources are needed to continuously audit models and monitor harms.


Assuntos
Modelos Estatísticos , Medição de Risco , Prevenção do Suicídio , Suicídio , Humanos , Registros Eletrônicos de Saúde/ética , Grupos Focais , Consentimento Livre e Esclarecido/ética , Medição de Risco/métodos , Participação dos Interessados , Prevenção do Suicídio/ética , Prevenção do Suicídio/métodos , Inquéritos e Questionários
5.
Rev. bioét. derecho ; (50): 271-294, nov. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-191358

RESUMO

La pandemia COVID-19 ha generado impactos sociales y políticos adicionales a los estrictamente sanitarios, llevando de un aparte a que los países, en el contexto de los estados de emergencia decretados, limiten de manera temporal algunos derechos y libertades civiles, para preservar la vida y salud de los ciudadanos; y de otra parte, han acelerado la transformación digital con el desarrollo y uso de herramientas tecnológicas para complementar las medidas de salud pública. Diversos organismos internacionales han expresado su preocupación respecto a la vulneración del derecho a la protección de datos personales en este nuevo escenario, e incluso han propuesto lineamientos éticos a tener en cuenta. En este artículo se analizarán las medidas que han sido implementadas en Colombia con ocasión de la COVID-19, desde la perspectiva del marco jurídico del derecho a la protección de datos personales vigente, y como los principios y derechos que lo componen, pueden ser reinterpretados a la luz de estas nuevas recomendaciones éticas


COVID-19 pandemic has generated additional social and political impacts beyond those strictly related to health, leading countries to, within the context of declared states of emergency, temporarily limit some civil rights and liberties in order to preserve their citizen's life and health. On the other hand, it has accelerated the digital transformation with the development and use of technological tools to complement public health measures. Several international organizations have voiced their concern about the violation of the right to personal data protection in this new scenario and have even proposed ethical guidelines to be taken into account. This article will analyses the measures that have been implemented in Colombia during COVID-19 pandemic, from the actual perspective of the legal framework of the right to personal data protection, and how its principles and rights may be reinterpreted in the light of these new ethical recommendations


La pandèmia COVID-19 ha generat impactes socials I polítics addicionals als estrictament sanitaris, portant d'un a part al fet que els països, en el context dels estats d'emergència decretats, limitin de manera temporal alguns drets I llibertats civils, per preservar la vida I salut dels ciutadans; I d'una altra banda, accelerant la transformació digital amb el desenvolupament I l'ús d'eines tecnològiques per complementar les mesures de salut pública. Diversos organismes internacionals han expressat la seva preocupació pel que fa a la vulneració del dret a la protecció de dades personals en aquest nou escenari, I fins I tot han proposat directrius ètiques a tenir en compte. En aquest article s'analitzaran les mesures que han estat implementades a Colòmbia amb motiu de la COVID-19, des de la perspectiva del marc jurídic del dret a la protecció de dades personals vigent, I com els principis I drets que el componen, poden ser reinterpretats a la llum d'aquestes noves recomanacions ètiques


Assuntos
Humanos , Informações Pessoalmente Identificáveis/ética , Registros Eletrônicos de Saúde/ética , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Monitoramento Epidemiológico , Colômbia/epidemiologia
6.
Milbank Q ; 98(4): 1257-1289, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33078879

RESUMO

Policy Points Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data. Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. CONTEXT: Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored. METHODS: Using pacemakers and implantable cardioverter-defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records. FINDINGS: Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device-collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the "little sister" of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device-derived data. CONCLUSIONS: Current health privacy legislation incompletely supports patients' normative claims for access to digital health data.


Assuntos
Registros Eletrônicos de Saúde/legislação & jurisprudência , Marca-Passo Artificial , Direitos do Paciente , Registros Eletrônicos de Saúde/ética , Ética Médica , Europa (Continente) , Health Insurance Portability and Accountability Act , Humanos , Estados Unidos
7.
Health Care Manag (Frederick) ; 39(4): 150-161, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33079766

RESUMO

Ethical issues related to electronic health records (EHRs) confront health personnel. Electronic health records create conflict among several ethical principals. Electronic health records may represent beneficence because they are alleged to increase access to health care, improve the quality of care and health, and decrease costs. Research, however, has not consistently demonstrated access for disadvantaged persons, the accuracy of EHRs, their positive effects on productivity, nor decreased costs. Should beneficence be universally acknowledged, conflicts exist with other ethical principles. Autonomy is jeopardized when patients' health data are shared or linked without the patients' knowledge. Fidelity is breached by the exposure of thousands of patients' health data through mistakes or theft. Lack of confidence in the security of health data may induce patients to conceal sensitive information. As a consequence, their treatment may be compromised. Justice is breached when persons, because of their socioeconomic class or age, do not have equal access to health information resources and public health services. Health personnel, leaders, and policy makers should discuss the ethical implications of EHRs before the occurrence of conflicts among the ethical principles. Recommendations to guide health personnel, leaders, and policy makers are provided.


Assuntos
Segurança Computacional , Atenção à Saúde , Registros Eletrônicos de Saúde/ética , Pessoal de Saúde/ética , Informática Médica , Mineração de Dados/normas , Acessibilidade aos Serviços de Saúde , Humanos
8.
Yearb Med Inform ; 29(1): 104-114, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32823304

RESUMO

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.


Assuntos
Sistemas de Informação/ética , Informática Médica/ética , Temas Bioéticos , Registros Eletrônicos de Saúde/ética , Análise Ética , Registros de Saúde Pessoal/ética , Humanos
10.
Artigo em Alemão | MEDLINE | ID: mdl-32410053

RESUMO

Digitization offers considerable potential for strengthening prevention in the healthcare system. Data from various clinical and nonclinical sources can be collected in a structured way and systematically processed using algorithms. Prevention needs can thus be identified more quickly and precisely, and interventions can be planned, implemented, and evaluated for specific target groups. At the same time, however, it is necessary that data processing not only meets high technical but also ethical standards and legal data protection regulations in order to avoid or minimize risks.This discussion article examines the potentials and risks of digital prevention first from a "data perspective," which deals with the use of health-related data for the purpose of prevention, and second from an "algorithm perspective," which focuses on the use of algorithmic systems, including artificial intelligence, for the assessment of needs and evaluation of preventive measures, from an ethical and legal point of view. Finally, recommendations are formulated for framework conditions that should be created to strengthen the further development of prevention in the healthcare system.


Assuntos
Algoritmos , Inteligência Artificial , Atenção à Saúde/ética , Registros Eletrônicos de Saúde/ética , Princípios Morais , Inteligência Artificial/ética , Inteligência Artificial/legislação & jurisprudência , Bioética , Conjuntos de Dados como Assunto/ética , Atenção à Saúde/métodos , Alemanha , Humanos
11.
Yearb Med Inform ; 29(1): 51-57, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32303098

RESUMO

OBJECTIVE: To create practical recommendations for the curation of routinely collected health data and artificial intelligence (AI) in primary care with a focus on ensuring their ethical use. METHODS: We defined data curation as the process of management of data throughout its lifecycle to ensure it can be used into the future. We used a literature review and Delphi exercises to capture insights from the Primary Care Informatics Working Group (PCIWG) of the International Medical Informatics Association (IMIA). RESULTS: We created six recommendations: (1) Ensure consent and formal process to govern access and sharing throughout the data life cycle; (2) Sustainable data creation/collection requires trust and permission; (3) Pay attention to Extract-Transform-Load (ETL) processes as they may have unrecognised risks; (4) Integrate data governance and data quality management to support clinical practice in integrated care systems; (5) Recognise the need for new processes to address the ethical issues arising from AI in primary care; (6) Apply an ethical framework mapped to the data life cycle, including an assessment of data quality to achieve effective data curation. CONCLUSIONS: The ethical use of data needs to be integrated within the curation process, hence running throughout the data lifecycle. Current information systems may not fully detect the risks associated with ETL and AI; they need careful scrutiny. With distributed integrated care systems where data are often used remote from documentation, harmonised data quality assessment, management, and governance is important. These recommendations should help maintain trust and connectedness in contemporary information systems and planned developments.


Assuntos
Inteligência Artificial/ética , Registros Eletrônicos de Saúde/ética , Atenção Primária à Saúde/ética , Confiabilidade dos Dados , Ética Médica , Humanos , Disseminação de Informação/ética , Informática Médica/ética , Sistemas Computadorizados de Registros Médicos/ética , Sistemas Computadorizados de Registros Médicos/normas
12.
JCO Clin Cancer Inform ; 4: 184-200, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32134684

RESUMO

Big data for health care is one of the potential solutions to deal with the numerous challenges of health care, such as rising cost, aging population, precision medicine, universal health coverage, and the increase of noncommunicable diseases. However, data centralization for big data raises privacy and regulatory concerns.Covered topics include (1) an introduction to privacy of patient data and distributed learning as a potential solution to preserving these data, a description of the legal context for patient data research, and a definition of machine/deep learning concepts; (2) a presentation of the adopted review protocol; (3) a presentation of the search results; and (4) a discussion of the findings, limitations of the review, and future perspectives.Distributed learning from federated databases makes data centralization unnecessary. Distributed algorithms iteratively analyze separate databases, essentially sharing research questions and answers between databases instead of sharing the data. In other words, one can learn from separate and isolated datasets without patient data ever leaving the individual clinical institutes.Distributed learning promises great potential to facilitate big data for medical application, in particular for international consortiums. Our purpose is to review the major implementations of distributed learning in health care.


Assuntos
Algoritmos , Gerenciamento de Dados/normas , Mineração de Dados/ética , Atenção à Saúde/ética , Registros Eletrônicos de Saúde/ética , Aprendizado de Máquina , Privacidade , Mineração de Dados/métodos , Bases de Dados Factuais/estatística & dados numéricos , Atenção à Saúde/métodos , Humanos , Medicina de Precisão/métodos
14.
J Am Board Fam Med ; 33(1): 106-117, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31907251

RESUMO

OBJECTIVE: The aim of this study is to explore whether specific ethical questions arise with the use of a shared electronic health record (EHR) system, based on the daily experience of primary care physicians (PCPs). METHODS: In this qualitative research project, we conducted 14 in-depth semistructured interviews with PCPs in a tertiary hospital setting. RESULTS: We identified 4 themes: 1) PCPs describe the EHR as a medicine with side effects, for which they provide suggestions for improvements; 2) A shared record raises ethical questions related to autonomy and trust; 3) Although use of the EHR often disturbs rapport with the patient, it can also support the patient-doctor interaction when it becomes an active part of the conversation; 4) A shared EHR may cause health care providers (and their relatives) to avoid seeking help for sensitive issues. DISCUSSION: PCPs fear access to results could cause confusion and anxiety in patients, resulting in tensions between autonomy and beneficence. Improved efficiency and quality of care with a shared EHR relies on doctors trusting each other's input to avoid duplicate tests. However, this might compromise a fundamental skeptical attitude in practicing medicine, and we should be aware of a risk of increased confirmation and anchoring bias. CONCLUSION: The EHR is considered to be a work in progress-EHR design could be improved by examining physicians' coping strategies and implementing their suggestions for improvement. Ethical questions related to autonomy, trust, and the status of records that belong to doctor-patients need to be considered in future research and EHR development.


Assuntos
Atitude do Pessoal de Saúde , Registros Eletrônicos de Saúde/ética , Atenção Primária à Saúde/métodos , Adulto , Idoso , Humanos , Pessoa de Meia-Idade , Relações Médico-Paciente , Pesquisa Qualitativa
15.
Nurse Educ ; 45(5): 243-247, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31923145

RESUMO

BACKGROUND: Restrictions on students' use of electronic health information have been anecdotally reported as a threat to clinical learning, development of informatics competency, and adherence to personal health information privacy laws. However, evidence on which informatics education and policy strategies can be designed is lacking. PURPOSE: This study describes the scope of nursing students' access to and use of electronic health information systems as reported by clinical instructors. METHODS: Clinical faculty (n = 193) in prelicensure programs from 25 states completed the online survey. RESULTS: Students are often restricted in retrieving patient health information, charting assessment data and delivered care, and using medication administration systems. Students alternatively use faculty or staff nurses' system security access. CONCLUSIONS: Results suggest the need for critical review of nursing curriculum related to informatics competency and clinical site health records access policies.


Assuntos
Educação em Enfermagem , Registros Eletrônicos de Saúde , Estudantes de Enfermagem , Currículo , Educação em Enfermagem/ética , Educação em Enfermagem/legislação & jurisprudência , Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/organização & administração , Humanos
16.
J Am Med Inform Assoc ; 27(3): 429-436, 2020 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-31913479

RESUMO

OBJECTIVE: The purpose of this study was to understand the ethical, legal, and social issues described by parents of children with known or suspected genetic conditions that cause intellectual and developmental disabilities regarding research use of their child's electronic health record (EHR). MATERIALS AND METHODS: We conducted 4 focus groups with parents of children with a known (n = 12) or suspected (n = 11) genetic condition, as well as 2 comparison groups with parents who had a child with no known genetic condition (n = 15). Focus group transcripts were coded and analyzed using directed content analysis. RESULTS: After weighing the risks and benefits, parents of children with known or suspected genetic conditions were willing to share their child's EHR for research studies under certain conditions. Preferences were for studies conducted by universities or nonprofits that might benefit their child or others with the same condition. Parents also valued return of research results. DISCUSSION: Trust, transparency, altruism, and concerns about privacy emerged as factors that affect parents' willingness to allow research use of their child's EHR. CONCLUSION: Researchers should consider how to build trust with parents by increasing transparency of the research process and explaining specifically how they will ensure the confidentiality of EHR data.


Assuntos
Transtorno do Espectro Autista , Registros Eletrônicos de Saúde/ética , Ética em Pesquisa , Síndrome do Cromossomo X Frágil , Genética Médica/ética , Disseminação de Informação/ética , Pais , Altruísmo , Atitude Frente a Saúde , Temas Bioéticos , Criança , Confidencialidade , Feminino , Grupos Focais , Humanos , Masculino , Confiança
17.
BMC Med Ethics ; 21(1): 8, 2020 01 21.
Artigo em Inglês | MEDLINE | ID: mdl-31964390

RESUMO

BACKGROUND: The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. MAIN TEXT: Here, the International Clinical Trial Center Network (ICN) reports the legal and ethical requirements governing data and sample exchange (DSE) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. CONCLUSION: With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE.


Assuntos
Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/legislação & jurisprudência , Disseminação de Informação/ética , Disseminação de Informação/legislação & jurisprudência , Cooperação Internacional/legislação & jurisprudência , Bancos de Tecidos/ética , Bancos de Tecidos/legislação & jurisprudência , Saúde Global , Humanos , Internacionalidade , Propriedade/ética , Propriedade/legislação & jurisprudência
18.
Dev World Bioeth ; 20(1): 27-37, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31368637

RESUMO

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples' health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant-centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe.


Assuntos
Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/legislação & jurisprudência , Registros de Saúde Pessoal/ética , Refugiados , Migrantes , Europa (Continente) , União Europeia , Humanos , Populações Vulneráveis
19.
Mol Genet Genomic Med ; 8(1): e1026, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31701651

RESUMO

BACKGROUND: Clinical care teams providing presymptomatic genetic testing often employ advanced confidentiality practices for documentation and result storage. However, patient requests for increased confidentiality may be in conflict with the legal obligations of medical providers to document patient care activities in the electronic health record (EHR). Huntington disease presents a representative case study for investigating the ways centers currently balance the requirements of EHRs with the privacy demands of patients seeking presymptomatic genetic testing. METHODS: We surveyed 23 HD centers (53% response rate) regarding their use of the EHR for presymptomatic HD testing. RESULTS: Our survey revealed that clinical care teams and laboratories have each developed their own practices, which are cumbersome and often include EHR avoidance. We found that a majority of HD care teams record appointments in the EHR (91%), often using vague notes. Approximately half of the care teams (52%) keep presymptomatic results of out of the EHR. CONCLUSION: As genetic knowledge grows, linking more genes to late-onset conditions, institutions will benefit from having professional recommendations to guide development of policies for EHR documentation of presymptomatic genetic results. Policies must be sensitive to the ethical differences and patient demands for presymptomatic genetic testing compared to those undergoing confirmatory genetic testing.


Assuntos
Registros Eletrônicos de Saúde/normas , Privacidade Genética/normas , Testes Genéticos/normas , Doença de Huntington/diagnóstico , Serviços de Laboratório Clínico/estatística & dados numéricos , Registros Eletrônicos de Saúde/ética , Testes Genéticos/ética , Humanos , Doença de Huntington/genética , Inquéritos e Questionários , Estados Unidos
20.
Rev. bras. oftalmol ; 78(6): 375-379, nov.-dez. 2019. tab
Artigo em Inglês | LILACS | ID: biblio-1057921

RESUMO

Abstract Purpose: To investigate the patients' perspectives regarding the introduction of the electronic medical record into use in an ophthalmologic hospital and its impact on the doctor/patient relationship. Methods: The cross-sectional study analyzed the impact of the electronic medical record on the doctor-patient relationship based on the patients' opinions after electronic medical record implementation compared with use of traditional paper records. The same doctor attended all patients and completed questionnaires during patient interviews that analyzed empathy, punctuality, efficiency, information clarity, doctor cordiality, respect, trustworthiness, patient benefits from the technology, confidentiality, and humanized care. The inclusion criteria included age of 18 years or older, adequate cognition, previous treatment in the same institution by the same doctor using paper medical records and later the electronic medical record, and free and informed written patient consent. The exclusion criteria included age below 18 years, inadequate time to answer the questionnaire, first patient visit, doubtful interview responses, and first visit before 6 months after electronic medical record implementation. The data were analyzed descriptively by relative and absolute frequencies. A previous pilot study of 20 patients yielded 95% confidence intervals for the percentages of agreement for the electronic medical record questionnaire responses obtained and found that 160 patients was adequate for performing the study. Results: The patients reported that the electronic medical record had a positive impact on the doctor-patient relationship in all areas considered. Over 94% of patients responded affirmatively when questioned about their confidence in the confidentiality of their data, 38.3% noted changes in the doctor's concern for service and 68% agreed that clarity of the information provided by the doctor was greater with the electronic medical record. Conclusion: Based on the patients' perceptions, the EMR positively affected the doctor-patient relationship after the implementation of the technology in a private ophthalmologic hospital.


Resumo Objetivo: Investigar as perspectivas dos pacientes em relação à introdução do prontuário eletrônico em uso em um hospital oftalmológico e seu impacto na relação médico / paciente. Métodos: O estudo transversal analisou o impacto do prontuário eletrônico na relação médico-paciente com base na opinião dos pacientes após a implementação do prontuário eletrônico em comparação com o uso de registros tradicionais em papel. O mesmo médico atendeu a todos os pacientes e completou questionários com pacientes que analisaram empatia, pontualidade, eficiência, clareza da informação, cordialidade do médico, respeito, confiabilidade, benefícios para o paciente da tecnologia, confidencialidade e cuidado humanizado. Os critérios de inclusão incluíam idade de 18 anos ou mais, cognição adequada, tratamento prévio na mesma instituição pelo mesmo médico, usando registros médicos em papel e, posteriormente, o prontuário eletrônico e consentimento livre e esclarecido por escrito do paciente. Os critérios de exclusão incluíram, idade abaixo de 18 anos, tempo inadequado para responder ao questionário, primeira consulta do paciente, respostas duvidosas à entrevista e primeira visita antes de 6 meses após a implementação do prontuário eletrônico. Os dados foram analisados descritivamente por frequências relativas e absolutas. Um estudo piloto prévio de 20 pacientes forneceu intervalos de confiança de 95% para as porcentagens de concordância para as respostas do questionário de prontuário eletrônico obtido e constatou que 160 pacientes eram adequados para realizar o estudo. Resultados: Os pacientes relataram que o prontuário eletrônico teve impacto positivo na relação médico-paciente em todas as áreas consideradas. Mais de 94% dos pacientes responderam afirmativamente quando questionados sobre sua confiança na confidencialidade de seus dados, 38,3% observaram alterações na preocupação do médico com o serviço e 68% concordaram que a clareza das informações fornecidas pelo médico era maior com o prontuário eletrônico. Conclusão: As vantagens do prontuário eletrônico foram o rápido acesso à informação, clareza dos dados, recuperação rápida e organizada da informação e agilidade nos serviços.


Assuntos
Humanos , Relações Médico-Paciente/ética , Registros Eletrônicos de Saúde/ética , Prontuários Médicos , Estudos Transversais , Inquéritos e Questionários , Sistemas Computadorizados de Registros Médicos/ética , Comunicação , Confidencialidade , Confiança
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