Search

The integration of genetic information (GI) into the electronic health record (EHR) seems inevitable as the mainstreaming of genomics continues. Such newly provided accessibility to GI could be beneficial for improving health care, as well as for supporting clinical decision-making and health management. Notwithstanding these promising benefits, the automatic integration of GI into the EHR, allowing unrestricted access to one's GI through patient portals, carries various knowledge-related risks for patients. This article is focused on the potential case of inadvertently revealing misattributed parentage through such practice. The article aims to identify key clinical and ethical implications of such revelation for adult patients. Clinical implications include, for example, altering the physician-patient interaction and the need to enhance physician's genetic literacy to improve genetic-information-specific communication skills. Ethical implications yield arguments supporting disclosure of MP, such as autonomy, individuals' right to know medical information pertaining to them, and the right to know one's genetic origins. Arguments opposing disclosure of MP centre on the right not to know GI and concerns for post-disclosure family relationships. Following the clinical and ethical analyses of these respective implications, we consider how such integration of GI into the EHR ought to be carried out, ethically. We therefore suggest a solution, featuring an autonomy-based approach, built around EHR users' right not to know. Our solution of nuanced consent options (including a 'genetic ignorance option') is designed to enable patients' informed exposure to GI through the EHR, allowing them some control over their self- and familial narrative., (© 2024 The Author(s). Bioethics published by John Wiley & Sons Ltd.)

Currently, there are no adequate methods for dealing with changes in the healthcare system brought about by electronic health applications (eHealth) or the associated ethical implications in practice. This can be attributed to the lack of comprehensive interdisciplinary approaches that could support teams in integrating ethical considerations into the agile software development process. To close this gap, the DARE approach has been developed and tested in interdisciplinary collaborative research. The DARE method is a modular system designed to improve the development of ethically sound software in a deliberative, agile, and responsive manner.

The American Psychological Association's multicultural guidelines encourage psychologists to use language sensitive to the lived experiences of the individuals they serve. In organized care settings, psychologists have important decisions to make about the language they use in the electronic health record (EHR), which may be accessible to both the patient and other health care providers. Language about patient identities (including but not limited to race, ethnicity, gender, and sexual orientation) is especially important, but little guidance exists for psychologists on how and when to document these identities in the EHR. Moreover, organizational mandates, patient preferences, fluid identities, and shifting language may suggest different documentation approaches, posing ethical dilemmas for psychologists to navigate. In this article, we review the purposes of documentation in organized care settings, review how each of the five American Psychological Association Code of Ethics' General Principles relates to identity language in EHR documentation, and propose a set of questions for psychologists to ask themselves and their patients when making choices about documenting identity variables in the EHR. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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.

This paper explores the security, privacy, and ethical implications of e-health data in Iran's healthcare network. A framework is proposed to ensure security and privacy in electronic health information processing across various institutions. The framework addresses aspects such as software/hardware, communication networks, patient safety, privacy, confidentiality, online health service regulations, commercial and judicial exploitation, and education/research. The study categorizes these requirements into seven main categories to safeguard health-oriented service recipients' security and privacy.

In the age of increasing transparency, dermatologists may encounter requests from patients to alter or withhold key medical information from their electronic medical records. Per the Health Insurance Portability and Accountability Act, patients have the right to view their medical record and request amendments; however, the physician is the final decision maker on what information should be included in the chart. It is integral that medically necessary information is included in the chart in accordance with the principle of beneficence and nonmaleficence. Withholding medically pertinent history may cause harm to the patient. Navigating such challenging situations while maintaining transparency requires a thorough understanding of the patient's dilemma. This contribution provides a framework by applying multiple ethical principles and will empower dermatologists to navigate such requests., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2024 by the American Academy of Pediatrics.)

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., (© 2024. The Author(s).)

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.

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., (© 2020 Milbank Memorial Fund.)

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.

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.

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., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart.)

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., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart.)

Competing Interests: Competing interests: None declared.

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.

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., (© 2019 John Wiley & Sons Ltd.)

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.

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., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

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.

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., Competing Interests: Conflict of interest: none declared., (© Copyright 2020 by the American Board of Family Medicine.)

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., (© 2019 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals, Inc.)

Background: While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials remains largely paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies, the current approach at times may raise challenges with respect to quality, compliance, participant understanding, and trial retention. Electronic informed consent (eConsent) is an enabling clinical technology to potentially address these issues by using multimedia components to create an interactive participant experience and improve data quality., Methods: The TransCelerate eConsent Initiative conducted a multifaceted engagement approach to better understand the perceptions, experiences, and concerns of impacted stakeholders, including participants, sites, ethics committees, and health authorities., Results: While all stakeholders were supportive of the use of multimedia components to deliver study information, several stakeholder-specific concerns were noted. Participant feedback, as collected through surveys (n = 3045) and an advisory board (n = 10), suggests that some participants may have data privacy concerns and a diversity of preferences for multimedia presentation. Site interviews (n = 9) suggest concerns related to additional operational activities and potential for technology failure. Health authorities' feedback, through nonbinding meetings, was geographically varied; ethics committee feedback, through interviews, suggests concern over impact on operational process changes., Conclusions: While the appetite for eConsent is increasing, involved stakeholders and industry must continue to raise awareness, communicate, and collaborate to develop appropriate technological capabilities, regulatory pathways, and operational processes to clear the path for mainstream use of eConsent.

Background: Patient and professional views about the impact of providing full real-time access to the medical record in the in-hospital setting are unknown., Methods: Likert-scale and free-text validated questionnaire survey of physicians and patients from acute medical units in two hospitals. The questionnaire explored recent experiences; views on the formation of trust, and views on sharing either the entire medical record or a summary., Results: Two-hundred and forty-eight patient questionnaires (62% response rate) and 32 physician questionnaires (21% response rate) were returned. Twenty-seven per cent of patients did not recall being told their diagnosis. Doctors and patients differed on what practices that they believed built trust.Eighty-one per cent of patients supported the idea of having access to the full medical record (for empowerment; the right to information about oneself; as an aide-memoire for discussion). Doctors feared it might provoke anxiety and change the nature of what was written. A written lay summary record was preferred by doctors and patients., Conclusions: The current system of providing information verbally to patients is inadequate. Patients want more information and are less concerned than physicians about potential negative effects of real-time access to their records. Patient access to medical records (in both full and summary forms) should be evaluated., (© 2019 Royal College of Physicians.)

Importance: Patients increasingly demand transparency in and control of how their medical records and biospecimens are shared for research. How much they are willing to share and what factors influence their sharing preferences remain understudied in real settings., Objectives: To examine whether and how various presentations of consent forms are associated with differences in electronic health record and biospecimen sharing rates and whether these rates vary according to user interface design, data recipients, data and biospecimen items, and patient characteristics., Design, Setting, and Participants: For this survey study, a data and biospecimen sharing preference survey was conducted at 2 academic hospitals from May 1, 2017, to September 31, 2018, after simple randomization of patients to 1 of 4 options with different layout and formats of indicating sharing preferences: opt-in simple, opt-in detailed, opt-out simple, and opt-out detailed., Interventions: All participants were presented with a list of data and biospecimen items that could be shared for research within the same health care organization or with other nonprofit or for-profit institutions. Participating patients were randomly asked to select the items that they would share (opt-in) or were asked to select items they would not share (opt-out). Patients in these 2 groups were further randomized to select only among 18 categories vs 59 detailed items (simple vs detailed form layout)., Main Outcomes and Measures: The primary end points were the percentages of patients willing to share data and biospecimen categories or items., Results: Among 1800 eligible participants, 1246 (69.2%) who completed their data sharing survey were included in the analysis, and 850 of these patients (mean [SD] age, 51.1 [16.7] years; 507 [59.6%] female; 677 [79.6%] white) responded to the satisfaction survey. A total of 46 participants (3.7%) declined sharing with the home institution, 352 (28.3%) with nonprofit institutions, and 590 (47.4%) with for-profit institutions. A total of 836 (67.1%) indicated that they would share all items with researchers from the home institution. When comparing opt-out with opt-in interfaces, all 59 sharing choice variables (100%) were associated with the sharing decision. When comparing simple with detailed forms, only 14 variables (23.7%) were associated with the sharing decision., Conclusions and Relevance: The findings suggest that most patients are willing to share their data and biospecimens for research. Allowing patients to decide with whom they want to share certain types of data may affect research that involves secondary use of electronic health records and/or biosamples for research.

Some clinicians feel that Ethics Committees act as a blockade to observational clinical studies. In the case of retrospective studies some have tried to solve this problem by reducing this sensitive data to simple administrative data in the hands of the government. Others see the new European General Data Protection Regulation 2016/679 (European Union) as being more liberal than the Portuguese Law nº 21/2014, April 16th (Clinical Research Law). Both solutions presume participant consent from his / her silence, even if nobody truly tried to specifically inform him / her. Such views do collide with the guarantees of protection of patient's ethical rights. In this article we propose an ethical alternative to those positions.

The last few months of 2018 saw a major battle over privacy, autonomy and use of health information in Australia as the basis for the national electronic health record changed from an opt-in system to one where every person had such a record unless they specifically requested to opt-out of the system. The debate was messy, involving both ethical and wider political concerns, with the ethical concerns partly heightened because of the political context. Canadian health leaders can learn from the mistakes and successes of this situation.

Contrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive., (© 2019 by The Hastings Center. All rights reserved.)

Purpose: To determine whether patients distinguish between biospecimens and electronic health records (EHRs) when considering research participation to inform research protections., Methods: We conducted 20 focus groups with individuals who identified as African American, Hispanic, Chinese, South Asian, and non-Hispanic white on the collection of biospecimens and EHR data for research., Results: Our study found that many participants did not distinguish between biospecimens and EHR data. However, some participants identified specific concerns about biospecimens. These included the need for special care and respect for biospecimens due to enduring connections between the body and identity; the potential for unacceptable future research, specifically the prospect of human cloning; heightened privacy risks; and the potential for unjust corporate profiteering. Among those who distinguished biospecimens from EHR data, many supported separate consent processes and would limit their own participation to EHR data., Conclusion: Considering that the potential misuse of EHR data is as great as, if not greater than, for biospecimens, more research is needed to understand how attitudes differ between biospecimens and EHR data across diverse populations. Such research should explore mechanisms beyond consent that can address diverse values, perspectives, and misconceptions about sources of patient information to build trust in research relationships.

Research examining whether and how adolescent patients should gain access to their electronic health records is gaining momentum. We conducted a survey to explore diversity in adolescent privacy policies and identify common approaches in health information technology management for adolescent patients. Through descriptive analyses of survey data, we found a wide range of institutional policies regarding adolescent patient privacy, and large variations in health IT executives' baseline knowledge of access policies. A majority of respondents agreed that formal guidelines pertaining to adolescent health record privacy would be helpful. Respondents suggested that these guidelines can be developed through the synthesis of multiple perspectives, including those of pediatricians, adolescent specialists, privacy experts, parents, patient advocates, and other professional entities.

General practitioners are increasingly approached to participate in research and share de-identified patient information. Research using electronic health records has considerable potential for improving the quality and safety of patient care. Obtaining individual patient consent for the use of the information is usually not feasible. In this article we explore the ethical issues in using personal health information in research without patient consent including the threat to confidentially and the doctor-patient relationship, and we discuss how the risks can be minimised and managed drawing on our experience as general practitioners and researchers.

This study reports on 13 semistructured in-depth interviews to qualitatively explore the experiences of individuals who publicly shared their direct-to-consumer genetic testing results on the platform openSNP. In particular, we focused on interviewees' understanding of privacy. Participants reported that the likelihood and the magnitude of privacy harms depend on gender, ethnicity, sexual orientation, the stigma associated with certain clinical conditions, the existence of adequate legislation, and the nature of national health care systems. Some participants expressed the view that those who enjoy higher socioeconomic status or are better protected by their country's legislation have a responsibility to share their genetic data. Our study shows that people who share their genetic data publicly online-far from being insensitive to privacy risks-have a complex understanding of the social, relational, and contextual nature of genetic privacy.

A learning health system provides opportunities to leverage data generated in the course of standard clinical care to improve clinical practice. One such opportunity includes a clinical decision support structure that would allow clinicians to query electronic health records (EHRs) such that responses from the EHRs could inform treatment recommendations. We argue that though using a clinical decision support system does not necessarily constitute a research activity subject to the Common Rule, it requires more ethical and regulatory oversight than activities of clinical practice are generally subjected to. In particular, we argue that the development and use of clinical decision support systems should be governed by a framework that (1) articulates appropriate conditions for their use, (2) includes processes for monitoring data quality and developing and validating algorithms, and (3) sufficiently protects patients' data., (© 2018 American Medical Association. All Rights Reserved.)

Objective: The use of electronic health records (EHRs) for research has the potential to improve the diagnosis and treatment of disease, yet contact with patients based on results of EHR phenotyping has received little attention. Researchers will almost certainly discover discrepancies in EHRs that call for resolution and, in some cases, raise the ethical dilemma of whether to contact patients about a potentially undiagnosed or untreated health concern. The objective of this study was to explore patients' attitudes and opinions about potential contact by researchers who have had access to their EHRs., Materials and Methods: We conducted 15 focus groups in four diverse counties in the southeastern United States. We designed vignettes to describe different situations in which researchers conducting a hypothetical study might have reason to consider contact with patients., Results: Many patients believed it was important for researchers to take action if they discovered information suggesting a current serious health concern. Relaying the information through patients' physicians was considered the most appropriate course of action. Across vignettes, there were significant differences between urban and rural sites., Discussion and Conclusions: Researchers may increasingly encounter situations involving contact with patients following EHR phenotyping. They should carefully consider the possibility of such contact when planning their studies, including the time and expertise needed to adjudicate potentially serious discrepancies. Our focus group results are one source of input for the development of ethical approaches to the research use of EHRs.

Background: The factors influencing parents' willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents' willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness., Methods: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of three consent and data-sharing scenarios., Results: In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5737 respondents were parents of minor children. Overall, 55% (95% confidence interval 50-59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate but not willing to allow one's child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public health care insurance, and higher religiosity., Conclusions: Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks.

There is great power and promise for mobile health (mHealth) technology in the realms of clinical practice and research. By offering the opportunity to reshape the interaction between clinician and patient or researcher and subject, the introduction of this technology allows clinicians and researchers access to larger quantities of more timely and reliable data. The potential developments are significant, and they are ethically relevant. With all technological developments, however, come new sets of ethical risks. In this paper, I assess the ethics of mHealth. I argue that while we have an ethical obligation to advance this work in order to further the quality and scope of care, the use of mHealth technology also presents challenges that must be addressed before and during the use of this technology. After describing the ethical landscape, I offer a pragmatic approach to meeting some of these challenges and minimizing ethical risk by switching from a privacy-centered frame to a consent-centered frame., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

This paper poses the question of whether people have a duty to participate in digital epidemiology. While an implied duty to participate has been argued for in relation to biomedical research in general, digital epidemiology involves processing of non-medical, granular and proprietary data types that pose different risks to participants. We first describe traditional justifications for epidemiology that imply a duty to participate for the general public, which take account of the immediacy and plausibility of threats, and the identifiability of data. We then consider how these justifications translate to digital epidemiology, understood as an evolution of traditional epidemiology that includes personal and proprietary digital data alongside formal medical datasets. We consider the risks imposed by re-purposing such data for digital epidemiology and propose eight justificatory conditions that should be met in justifying a duty to participate for specific digital epidemiological studies. The conditions are then applied to three hypothetical cases involving usage of social media data for epidemiological purposes. We conclude with a list of questions to be considered in public negotiations of digital epidemiology, including the application of a duty to participate to third-party data controllers, and the important distinction between moral and legal obligations to participate in research.

School districts are commonly adopting electronic storage systems, including electronic health records. Included in this adoption is a move toward cloud-based record storage systems to handle the increasing volumes of data. Deciding which system to adopt is especially difficult in times of tightening school district budgets. While there are several options to consider, including the outright purchase of a proprietary system or choosing one of a relatively new group of free programs, lead nurses must work to ensure that student information is protected and that any chosen system complies with privacy laws. This article provides a case study and presents legal and ethical considerations related to maintaining the privacy of health records in the school setting.