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Much anticipation surrounds artificial intelligence's (AI) emergence as a promising tool in health care. It offers potential to revolutionise clinical practice through assistive and autonomous operation. The high prevalence of cardiac disease globally provides an opportunity for AI technology to increase health care efficiency and improve patient outcomes. This article explores the ethical considerations necessary for safe and acceptable implantation of AI within the health care space. We aim to highlight several challenges such as data privacy, consent, sustainability, and cybersecurity. In addition, we outline the future opportunities for AI use in cardiovascular medicine. Overall, we argue that AI deployment demands robust regulation, transparent algorithms, and safeguarding of patient privacy., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Drawing on the authors' own ethnographic research, this article discusses the importance of developing polymedia literacy as a key step toward ethical online research on social networking sites (SNS). Polymedia literacy entails the ability to critically analyze the vast landscape of SNS, their affordances, and users' social motivations for choosing specific SNS for their interactions. Internet researchers face several ethical challenges, including issues of informed consent, "public" and "private" online spaces, and data protection. Even when research ethics committees waive the need for a formal ethics approval process, researchers of online spaces need to ensure that their studies are conducted and presented in an ethical and responsible manner. This is particularly important in research contexts that pertain to vulnerable populations in online communities., (© 2024 The Authors. Ethics & Human Research, published by Wiley Periodicals LLC on behalf of The Hastings Center.)

The accelerated adoption of digital health technologies in the last decades has raised important ethical and safety concerns. Despite the potency and usefulness of digital health technologies, addressing safety, and ethical considerations needs to take greater prominence. This review paper focuses on ethical and safety facets, including health technology-related risks, users' safety and well-being risks, security and privacy concerns, and risks to transparency and diminished accountability associated with the utilization of digital health technologies. In order to maximize the potential of health technology benefits, awareness of safety risks, and ethical concerns should be increased, and the use of appropriate strategies and measures should be considered., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Advances in biomedical data science and artificial intelligence (AI) are profoundly changing the landscape of healthcare. This article reviews the ethical issues that arise with the development of AI technologies, including threats to privacy, data security, consent, and justice, as they relate to donors of tissue and data. It also considers broader societal obligations, including the importance of assessing the unintended consequences of AI research in biomedicine. In addition, this article highlights the challenge of rapid AI development against the backdrop of disparate regulatory frameworks, calling for a global approach to address concerns around data misuse, unintended surveillance, and the equitable distribution of AI's benefits and burdens. Finally, a number of potential solutions to these ethical quandaries are offered. Namely, the merits of advocating for a collaborative, informed, and flexible regulatory approach that balances innovation with individual rights and public welfare, fostering a trustworthy AI-driven healthcare ecosystem, are discussed.

The rapidly advancing field of brain-computer (BCI) and brain-to-brain interfaces (BBI) is stimulating interest across various sectors including medicine, entertainment, research, and military. The developers of large-scale brain-computer networks, sometimes dubbed 'Mindplexes' or 'Cloudminds', aim to enhance cognitive functions by distributing them across expansive networks. A key technical challenge is the efficient transmission and storage of information. One proposed solution is employing blockchain technology over Web 3.0 to create decentralised cognitive entities. This paper explores the potential of a decentralised web for coordinating large brain-computer constellations, and its associated benefits, focusing in particular on the conceptual and ethical challenges this innovation may pose pertaining to (1) Identity, (2) Sovereignty (encompassing Autonomy, Authenticity, and Ownership), (3) Responsibility and Accountability, and (4) Privacy, Safety, and Security. We suggest that while a decentralised web can address some concerns and mitigate certain risks, underlying ethical issues persist. Fundamental questions about entity definition within these networks, the distinctions between individuals and collectives, and responsibility distribution within and between networks, demand further exploration., (© 2024. The Author(s).)

Background: Artificial intelligence (AI) is considered the fourth industrial revolution that will change the evolution of humanity technically and relationally. Although the term has been around since 1956, it has only recently become apparent that AI can revolutionize technologies and has many applications in the medical field., Areas of Uncertainty: The ethical dilemmas posed by the use of AI in medicine revolve around issues related to informed consent, respect for confidentiality, protection of personal data, and last but not least the accuracy of the information it uses., Data Sources: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2022) using combinations of keywords, including: AI, future in medicine, and machine learning plus ethical dilemma., Ethics and Therapeutic Advances: The ethical analysis of the issues raised by AI used in medicine must mainly address nonmaleficence and beneficence, both in correlation with patient safety risks, ability versus inability to detect correct information from inadequate or even incorrect information. The development of AI tools that can support medical practice can increase people's access to medical information, to obtain a second opinion, for example, but it is also a source of concern among health care professionals and especially bioethicists about how confidentiality is maintained and how to maintain cybersecurity. Another major risk may be related to the dehumanization of the medical act, given that, at least for now, empathy and compassion are accessible only to human beings., Conclusions: AI has not yet managed to overcome certain limits, lacking moral subjectivity, empathy, the level of critical thinking is still insufficient, but no matter who will practice preventive or curative medicine in the next period, they will not be able to ignore AI, which under human control can be an important tool in medical practice., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

The introduction of artificial intelligence (AI) into radiology promises to enhance efficiency and improve diagnostic accuracy, yet it also raises manifold ethical questions. These include data protection issues, the future role of radiologists, liability when using AI systems, and the avoidance of bias. To prevent data bias, the datasets need to be compiled carefully and to be representative of the target population. Accordingly, the upcoming European Union AI act sets particularly high requirements for the datasets used in training medical AI systems. Cognitive bias occurs when radiologists place too much trust in the results provided by AI systems (overreliance). So far, diagnostic AI systems are used almost exclusively as "second look" systems. If diagnostic AI systems are to be used in the future as "first look" systems or even as autonomous AI systems in order to enhance efficiency in radiology, the question of liability needs to be addressed, comparable to liability for autonomous driving. Such use of AI would also significantly change the role of radiologists., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

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.

The field of dermatology is experiencing the rapid deployment of artificial intelligence (AI), from mobile applications (apps) for skin cancer detection to large language models like ChatGPT that can answer generalist or specialist questions about skin diagnoses. With these new applications, ethical concerns have emerged. In this scoping review, we aimed to identify the applications of AI to the field of dermatology and to understand their ethical implications. We used a multifaceted search approach, searching PubMed, MEDLINE, Cochrane Library and Google Scholar for primary literature, following the PRISMA Extension for Scoping Reviews guidance. Our advanced query included terms related to dermatology, AI and ethical considerations. Our search yielded 202 papers. After initial screening, 68 studies were included. Thirty-two were related to clinical image analysis and raised ethical concerns for misdiagnosis, data security, privacy violations and replacement of dermatologist jobs. Seventeen discussed limited skin of colour representation in datasets leading to potential misdiagnosis in the general population. Nine articles about teledermatology raised ethical concerns, including the exacerbation of health disparities, lack of standardized regulations, informed consent for AI use and privacy challenges. Seven addressed inaccuracies in the responses of large language models. Seven examined attitudes toward and trust in AI, with most patients requesting supplemental assessment by a physician to ensure reliability and accountability. Benefits of AI integration into clinical practice include increased patient access, improved clinical decision-making, efficiency and many others. However, safeguards must be put in place to ensure the ethical application of AI., Competing Interests: Conflicts of interest The authors declare no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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).)

Telemedicine, defined as the practice of delivering healthcare services remotely using information and communications technologies, raises a plethora of ethical considerations. As telemedicine evolves, its ethical dimensions play an increasingly pivotal role in balancing the benefits of advanced technologies, ensuring responsible healthcare practices within telemedicine environments, and safeguarding patient rights. Healthcare providers, patients, policymakers, and technology developers involved in telemedicine encounter numerous ethical challenges that need to be addressed. Key ethical topics include prioritizing the protection of patient rights and privacy, which entails ensuring equitable access to remote healthcare services and maintaining the doctor-patient relationship in virtual settings. Additional areas of focus encompass data security concerns and the quality of healthcare delivery, underscoring the importance of upholding ethical standards in the digital realm. A critical examination of these ethical dimensions highlights the necessity of establishing binding ethical guidelines and legal regulations. These measures could assist stakeholders in formulating effective strategies and methodologies to navigate the complex telemedicine landscape, ensuring adherence to the highest ethical standards and promoting patient welfare. A balanced approach to telemedicine ethics should integrate the benefits of telemedicine with proactive measures to address emerging ethical challenges and should be grounded in a well-prepared and respected ethical framework.

Phishing is a fraudulent form of email that solicits personal or financial information from the recipient, such as a password, username, or social security or bank account number. The scammer may use the illicitly obtained information to steal the victim’s money or identity or sell the information to another party. The direct costs of phishing on consumers are exceptionally high and have risen substantially over the past 12 years. Phishing experiments that simulate real world conditions can provide cybersecurity experts with valuable knowledge they can use to develop effective countermeasures and prevent people from being duped by phishing emails. Although these experiments contravene widely accepted informed consent requirements and involve deception, we argue that they can be conducted ethically if risks are minimized, confidentiality and privacy are protected, potential participants have an opportunity to opt out of the research before it begins, and human subjects are debriefed after their participation ends. [ABSTRACT FROM AUTHOR]

This paper explores the potential of data mining as a technique that could be used by malicious data miners to threaten the privacy of social network sites (SNS) users. It applies a data mining algorithm to a real dataset to provide empirically-based evidence of the ease with which characteristics about the SNS users can be discovered and used in a way that could invade their privacy. One major contribution of this article is the use of the decision forest data mining algorithm (SysFor) to the context of SNS, which does not only build a decision tree but rather a forest allowing the exploration of more logic rules from a dataset. One logic rule that SysFor built in this study, for example, revealed that anyone having a profile picture showing just the face or a picture showing a family is less likely to be lonely. Another contribution of this article is the discussion of the implications of the data mining problem for governments, businesses, developers and the SNS users themselves. [ABSTRACT FROM AUTHOR]

In this commentary, we focus on the ethical challenges of data sharing and its potential in supporting biomedical research. Taking human genomics (HG) and European governance for sharing genomic data as a case study, we consider how to balance competing rights and interests-balancing protection of the privacy of data subjects and data security, with scientific progress and the need to promote public health. This is of particular relevancy in light of the current pandemic, which stresses the urgent need for international collaborations to promote health for all. We draw from existing ethical codes for data sharing in HG to offer recommendations as to how to protect rights while fostering scientific research and open science.

Competing Interests: I declare no competing interests.

Competing Interests: Competing interests: None declared.

Objective: This survey article presents a literature review of relevant publications aiming to explore whether the EU's General Data Protection Regulation (GDPR) has held true during a time of crisis and the implications that arose during the COVID-19 outbreak., Method and Results: Based on the approach taken and the screening of the relevant articles, the results focus on three themes: a critique on GDPR; the ethics surrounding the use of digital health technologies, namely in the form of mobile applications; and the possibility of cross border transfers of said data outside of Europe. Within this context, the article reviews the arising themes, considers the use of data through mobile health applications, and discusses whether data protection may require a revision when balancing societal and personal interests., Conclusions: In summary, although it is clear that the GDPR has been applied through a mixed and complex experience with data handling during the pandemic, the COVID-19 pandemic has indeed shown that it was a test the GDPR was designed and prepared to undertake. The article suggests that further review and research is needed to first ensure that an understanding of the state of the art in data protection during the pandemic is maintained and second to subsequently explore and carefully create a specific framework for the ethical considerations involved. The paper echoes the literature reviewed and calls for the creation of a unified and harmonised network or database to enable the secure data sharing across borders., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (IMIA and Thieme. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: Various techniques are used to support contact tracing, which has been shown to be highly effective against the COVID-19 pandemic. To apply the technology, either quarantine authorities should provide the location history of patients with COVID-19, or all users should provide their own location history. This inevitably exposes either the patient's location history or the personal location history of other users. Thus, a privacy issue arises where the public good (via information release) comes in conflict with privacy exposure risks., Objective: The objective of this study is to develop an effective contact tracing system that does not expose the location information of the patient with COVID-19 to other users of the system, or the location information of the users to the quarantine authorities., Methods: We propose a new protocol called PRivacy Oriented Technique for Epidemic Contact Tracing (PROTECT) that securely shares location information of patients with users by using the Brakerski/Fan-Vercauteren homomorphic encryption scheme, along with a new, secure proximity computation method., Results: We developed a mobile app for the end-user and a web service for the quarantine authorities by applying the proposed method, and we verified their effectiveness. The proposed app and web service compute the existence of intersections between the encrypted location history of patients with COVID-19 released by the quarantine authorities and that of the user saved on the user's local device. We also found that this contact tracing smartphone app can identify whether the user has been in contact with such patients within a reasonable time., Conclusions: This newly developed method for contact tracing shares location information by using homomorphic encryption, without exposing the location information of patients with COVID-19 and other users. Homomorphic encryption is challenging to apply to practical issues despite its high security value. In this study, however, we have designed a system using the Brakerski/Fan-Vercauteren scheme that is applicable to a reasonable size and developed it to an operable format. The developed app and web service can help contact tracing for not only the COVID-19 pandemic but also other epidemics., (©Yongdae An, Seungmyung Lee, Seungwoo Jung, Howard Park, Yongsoo Song, Taehoon Ko. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 12.07.2021.)

The article reports on the differences between ethics and morality and questions that affect the hacker's white-hat motivations. Information Technology professional not associating themselves with professional associations is a major shortfall. Topics discusses include the benefits and limitations of ethical hacking and moral justification for the act. [ABSTRACT FROM PUBLISHER]

Multisite medical data sharing is critical in modern clinical practice and medical research. The challenge is to conduct data sharing that preserves individual privacy and data utility. The shortcomings of traditional privacy-enhancing technologies mean that institutions rely upon bespoke data sharing contracts. The lengthy process and administration induced by these contracts increases the inefficiency of data sharing and may disincentivize important clinical treatment and medical research. This paper provides a synthesis between 2 novel advanced privacy-enhancing technologies-homomorphic encryption and secure multiparty computation (defined together as multiparty homomorphic encryption). These privacy-enhancing technologies provide a mathematical guarantee of privacy, with multiparty homomorphic encryption providing a performance advantage over separately using homomorphic encryption or secure multiparty computation. We argue multiparty homomorphic encryption fulfills legal requirements for medical data sharing under the European Union's General Data Protection Regulation which has set a global benchmark for data protection. Specifically, the data processed and shared using multiparty homomorphic encryption can be considered anonymized data. We explain how multiparty homomorphic encryption can reduce the reliance upon customized contractual measures between institutions. The proposed approach can accelerate the pace of medical research while offering additional incentives for health care and research institutes to employ common data interoperability standards., (©James Scheibner, Jean Louis Raisaro, Juan Ramón Troncoso-Pastoriza, Marcello Ienca, Jacques Fellay, Effy Vayena, Jean-Pierre Hubaux. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 25.02.2021.)

Teledermatology is now fully incorporated into our clinical practice. However, after reviewing current legislation on the ethical aspects of teledermatology (data confidentiality, quality of care, patient autonomy, and privacy) as well as insurance and professional responsibility, we observed that a specific regulatory framework is still lacking and related legal aspects are still at a preliminary stage of development. Safeguarding confidentiality and patient autonomy and ensuring secure storage and transfer of data are essential aspects of telemedicine. One of the main topics of debate has been the responsibilities of the physicians involved in the process, with the concept of designating a single responsible clinician emerging as a determining factor in the allocation of responsibility in this setting. A specific legal and regulatory framework must be put in place to ensure the safe practice of teledermatology for medical professionals and their patients., (Copyright © 2020 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

In September 2015, "the Act on the Protection of Personal Information" was amended. Accordingly, "the Ethical Guidelines for Medical Research Involving Human Subjects" were also amended. "The Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field," which came into effect in May 2018, aims to collect and utilize medical information of each patient from medical institutions for the purpose of research and development in the medical field. Thus, the rules of personal information that need to be followed are changing considerably in the balance between importance of protection and utilization for medical development. Therefore, health care professionals and researchers are required to fully understand the current situation and the future.

Confidentiality is based on principles of deontology and ethics, which are included in French regulations and supported by the professional orders. It contributes to the respect and dignity of the patient. If this consideration of the human person is old, it has been updated to build the framework imposed by the accreditation of medical biology laboratories. Confidentiality is thus reflected in a charter of ethics, a model of which we propose here. It reflects the commitments of healthcare professionals in the processing of biological samples from patients. Confidentiality is thus applied, in a practical way, at each phase of the laboratory's activity. In the pre-analytical phase, it organizes the reception of the patient and the taking of samples, taking into account the particular case of minors. In the analytical phase, confidentiality imposes limited access to the technical premises and the organization of the flow of personnel from outside the laboratory. Finally, in the post-analytical phase, the reporting of results is regulated, depending on the type of analyses performed and the person to whom the results are to be reported (patient or prescriber). The particular case of spermiology illustrates all these points. Finally, during these phases of sample processing, document management is also a matter of confidentiality and data protection. Confidentiality is essential to the functioning of a health care structure, but it is restrictive in its day-to-day implementation. Nevertheless, it must be combined with an awareness of all staff to address the ethical issue of human dignity.

Linked survey and Twitter data present an unprecedented opportunity for social scientific analysis, but the ethical implications for such work are complex-requiring a deeper understanding of the nature and composition of Twitter data to fully appreciate the risks of disclosure and harm to participants. In this article, we draw on our experience of three recent linked data studies, briefly discussing the background research on data linkage and the complications around ensuring informed consent. Particular attention is paid to the vast array of data available from Twitter and in what manner it might be disclosive. In light of this, the issues of maintaining security, minimizing risk, archiving, and reuse are applied to linked Twitter and survey data. In conclusion, we reflect on how our ability to collect and work with Twitter data has outpaced our technical understandings of how the data are constituted and observe that understanding one's data is an essential prerequisite for ensuring best ethical practice.

With the advent of modern technology, the way society handles and performs monetary transactions has changed tremendously. The world is moving swiftly towards the digital arena. The use of Automated Teller Machine (ATM) cards (credit and debit) has led to a "cash-less society" and has fostered digital payments and purchases. In addition to this, the trust and reliance of the society upon these small pieces of plastic, having numbers engraved upon them, has increased immensely over the last two decades. In the past few years, the number of ATM fraud cases has increased exponentially. With the money of the people shifting towards the digital platform, ATM skimming has become a problem that has eventually led to a global outcry. The present review discusses the serious repercussions of ATM card cloning and the associated privacy, ethical and legal concerns. The preventive measures which need to be taken and adopted by the government authorities to mitigate the problem have also been discussed.

Objectives: The aim of the study was to identify reasons for protocol deviations during conduct of large epidemiological surveys despite training of field workers, validating clinicians, and providing field supervisory support. Enquiries focused on breaches of recruitment procedures, privacy, confidentiality, and informed consent. The case study was a household survey conducted in Ile-Ife, Nigeria., Results: The study reveals that despite training of field workers, providing supervisory support, and conducting validation exercises, protocol deviation still occurred. Measures to improve internal research validity during the conduct of surveys can minimise but not eliminate protocol deviations. Individual and environmental factors increase the risk for protocol deviation. Individual factors include personal bias against adherence to elements of the protocols, and pressure to meet personal recruitment targets to maximise remuneration. These pressures increase the risk of breaching study participants' recruitment process. Environmental pressures resulted from low research literacy that made it possible for field workers not to consent participants and for participants not to prioritise privacy. The use of electronic data collection enhanced data security. A key recommendation from the study was that improved field supervision will reduce the risk for protocol violation.

Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulatory and legislative framework, including the general data protection regulation (GDPR). A roundtable was organized in Giens, France in October 2018 to identify problem areas, the need for clarification and streamlining, and to make recommendations to promote clinical research while ensuring a high level of patient protection. After details were given about these developments, the roundtable participants were able to propose recommendations, primarily (1) to clarify: what is considered anonymized data, and what is "public interest" within the meaning of the GDPR; (2) for the French data protection authority (CNIL) to continue preparing reference methodologies to simplify the approval system; (3) to promote the secondary use of data by making it easier to inform patients and obtain broad patient consent, by specifying the circumstances under which their withdrawal and opposition rights apply, so as to limit the risk of bias; (4) to facilitate access to data warehouses by providing technological and methodological aids. The roundtable also recommends increasing discussions between authorities in Europe on research topics, encouraging French authorities to contribute to the preparation of codes of conduct and setting up a voluntary harmonization procedure to coordinate the opinions of data protection authorities, while ensuring that key documents are available in English., (Copyright © 2019 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Background: On the May 25, 2018 the General Data Protection Regulation (hereafter the GDPR or the Regulation) came into force, replacing the Data Protection Directive 95/46/EC (upon which the Data Protection Act 1998 is based), and imposing new responsibilities on organizations which process the data of European Union citizens., Sources of Data: This piece examines the impact of the Regulation on health research., Areas of Agreement: The Regulation seeks to harmonize data privacy laws across Europe, to protect and empower all EU citizen's data privacy and to reshape the way that organizations approach data privacy (See the GDPR portal at: https://www.eugdpr.org/ (accessed 8 May 2018). As a Regulation the GDPR is directly applicable in all member states as opposed to a directive which requires national implementing measures (In the UK the Data Protection Act 1998 was the implementing legislation for the Data Protection Directive 95/46/EC.)., Areas of Controversy: The Regulation is sector wide, but its impact on organizations us sector specific. In some sectors, the Regulation inhibits the processing of personal data, whilst in others it enables that processing. The Regulation takes the position that the 'processing of data should be designed to serve mankind' (Recital 4). Whilst it does not spell out what exactly is meant by this, it indicates that a proportionate approach will be taken to the protection of personal data, where that data can be processed for common goods such as healthcare. Thus, the protection of personal data is not absolute, but considered in relation to its function in society and balance with other fundamental rights in accordance with the principle of proportionality (Recital 4). Differing interpretations of proportionality can detract from the harmonization objective of the Regulation., Growing Points: Reflecting the commitment to proportionality, scientific research holds a privileged position in the Regulation. Throughout the Regulation provision is made for organizations that process personal data for scientific research purposes to avoid restrictive measures which might impede the increase of knowledge. However, the application of the Regulation differs across health research sectors and across jurisdictions. Transparency and engagement across the health research sector is required to promote alignment., Areas Timely for Developing Research: Research which focuses on the particular problems which arise in the context of the regulation's application to health research would be welcome. Particularly in the context of the operation of the Regulation alongside the duty of confidentiality and the variation in approaches across Member States.

Background: Genetic information is unique among all laboratory data because it not only informs the current health of the specific person tested but may also be predictive of the future health of the individual and, to varying degrees, all biological relatives., Content: As DNA sequencing has become ubiquitous with decreasing cost, large repositories of genomic data have emerged from the domains of research, healthcare, law enforcement, international security, and recreational consumer interest (i.e., genealogy). Broadly shared genomic data are believed to be a key element for future discoveries in human disease. For example, the National Cancer Institute's Genomic Data Commons is designed to promote cancer research discoveries by providing free access to the genome data sets of 12000 cancer patients. However, in parallel with the promise of curing diseases, genomic data also have the potential for harm. Genomic data that are deidentified by standard healthcare practices (e.g., removal of name, date of birth) can be reidentified by methods that combine genomic software with publicly available demographic databases (e.g., phone book). Recent law enforcement cases (i.e., Bear Brook Murders, Golden State Killer) in the US have demonstrated the power of combining DNA profiles with genealogy databases., Summary: We examine the current environment of genomic privacy and confidentiality in the US and describe current and future risks to genomic privacy. Reidentification and inference of genetic information of biological relatives will become more important as larger databases of clinical, criminal, and recreational genomic information are developed over the next decade., (© 2018 American Association for Clinical Chemistry.)

Effy Vayena and colleagues argue that machine learning in medicine must offer data protection, algorithmic transparency, and accountability to earn the trust of patients and clinicians., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: EV has received speaking fees from SwissRe, Novartis R&D Academy, and Google Netherlands. IGC served as a consultant for Otsuka Pharmaceuticals advising on the use of digital medicine for its Abilify MyCite product. IGC is supported by the Collaborative Research Program for Biomedical Innovation Law, which is a scientifically independent collaborative research program supported by Novo Nordisk Foundation. AB served as a consultant for Celgene Corporation for the preparation of a workshop on pharmaceutical innovation and received honoraria from SwissRe for participating at an internal event on genome editing.

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.

There are clear benefits from genomics and health data sharing in research and in therapy for individuals across societies. At the same time, citizens have different expectations and fears about that data sharing. International legislation in relation with research ethics and practice and, particularly, data protection create a particular environment that, as is seen in the articles in part two of this special issue, are crying out for harmonisation both at a procedural but at fundamental conceptual levels. The law of data sharing is pulling in different directions. This paper poses the question, 'harmonisation, an impossible dream?' and the answer is a qualified 'no'. The paper reflects on what can be seen in the papers in part two of the special issue. It then identifies three major areas of conceptual uncertainty in the new EU General Data Protection Regulation (not because it has superiority over other jurisdictions, but because it is a recent revision of data protection law that leaves universal conceptual questions unclear). Thereafter, the potential for Artificial Intelligence to meet some of the shortcomings is discussed. The paper ends with a consideration of the conditions under which data sharing harmonisation might be achieved: an understanding of a human rights approach and citizen sensitivities in considering the 'public interest'; social liberalism as a basis of solidarity; and the profession of 'researcher'.

Objective: We describe current practices of ethics-related data governance in large neuro-ICT projects, identify gaps in current practice, and put forward recommendations on how to collaborate ethically in complex regulatory and normative contexts., Methods: We undertake a survey of published principles of data governance of large neuro-ICT projects. This grounds an approach to a normative analysis of current data governance approaches., Results: Several ethical issues are well covered in the data governance policies of neuro-ICT projects, notably data protection and attribution of work. Projects use a set of similar policies to ensure users behave appropriately. However, many ethical issues are not covered at all. Implementation and enforcement of policies remain vague., Conclusions: The data governance policies we investigated indicate that the neuro-ICT research community is currently close-knit and that shared assumptions are reflected in infrastructural aspects. This explains why many ethical issues are not explicitly included in data governance policies at present. With neuro-ICT research growing in scale, scope, and international involvement, these shared assumptions should be made explicit and reflected in data governance.

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.)

Accurate clinical interpretation of children's whole-genome and whole-exome sequences relies on comparing the patient's linked genomic and phenotypic data with variant reference databases of both healthy and affected patients. The robustness of such comparisons, in turn, is made possible by sharing pediatric genomic and associated clinical data. Despite this, sparse ethical-legal policy attention has been paid to making such sharing routine in practice. The interdisciplinary Paediatric Task Team of the Global Alliance for Genomics and Health considered in detail the current ethical, legal, and social implications of sharing genomic and associated clinical data involving children. An initial set of points to consider was presented at a meeting of the Paediatric Task Team at the 4th Plenary of the Global Alliance for Genomics and Health. The Key Implications for Data Sharing (KIDS) framework for pediatric genomics was developed based on feedback from this group and was supplemented by findings from a critical appraisal of the data-sharing literature. The final points to consider that comprise the KIDS framework are categorized into the following 4 primary themes: children's involvement, parental consent, balancing benefits and risks, and data protection and release requirements.

In spite of the acknowledged importance of professional ethics, technical students often show little enthusiasm for studying the subject. This paper considers how such engagement might be improved. Four guiding principles for promoting engagement are identified: (1) aligning teaching content with student interests; (2) taking a pragmatic rather than a philosophical approach to issue resolution; (3) addressing the full complexity of real-world case studies; and (4) covering content in a way that students find entertaining. The use of these principles is then discussed with respect to the specific experience of developing and presenting a master's module in Ethical and Legal Issues in Cyber Security at Queens University Belfast. One significant aspect of the resulting design is that it encourages students to see ethical issues in systemic terms rather than from an individual perspective, with issues emerging from a conflict between different groups with different vested interests. Case studies are used to examine how personal and business priorities create conflicts that can lead to negative press, fines and punitive legal action. The module explores the reasons why organisations may be unaware of the risks associated with their actions and how an inappropriate response to an ethical issue can significantly aggravate a situation. The module has been delivered in three successive years since 2014 and been well received on each occasion. The paper describes the design of the module and the experience of delivering it, concluding with a discussion of the effectiveness of the approach.

Purpose: The main purpose of the present paper is to analyze the rules for processing of special categories of personal data (genetic data, including biological samples, biometric and health data) in the light of the new General Data Protection Regulation (GDPR), thus contributing to overview the health status and the biomedical state of the data subject., Background: Over the last two decades, debating the European Union's (EU) major legislation with regard to personal data and patients' rights became relevant for the scientific research. The paper assesses the basic legal provisions with regard to the genetic, biometric and data concerning health considered as "sensitive data", while safeguarding the ethical standards of the scientific research. The present article investigates the ethical and legal approaches to processing personal data in the understanding of the new regulatory guidelines regarding the data protection, here including the health status and the rights of a data subject., Conclusions: The protection of natural persons with regard to the processing of genetic, biometric and health data and the free movement of such data are reinforced in the new GDPR entered into force in May 2016 and applied from 25 May 2018. The new legal context elucidates: the special categories of personal data ("sensitive data"), the "consent" and the research exemption by explicitly recognizing the "pseudonymised" data. Although the new guidelines revisit the EU data protection reform, it also grants the EU Member States the right to maintain or introduce further limitations to the processing of such data.

Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general.

Data science can offer huge opportunities for government. With the ability to process larger and more complex datasets than ever before, it can provide better insights for policymakers and make services more tailored and efficient. As with all new technologies, there is a risk that we do not take up its opportunities and miss out on its enormous potential. We want people to feel confident to innovate with data. So, over the past 18 months, the Government Data Science Partnership has taken an open, evidence-based and user-centred approach to creating an ethical framework. It is a practical document that brings all the legal guidance together in one place, and is written in the context of new data science capabilities. As part of its development, we ran a public dialogue on data science ethics, including deliberative workshops, an experimental conjoint survey and an online engagement tool. The research supported the principles set out in the framework as well as provided useful insight into how we need to communicate about data science. It found that people had a low awareness of the term 'data science', but that showing data science examples can increase broad support for government exploring innovative uses of data. But people's support is highly context driven. People consider acceptability on a case-by-case basis, first thinking about the overall policy goals and likely intended outcome, and then weighing up privacy and unintended consequences. The ethical framework is a crucial start, but it does not solve all the challenges it highlights, particularly as technology is creating new challenges and opportunities every day. Continued research is needed into data minimization and anonymization, robust data models, algorithmic accountability, and transparency and data security. It also has revealed the need to set out a renewed deal between the citizen and state on data, to maintain and solidify trust in how we use people's data for social good.This article is part of the themed issue 'The ethical impact of data science'., (© 2016 The Author(s).)

Online service providers (OSPs)-such as AOL, Facebook, Google, Microsoft, and Twitter-significantly shape the informational environment (infosphere) and influence users' experiences and interactions within it. There is a general agreement on the centrality of OSPs in information societies, but little consensus about what principles should shape their moral responsibilities and practices. In this article, we analyse the main contributions to the debate on the moral responsibilities of OSPs. By endorsing the method of the levels of abstract (LoAs), we first analyse the moral responsibilities of OSPs in the web (LoA IN ). These concern the management of online information, which includes information filtering, Internet censorship, the circulation of harmful content, and the implementation and fostering of human rights (including privacy). We then consider the moral responsibilities ascribed to OSPs on the web (LoA ON ) and focus on the existing legal regulation of access to users' data. The overall analysis provides an overview of the current state of the debate and highlights two main results. First, topics related to OSPs' public role-especially their gatekeeping function, their corporate social responsibilities, and their role in implementing and fostering human rights-have acquired increasing relevance in the specialised literature. Second, there is a lack of an ethical framework that can (a) define OSPs' responsibilities, and (b) provide the fundamental sharable principles necessary to guide OSPs' conduct within the multicultural and international context in which they operate. This article contributes to the ethical framework necessary to deal with (a) and (b) by endorsing a LoA enabling the definition of the responsibilities of OSPs with respect to the well-being of the infosphere and of the entities inhabiting it (LoA For ).

The article offers information on the 37th annual conference of the Pacific Telecommunications Council held in Honolulu, Hawaii in January 2015. Topics discussed include networked planet, ethics of "cyber threats" to corporate and national stability, and the dialogue between China and the U.S. regarding cyber security.