Data for sale: trust, confidence and sharing health data with commercial companies.

Powered by 'big health data' and enormous gains in computing power, artificial intelligence and related technologies are already changing the healthcare landscape. Harnessing the potential of these technologies will necessitate partnerships between health institutions and commercial companies, particularly as it relates to sharing health data. The need for commercial companies to be trustworthy users of data has been argued to be critical to the success of this endeavour. I argue that this approach is mistaken. Our interactions with commercial companies need not, and should not, be based on trust. Rather, they should be based on confidence. I begin by elucidating the differences between trust, reliability, and confidence, and argue that trust is not the appropriate attitude to adopt when it comes to sharing data with commercial companies. I argue that what we really should want is confidence in a system of data sharing. I then provide an outline of what a confidence-worthy system of data sharing with commercial companies might look like, and conclude with some remarks about the role of trust within this system.

Deidentification of facial photographs: a survey of editorial policies and practices.

We analysed all journals from two Journal Citation Reports (JCR) categories: 'Dentistry, Oral Surgery and Medicine' and 'Otorhinolaryngology' published in 2018 for their policies on publishing facial photographs and actual practices of publishing these photographs in articles. We extracted the following data for each journal: JCR category, impact factor, volume, issue, instructions for authors regarding ethical issues, instructions for photograph deidentification, journals' references to standard research and publishing policies, presence and type of published clinical images, separate informed consent for the publication of patient photograph and methods of deidentification. The sample included 103 journals, which published 568 articles with 1404 clinical images. Around a half of the journals (52%) had a policy on clinical images, however, the only predictor of having a journal policy on clinical images was reference in the policy to International Committee of Medical Journal Editors Recommendations (OR=3.00, 95% CI 1.26 to 7.14, p=0.013). Identifiable patient photographs were found in 13% (79/568) of the articles, constituting 9% (128/1404) of the total sample of images. Only 16% (13/79) of articles publishing recognisable patient facial images included a statement about consent for publication of the image. From the total sample of articles, 34% (27/79) contained deidentified but recognisable patient photographs and only 22% (6/27) of them had a statement about patient consent for photograph publication. The patients' consent was more likely stated in the article in cases of recognisable facial images (OR=2.81, 95% CI 1.41 to 5.63, p=0.004). Journals publishing clinical research involving the face and neck region need to establish and enforce policies on publishing clinical images.

#warriors: sick children, social media and the right to an open future.

The phenomenon of 'sharenting', whereby a parent shares news and images of their child on social media, is of growing popularity in contemporary society. There is emerging research into children's attitudes regarding sharenting and their associated concerns regarding privacy; however, this research most often involves young people who are approaching adulthood and are competent to participate. As a result, children who experience illness or disability are largely absent from current research, and as such, the moral permissibility of a parent sharing their child's illness journey on a public social media platform is largely unexplored. In this essay, I explore this issue by using the United Nations Convention on the Rights of the Child and Joel Feinberg's principle of the child's right to an open future as the basis of my argument: that children with illness and disability have the same rights as healthy children to privacy, identity and an open future and that publication of their illness on a social media platform violates these rights. I conclude that parents, as surrogate decision makers for their children, have the same responsibilities in protecting their child's privacy as they do in making medical decisions on behalf of their children. As children of the social media generation approach adulthood, it is important to consider the rights of those who cannot speak for themselves and the ethical consequences of sharenting for children with illness and disability.

Medical ethics when moving towards non-anonymous gamete donation: the views of donors and recipients.

Drawing on the views of donors and recipients about anonymity in a country that is experiencing a transition towards non-anonymous gamete donation mandated by the Constitutional Court, we explore how the intersection between rights-based approaches and an empirical framework enhances recommendations for ethical policy and healthcare. Between July 2017 and April 2018, 69 donors and 147 recipients, recruited at the Portuguese Public Bank of Gametes, participated in this cross-sectional study. Position towards anonymity was assessed through an open-ended question in a self-report questionnaire, which was subject to content analysis. Preference for an anonymous donation regime was mentioned by 82.6% of donors and 89.8% of recipients; and all those with children. Instead of the rights-based reasoning used by the Constitutional Court, donors highlighted concerns over future relationships and recipients focused on socioethical values linked with the safeguard of safety, privacy and confidentiality. The remaining participants advocated the choice between anonymity or non-anonymity (double-track policy), invoking respect for their autonomy. The complex, diverse ethical views and reasoning of donors and recipients expand a traditionally dichotomous discussion. Their perspectives challenge the transition towards non-anonymity and international guidelines, raising awareness to the need for their involvement in the design of policies to enable choice according to their values and preferences, and of psychosocial counselling responsive to their socioethical concerns and sensitive to their parental status. Empirical frameworks complement rights-based approaches to uphold justice, fairness and equal respect, and to incorporate utility, beneficence and non-maleficence in policymaking and healthcare in the transition towards non-anonymity.

Patients' and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence.

INTRODUCTION: International sharing of health data opens the door to the study of the so-called 'Big Data', which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a 'social license' is identifying the views patients and the public may hold with regard to data sharing for health research. METHODS: We performed a narrative review of the empirical evidence addressing patients' and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed (MEDLINE), Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients' and public attitudes were extracted from selected references and thematically categorised. RESULTS: Twenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread-though conditional-support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability. CONCLUSIONS: Our results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests.

From proband to provider: is there an obligation to inform genetic relatives of actionable risks discovered through direct-to-consumer genetic testing?

Direct-to-consumer genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband's duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and Lucassen's (2004) 'joint account model', we adapt Kilbride's (2018) application of the rule of rescue and balance it against the relative's right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband's objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband's privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive.

Genomic privacy, identity and dignity.

Significant advancements towards a future of big data genomic medicine, associated with large-scale public dataset repositories, intensify dilemmas of genomic privacy. To resolve dilemmas adequately, we need to understand the relative force of the competing considerations that make them up. Attitudes towards genomic privacy are complex and not well understood; understanding is further complicated by the vague claim of 'genetic exceptionalism'. In this paper, we distinguish between consequentialist and non-consequentialist privacy interests: while the former are concerned with harms secondary to exposure, the latter represent the interest in a private sphere for its own sake, as an essential component of human dignity. Empirical studies of attitudes towards genomic privacy have almost never targeted specifically this important dignitary component of the privacy interest. In this paper we first articulate the question of a non-consequentialist genomic privacy interest, and then present results of an empirical study that probed people's attitudes towards that interest. This was done via comparison to other non-consequentialist privacy interests, which are more tangible and can be more easily assessed. Our results indicate that the non-consequentialist genomic privacy interest is rather weak. This insight can assist in adjudicating dilemmas involving genomic privacy.

Protecting privacy in mandatory reporting of infectious diseases during the COVID-19 pandemic: perspectives from a developing country.

Mandatory reporting of infectious diseases (MRID) is an essential practice to prevent disease outbreaks. Disease notification is a mandatory procedure for most infectious diseases, even during non-pandemic periods in healthcare. The main rationale behind MRID is the protection of public health. The information and data provided by infectious disease reports are used for many purposes, such as preventing the spread and potential negative impact of infectious diseases, assessing the national and global situation regarding reported diseases, conducting scientific research and planning health policy. In this context, the relevant information benefits public health, health systems and scientific work. Additionally, the follow up and treatment of individuals with infectious diseases is a necessity in certain cases to protect those who cohabit with them. However, these benefits cannot be accepted as unrestricted justifications for MRID, since it is evident that reporting should be conducted within ethical and legal boundaries. MRID should only be devised and implemented with due regard to balancing potential benefits between all individuals, as well as between the individual and the rest of society. Disease notification systems that are not designed with a balancing and harm-reductionist approach may lead to stigmatisation and discrimination. This study aims to investigate the legal framework and ethical issues regarding the reporting of individuals diagnosed with COVID-19 in Turkey-which is a primary example of a developing country.

The devil is in the details: an analysis of patient rights in Swiss cancer registries.

Cancer registries are an important part of the public health infrastructure, since they allow to monitor the temporal trends of this illness as well as facilitate epidemiological research. In order to effectively set up such registries, it is necessary to create a system of data collection that permits to record health-related information from patients who are diagnosed with cancer. Given the sensitive nature of such data, it is debated whether their recording should be based on consent or whether alternative arrangements are possible (eg, opt-out systems where information is automatically collected but patients can later withdraw). In the recent reform of the Swiss cancer registration legislation, the lawmaker set out to implement rules about the recording of data in cancer registries that would allegedly go beyond a consent-based model, in order to balance accurate registration with respect of patient rights. However, by analysing the operational norms of the new legislation and comparing them with those of other systems, it emerges that the Swiss rules de facto closely resemble a system of registration based on informed consent-in partial contradiction with the objective pursued by the lawmaker. In this paper, we show how the details of a policy are crucial to determine its true nature and we highlight some critical elements-from an ethical standpoint-of the recently reformed Swiss policy on cancer registration.

Ethics of digital contact tracing wearables.

The success of digital COVID-19 contact tracing requires a strategy that successfully addresses the digital divide-inequitable access to technology such as smartphones. Lack of access both undermines the degree of social benefit achieved by the use of tracing apps, and exacerbates existing social and health inequities because those who lack access are likely to already be disadvantaged. Recently, Singapore has introduced portable tracing wearables (with the same functionality as a contact tracing app) to address the equity gap and promote public health. We argue that governments have an ethical obligation to ensure fair access to the protective benefits of contract tracing during the pandemic and that wearables are an effective way of addressing some important equity issues. The most contentious issues about contact tracing apps have been the potential infringements of privacy and individual liberty, especially where the use of apps or other technology (such as wearables or QR codes) is required for access to certain spaces. Here we argue that wearables, as opposed to apps alone, will make a digital contact tracing mandate more practical and explain some conditions under which such a mandate would be justified. We focus on Singapore as a case study that has recently deployed contact tracing wearables nationally, but also reference debate about wearables in Australia and New Zealand. Our analysis will be relevant to counties trialling similar portable tracing wearables.

Commercial DNA tests and police investigations: a broad bioethical perspective.

Over 30 million people worldwide have taken a commercial at-home DNA test, because they were interested in their genetic ancestry, disease predisposition or inherited traits. Yet, these consumer DNA data are also increasingly used for a very different purpose: to identify suspects in criminal investigations. By matching a suspect's DNA with DNA from a suspect's distant relatives who have taken a commercial at-home DNA test, law enforcement can zero in on a perpetrator. Such forensic use of consumer DNA data has been performed in over 200 criminal investigations. However, this practice of so-called investigative genetic genealogy (IGG) raises ethical concerns. In this paper, we aim to broaden the bioethical analysis on IGG by showing the limitations of an individual-based model. We discuss two concerns central in the debate: privacy and informed consent. However, we argue that IGG raises pressing ethical concerns that extend beyond these individual-focused issues. The very nature of the genetic information entails that relatives may also be affected by the individual customer's choices. In this respect, we explore to what extent the ethical approach in the biomedical genetic context on consent and consequences for relatives can be helpful for the debate on IGG. We argue that an individual-based model has significant limitations in an IGG context. The ethical debate is further complicated by the international, transgenerational and commercial nature of IGG. We conclude that IGG should not only be approached as an individual but also-and perhaps primarily-as a collective issue.

Protecting health privacy even when privacy is lost.

The standard approach to protecting privacy in healthcare aims to control access to personal information. We cannot regain control of information after it has been shared, so we must restrict access from the start. This 'control' conception of privacy conflicts with data-intensive initiatives like precision medicine and learning health systems, as they require patients to give up significant control of their information. Without adequate alternatives to the control-based approach, such data-intensive programmes appear to require a loss of privacy. This paper argues that the control view of privacy is shortsighted and overlooks important ways to protect health information even when widely shared. To prepare for a world where we no longer control our data, we must pursue three alternative strategies: obfuscate health data, penalise the misuse of health data and improve transparency around who shares our data and for what purposes. Prioritising these strategies is necessary when health data are widely shared both within and outside of the health system.

Is there room for privacy in medical crowdfunding?

When people use online platforms to solicit funds from others for health-related needs, they are engaging in medical crowdfunding. This form of crowdfunding is growing in popularity, and its visibility is increasing as campaigns are commonly shared via social networking. A number of ethical issues have been raised about medical crowdfunding, one of which is that it introduces a number of privacy concerns. While campaigners are encouraged to share very personal details to encourage donations, the sharing of such details may result in privacy losses for the beneficiary. Here, we explore the ways in which privacy can be threatened through the practice of medical crowdfunding by exploring campaigns (n=100) for children with defined health needs scraped from the GoFundMe platform. We found specific privacy concerns related to the disclosure of private details about the beneficiary, the inclusion of images and the nature of the relationship between campaigner, funding recipient and beneficiary. For example, it was found that identifying personal and medical details about the beneficiary, including symptoms (n=52) and treatment history (n=43), were often mentioned by campaigners. While the privacy concerns identified are problematic, they are also difficult to remedy given the strong financial incentive to crowdfund. However, crowdfunding platforms can enhance privacy protections by, for example, requiring those campaigning on behalf of child beneficiaries to ensure consent has been obtained from their guardians and providing additional guidelines for the inclusion of personal information in campaigns made on behalf of those not able to give their consent to the campaign.

Accessing medical biobanks to solve crimes: ethical considerations.

Millions of human biological samples are stored worldwide for medical research or treatment purposes. These biospecimens are of enormous potential value to law enforcement as DNA profiles can be obtained from these samples. However, forensic use of such biospecimens raises a number of ethical questions. This article aims to explore ethical issues of using human bodily material in medical biobanks for crime investigation and prosecution purposes. Concerns about confidentiality, trust, autonomy and justice will be discussed. We explore how to balance these concerns against the importance of crime solving. Relevant case examples of forensic use of medical biobanks show that requests by law enforcement to access biobanks are handled in disparate ways. We identify some core ethical issues and conclude that further research on these issues is needed to provide ethical guidance.

Blockchain, consent and prosent for medical research.

Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances-blockchain technologies-and argues that they can be used to share medical data in a secure and auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion.

Assessing data protection and governance in health information systems: a novel methodology of Privacy and Ethics Impact and Performance Assessment (PEIPA).

BACKGROUND: Data processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union (EU) General Data Protection Regulation (GDPR). We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health. METHODS: Computerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results. RESULTS: A total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage (median, range of adoption: 45%, 30%-80%), access and accuracy of personal data (50%, 0%-100%) and anonymisation procedures (56%, 11%-100%). A high variability was noted in the application of privacy principles. CONCLUSIONS: A comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy.

Pros and cons of prosent as an alternative to traditional consent in medical research.

In their recent article, Porsdam Mann et al propose to share biomedical research data more widely, securely and efficiently using blockchain technologies.1 They present compelling arguments for how the blockchain presents both a technological innovation, and a deontologically grounded policy innovation to traditional research consent. Their proposal can be read in conversation with a rich body of evidence to suggest current consent processes are problematic on at least one of tripartite bases in biomedical research: that it be fully informed. This response attempts to further the author's discussion of social justice discourse in, and of their proposed prosent model to enhance engagement among under-represented and vulnerable populations in research, specifically. Motivating this response is the view that advancing technological capabilities is no doubt necessary, but on its own insufficient to reinvigorate distributive, procedural and social justice as guiding principles for con/prosent processes. I offer three pros and cons to consider in effort to deepen the model's commitments to social justice to historically marginalised groups in the biomedical research enterprise.

Trust, trustworthiness and sharing patient data for research.

When it comes to using patient data from the National Health Service (NHS) for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature of trust and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by 'trust' and 'trustworthiness' matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a 'public ethics' coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context.

Addressing the conflict between partner notification and patient confidentiality in serodiscordant relationships: How can Ubuntu help?

This study evaluates the conflict between patient confidentiality and partner notification in sero-discordant relationships, and argues the thesis that based on a theoretical formulation of Ubuntu, a health provider is obliged to facilitate friendly relationships in which individuals are true subjects and/or objects of communal friendship. In serodiscordant relationships, the health professional can fulfil this obligation by notifying "others" (particularly a partner with whom an HIV positive patient has a "present" and "actual relationship") of their spouse's HIV seroconversion, since without such relevant information a partner (subject) of an HIV positive patient cannot "appropriately" care for the patient's condition (object). There is a need to move away from the medical traditional emphasis that has for so long put primacy on doctor-patient confidentiality as is the case with the Health Professions Council of South Africa Guidelines (Booklet 12) which favours patient confidentiality over partner notification. Given empirical evidence to support effectiveness of partner notification amongst sero-discordant couples, there is thus, a need to focus emphasis on latter. This shift is necessary for achieving the United Nations' Sustainable Development of Goal of ending HIV/AIDS epidemic by 2030. I proposed in this study that African ethics, specifically Ubuntu, will do a better job than current ethical frameworks at ensuring that partner notification receives more emphasis in the care of serodiscordant couples. If this framework is integrated into ethical guidelines and codes, it would significantly enhance the care of serodiscordant couples, as well as further boost global effort at ending HIV/AIDS epidemic by 2030.

Protecting privacy to protect mental health: the new ethical imperative.

Confidentiality is a central bioethical principle governing the provider-patient relationship. Dating back to Hippocrates, new laws have interpreted it for the age of precision medicine and electronic medical records. This is where the discussion of privacy and technology often ends in the scientific health literature when Internet-related technologies have made privacy a much more complex challenge with broad psychological and clinical implications. Beyond the recognised moral duty to protect patients' health information, clinicians should now advocate a basic right to privacy as a means to safeguard psychological health. The article reviews empirical research into the functions of privacy, the implications for psychological development and the resigned sentiment taking hold regarding the ability to control personal data. The article concludes with a call for legislative, educational and research steps to readjust the equilibrium between the individual and 'Big Data'.