Canadian Association of Radiologists White Paper on De-Identification of Medical Imaging: Part 1, General Principles.

The application of big data, radiomics, machine learning, and artificial intelligence (AI) algorithms in radiology requires access to large data sets containing personal health information. Because machine learning projects often require collaboration between different sites or data transfer to a third party, precautions are required to safeguard patient privacy. Safety measures are required to prevent inadvertent access to and transfer of identifiable information. The Canadian Association of Radiologists (CAR) is the national voice of radiology committed to promoting the highest standards in patient-centered imaging, lifelong learning, and research. The CAR has created an AI Ethical and Legal standing committee with the mandate to guide the medical imaging community in terms of best practices in data management, access to health care data, de-identification, and accountability practices. Part 1 of this article will inform CAR members on principles of de-identification, pseudonymization, encryption, direct and indirect identifiers, k-anonymization, risks of reidentification, implementations, data set release models, and validation of AI algorithms, with a view to developing appropriate standards to safeguard patient information effectively.

Canadian Association of Radiologists White Paper on De-identification of Medical Imaging: Part 2, Practical Considerations.

The application of big data, radiomics, machine learning, and artificial intelligence (AI) algorithms in radiology requires access to large data sets containing personal health information. Because machine learning projects often require collaboration between different sites or data transfer to a third party, precautions are required to safeguard patient privacy. Safety measures are required to prevent inadvertent access to and transfer of identifiable information. The Canadian Association of Radiologists (CAR) is the national voice of radiology committed to promoting the highest standards in patient-centered imaging, lifelong learning, and research. The CAR has created an AI Ethical and Legal standing committee with the mandate to guide the medical imaging community in terms of best practices in data management, access to health care data, de-identification, and accountability practices. Part 2 of this article will inform CAR members on the practical aspects of medical imaging de-identification, strengths and limitations of de-identification approaches, list of de-identification software and tools available, and perspectives on future directions.

Anonymity and Organ Donation: Ethical and Policy Implications After the Opinion Released by the Italian Committee for Bioethics.

According to Law 91/1999, art. 18, in Italy, health care professionals and administrative staff involved in the process of organ collection and transplantation are required to ensure anonymity of both the donor and the recipient. Against this backdrop, in 2018, the Italian Committee for Bioethics (ICB) released an official opinion titled "Opinion on the preservation of the anonymity of donor and receiver in the transplantation of organs" that offers a new perspective on the topic, effectively opening the possibility of anonymity ending at certain conditions. The relevance of anonymity within the transplant network is a globally recognized principle with a strong ethical value. In this article, based on the experience of one author directly involved in the ICB opinion drafting, we examine the document and discuss how such a proposal could be implemented at the legislative level.

Ética de la revisión por pares en publicaciones científicas / Ethics of peer reviewing in scientific publications

RESUMEN La revisión por pares garantiza que los materiales publicados sean válidos y confiables, tanto como sea posible. El objetivo fue reconocer la importancia del trabajo de los revisores en las publicaciones científicas médicas y de la observación de los aspectos éticos durante su desempeño. Las revisiones por pares pueden ser a ciegas, a doble ciegas o abiertas, cada una de ellas con ventajas y desventajas. Durante las publicaciones de resultados de investigaciones científicas pueden producirse sesgos por parte de los revisores. Entre los sesgos de los revisores relacionados con faltas éticas se encuentran: los incumplimientos en plazos de revisión, la superficialidad de las revisiones, el lenguaje ofensivo contra editores o autores, el "amiguismo cognitivo" y el "sesgo de ego" por propia voluntad, entre otros. No obstante, es posible implementar acciones para minimizar los sesgos relacionados con esas faltas éticas. El trabajo de los revisores es digno de reconocer, teniendo en cuenta que casi siempre es realizado durante el tiempo libre, de forma voluntaria y por personas de alto prestigio como investigadores. En el mundo actual esta labor ha sido amenazada con la proliferación de revistas predadoras, pero también destacan los intentos para su reivindicación y promoción, como el del sitio web Publons. En el trabajo de los revisores intervienen múltiples factores, a veces contradictorios: intereses, deberes, derechos; pero todos ellos deben ponderarse sobre la base de una sólida formación y desempeño éticos (AU).

ABSTRACT Peer reviews guarantee published materials be as valid and reliable as it be possible. Recognize reviewers' work importance on scientific medical publication as well as the ethics issues to be accomplished during their performance. Development: Peer reviews could be single blind, double blind or open, each one with its advantages and disadvantages. During scientific research results publications, peer reviewer biases could be occurred. Some peer reviewer biases are related to ethical mistakes: no fulfillment of time limits, superficial evaluations, offense languages against editors or authors, at will cognitive cronyism and "ego bias", among others. Nevertheless, measures' implementation to minimize biases related to ethical mistakes is possible. The reviewers' work is suitable to be recognized, taking into account it is done almost all the times on free time, without financial compensation and by researchers with recognized prestige. In the present word, even when this work has been threat by predatory journals spreads, some intent to do it justice and promotion are highlight, as do the website Publons. Multiple factors, contradictory sometime, are involved in the reviewers' work: interests, duties, rights; but all of them should be pondering over the base of a solid ethic education and behavior (AU).

Kenyan health stakeholder views on individual consent, general notification and governance processes for the re-use of hospital inpatient data to support learning on healthcare systems.

BACKGROUND: Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. METHODS: We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. RESULTS: Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. CONCLUSIONS: As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs.

Pesquisa com prontuário: análise ético-jurídica à luz dos direitos humanos dos pacientes / Research ethics and access to medical records based on the human rights of patients

Este artigo objetiva analisar as normas internacionais e nacionais que tratam de ética em pesquisa e do acesso a dados de prontuário com base no referencial dos Direitos Humanos dos Pacientes, particularmente do direito à privacidade e do direito à confidencialidade. Neste estudo optou-se pela análise de normas nacionais e internacionais, com base no direito à privacidade e no direito à confidencialidade da informação pessoal. A partir das normas objeto dessa investigação, extraem-se as seguintes prescrições ético-jurídicas: a) o direito à privacidade e à confidencialidade do paciente/participante é o balizador ético jurídico da pesquisa envolvendo seres humanos e os interesses da produção científica não se sobrepõem ao do participante; b) o segundo uso de informação pessoal do paciente para fins de pesquisa não deve ser, prima facie, legalmente vedado; c) ferramentas devem ser adotadas visando assegurar a eticidade do segundo uso de dados pessoais para fins de pesquisa, tal como a anonimização de dados e o emprego de cláusulas especificas. Conclui-se que o segundo uso de dados do prontuário para fins de pesquisa há que ser legalmente autorizado e regulado e que a regra geral deve ser o acesso ao prontuário para fins de pesquisa consentido pelo paciente/participante, essa é a premissa de atuação de qualquer órgão de ética em pesquisa

This article aims to analyze international and national norms on research ethics and access to medical records based on the Human Rights of Patients, particularly the right to privacy and the right to confidentiality. It is a research of theoretical nature based on the Human Rights of Patients. In this study, we opted for the analysis of national and international norms based on the right to privacy and the right to confidentiality of personal information. The following ethical and legal prescriptions are taken out from the norms analyzed: a) the right to privacy and to confidentiality is the ethical-legal benchmark of research involving human subjects and the interests of scientific knowledge do not overlap the participant interest; b) the second use of the patient's personal information for research purposes should not be prima facie legally prohibited; c) tools should be adopted to ensure the ethics of the second use of personal data for research purposes, such as data anonymization and the use of specific clauses. It was concluded that the second use of the medical record for research purposes must be legally authorized and regulated and that the general rule should be access to medical records for the purposes of research by consent of the patient / participant, this is the premiseof any body of research ethics

Donor and Recipient Perspectives on Anonymity in Kidney Donation From Live Donors: A Multicenter Survey Study.

BACKGROUND: Maintaining anonymity is a requirement in the Netherlands and Sweden for kidney donation from live donors in the context of nondirected (or unspecified) and paired exchange (or specified indirect) donation. Despite this policy, some donors and recipients express the desire to know one another. Little empirical evidence informs the debate on anonymity. This study explored the experiences, preferences, and attitudes of donors and recipients toward anonymity. STUDY DESIGN: Retrospective observational multicenter study using both qualitative and quantitative methods. SETTING & PARTICIPANTS: 414 participants from Dutch and Swedish transplantation centers who received or donated a kidney anonymously (nondirected or paired exchange) completed a questionnaire about anonymity. Participation was a median of 31 months after surgery. FACTORS: Country of residence, donor/recipient status, transplant type, time since surgery. OUTCOMES: Experiences, preferences, and attitudes toward anonymity. RESULTS: Most participants were satisfied with their experience of anonymity before and after surgery. A minority would have liked to have met the other party before (donors, 7%; recipients, 15%) or after (donors, 22%; recipients, 31%) surgery. Significantly more recipients than donors wanted to meet the other party. Most study participants were open to meeting the other party if the desire was mutual (donors, 58%; recipients, 60%). Donors agree significantly more with the principle of anonymity before and after surgery than recipients. Donors and recipients thought that if both parties agreed, it should be permissible to meet before or after surgery. There were few associations between country or time since surgery and experiences or attitudes. The pros and cons of anonymity reported by participants were clustered into relational and emotional, ethical, and practical and logistical domains. LIMITATIONS: The relatively low response rate of recipients may have reduced generalizability. Recall bias was possible given the time lag between transplantation and data collection. CONCLUSIONS: This exploratory study illustrated that although donors and recipients were usually satisfied with anonymity, the majority viewed a strict policy on anonymity as unnecessary. These results may inform policy and education on anonymity.

Informed consent and registry-based research - the case of the Danish circumcision registry.

BACKGROUND: Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of 'big data'. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences of ritual circumcision. DISCUSSION: This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent - Meta consent - aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised.

Criminal Prohibition of Wrongful Re­identification: Legal Solution or Minefield for Big Data?

The collapse of confidence in anonymization (sometimes also known as de-identification) as a robust approach for preserving the privacy of personal data has incited an outpouring of new approaches that aim to fill the resulting trifecta of technical, organizational, and regulatory privacy gaps left in its wake. In the latter category, and in large part due to the growth of Big Data-driven biomedical research, falls a growing chorus of calls for criminal and penal offences to sanction wrongful re-identification of "anonymized" data. This chorus cuts across the fault lines of polarized privacy law scholarship that at times seems to advocate privacy protection at the expense of Big Data research or vice versa. Focusing on Big Data in the context of biomedicine, this article surveys the approaches that criminal or penal law might take toward wrongful re-identification of health data. It contextualizes the strategies within their respective legal regimes as well as in relation to emerging privacy debates focusing on personal data use and data linkage and assesses the relative merit of criminalization. We conclude that this approach suffers from several flaws and that alternative social and legal strategies to deter wrongful re-identification may be preferable.

Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 9: anonymization and ethics considerations for capturing and sharing patient reported outcomes.

BACKGROUND: Patient-reported outcomes (PROs) are collected with consent for care; however, using the data for any other purpose requires consent for that additional purpose, or the anonymization of the data. Collecting explicit consent to use this data for secondary purposes, before the patient completes a PRO, can also bias the responses. OBJECTIVE: We consider the ethical and security issues related to the collection of data at the point of care or in the population and the aggregation and integration of PRO data with administrative databases to facilitate decision making and comparative effectiveness research. DISCUSSION: In this article, we describe risk-based anonymization, taking the context of the data release into account, so that we may consider the degree by which the release is considered anonymized. We also consider the ethical use of anonymized data, the anonymization of free-form text, and the secure linking data sets without sharing any personal information. Many good standards and best practices exist for the sharing of health data and could be used as a baseline in the development of a national PRO initiative.

Confidentiality considerations for use of social-spatial data on the social determinants of health: Sexual and reproductive health case study.

Understanding whether and how the places where people live, work, and play are associated with health behaviors and health is essential to understanding the social determinants of health. However, social-spatial data which link a person and their attributes to a geographic location (e.g., home address) create potential confidentiality risks. Despite the growing body of literature describing approaches to protect individual confidentiality when utilizing social-spatial data, peer-reviewed manuscripts displaying identifiable individual point data or quasi-identifiers (attributes associated with the individual or disease that narrow identification) in maps persist, suggesting that knowledge has not been effectively translated into public health research practices. Using sexual and reproductive health as a case study, we explore the extent to which maps appearing in recent peer-reviewed publications risk participant confidentiality. Our scoping review of sexual and reproductive health literature published and indexed in PubMed between January 1, 2013 and September 1, 2015 identified 45 manuscripts displaying participant data in maps as points or small-population geographic units, spanning 26 journals and representing studies conducted in 20 countries. Notably, 56% (13/23) of publications presenting point data on maps either did not describe approaches used to mask data or masked data inadequately. Furthermore, 18% (4/22) of publications displaying data using small-population geographic units included at least two quasi-identifiers. These findings highlight the need for heightened education for researchers, reviewers, and editorial teams. We aim to provide readers with a primer on key confidentiality considerations when utilizing linked social-spatial data for visualizing results. Given the widespread availability of place-based data and the ease of creating maps, it is critically important to raise awareness on when social-spatial data constitute protected health information, best practices for masking geographic identifiers, and methods of balancing disclosure risk and scientific utility. We conclude with recommendations to support the preservation of confidentiality when disseminating results.

Realising the technological promise of smartphones in addiction research and treatment: An ethical review.

BACKGROUND: Smartphone technologies and mHealth applications (or apps) promise unprecedented scope for data collection, treatment intervention, and relapse prevention when used in the field of substance abuse and addiction. This potential also raises new ethical challenges that researchers, clinicians, and software developers must address. AIMS: This paper aims to identify ethical issues in the current uses of smartphones in addiction research and treatment. METHODS: A search of three databases (PubMed, Web of Science and PsycInfo) identified 33 studies involving smartphones or mHealth applications for use in the research and treatment of substance abuse and addiction. A content analysis was conducted to identify how smartphones are being used in these fields and to highlight the ethical issues raised by these studies. RESULTS: Smartphones are being used to collect large amounts of sensitive information, including personal information, geo-location, physiological activity, self-reports of mood and cravings, and the consumption of illicit drugs, alcohol and nicotine. Given that detailed information is being collected about potentially illegal behaviour, we identified the following ethical considerations: protecting user privacy, maximising equity in access, ensuring informed consent, providing participants with adequate clinical resources, communicating clinically relevant results to individuals, and the urgent need to demonstrate evidence of safety and efficacy of the technologies. CONCLUSIONS: mHealth technology offers the possibility to collect large amounts of valuable personal information that may enhance research and treatment of substance abuse and addiction. To realise this potential researchers, clinicians and app-developers must address these ethical concerns to maximise the benefits and minimise risks of harm to users.

Standardization of Guidelines for Patient Photograph Deidentification.

IMPORTANCE: This work was performed to advance patient care by protecting patient anonymity. OBJECTIVES: This study aimed to analyze the current practices used in patient facial photograph deidentification and set forth standardized guidelines for improving patient autonomy that are congruent with medical ethics and Health Insurance Portability and Accountability Act. DESIGN: The anonymization guidelines of 13 respected journals were reviewed for adequacy in accordance to facial recognition literature. Simple statistics were used to compare the usage of the most common concealment techniques in 8 medical journals which may publish the most facial photographs. SETTING: Not applicable. PARTICIPANTS: Not applicable. MAIN OUTCOME MEASURES: Facial photo deidentification guidelines of 13 journals were ascertained. Number and percentage of patient photographs lacking adequate anonymization in 8 journals were determined. RESULTS: Facial image anonymization guidelines varied across journals. When anonymization was attempted, 87% of the images were inadequately concealed. The most common technique used was masking the eyes alone with a black box. CONCLUSIONS: Most journals evaluated lack specific instructions for properly de-identifying facial photographs. The guidelines introduced here stress that both eyebrows and eyes must be concealed to ensure patient privacy. Examples of proper and inadequate photo anonymization techniques are provided. RELEVANCE: Improving patient care by ensuring greater patient anonymity.