Ethical Issues in the Utilization of Black Boxes for Artificial Intelligence in Medicine.

Artificial Intelligence (AI) has made major progress in recent years in many fields. With regard of medicine however, the utilization of AI raises numerous ethical questions, especially since newer and much more accurate algorithms function as black boxes. A trade-off must then be made between having algorithms being very accurate and effective, and algorithms that are explainable but less proficient. In this paper we address the ethical implications of utilizing black box algorithms in medicine.

Patients' Perception of Privacy of Personal Data, Shared in Online Communities: Are We in the Presence of a Paradox?

Virtual online communities help people in coping with complex health issues, such as those present in patients suffering chronic diseases. Further research is required in order to clarify the impact of sharing of personal experiences on the perception of privacy and confidentiality by patients. We studied the case of Carenity an online social network created in France in 2011 bringing together 300,000 patients across Europe, and selected patients suffering Multiple Sclerosis. We conducted an exploratory-descriptive survey, and 253 patients completed an online questionnaire. Most participants did not consider that their privacy was threatened when sharing their personal experiences and data associated with their health condition. As common sense prevents one to share information to strangers to ensure privacy, such paradox may be explained by new strategies to face challenges imposed by chronic conditions disease, where sharing personal experiences may be considered as a complementary source of social support by patients.

The Meaning of Patient Empowerment in the Digital Age: The Role of Online Patient-Communities.

Traditionally, patient empowerment has been used as a strategy for health promotion. The rise of online communities of patients represents a good example of how patient empowerment occurs, independently of the intervention of existing healthcare providers and insurers, allowing thus a more accurate definition of meaning of this concept. We describe two situations related with the development of health-related social networks: (1) The emergence of a new biomedical research model in which patients lead research, shifting the equilibrium of power from the professionals to research subjects themselves, and (2) The emergence of Lay Crowd-Sourced Expertise in these communities, arising from the daily exchange among patients affected by chronic conditions and their relatives, giving place to a new era of bottom-up data generation, previously unknown in biomedical sciences. We enrich these descriptions by analyzing interviews to key actors of these "on line" communities": Michael Chekroun, founder of "Carenity, France", and Paul Wicks Vice President at "PatientsLikeMe, USA".

Lay Crowd-Sourced Expertise (LCE) and Its Influence on the New Role of Patients: Ethical and Societal Issues.

The emergence of social media on the Internet allows patients to discuss about their chronic diseases within online communities sharing common interests. This allows patients to gather other patients' experience, and gain new knowledge that is usually not shared by healthcare professionals. In this context, further studies are required on the actual impact of the use of social networks on the quality of life of patients participating in these online communities, focusing on the evolving role and impact of Lay Crowdsourced expertise (LCE) in improving disease management and control. We present a study on a large number of posts from social networks of different online communities. This study allowed us to choose four pathologies, with distinctive characteristics relevant for our future analysis, and to define the themes that will be covered in future work by online questionnaires. The analysis of responses from patients, who volunteer to participate, will help us in exploring how interactions between patients, on these online communities, may help them to gain useful information for managing their conditions and improving their quality of life. Furthermore, we will identify new ethical issues that arise in the sharing of health data.

A New Challenge to Research Ethics: Patients-Led Research (PLR) and the Role of Internet Based Social Networks.

A characteristic feature of the development of health-related social networks is the emergence of internet-based virtual communities, composed of patients. These communities go beyond the mere interchange of information concerning their conditions, intervening in the planning and execution of clinical research, including randomised controlled trials, in collaboration with health professionals. That was the case, in 2009, when patients suffering amyotrophic lateral sclerosis, a rare and severe disease, conducted a clinical trial in USA, organising themselves through an online platform. This initiative launched a new model for the planning and conduction of clinical research: "Participants-Led Research" (PLR). The distinctive particularities of this new research paradigm represent a challenge to the traditional standards used for judging the ethical soundness of clinical investigation. That is the case, for example, of informed consent. This article aims at identifying the ethical, legal, and social issues (ELSI) posed by PLR and the relevant concepts that may help in solving them. The following issues, in particular, are analysed, that may give place to a new social contract for the ethical assessment of clinical research: consent for participating in research and personal integrity; data protection and confidentiality; benefits sharing and intellectual property.

Ethical, Legal and Social Issues related to the health data-warehouses: re-using health data in the research and public health research.

Research derived from the application of information and communication technologies in medicine operates in a context involving the globalization of collecting, sharing, storage, transfer and re-use of personal health data. Health data computerization within Clinical Information Systems (as Electronic Healthcare Records) should allow the re-use of health data for clinical research and public health purposes. One of the objects allowing the integration of healthcare and research information systems is the health data-warehouse (DWH). However, ethical-legal frameworks in force are not adapted to these DWHs because they were not conceived for re-using data in a different context than the one of their acquisition. For that matter, access modalities to data-warehouses must ensure the respect of patients' rights: information to the patient, as well as confidentiality and security. Through a bibliography research, some Ethical, legal and Social Issues (ELSI) have been identified: Patients' rights Modalities of implementation of the DWs; Solidarity and common good; Transparency and Trust. Comparative analysis between the Directive 95/46/CE and the "Proposal for regulation on protection of individuals with regard to the processing of personal data" shows that this regulation pretends allowing the re-use of key-coded data when aimed at a scientific purpose. However, since this new regulation does not align with the ethical and legal requirements at an operational level, a Code of practice on secondary use of Medical Data in scientific Research Projects has been developed at the European Level. This Code provides guidance for Innovative Medicine Initiative (IMI) and will help to propose practical solutions to overcome the issue of the re-use of data for research purposes.

Assessing ethical and social issues of transtelephonic electrocardiography (TTEGG) in Chile / Evaluación de los aspectos éticos y sociales de la electrocardiografía transtelefónica (TTEGG) en Chile / Avaliação das questões éticas e sociais da eletrocardiografia transtelefônica (TTEGG) no Chile

The aim of this study was to focus on the ethical and social issues derived from the implementation of transtelephonic electrocardiography (TTECG) in the public healthcare sector in Chile, studying patients and healthcare providers' acceptance and expectations concerning: (a) TTECG effectiveness and safety; and (b) data protection issues, such as confidentiality, privacy and security. For this purpose, we developed two psychosocial surveys; the first was addressed to patients receiving transtelephonic electrocardiogram (either in the emergency services of hospitals or in distant primary care services) and the second one aimed at healthcare providers involved in either administering and/or interpreting it. Results included: (a) major acceptability of TTECG in terms of safety and security; (b) privacy and confidentiality of the patients were considered to be well protected; and (c) the patient-doctor relationship was not affected by this device.

El objetivo de este estudio fue centrarse en los asuntos éticos y sociales, derivados de la aplicación de la tele-electrocardiografía (TTECG), en el sector público de salud en Chile, estudiando la aceptación y expectativas de pacientes y proveedores de servicios de salud en relación con: (a) eficacia y seguridad de la TTECG; y (b) cuestiones relacionadas con la protección de datos, tales como la confidencialidad, privacidad y seguridad. Para este fin, aplicamos dos encuestas psicosociales; la primera fue dirigida a los pacientes que reciben TTECG (ya sea en los servicios de urgencias de los hospitales, o en servicios de atención primaria alejados) y la segunda dirigida a los profesionales de la salud dedicados a la aplicación y/o interpretación. Los resultados fueron los siguientes: (a) gran aceptabilidad de TTECG en términos de seguridad y protección; (b) se considera que la privacidad y confidencialidad de los pacientes están protegidos; y (c) la relación entre los pacientes y el médico no se considera afectada por este dispositivo.

O objetivo do presente estudo foi concentrar-se sobre as questões éticas e sociais decorrentes da implementação da eletrocardiografia transtelefônica (TTECG) no sector público da saúde no Chile, estudando a aceitação de pacientes e prestadores de cuidados de saúde e suas expectativas relativas a: (a) eficácia e segurança da TTECG; e (b) questões relacionadas com a proteção de dados, tais como a confidencialidade, privacidade e segurança. Para esse efeito, desenvolvemos dois questionários psicossociais; o primeiro foi dirigido a pacientes recebendo TTECG (quer em serviços de emergência de hospitais ou no distante atendimento primário), e o segundo foi destinado a prestadores de cuidados de saúde envolvidos em qualquer administração ou interpretando-a. Os resultados foram: (a) grande aceitabilidade das TTECG em termos de segurança; (b) a privacidade e a confidencialidade dos pacientes foram consideradas como bem protegidas; e (c) a relação médico-paciente não foi afetada por esse dispositivo.

Assessing ethical and social issues of transtelephonic electrocardiography (TTEGG) in Chile.

The aim of this study was to focus on the ethical and social issues derived from the implementation of transtelephonic electrocardiography (TTECG) in the public healthcare sector in Chile, studying patients and healthcare providers' acceptance and expectations concerning: (a) TTECG effectiveness and safety; and (b) data protection issues, such as confidentiality, privacy and security. For this purpose, we developed two psychosocial surveys; the first was addressed to patients receiving transtelephonic electrocardiogram (either in the emergency services of hospitals or in distant primary care services) and the second one aimed at healthcare providers involved in either administering and/or interpreting it. Results included: (a) major acceptability of TTECG in terms of safety and security; (b) privacy and confidentiality of the patients were considered to be well protected; and (c) the patient-doctor relationship was not affected by this device.

Legal aspects of personal health monitoring.

Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this paper. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonised medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g. the way in which hospitals are organised in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper analyses finally also how health monitoring projects may change the traditional (non-)relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require new legal rules.

A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects.

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.

Quantitative fluorescence imaging approach for the study of polyploidization in hepatocytes.

We applied automatic quantitative fluorescence imaging of nuclear DNA to rat liver cells obtained from animals at various times after birth up to 3 months of age. We show that, in conditions best preserving the native cellular structures, DNA content measurements, performed on whole single cells in situ after Hoechst staining, were precise and accurate. Cells in the various ploidy and nuclearity classes could thus be identified correctly and their percentages were estimated on a total of 300 cells or more. DNA synthesis was shown to occur asynchronously in all ploidy and nuclearity classes around weaning time. Observation of the labeling patterns, after in vivo BrdU pulse and short-term culture (chase), showed that the cell cycle was shorter in diploid cells compared with cells undergoing polyploidization. These results show that the approach of fluorescence imaging is well suited to investigations on polyploidization mechanisms.