Pricing through health apps generated data-Digital dividend as a game changer: Discrete choice experiment.

OBJECTIVES: The objective of this paper is to study under which circumstances wearable and health app users would accept a compensation payment, namely a digital dividend, to share their self-tracked health data. METHODS: We conducted a discrete choice experiment alternative, a separated adaptive dual response. We chose this approach to reduce extreme response behavior, considering the emotionally-charged topic of health data sales, and to measure willingness to accept. Previous experiments in lab settings led to demands for high monetary compensation. After a first online survey and two pre-studies, we validated four attributes for the final online study: monthly bonus payment, stakeholder handling the data (e.g., health insurer, pharmaceutical or medical device companies, universities), type of data, and data sales to third parties. We used a random utility framework to evaluate individual choice preferences. To test the expected prices of the main study for robustness, we assigned respondents randomly to one of two identical questionnaires with varying price ranges. RESULTS: Over a period of three weeks, 842 respondents participated in the main survey, and 272 respondents participated in the second survey. The participants considered transparency about data processing and no further data sales to third parties as very important to the decision to share data with different stakeholders, as well as adequate monetary compensation. Price expectations resulting from the experiment were high; pharmaceutical and medical device companies would have to pay an average digital dividend of 237.30€/month for patient generated health data of all types. We also observed an anchor effect, which means that people formed price expectations during the process and not ex ante. We found a bimodal distribution between relatively low price expectations and relatively high price expectations, which shows that personal data selling is a divisive societal issue. However, the results indicate that a digital dividend could be an accepted economic incentive system to gather large-scale, self-tracked data for research and development purposes. After the COVID-19 crisis, price expectations might change due to public sensitization to the need for big data research on patient generated health data. CONCLUSION: A continuing success of existing data donation models is highly unlikely. The health care sector needs to develop transparency and trust in data processing. An adequate digital dividend could be an effective long-term measure to convince a diverse and large group of people to share high-quality, continuous data for research purposes.

Informed consent: its importance for retrolective research and medical science progress.

In retrolective research, the information necessary to answer the research question is directly generated from medical records and other clinical-documentary sources. This article analyzes the waiver of informed consent and privacy notice when research is retrolective, from which two lines of argument emerge: one is the physician's duty to protect patient dignity, integrity, right to self-determination and privacy, as well as the confidentiality of the information obtained from him; the other is retrolective research contribution to the control of diseases and society's health improvement. Waiver of informed consent or privacy notice documented in the medical record is important for retrolective research, but it has ethical implications for researchers who do not comply with the rationality and personal responsibility they have before society.

En la investigación retrolectiva, la información necesaria para responder la pregunta de investigación se genera directamente de expedientes clínicos y de otras fuentes clínico-documentales. Este artículo analiza la dispensa del consentimiento informado y el aviso de privacidad cuando la investigación es retrolectiva, de lo cual emergen dos líneas de argumentación: una es el deber del médico de proteger la dignidad, la integridad, el derecho a la autodeterminación, la intimidad del enfermo y la confidencialidad de la información obtenida de él; la otra es la contribución de las investigaciones retrolectivas al control de las enfermedades y a la mejora de la salud de la sociedad. La dispensa del consentimiento o el aviso de privacidad en el expediente clínico es importante para la investigación retrolectiva, pero tiene implicaciones éticas para los investigadores que no cumplan con la racionalidad y responsabilidad personal que tienen ante la sociedad.

Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?

The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.

El consentimiento informado: su importancia para la investigación retrolectiva y el progreso de la ciencia médica / Informed consent: its importance for retrolective research and medical science progress

Resumen En la investigación retrolectiva, la información necesaria para responder la pregunta de investigación se genera directamente de expedientes clínicos y de otras fuentes clínico-documentales. Este artículo analiza la dispensa del consentimiento informado y el aviso de privacidad cuando la investigación es retrolectiva, de lo cual emergen dos líneas de argumentación: una es el deber del médico de proteger la dignidad, la integridad, el derecho a la autodeterminación, la intimidad del enfermo y la confidencialidad de la información obtenida de él; la otra es la contribución de las investigaciones retrolectivas al control de las enfermedades y a la mejora de la salud de la sociedad. La dispensa del consentimiento o el aviso de privacidad en el expediente clínico es importante para la investigación retrolectiva, pero tiene implicaciones éticas para los investigadores que no cumplan con la racionalidad y responsabilidad personal que tienen ante la sociedad.

Abstract In retrolective research, the information necessary to answer the research question is directly generated from medical records and other clinical-documentary sources. This article analyzes the waiver of informed consent and privacy notice when research is retrolective, from which two lines of argument emerge: one is the physician’s duty to protect patient dignity, integrity, right to self-determination and privacy, as well as the confidentiality of the information obtained from him; the other is retrolective research contribution to the control of diseases and society’s health improvement. Waiver of informed consent or privacy notice documented in the medical record is important for retrolective research, but it has ethical implications for researchers who do not comply with the rationality and personal responsibility they have before society.

La compartición internacional de datos personales relativos a la salud en tiempos de la COVID-19: aspectos éticos y legales para el impulso de la necesaria cooperación / The international sharing of personal data concerning health in times of the COVID-19: Ethical and legal issues for the impulse of a necessary cooperation / La compartició internacional de dades personals relatives a la salut en temps de la COVID-19: aspectes ètics I legals per a l'impuls de la necessària cooperación

El presente artículo ambiciona defender la necesidad y la virtualidad de emprender una acción colectiva, primero, paneuropea y luego, internacional para hacer frente con la mayor celeridad, eficiencia y eficacia posibles a la emergencia sanitaria suscitada por la COVID-19, abordando, específicamente, la problemática ética y legal de la compartición internacional de datos personales. Todo ello con la firme pretensión de lograr una mayor y mejor cooperación internacional en materia de investigación médico-científica con datos de carácter personal

This article aims to defend the need of taking a pan-European and international collective action to tackle as rapidly, efficiently and effectively as possible the public health emergency caused by the COVID-19, addressing, specifically, the ethical and legal issues of the international sharing of personal data. On the whole, intending to improve international cooperation in medical and scientific research with personal data

El present article ambiciona defensar la necessitat I la virtualitat d'emprendre una acció col·lectiva, primer, paneuropea I després, internacional per fer front amb la major celeritat, eficiència I eficàcia possibles a l'emergència sanitària suscitada per la COVID-19, abordant, específicament, la problemàtica ètica I legal de la compartició internacional de dades personals. Tot això amb la ferma pretensió d'aconseguir una major I millor cooperació internacional en matèria d'investigació medico-científica amb dades de caràcter personal

Adoption of a Personal Health Record in the Digital Age: Cross-Sectional Study.

BACKGROUND: As health care organizations strive to improve health care access, quality, and costs, they have implemented patient-facing eHealth technologies such as personal health records to better engage patients in the management of their health. In the Kingdom of Saudi Arabia, eHealth is also growing in accordance with Vision 2030 and its National Transformation Program framework, creating a roadmap for increased quality and efficiency of the health care system and supporting the goal of patient-centered care. OBJECTIVE: The aim of this study was to investigate the adoption of the personal health record of the Ministry of National Guard Health Affairs (MNGHA Care). METHODS: A cross-sectional survey was conducted in adults visiting outpatient clinics in hospitals at the Ministry of National Guard Health Affairs hospitals in Riyadh, Jeddah, Dammam, Madinah, and Al Ahsa, and primary health care clinics in Riyadh and Qassim. The main outcome measure was self-reported use of MNGHA Care. RESULTS: In the sample of 546 adult patients, 383 (70.1%) reported being users of MNGHA Care. MNGHA Care users were more likely to be younger (P<.001), high school or university educated (P<.001), employed (P<.001), have a chronic condition (P=.046), use the internet to search for health-related information (P<.001), and use health apps on their mobile phones (P<.001). CONCLUSIONS: The results of this study show that there is substantial interest for the use of MNGHA Care personal health record with 70% of participants self-reporting use. To confirm these findings, objective data from the portal usage logs are needed. Maximizing the potential of MNGHA Care supports patient engagement and is aligned with the national eHealth initiative to encourage the use of technology for high-quality, accessible patient-centered care. Future research should include health care provider perspectives, incorporate objective data, employ a mixed-methods approach, and use a theoretical framework.

Human-Computer Interaction, Ethics, and Biomedical Informatics.

OBJECTIVES: To provide an overview of recent work at the intersection of Biomedical Informatics, Human-Computer Interaction, and Ethics. METHODS: Search terms for Human-Computer Interaction, Biomedical Informatics, and Ethics were used to identify relevant papers published between 2017 and 2019.Relevant papers were identified through multiple methods, including database searches, manual reviews of citations, recent publications, and special collections, as well as through peer recommendations. Identified articles were reviewed and organized into broad themes. RESULTS: We identified relevant papers at the intersection of Biomedical Informatics, Human-Computer Interactions, and Ethics in over a dozen journals. The content of these papers was organized into three broad themes: ethical issues associated with systems in use, systems design, and responsible conduct of research. CONCLUSIONS: The results of this overview demonstrate an active interest in exploring the ethical implications of Human-Computer Interaction concerns in Biomedical Informatics. Papers emphasizing ethical concerns associated with patient-facing tools, mobile devices, social media, privacy, inclusivity, and e-consent reflect the growing prominence of these topics in biomedical informatics research. New questions in these areas will likely continue to arise with the growth of precision medicine and citizen science.

Clinical Information Systems - Seen through the Ethics Lens.

OBJECTIVE: The more people there are who use clinical information systems (CIS) beyond their traditional intramural confines, the more promising the benefits are, and the more daunting the risks will be. This review thus explores the areas of ethical debates prompted by CIS conceptualized as smart systems reaching out to patients and citizens. Furthermore, it investigates the ethical competencies and education needed to use these systems appropriately. METHODS: A literature review covering ethics topics in combination with clinical and health information systems, clinical decision support, health information exchange, and various mobile devices and media was performed searching the MEDLINE database for articles from 2016 to 2019 with a focus on 2018 and 2019. A second search combined these keywords with education. RESULTS: By far, most of the discourses were dominated by privacy, confidentiality, and informed consent issues. Intertwined with confidentiality and clear boundaries, the provider-patient relationship has gained much attention. The opacity of algorithms and the lack of explicability of the results pose a further challenge. The necessity of sociotechnical ethics education was underpinned in many studies including advocating education for providers and patients alike. However, only a few publications expanded on ethical competencies. In the publications found, empirical research designs were employed to capture the stakeholders' attitudes, but not to evaluate specific implementations. CONCLUSION: Despite the broad discourses, ethical values have not yet found their firm place in empirically rigorous health technology evaluation studies. Similarly, sociotechnical ethics competencies obviously need detailed specifications. These two gaps set the stage for further research at the junction of clinical information systems and ethics.

An Architecture and Management Platform for Blockchain-Based Personal Health Record Exchange: Development and Usability Study.

BACKGROUND: Personal health record (PHR) security, correctness, and protection are essential for health and medical services. Blockchain architecture can provide efficient data retrieval and security requirements. Exchangeable PHRs and the self-management of patient health can offer many benefits to traditional medical services by allowing people to manage their own health records for disease prevention, prediction, and control while reducing resource burdens on the health care infrastructure and improving population health and quality of life. OBJECTIVE: This study aimed to build a blockchain-based architecture for an international health record exchange platform to ensure health record confidentiality, integrity, and availability for health management and used Health Level 7 Fast Healthcare Interoperability Resource international standards as the data format that could allow international, cross-institutional, and patient/doctor exchanges of PHRs. METHODS: The PHR architecture in this study comprised 2 main components. The first component was the PHR management platform, on which users could upload PHRs, view their record content, authorize PHR exchanges with doctors or other medical health care providers, and check their block information. When a PHR was uploaded, the hash value of the PHR would be calculated by the SHA-256 algorithm and the PHR would be encrypted by the Rivest-Shamir-Adleman encryption mechanism before being transferred to a secure database. The second component was the blockchain exchange architecture, which was based on Ethereum to create a private chain. Proof of authority, which delivers transactions through a consensus mechanism based on identity, was used for consensus. The hash value was calculated based on the previous hash value, block content, and timestamp by a hash function. RESULTS: The PHR blockchain architecture constructed in this study is an effective method for the management and utilization of PHRs. The platform has been deployed in Southeast Asian countries via the Asia eHealth Information Network (AeHIN) and has become the first PHR management platform for cross-region medical data exchange. CONCLUSIONS: Some systems have shown that blockchain technology has great potential for electronic health record applications. This study combined different types of data storage modes to effectively solve the problems of PHR data security, storage, and transmission and proposed a hybrid blockchain and data security approach to enable effective international PHR exchange. By partnering with the AeHIN and making use of the network's regional reach and expert pool, the platform could be deployed and promoted successfully. In the future, the PHR platform could be utilized for the purpose of precision and individual medicine in a cross-country manner because of the platform's provision of a secure and efficient PHR sharing and management architecture, making it a reasonable base for future data collection sources and the data analytics needed for precision medicine.

Are Patient Privacy and Health Data at Risk?

Partnerships between tech companies and health systems challenge privacy expectations and laws.

CART-WHEEL.org: An Ethically Approved Online Database for Patient-Entered Data to Facilitate Rare Cancer Research.

PURPOSE: Rare cancers are challenging for researchers, as clinicians and scientists have difficulty recruiting sufficient patient cases to power studies appropriately. Likewise, patients often are frustrated by a lack of specific information or evidence base for their cancer and, although eager to participate in research, have limited opportunities. We established CART-WHEEL.org, an online patient-entered database, to directly engage patients in the research process, collect rare cancer data, and facilitate their entry into additional research. PATIENTS AND METHODS: Patients access CART-WHEEL.org directly online. Clinical information is collected from users via a streamlined questionnaire developed collaboratively with consumer groups to ensure accessibility and relevance. Data collected include the following: patient demographics, comorbidities, and risk factors and tumor diagnostic, biomarker, and treatment history. Patients can download a medical summary for personal use; consent for research use of data; and indicate willingness to be contacted about other research or clinical trials. We describe data collected to date and its validation, and we provide examples of how CART-WHEEL.org can facilitate rare cancer research. RESULTS: From January 2010 to March 2018, 558 patients provided consent and entered their rare cancer data. One hundred distinct rare tumor types and patients from 22 countries were included. Validation of data entered by 21 patients with sarcoma against a hospital database demonstrated accuracy sufficient to facilitate future research in key fields, such as tumor site (95%) and histopathologic diagnosis (90%). Examples of CART-WHEEL-based disease-specific projects, subsequent recruitment to other rare cancer projects, and rare cancer patient cases of interest are described. CONCLUSIONS: Online platforms like CART-WHEEL.org can engage consumers directly, facilitating collection of patient-entered rare cancer data for hypothesis generation, and connect patients with researchers to enable specific rare cancer research and clinical trials.

Privacy Concerns About Personal Health Information and Fear of Unintended Use of Biospecimens Impact Donations by African American Patients.

Biospecimen donation is essential for studies of cancer prevention, early detection, and treatment. Donations from minority groups, for whom the cancer burden is high, are infrequent and inadequate for research purposes. The obstacles to donation of biospecimens by African Americans and other minority groups must be identified. Patients aged 18-85 years were surveyed based on the clinic visited (group A: GI/primary care and group B: oncology with confirmed cancer diagnosis) and analyzed as separate groups. The validated biobanking attitudes and knowledge survey (BANKS) as well as pancreatic cancer questions were used. In group A, 278/292 surveys were completed (5/6 patients participated). In group B, 54/59 surveys were completed (4/5 patients participated). There were low mean scores on the BANKS knowledge sections, specifically in regard to specimen ownership and the separation of research and medical records. Also, two major concerns limited donation: (1) fear that personal, medical, and family medical information may be stolen from the biobank; and (2) mistrust that biospecimens could be used for unintended purposes. Low knowledge about biospecimen acquisition, added to mistrust, warrant community-based, and patient education in an effort to improve attitudes, increase participation, and regain healthy therapeutic alliances.

European Electronic Personal Health Records initiatives and vulnerable migrants: A need for greater ethical, legal and social safeguards.

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples' health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant-centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe.

Issues and Ethical Considerations in Pharmaco-oncogenomics.

The rapid advancements of treatment modalities and vast amounts of information being generated through novel technologies, paint the picture of a very promising future, one that will allow for a more efficient and precise DNA sequencing and potentially more tailored cancer therapies for patients. However, with all these advances we must address the ethical and legal considerations each one of these technologies will raise. This is a necessity in order for advancement, not to stand in the way of science and development, but as a safeguard in protecting humanity and our personal genetic information.

Connected Health User Willingness to Share Personal Health Data: Questionnaire Study.

BACKGROUND: Connected health has created opportunities for leveraging health data to deliver preventive and personalized health care services. The increasing number of personal devices and advances in measurement technologies contribute to an exponential growth in digital health data. The practices for sharing data across the health ecosystem are evolving as there are more opportunities for using such data to deliver responsive health services. OBJECTIVE: The objective of this study was to explore user attitudes toward sharing personal health data (PHD). The study was executed within the first year after the implementation of the new General Data Protection Regulation (GDPR) legal framework. METHODS: The authors analyzed the results of an online questionnaire survey to explore the willingness of 8004 people using connected health services across four European countries to share their PHD and the conditions under which they would be willing to do so. RESULTS: Our findings indicate that the majority of users are willing to share their personal PHD for scientific research (1811/8004, 22.63%). Age, education level, and occupation of the participants, in addition to the level of digitalization in their country were found to be associated with data sharing attitudes. CONCLUSIONS: Positive attitudes toward data sharing for scientific research can be perceived as an indication of trust established between users and academia. Nevertheless, the interpretation of data sharing attitudes is a complex process, related to and influenced by various factors.

[Use of Electronic Medical Records for Research: New Ethical Challenges and Possible Solutions]. / Uso dos Registos Clínicos Eletrónicos para Investigação: Novos Desafios Éticos e Soluções Possíveis.

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

Alguns investigadores entendem que as Comissões de Ética para a Saúde são um bloqueio aos estudos clínicos observacionais. No que toca aos estudos retrospetivos há quem proponha resolver este problema tratando os Dados Pessoais de Saúde como dados administrativos simples na posse do Estado e há quem interprete o novo Regulamento Geral de Proteção de Dados (União Europeia) 2016/679 de forma menos garantista que a Lei nº 21/2014, de 16 de abril (sobre a Investigação Clínica), resultando em ambos os casos na presunção que o silêncio do participante constitui consentimento, mesmo se ninguém tentar sequer informá-lo do novo usodos seus dados. Estas soluções colidem com garantias éticas de proteção dos direitos dos doentes. Propomos uma alternativa ética a estas propostas.

The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks.

The General Data Protection Regulation (GDPR) came into force in May 2018. The aspiration of providing for a high level of protection to individuals' personal data risked placing considerable constraints on scientific research, which was contrary to various research traditions across the EU. Therefore, along with the set of carefully outlined data subjects' rights, the GDPR provides for a two-level framework to enable derogations from these rights when scientific research is concerned. First, by directly invoking provisions of the GDPR on a condition that safeguards that must include 'technical and organisational measures' are in place and second, through the Member State law. Although these derogations are allowed in the name of scientific research, they can simultaneously be challenging in light of the ethical requirements and well-established standards in biobanking that have been set forth in various research-related soft legal tools, international treaties and other legal instruments. In this article, we review such soft legal tools, international treaties and other legal instruments that regulate the use of health research data. We report on the results of this review, and analyse the rights contained within the GDPR and Article 89 of the GDPR vis-à-vis these instruments. These instruments were also reviewed to provide guidance on possible safeguards that should be followed when implementing any derogations. To conclude, we will offer some commentary on limits of the derogations under the GDPR and appropriate safeguards to ensure compliance with standard ethical requirements.