Consent Management Research Articles

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

A Blockchain-based platform for data management and sharing

Data management is the collection, processing, storing, and sharing of data. In today's dispensation, data sharing and collaborative data processing is a necessity for multi-partner organizations as it can lead to the discovery of new insight. Shared data is generally for the purpose of marketing, advertising, and other institutional decision-making reasons. A challenge however is that the collected data (mostly about individuals known as data subjects or producers) is disseminated among organizations without meaningful consent from the data subjects. Hence, data subjects are not aware of what is happening to their data regarding use and misuse. Furthermore, data subjects can hardly determine which third-party institutions have access to their data. In this paper, we opined that data should be managed in a manner that can persuade the trust of data subjects. To achieve this, data subjects should have the rights to be informed about details of their data. Thus, this paper proposes a cloud-based data management and sharing platform to enable data subjects to control who can access their data and consent to its collection and usage based on smart contracts. The proposed system leverages blockchain to enforce accountability, provenance, and auditability of all events. We implemented a dynamic consent management prototype on top of Ethereum blockchain to demonstrate the feasibility of the proposed work.

Data and consent management services: An opportunity for banks to redefine themselves

We are producing increasing amounts of data, which is fast becoming an extremely valuable asset. A handful of companies, dubbed Big Tech, control most of this ‘asset’ and are making forays into financial services, which is bound to commoditise financial services. How this ‘asset’ will be managed in the future, however, presents a potentially huge opportunity for banks if they can leverage their current advantages and boldly create new business models. This paper recalls the basics of the data economy, proposes three major approaches to fend off the threat of commoditisation and defines the opportunity to be seized.

A Smart Contract-Based Dynamic Consent Management System for Personal Data Usage under GDPR.

A massive amount of sensitive personal data is being collected and used by scientists, businesses, and governments. This has led to unprecedented threats to privacy rights and the security of personal data. There are few solutions that empower individuals to provide systematic consent agreements on distinct personal information and control who can collect, access, and use their data for specific purposes and periods. Individuals should be able to delegate consent rights, access consent-related information, and withdraw their given consent at any time. We propose a smart-contract-based dynamic consent management system, backed by blockchain technology, targeting personal data usage under the general data protection regulation. Our user-centric dynamic consent management system allows users to control their personal data collection and consent to its usage throughout the data lifecycle. Transaction history and logs are recorded in a blockchain that provides trusted tamper-proof data provenance, accountability, and traceability. A prototype of our system was designed and implemented to demonstrate its feasibility. The acceptability and reliability of the system were assessed by experimental testing and validation processes. We also analyzed the security and privacy of the system and evaluated its performance.

Data-Driven Decision Making and Proactive Citizen-Scientist Communication: A Cross-Sectional Study on COVID-19 Vaccination Adherence.

Due to the severe impact of COVID-19 on public health, rollout of the vaccines must be large-scale. Current solutions are not intended to promote an active collaboration between communities and public health researchers. We aimed to develop a digital platform for communication between scientists and the general population, and to use it for an exploratory study on factors associated with vaccination readiness. The digital platform was developed in Latvia and was equipped with dynamic consent management. During a period of six weeks 467 participants were enrolled in the population-based cross-sectional exploratory study using this platform. We assessed demographics, COVID-19-related behavioral and personal factors, and reasons for vaccination. Logistic regression models adjusted for the level of education, anxiety, factors affecting the motivation to vaccinate, and risk of infection/severe disease were built to investigate their association with vaccination readiness. In the fully adjusted multiple logistic regression model, factors associated with vaccination readiness were anxiety (odds ratio, OR = 3.09 [95% confidence interval 1.88; 5.09]), feelings of social responsibility (OR = 1.61 [1.16; 2.22]), and trust in pharmaceutical companies (OR = 1.53 [1.03; 2.27]). The assessment of a large number of participants in a six-week period show the potential of a digital platform to create a data-driven dialogue on vaccination readiness.

Data Protection by Design in the Context of Smart Cities: A Consent and Access Control Proposal.

The growing availability of mobile devices has lead to an arising development of smart cities services that share a huge amount of (personal) information and data. Without accurate and verified management, they could become severe back-doors for security and privacy. In this paper, we propose a smart city infrastructure able to integrate a distributed privacy-preserving identity management solution based on attribute-based credentials (p-ABC), a user-centric Consent Manager, and a GDPR-based Access Control mechanism so as to guarantee the enforcement of the GDPR’s provisions. Thus, the infrastructure supports the definition of specific purpose, collection of data, regulation of access to personal data, and users’ consents, while ensuring selective and minimal disclosure of personal information as well as user’s unlinkability across service and identity providers. The proposal has been implemented, integrated, and evaluated in a fully-fledged environment consisting of MiMurcia, the Smart City project for the city of Murcia, CaPe, an industrial consent management system, and GENERAL_D, an academic GDPR-based access control system, showing the feasibility.

Proximal junctional kyphosis in pediatric spinal deformity surgery: a systematic review and critical analysis.

Proximal junctional kyphosis (PJK) is a commonly encountered clinical and radiographic phenomenon after pediatric and adolescent spinal deformity surgery that may lead to post-operative deformity, pain, and dissatisfaction. Understanding the risk factors of PJK can be useful for pre-operative informed consent as well as to identify any potential preventative strategies. We performed a systematic review and critical analysis following the PRISMA statement in July 2019 by searching the PubMed, Scopus, and Embase databases, including all prior published studies. We included articles with data on PJK in patients with operative pediatric and adolescent scoliosis and those that detailed risk factors and/or preventative strategies for PJK. Levels of evidence were determined based on consensus. Findings were summarized and grades of recommendation were assigned by consensus. This study was registered in the PROSPERO database; 202,457. Six hundred and thirty five studies were identified. Thirty-seven studies met criteria for inclusion into the analysis. No studies including neuromuscular scoliosis met inclusion criteria. No findings had Grade A evidence. There were 4 findings found to contribute to PJK with Grade B evidence in EOS: higher number of distractions, disruption of posterior elements, greater sagittal plane correction. There was no difference in incidence noted between etiology of the curvature. Five findings with Grade B evidence were found to contribute to PJK in AIS populations: higher pre-operative thoracic kyphosis, higher pre-operative lumbar lordosis, longer fusion constructs, greater sagittal plane correction, and posterior versus anterior fusion constructs. Greater sagittal plane correction has Grade B evidence as a risk factor for PJK in both EOS and AIS populations. In EOS patients, an increased number of distractions and posterior element disruption are Grade B risk factors. In AIS patients, longer fusion constructs, higher pre-operative thoracic kyphosis and lumbar lordosis, and posterior (as opposed to anterior) constructs also contributed to PJK with Grade B evidence. These findings can guide informed consent and surgical management, and provide the foundation for future studies.

6.G. Workshop: Developing a consent model for health information – challenges in a rapidly changing digital world

Abstract Advances in eHealth and digital technologies have the potential to improve the quality of patient care and promote efficiency across a health service. The potential benefits have often not been realised, however, due to a sometimes greater focus on organisational needs rather than pursuing a person-centred approach. There are some concerns from the public in relation to the privacy and security of data, issues in relation to digital literacy and inadequate digital infrastructure, and the potential erosion of the patient-healthcare professional relationship. The introduction of new information systems requires clarity around consent to align with good information governance practices and support people's rights and involvement in relation to health information decisions. Internationally, the successful introduction of digital technologies in healthcare have been informed by effective public engagement and involvement from the outset. Public engagement helps to build trust and confidence in relation to health information use, and gives insight into important considerations for the development of a consent model. As part of this workshop, we will share the experiences of three different European countries who are at varying stages of development and implementation of eHealth solutions. Ireland is at the early stages of transition to a more digital healthcare service. In England, there are a number of eHealth systems in place although difficulties have been experienced at stages; understanding public expectations and involving the public in decision-making has been an important component of their progress. Estonia is recognised as a leader in eHealth and has much to offer in relation to the fundamental principles of successful implementation. The objectives of this workshop are to: 1) share experiences in relation to the process of public engagement across different contexts; 2) examine the eHealth landscape in relation to health information sharing; and 3) lead a discussion on the opportunities and challenges faced for the future of health information in a digital world. This workshop will be comprised of three presentations, from each of the above country perspectives, followed by a panel discussion with contributions invited from the audience. Key messages Building public trust, via public engagement, is essential for successful implementation of digital health technologies. Digital health can transform future health systems but success requires strong national leadership, information governance, robust standards, consent management, and access rights.

COVID-19 vaccination readiness: use of digital technologies for data-driven decision making

BackgroundDigital technology can help scientists and governments to inform large auditoriums about COVID-19 and vaccination. Existing technological solutions for assessment of risk of COVID-19 are foreseen for individual use but not for use in scientific research. We aimed to develop a digital platform for communication between scientists and the general population and to use this digital platform for a pilot study on factors associated with the vaccination readiness.MethodsWe developed a digital platform, ensuring researchers an ability to create and manage study projects and to stratify participant cohorts in real-time. Platform provides an interface for participants to be engaged in the studies and receive personalized reports. We assessed demographic (9 items), COVID-19-related behavioral factors that increase a risk of infection (15 items) and a risk of severe disease (10 items), and a readiness for vaccination (10 items). Multiple logistic regression models adjusted for personal covariates, factors affecting the motivation to vaccinate, and risk of infection/severe disease were built to investigate their association with a vaccination readiness.ResultsThe newly developed digital platform was equipped with a dynamic consent management, allowing participants to opt-out or/and receive invitations for follow-up studies. Data collection was performed between 2021.02.01 and 2021.03.10, and 467 participants were enrolled during this period. In fully adjusted multiple logistic regression models, factors associated with the vaccination readiness were anxiety (odds ratio, OR = 3.09 [95% confidence interval 1.88; 5.09]), trust in pharmaceutical companies (OR = 1.53 [1.03; 2.27]), and social responsibility (OR = 1.61 [1.16; 2.22]).ConclusionsThe major factor that affects the vaccination readiness was anxiety. Lack of association with the risk of infection/severe disease indicates that people do not understand how the vaccine can help them to avoid the infection.Key messages Assessment of a large number of participants in a short time confirms the fact that people are motivated to collaborate using digital platforms.Applying a digital platform can help to create a data-driven dialogue on vaccination readiness, opening an evidence-based scientific discussion between state authorities and the population.

The Road to eHealth in Estonia: Lessons Learned and Future Opportunities and Challenges

Abstract Estonia has one of the leading eHealth solutions in Europe. Since its inception in 2008, it has been further developed to include new services, integrate private sector partners and Blockchain technology for system access and data integrity. This presentation will discuss the extensive progress and current developments in relation to eHealth and information sharing in Estonia, the factors that have been fundamental in achieving strategic goals in relation to eHealth, and future opportunities and challenges for eHealth in Estonia and across Europe. Strong national leadership that coordinates the actions of various stakeholders and finds a balance between patient autonomy and personal data use and societal benefits has been essential. Patient engagement and trust building was a core component from the beginning. There has been a specific focus on addressing digital literacy concerns and implementing strict legislation for data misuse to build trust. Realising the potential benefits of eHealth depends on the completeness and quality of the data. Continued engagement with healthcare professionals and organisations are needed to understand and address their concerns in relation to design and functionality, financial cost, and sharing information with patients. The implementation of eHealth systems internationally paves the way for the creation of a unique international health account number. Artificial intelligence offers a potential solution of addressing the complexity of healthcare and may contribute to a more efficient and effective patient experience. Careful consideration is needed in relation to consent management and developing appropriate and transferable standards.

IMPILO Platform - An Innovative Blockchain-Based Global Open Healthcare Social Network

The current research project focuses on the development of an innovative social health network and electronic health record system (IMPILO platform) which is based on Blockchain technology. The purpose of this project is to provide a series of health services (e.g. booking of medical appointments and tele-counselling meetings) to both citizens and doctors that would offer a more direct communication and cooperation between them and thus help reduce critical delays in medical care provision. As IMPILO manages health data, in addition to the group of friends found in some forms on all social networks, two additional certain types of user relationships have been defined: Circle of Trust (which includes a limited number of people with full rights to review and modify each user's profile and health record) and Care Team (which consists of the users-doctors that have access to their profile and medical data and can perform certain actions on their behalf). This feature is useful for keeping profiles of elderly and minors. The utilization of the capabilities of the blockchain technology in areas beyond cryptocurrencies is of particular value, especially in the field of health, where the IMPILO platform creates more reliable and durable networks, using the blockchain technology, while helping to the seamless communication between the various stakeholders (doctors, patients, hospitals, etc.). The decentralized data storage and full control of a patient's consent management process helps overcome issues such as the secure management of sensitive personal data and authorization to access medical data. Thus, blockchain is one of the most important components of the IMPILO platform that acts as a basis for recording all meaningful events in the application and provides security to users for the integrity of their data. The application is accessible via a smartphone application (for both Android and iOS operating systems) and a web interface, with a special emphasis on the design of functional, efficient and easy-to-use user interfaces, taking into account the requirements of the end users of the application and the specifics of the health sector.

Enabling personal consent in databases

Users have the right to consent to the use of their data, but current methods are limited to very coarse-grained expressions of consent, as "opt-in/opt-out" choices for certain uses. In this paper we identify the need for fine-grained consent management and formalize how to express and manage user consent and personal contracts of data usage in relational databases. Unlike privacy approaches, our focus is not on preserving confidentiality against an adversary, but rather cooperate with a trusted service provider to abide by user preferences in an algorithmic way. Our approach enables data owners to express the intended data usage in formal specifications, that we call consent constraints , and enables a service provider that wants to honor these constraints, to automatically do so by filtering query results that violate consent; rather than both sides relying on "terms of use" agreements written in natural language. We provide formal foundations (based on provenance), algorithms (based on unification and query rewriting), connections to data privacy, and complexity results for supporting consent in databases. We implement our framework in an open source RDBMS, and provide an evaluation against the most relevant privacy approach using the TPC-H benchmark, and on a real dataset of ICU data.

Applicability of Different Electronic Record Types for Use in Patient Recruitment Support Systems: Comparative Analysis

BackgroundClinical trials constitute an important pillar in medical research. It is beneficial to support recruitment for clinical trials using software tools, so-called patient recruitment support systems; however, such information technology systems have not been frequently used to date. Because medical information systems' underlying data collection methods strongly influence the benefits of implementing patient recruitment support systems, we investigated patient recruitment support system requirements and corresponding electronic record types such as electronic medical record, electronic health record, electronic medical case record, personal health record, and personal cross-enterprise health record.ObjectiveThe aim of this study was to (1) define requirements for successful patient recruitment support system deployment and (2) differentiate and compare patient recruitment support system–relevant properties of different electronic record types.MethodsIn a previous study, we gathered requirements for patient recruitment support systems from literature and unstructured interviews with stakeholders (15 patients, 3 physicians, 5 data privacy experts, 4 researchers, and 5 staff members of hospital administration). For this investigation, the requirements were amended and categorized based on input from scientific sessions. Based on literature with a focus on patient recruitment support system–relevant properties, different electronic record types (electronic medical record, electronic health record, electronic medical case record, personal health record and personal cross-enterprise health record) were described in detail. We also evaluated which patient recruitment support system requirements can be achieved for each electronic record type.ResultsPatient recruitment support system requirements (n=16) were grouped into 4 categories (consent management, patient recruitment management, trial management, and general requirements). All 16 requirements could be partially met by at least 1 type of electronic record. Only 1 requirement was fully met by all 5 types. According to our analysis, personal cross-enterprise health records fulfill most requirements for patient recruitment support systems. They demonstrate advantages especially in 2 domains (1) supporting patient empowerment and (2) granting access to the complete medical history of patients.ConclusionsIn combination with patient recruitment support systems, personal cross-enterprise health records prove superior to other electronic record types, and therefore, this integration approach should be further investigated.

Privacy Preference Signals: Past, Present and Future

Abstract Privacy preference signals are digital representations of how users want their personal data to be processed. Such signals must be adopted by both the sender (users) and intended recipients (data processors). Adoption represents a coordination problem that remains unsolved despite efforts dating back to the 1990s. Browsers implemented standards like the Platform for Privacy Preferences (P3P) and Do Not Track (DNT), but vendors profiting from personal data faced few incentives to receive and respect the expressed wishes of data subjects. In the wake of recent privacy laws, a coalition of AdTech firms published the Transparency and Consent Framework (TCF), which defines an optin consent signal. This paper integrates post-GDPR developments into the wider history of privacy preference signals. Our main contribution is a high-frequency longitudinal study describing how TCF signal gained dominance as of February 2021. We explore which factors correlate with adoption at the website level. Both the number of third parties on a website and the presence of Google Ads are associated with higher adoption of TCF. Further, we show that vendors acted as early adopters of TCF 2.0 and provide two case-studies describing how Consent Management Providers shifted existing customers to TCF 2.0. We sketch ways forward for a pro-privacy signal.

Sexual dysfunction following surgery for rectal cancer: a single-institution experience.

Although much focus is placed on oncological outcomes for rectal cancer, it is important to assess quality of life after surgery of which sexual function is an important component. This study set about to describe the prevalence of sexual dysfunction by resection type and gender among patients undergoing surgery for rectal cancer, usingretrospective analysis. All English-speaking living patients who underwent surgery for stage I-III rectal cancer with curative intent between 2012 and 2016 were identified from a prospectively maintained database at our institution. Eligible patients were invited to complete either the Female Sexual Function Index (FSFI) or the International Index of Erectile Function (IIEF). Primary outcomes were overall rates of sexual dysfunction, defined as more than one standard deviation below the mean of the normal population for each tool. A total of 147 patients responded, yielding a response rate of 38%. The overall sexual dysfunction rate was 70% at a median time from surgery of 38months. Sixty-two men (62%) and 41 women (87%) reported overall scores that fell below one standard deviation of the population mean. There was no significant difference in sexual dysfunction for both male and female patients between low anterior resection, coloanal anastomosis, or abdominoperineal resection.. The present study revealed a high rate of sexual dysfunction after rectal cancer surgery, particularly in female patients. This study serves as a reminder to surgeons and their teams to openly discuss the impact of surgery on sexual function and ensure adequate consent and appropriate peri-operative management strategies. The retrospective nature of the analysis is the limitation of this study.

An Efficient User-Centric Consent Management Design for Multiservices Platforms

This paper presents an efficient user-centric consent management system to access online services of the Territorial Collectivities and Public Administration (TCPA) as well as user-authorized third parties. It defines a novel PII manager that supports a set of sources obeying to different authorization and PII retrieval protocols. This contribution is motivated by the necessity to interface TCPA services with remote sources that provide Personally Identifiable Information (PII). Hence, the originality of our solution is multifold. First, the burden for enforcing the interoperability between the sources and the TCPA services collecting the PII is reduced from the point of view of the user, the administrator of the User-Relationship Management (URM) platform, and the territorial agent responsible for processing the user’s queries. Second, it defines a unified consent model supporting four types of sources. Third, it goes into details of practical implementations. Fourth, the relevance of the proposed PII manager for a relevant TCPA use case is demonstrated through a functional analysis.

Blockchain Applications in Health Care and Public Health: Increased Transparency.

BackgroundAlthough big data and smart technologies allow for the development of precision medicine and predictive models in health care, there are still several challenges that need to be addressed before the full potential of these data can be realized (eg, data sharing and interoperability issues, lack of massive genomic data sets, data ownership, and security and privacy of health data). Health companies are exploring the use of blockchain, a tamperproof and distributed digital ledger, to address some of these challenges.ObjectiveIn this viewpoint, we aim to obtain an overview of blockchain solutions that aim to solve challenges in health care from an industry perspective, focusing on solutions developed by health and technology companies.MethodsWe conducted a literature review following the protocol defined by Levac et al to analyze the findings in a systematic manner. In addition to traditional databases such as IEEE and PubMed, we included search and news outlets such as CoinDesk, CoinTelegraph, and Medium.ResultsHealth care companies are using blockchain to improve challenges in five key areas. For electronic health records, blockchain can help to mitigate interoperability and data sharing in the industry by creating an overarching mechanism to link disparate personal records and can stimulate data sharing by connecting owners and buyers directly. For the drug (and food) supply chain, blockchain can provide an auditable log of a product’s provenance and transportation (including information on the conditions in which the product was transported), increasing transparency and eliminating counterfeit products in the supply chain. For health insurance, blockchain can facilitate the claims management process and help users to calculate medical and pharmaceutical benefits. For genomics, by connecting data buyers and owners directly, blockchain can offer a secure and auditable way of sharing genomic data, increasing their availability. For consent management, as all participants in a blockchain network view an immutable version of the truth, blockchain can provide an immutable and timestamped log of consent, increasing transparency in the consent management process.ConclusionsBlockchain technology can improve several challenges faced by the health care industry. However, companies must evaluate how the features of blockchain can affect their systems (eg, the append-only nature of blockchain limits the deletion of data stored in the network, and distributed systems, although more secure, are less efficient). Although these trade-offs need to be considered when viewing blockchain solutions, the technology has the potential to optimize processes, minimize inefficiencies, and increase trust in all contexts covered in this viewpoint.

Ethical and efficient consent management

The need for consent management on websites does not need to be a barrier to success. This paper discusses how ‘cookie banners’ offer an opportunity to start a conversation, and build a mutually valuable relationship with users. Collecting analytics data requires a responsible attitude with a human touch. By understanding technology, regulation and users’ needs, site owners can use consent management as a competitive advantage rather than a hindrance.

Urological litigation trends in the UK National Health Service: an analysis of claims over 20years.

To look into the urology litigation trends and successful claims in the National Health Service (NHS) over the last 20years. We requested data from NHS Resolutions to investigate current litigation numbers, costs and causes for claims. Data collected included the number of claims dating from 1996 to 2019, the total sum of damages paid out each year for urology and the causes for the claims dating from 2009 to 2019. Data from NHS Resolutions were analysed, stratified and categorized by the authors from this information, which was provided as two separate documents. The total cost of damages between 1997 and 2017 was £74.5m (range: £241325-£7.8m per year). While the number of successful claims was 1653 (range 7-168 per year), the total number of claims was 3341 (range 31-347 per year) and, over time, this has increased almost sevenfold. The cost of damages has increased roughly in line with the number of claims. Over the last 10 years, non-operative-related claims accounted for 984 claims, of which the largest subset was for 'the failure to diagnose and/or treat' (n = 639, 65%), with 88 (9%) successful consent-related claims. There were 226 intra-operative-related claims. Of these, wrong-site surgery, a never-event, accounted for eight claims and there were six successful claims for failing to supervise juniors. A total of 1129 claims were postoperative claims, with retained foreign body or instrument accounting for 71 (6%) of these. The number and cost of litigation claims have increased year on year. There is a need for continual improvement in patient care, surgical training, counselling, informed consent and early management of complications. The evidence reviewed in this paper suggests that the best approach to this is the combination of rigid adherence to and re-enforcement of common surgical guidelines and implementation of the national 'Getting it right first time' initiative.

A conceptual IoT-based early-warning architecture for remote monitoring of COVID-19 patients in wards and at home

Due to the COVID-19 pandemic, health services around the globe are struggling. An effective system for monitoring patients can improve healthcare delivery by avoiding in-person contacts, enabling early-detection of severe cases, and remotely assessing patients’ status. Internet of Things (IoT) technologies have been used for monitoring patients’ health with wireless wearable sensors in different scenarios and medical conditions, such as noncommunicable and infectious diseases. Combining IoT-related technologies with early-warning scores (EWS) commonly utilized in infirmaries has the potential to enhance health services delivery significantly. Specifically, the NEWS-2 has been showing remarkable results in detecting the health deterioration of COVID-19 patients. Although the literature presents several approaches for remote monitoring, none of these studies proposes a customized, complete, and integrated architecture that uses an effective early-detection mechanism for COVID-19 and that is flexible enough to be used in hospital wards and at home. Therefore, this article's objective is to present a comprehensive IoT-based conceptual architecture that addresses the key requirements of scalability, interoperability, network dynamics, context discovery, reliability, and privacy in the context of remote health monitoring of COVID-19 patients in hospitals and at home. Since remote monitoring of patients at home (essential during a pandemic) can engender trust issues regarding secure and ethical data collection, a consent management module was incorporated into our architecture to provide transparency and ensure data privacy. Further, the article details mechanisms for supporting a configurable and adaptable scoring system embedded in wearable devices to increase usefulness and flexibility for health care professions working with EWS.