Consent Management System on Patient-Generated Health Data
Randine P, Salant E, Muzny M, Pape-Haugaard L
Studies in Health Technology and Informatics, 1 January 2024
Abstract
We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.

Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities
Pillay N, Ncube N, Moopelo K, Mothoagae G, Welte O, Shogole M, Gwiji N, Scott L, Moshani N, Tiffin N, Boulle A, Griffiths F, Fairlie L, Mehta U, LeFevre A, Scott K
Sexual and Reproductive Health Matters, 1 December 2023
Abstract
The increasing digitisation of personal health data has led to an increase in the demand for onward health data. This study sought to develop local language scripts for use in public sector maternity clinics to capture informed consent for onward health data use. The script considered five possible health data uses: 1. Sending of general health information content via mobile phones; 2. Delivery of personalised health information via mobile phones; 3. Use of women’s anonymised health data; 4. Use of child’s anonymised health data; and 5. Use of data for recontact. Qualitative interviews (n = 54) were conducted among women attending maternity services in three public health facilities in Gauteng and Western Cape, South Africa. Using cognitive interviewing techniques, interviews sought to:(1) explore understanding of the consent script in five South African languages, (2) assess women’s understanding of what they were consenting to, and (3) improve the consent script. Multiple rounds of interviews were conducted, each followed by revisions to the consent script, until saturation was reached, and no additional cognitive failures identified. Cognitive failures were a result of: (1) words and phrases that did not translate easily in some languages, (2) cognitive mismatches that arose as a result of different world views and contexts, (3) linguistic gaps, and (4) asymmetrical power relations that influence how consent is understood and interpreted. Study activities resulted in the development of an informed consent script for onward health data use in five South African languages for use in maternity clinics.

Patient Perspectives on Data Sharing
Book Chapter
Louise C. Druedahl, Sofia Kälvemark Sporrong
The Law and Ethics of Data Sharing in Health Sciences, 20 December 2023 [Springer]
Open Access
Abstract
Data sharing is key for artificial intelligence and for future healthcare systems, but the perspectives of patients are seldom included in the larger debates of how, when, and what data to share. This chapter provides an overview of research on patient perspectives on data sharing and associated aspects, including patients’ motivations, concerns, and views on privacy and conditions for sharing. Moreover, these perspectives are put into the evolving context of informed consent and today’s European context of the General Data Protection Regulation (GDPR) and Data Governance Act (DGA). Overall, there seems to be a discrepancy between the patients’ perspective on data sharing and the reality in which their data are to be shared. The current patient views are researched within relatively ‘local’ contexts, where the patient would consent to collecting data for primary use and on patients’ preferences regarding consent and what they see as barriers and motivators for data sharing. However, the reality of data use is moving towards re-use of data for secondary purposes and a context of more altruistic consent such as the DGA. Questions remain regarding how patients perceive sharing and the role of their data in the larger governance of data; seemingly, patient views are lost in the wider debate of innovation and jurisdictional competitiveness. Ensuring that patients’ voices are heard is essential for public acceptance of data sharing, and thus for inclusiveness and equity of results and innovations originating from patients’ shared data.

How to Design Consent for Health Data Research? An Analysis of Arguments of Solidarity
Original Article
Svenja Wiertz
Public Health Ethics, 12 December 2023
Excerpt
…Informed consent has been set down as a core ethical requirement for medical research in the Declaration of Helsinki and the Nuremberg Code but was traditionally understood to apply to research with direct involvement of patients. As research without direct involvement of patients—based solely on collected data or biospecimen—becomes more relevant and prevalent, another set of normative requirements, also operating under the name of consent, comes into play: Gefenas et al. have employed the terms of ‘interventional consent’ and ‘informational consent’ to mark this difference. Informational consent, governed in the European Union today mainly under the General Data Protection Regulation (GDPR) sets the legal standards for processing personal data…

In safe hands: child health data storage, linkage and consent for use
Cervantée E K Wild, Ngauru T Rawiri, Ken Taiapa, Yvonne C Anderson
Health Promotion International, 6 December 2023; 38(6)
Abstract
While there is potential for societal benefit from linkage and integration of large datasets, there are gaps in our understanding of the implications for children and young people, and limited inclusion of their views within this discourse. We aimed to understand the views and expectations of children, young people and their parents/caregivers in Aotearoa New Zealand regarding child health data storage, linkage and consent for use. This qualitative study included 24 Māori and non-Māori children, young people and their families across five focus groups, recruited from a community-based health service. A mixed Māori and non-Māori research team facilitated participant recruitment and data collection. Child, adolescent and parent/caregiver groups were held separately. Sessions were audio-recorded and the verbatim transcripts were analysed thematically. We identified three themes: (i) I am more than a number: seeing patients as people; (ii) In safe hands: data as power; and (iii) What are your intentions with my data? Consent as an active relationship. A key challenge was the reductive and stigmatizing potential of data integration for minoritised groups. Hypothetical discussions of data sharing and linkage were contingent on trust between the participant and the health professional, with negotiated data ownership. Consent was conceived as an active relationship needing renewal and renegotiation as children reached adulthood. Current consent processes for ongoing use of child data require further deliberation. Without a strong ethical and child rights-based approach to issues of child health data management, consent and linkage, we risk exacerbating health inequities and experiences of breach of trust.

Preferences for onward health data use in the electronic age among maternity patients and providers in South Africa: a qualitative study
LeFevre A, Welte O, Moopelo K, Tiffin N, Mothoagae G, Ncube N, Gwiji N, Shogole M, Slogrove AL, Moshani N, Boulle A, Goudge J, Griffiths F, Fairlie L, Mehta U, Scott K, Pillay N
Sexual and Reproductive Health Matters, 20 November 2023; 31(4)
Abstract
Despite the expanding digitisation of individual health data, informed consent for the collection and use of health data is seldom explicitly sought in public sector clinics in South Africa. This study aims to identify perceptions of informed consent practices for health data capture, access, and use in Gauteng and the Western Cape provinces of South Africa. Data collection from September to December 2021 included in-depth interviews with healthcare providers (n = 12) and women (n = 62) attending maternity services. Study findings suggest that most patients were not aware that their data were being used for purposes beyond the individualised provision of medical care. Understanding the concept of anonymised use of electronic health data was at times challenging for patients who understood their data in the limited context of paper-based folders and booklets. When asked about preferences for electronic data, patients overwhelmingly were in favour of digitisation. They viewed electronic access to their health data as facilitating rapid and continuous access to health information. Patients were additionally asked about preferences, including delivery of health information, onward health data use, and recontacting. Understanding of these use cases varied and was often challenging to convey to participants who understood their health data in the context of information inputted into their paper folders. Future systems need to be established to collect informed consent for onward health data use. In light of perceived ties to the care received, these systems need to ensure that patient preferences do not impede the content nor quality of care received.

Enhancing the reuse of health data for research purposes: laws and regulations as pillars of trust
R Verheij, E B Van Veen
European Journal of Public Health, 24 October 2023
Abstract
Background
Routinely recorded health data are increasingly used for research purposes and indispensable to stimulating appropriate and sustainable health care. In many countries access to data has proven to be a challenge. Trust by researchers, organisations and the general public is key, and adherence to the rule of law is one of the key elements determining that trust. We investigated the laws and regulations regarding the reuse of health data and how they work out practically for researchers.
Methods
Our study focuses on France, Finland, Denmark, Germany, England and The Netherlands. We investigated consent mechanisms, the possibilities of record linkage, and how the sharing of data for research purposes was organised, with a combination of desk research and interviews with researchers in these countries.
Results
All countries investigated except England are subject to the General Data Protection Regulation. However, explicit consent is the default in Germany and the Netherlands, while other countries maintain an opt-out system or even a system of neither consent nor opt-out. A central data access authority is in place in all countries investigated except Germany and the Netherlands. The nature and level of detail of data varies widely.
Conclusions
GDPR does not dictate a specific modality for the reuse of data. In terms of the reuse of health data, Germany and the Netherlands are lagging. The Netherlands seems to be the only country with continuing discussions about consent modalities. A broader societal debate about the balance between trust and the reuse of health data is needed, also against the background of a European Health Data Space. In the Netherlands, widespread government distrust is one of the challenges. Options to counteract this distrust will be discussed.

Blockchain Based Dynamic Consent Management Systems for Enhancing Quality of Life for People with Disabilities
Conference Paper
Muhammad Irfan Khalid, Mansoor Ahmed
IEEE International Smart Cities Conference, September 2023
Abstract
This research investigates the potential impact of dynamic consent management systems (DCMSs) on individuals with disabilities (PwDs). An extensive literature review found a lack of discussion regarding using advanced tools like blockchains to give PwDs control over their data in smart cities. Our study aims to fill this gap by demonstrating how blockchain-based DCMSs can improve the quality of life (QoL) for people with disabilities. We present a conceptual model that showcases the feasibility of using dynamic consent management systems to enhance the quality of life (QoL) for people with disabilities. This model emphasizes the importance of managing consent choices during their participation in research or data sharing with third parties. Using blockchain-based DCMSs, PwDs can securely exercise their data rights, maintaining privacy while enabling researchers to conduct their work. Existing works in dynamic consent management systems utilizing blockchain technology focus on security and privacy but do not address the unique needs of PwDs or their QoL. Our proposed model illustrates how blockchain-based DCMSs can positively impact people with disabilities’s quality of life. We advocate for adopting advanced tools and techniques to fully implement these models, ensuring tailored solutions for PwDs’ specific requirements.

The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardized Consent
Brief Report
Stefanie Brückner, Toralf Kirsten, Peter Schwarz, Fabienne Cotte, Michael Tsesis, Stephen Gilbert
Mayo Clinic Proceedings: Digital Health, December 2023; 1(4) pp 527-533
Open Access
Abstract
The rise of health and wellness applications has led to a new category of citizen-generated health data, which are collected through sensors and user inputs. As more parameters are measured over longer time periods, these data will gradually become more important for disease prediction, care, and research than classical clinic-generated health data. Policymakers now recognize the potential of both data types in initiatives such as the European Health Data Space, which aims to enable data sharing for patient care and research at scale. Although it could be argued that clinic-generated data come from public-funded health systems and should therefore be sharable, after depersonalization, for public service, this argument extends poorly to data from wearables and applications. We propose a new approach for standardized health consent, both broad and dynamic, to overcome consent fatigue and engage citizens in data sharing.

Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature
Review Article
Julie-Anne R. Smit, Menno Mostert, Rieke van der Graaf, Diederick E. Grobbee, Johannes J. M. van Delden
European Journal of Human Genetics, 17 October 2023
Open Access
Abstract
It is a common misunderstanding of current European data protection law that when consent is not being used as lawful basis, the processing of personal data is prohibited. Article 9(2)(j) of the European General Data Protection Regulation (GDPR) permits Member States to establish a legal basis in national law that allows for the processing of personal data for scientific research purposes without consent. However, the European legislator has formulated this “research exemption” as an opening clause, rendering the GDPR not specific as to what measures exactly are required to comply with the research exemption. This may have significant implications for both the protection of personal data and the advancement of data-intensive health research. We performed a systematic review of relevant soft law instruments and academic literature to identify what measures are mentioned in those documents. Our analysis resulted in the identification of four overarching themes of suggested measures: organizational measures; technical measures; oversight and review mechanisms; and public engagement and participation. Some of the suggested measures do not substantially contribute to the clarification of the GDPR’s “suitable and specific measures” requirement because they remain vague or broad in nature and encompass all types of data processing. However, the themes oversight and review mechanisms and public engagement and participation provide valuable insights which can be put to practice. Nevertheless, further clarification of the measures and safeguards that should be installed when invoking the research exemption remains necessary.