Health data sharing for clinical research : Designing a patient-centric approach

Abstract

The use of Electronic Health Records (EHRs) has seen a breakthrough in clinical research for personalized treatments (Hamburg & Collins, 2010.) Despite the potential advantages of vast EHR data available, constraints of privacy and legislation hinder its use (Rieke et al., 2020.) Health data exists in an interconnected healthcare system (Harris et al., 2009), comprising of stakeholders responsible for health data management within the constraints of GDPR. Data sharing platforms, through the use of secure data sharing practices and encrypted technology, can potentially change the landscape of health data in clinical research (Obermeyer & Emanuel, 2016.)

This project examines the privacy and stakeholder landscape of health data sharing through an evaluation of interaction with patients. It uses a Value-Sensitive design approach (Friedman et al., 2002) to contextualize the privacy values in clinical research for patients, doctors, patient organizations, clinical researchers, pharmaceutical industries and data sharing platforms. Through this examination, it identifies lack of transparent data use and research practices as a hindrance to the use of health data on a data sharing platform. Transparency is examined through a patient-centric lens, wherein information and control over preferences of participation are found to be crucial. This evaluation further identifies roles of researchers and data sharing platforms for a transparent approach.

The project results in a concept termed ‘Negotiated Consent‘, which examines the use of data sharing platforms in offering individuals transparency. This is contextualized within patient consent for recruitment in clinical research, wherein data sharing platforms are responsible for data processing through the use of Federated Learning and Natural Language Processing. The stakeholder landscape for the same is defined in 3 functions for the platform- Access to Health Data, Patient Consent and Recruitment, and Data-Driven Insights. The results are tested through a study of the prototyped user experience of ‘Negotiated Consent‘, wherein participants emphasized ‘feeling more informed and in control’ in comparison to the current informed consent.

Whilst the study examines a patient-centric approach towards health data sharing for clinical research, it has limitations in addressing the multi-faceted reality of patient’s lives that informs their choices to enrol in clinical research. The further development of patient-centricity in the domain requires examination of motivations through a lens of disease-specific patient groups, demographics, and personal history with diseases (Hong et al., 2020) will lead to richer insights. Furthermore, Negotiated Consent is a proof-of-concept for dynamic consent (Mascalzoni et al., 2022), that demonstrates revision over participation choices within one moment of patient consent.

This project contributes to an understanding of the privacy and stakeholder dynamics for health data sharing. It illuminates a transparent approach to recruitment for clinical research through a collaborative effort that emphasizes on patient-centric approaches. Using a mutually responsible approach, data sharing platforms can lead the way for use of data in clinical research that simultaneously empowers patients to control their data through a negotiated lens.