Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians

Peer reviewedPublisher PD

A Decentralised Digital Identity Architecture

Current architectures to validate, certify, and manage identity are based on centralised, top-down approaches that rely on trusted authorities and third-party operators. We approach the problem of digital identity starting from a human rights perspective, with a primary focus on identity systems in the developed world. We assert that individual persons must be allowed to manage their personal information in a multitude of different ways in different contexts and that to do so, each individual must be able to create multiple unrelated identities. Therefore, we first define a set of fundamental constraints that digital identity systems must satisfy to preserve and promote privacy as required for individual autonomy. With these constraints in mind, we then propose a decentralised, standards-based approach, using a combination of distributed ledger technology and thoughtful regulation, to facilitate many-to-many relationships among providers of key services. Our proposal for digital identity differs from others in its approach to trust in that we do not seek to bind credentials to each other or to a mutually trusted authority to achieve strong non-transferability. Because the system does not implicitly encourage its users to maintain a single aggregated identity that can potentially be constrained or reconstructed against their interests, individuals and organisations are free to embrace the system and share in its benefits.Comment: 30 pages, 10 figures, 3 table

Electronic health records to facilitate clinical research

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research