Information Governance, Registries and the integration of Consents and Permissions

This white paper presents a new approach to Information Governance (IG), describing it as a repeatable protocol integrating legal and ethical processes directly with technology infrastructure to accelerate the delivery of biomedical research and development using sensitive patient data. Fundamentally, this approach is trying to solve the bottleneck that current IG approaches present to research. Most large trusted research environments support of the order of 100 projects per year. The number of public funded clinical research grants is over 16000, and every grant can generate multiple projects. This of course doesn’t include commercial R&D, so we can safely assume the addressable space of projects working with clinical data is of the order of 100,000 per annum in the UK, with major data infrastructures meeting significantly less than 10% of that demand. To meet that need, and truly unlock the potential of sensitive healthcare data in life-saving research, IG therefore needs to be deliverable at a thousand-fold scale from today, without any loss of privacy or data control, and without costing a thousand times more.