Unlocking the Potential of Interoperable Linked Low-Latency National Health Data in England to Protect Vulnerable Patients While Safeguarding Their Privacy: A Brave New World

Speaker(s)

Justo N1, Taylor S2, Antonarou A3, Lu Y4, Dube S2, Ejaz M3, Evans K5, Talarico C6, Olson V7, Kasan J3, Turner D7
1Evidera, part of the PPD clinical research business of Thermo Fisher Scientific, Stockholm, AB, Sweden, 2Medical Evidence, Vaccine & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK, 3NHS England, London, UK, 4Evidera, part of PPD clinical research business of Thermo Fisher Scientific, London, LON, UK, 5Evidera, part of PPD clinical research business of Thermo Fisher Scientific, Waltham, MA, USA, 6Medical Evidence, Vaccine & Immune Therapies, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA, 7Evidera, part of PPD clinical research business of Thermo Fisher Scientific, London, UK

Presentation Documents

OBJECTIVES: National Health Services England (NHSE) routinely collects national healthcare data, which is provisioned for research for approved researchers to access for approved projects. Despite this wealth of data, the timely, secure, and continuous access during and after the COVID-19 pandemic challenged the traditional data sharing model. Evidera and AstraZeneca piloted NHSE's Secure Data Environment (SDE), part of the NHS Research SDE Network, for their burden of COVID-19 study (INFORM). We aim to describe this case study.

METHODS: INFORM investigates COVID-19 burden focusing on vulnerable populations, leveraging 5+ billion linked health records with minimal lag on 25% random sample of England's population on primary and secondary care visits, vaccination, COVID-19 surveillance, primary care medication dispensations, socio-demographics, and mortality.

RESULTS: This pilot revealed priorities to focus the diligent scrutiny to optimize data-access application process, new user qualification and onboarding, secured output review and release process, and IT infrastructure capabilities. Study findings were incorporated into dossiers for submission to health authorities (e.g., EMA, MHRA, NICE), published in Lancet Regional Health, and disseminated through conference abstracts, presentations, and institutional channels. Despite COVID-19 transitioning to an endemic phase, immunocompromised populations continued to face a disproportionately higher risk of COVID-19 hospitalization, ICU admissions, and deaths. Study findings have raised awareness among healthcare-decision makers, physicians, patients, and their families, and informed preventive behaviours and strategies.

CONCLUSIONS: The INFORM study’s success is ascribed to the collaboration between NHSE, Evidera, AstraZeneca, and advisory clinical experts, who relied on collaboration among multi-disciplinary teams including scientists, data analysts and programmers, and specialists from their legal, privacy, IT, operations, and compliance functions.

The NHSE's SDE, operational since December 2022, continues to expand its technical and service capabilities to enable secure data access to health and social care data.

Code

RWD188

Topic

Real World Data & Information Systems, Study Approaches

Topic Subcategory

Electronic Medical & Health Records, Health & Insurance Records Systems, Registries

Disease

No Additional Disease & Conditions/Specialized Treatment Areas