OpenSAFELY

Abstract

OpenSAFELY is a secure, transparent, open-source software platform for the analysis of electronic health records data. It allows researchers to conduct analyses on NHS data without accessing raw patient records. Its combination of federated data storage, secure environments, transparent processes, and strict ethical governance ensures that sensitive data is used effectively for public benefit while minimizing risks.

OpenSAFELY avoids direct sharing of sensitive data by ensuring that data analysis occurs within secure environments, aligning with the principle of “access as open as possible, as restricted as necessary.” It incorporates tools for de-identifying data and ensuring aggregated results protect individual privacy while allowing meaningful analysis.

It enables restricted access for certified researchers and restricts data usage to approved purposes and provides tools and frameworks to ensure that research outcomes are derived safely without risking data breaches.

By publishing all analysis code on GitHub, OpenSAFELY adheres to the principle of transparency. It ensures that the public, stakeholders, and other researchers can see how sensitive data is being used. Its transparent approach to governance and data use fosters public trust and accountability.

Overview

Country	United Kingdom
Start date	2020
Annual Budget	n/a
Responsible organisation(s)	Government agency
Target group(s)	Researchers, healthcare professionals, and policymakers
Policy instrument type	Open-source software platform and related policy for the analysis of electronic health records data

Background

OpenSAFELY operates within the National Health Service (NHS) systems, which have established protocols for managing data breaches or security incidents. These protocols ensure that affected stakeholders are informed of any risks to their data. Developed in response to the COVID-19 pandemic, OpenSAFELY has facilitated numerous research projects by providing access to over 58 million patients’ health records.

Objective(s)

To provide a secure environment for health data analysis, ensuring patient confidentiality while enabling high-quality research.

Public access URL

https://www.opensafely.org/

All tags

• Data governance for trust
• United Kingdom
• 2020
• Government agency
• Established researchers
• Higher education institutes
• National government
• Public research institutes
• Strategies, agendas and plans
• Risk management and mitigation

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