EHDS Q&A: Understanding the basics – Part 1
Part 1 of our EHDS Q&A explains why compliance is urgent, outlining key deadlines, enforcement rules, and the financial risks of falling behind.
Trusted Research Environments: powering secure and scalable health data research
Collaboration, security, and scalability for the data-driven future of healthcare
The world of research is at an inflection point. On one hand, data-driven insights can transform patient care, accelerate drug discovery, and improve public health. On the other, privacy concerns, regulatory constraints, and fragmented data sources continue to slow progress. How can organizations strike the right balance between innovation and security?
The answer lies in TREs — also known as Secure Data Environments (SDEs) or Data Safe Havens — which provide a secure space for researchers to access and analyse health data without compromising privacy or compliance.
A Trusted Research Environment provides a secure space where Real-World Data can be accessed and analysed without compromising privacy. In pharmaceutical and life sciences research, it enables advanced analytics on large datasets, supporting drug development, safety monitoring, and evidence-based decision-making—all while ensuring data security and regulatory compliance. Turning data into knowledge, safely and responsibly!
Åsa Carlsheimer, Data Science and Analytics, BC Platforms
Why trust matters in TREs
The “trust” in Trusted Research Environments must be earned through rigorous safeguards and accountability. As a BMJ analysis notes, “Trust should be built on transparency, governance, and accountability — not assumed as a given.” [1]
TREs allow approved researchers to work with sensitive, pseudonymised datasets in a fully governed setting. Unlike traditional data-sharing models that require duplication or extraction, TREs keep data centralized, reducing the risk of breaches while maintaining access to analytical tools and diverse datasets.
Data custodians such as hospitals, biobanks, and research institutions ensure datasets remain secure and governed, accessible only to authorized users [2]. In a 2018 study, data sensitivity was cited as the top concern for 66 % of medical researchers — reinforcing the need for privacy-first solutions.
Lack of standardization also poses challenges. As reported in the International Journal of Population Data Science, “Interoperability remains a major barrier to seamless health-data sharing. Without standardized frameworks, researchers struggle to collaborate across TREs.” [3]
By enabling secure collaboration and reducing inefficiencies, TREs empower researchers to extract insights faster and drive scientific breakthroughs — while maintaining alignment with GDPR, HIPAA, and other data-protection frameworks.
Who uses TREs and why
TREs are essential for unlocking the full potential of Real-World Data, enabling researchers to collaborate across institutions while ensuring privacy-first, federated access.
Lifebit, The Complete Guide to Trusted Research Environments [4]
- Healthcare institutions: Analyse patient data securely for clinical research, epidemiology, and evidence-based decision-making.
- Pharmaceutical companies: Conduct real-world evidence studies, identify trial candidates, and evaluate treatment efficacy without compromising privacy.
- Researchers: Access high-quality datasets for genomics, epidemiology, and personalized medicine.
- Government and regulators: Monitor public-health trends and evaluate healthcare policies to improve outcomes.
BC Platforms’ TRE solution
While TREs enhance data security, interoperability between systems often remains a challenge. A PHG Foundation report notes that “Researchers accessing multiple TREs must navigate complex governance structures and data-use agreements, causing delays in research.” [5]
BC Platforms’ TRE solution eliminates these barriers. Built on a cloud-agnostic, federated architecture, it offers seamless, privacy-preserving access to global, research-ready, regulatory-grade patient data — compliant with GDPR, HIPAA, and ISO 27001.
By integrating federated data discovery, advanced data management, and secure researcher workspaces, BC Platforms enables:
- Analysis without data duplication or movement
- End-to-end encryption and airlocked secure desktops
- Scalable deployment across on-premises, hybrid, or public-cloud environments (Azure, AWS, GCP)
- Dynamic resource allocation for heavy computing workloads
This approach helps hospitals, research institutions, and pharma organizations collaborate securely while maintaining governance, compliance, and performance.
The European vision for secure health-data sharing
Europe is leading the way with the European Health Data Space (EHDS), a transformative initiative creating a unified, interoperable framework for secure, cross-border data sharing.
As regulations like GDPR and EHDS evolve, TREs will become the standard for ethical, secure, and scalable health-data research across borders.
Lifebit, The Complete Guide to Trusted Research Environments [4]
BC Platforms’ EHDS-ready TRE supports this vision, empowering healthcare institutions to collaborate on large-scale studies, helping pharmaceutical companies conduct regulatory-grade research, and enabling public-health agencies to monitor disease trends and policy outcomes. This new era of health-data collaboration will accelerate scientific discoveries, improve patient outcomes, and position Europe as a global leader in ethical, secure health-data research.
Secure. Compliant. EHDS-ready.
Explore how our Trusted Research Environment powers the next generation of Real-World Data collaboration — or reach ou to discuss your specific needs.
References
- Laurie, G., & Jones, K. (2022, September 5). Why Trusted Research Environments Are Not About Trust. BMJ Medical Ethics Blog. https://blogs.bmj.com/medical-ethics/2022/09/05/why-trusted-research-environments-are-not-about-trust/
- Raman, B., Samal, A., Johnston, S., & Ravichandran, V. (2024, December 18). Integrating Research and Engineering Studio in Trusted Research Environments Built on AWS. AWS HPC Blog. https://aws.amazon.com/blogs/hpc/integrating-research-and-engineering-studio-in-trusted-research-environments-built-on-aws/
- International Journal of Population Data Science (2023, November 8). Bridging the Gap to Unite Trusted Research Environments. https://ijpds.org/news/08-11-2023-bridging-the-gap
- Lifebit (2023, March 23). The Complete Guide to Trusted Research Environments in 2024. https://www.lifebit.ai/trusted-research-environment/complete-guide-2024
- PHG Foundation (2024, November). The Federation of Trusted Research Environments for Genomics and Health. https://www.phgfoundation.org/app/uploads/2024/11/The-federation-of-trusted-research-environments-for-genomics-and-health-.pdf