Can TREs actually scale up healthcare data use?

Executive summary

As healthcare organizations generate unprecedented volumes of data—yet leave up to 97% of it unused—Trusted Research Environments (TREs) offer a pathway to unlock this potential safely. Drawing on BC Platforms’ real-world deployments from Finland to Singapore, we explores how TREs are transforming collaboration, enabling AI-driven analytics, and preparing healthcare systems for the coming EHDS era.

Key insights:

• TREs balance privacy and progress, enabling compliant analysis without data movement.
• Federated, cloud-agnostic TREs scale globally, powering projects like FinnGen and EHDS.
• Secure TREs like BC Platforms’ accelerate precision medicine and real-world evidence.

Access to data is crucial for developing personalised medicine, as is understanding which treatments and drugs work for different patients. Data is also used for continuously monitoring the efficacy and safety of new drugs after launch, as well as for navigating value-based medicine, where drug manufacturers get reimbursed based upon patient health outcomes. Despite the critical role of data, however, 97% of all data produced by hospitals has been reported as being unused [1]. Is it possible to access and unlock all of this unused healthcare data effectively?

The life sciences and healthcare industries are undergoing rapid transformation with the ongoing convergence of data and technology, to be able to benefit from the unused 97%. While real-world data and AI-driven analytics are accelerating medical innovation and improving health outcomes, such gains can, unfortunately, be hindered by data privacy concerns, regulatory constraints, and fragmented data sources. As reported in a recent study, the healthcare industry is highly vulnerable to data breaches, and compromised data makes patients less likely to seek healthcare [2]. Striking the right balance between security and innovation is therefore crucial.

To overcome such hurdles while driving innovation, the industry has developed secure processing environments (SPEs), which are secure Cloud or computer hardware, as well as trusted research environments (TREs) – software that runs within SPEs, providing tools and controls for data analysis. Together SPEs and TREs deliver a secure space where researchers can access and analyse health data while preserving security, privacy, and compliance.

The upcoming European Health Data Space (EHDS) regulation will, in addition to facilitating using healthcare data for research across the European Union (EU), defines specifications for approved SPEs, and BC Platforms will be a key provider delivering the TREs to run in these approved environments. The new regulations also require all university hospitals (trusted data holders) have access to some TREs to provide access to their approved data also for external researchers, excluding intranet-based solutions.

Addressing healthcare challenges while safeguarding patient data

As secure computing platforms, TREs allow approved researchers to work with approved, pseudonymised datasets in a fully governed setting, without possibility to export or download any data out from the server. Unlike traditional data-sharing models that require duplication or extraction, TREs keep data in one secure place, minimizing the risk of unauthorized access or breaches while providing researchers with a seamless experience to access analytical tools and diverse datasets. When running TREs in Cloud environment, practically unlimited computing and storage resources are available for data analyses. By enabling secure collaboration and reducing inefficiencies, TREs also empower researchers to extract insights faster to drive scientific breakthroughs.

When data has been harmonized to a standard format, then federated analysis can be applied. Instead of accessing individual level data, researchers can send scripts to produce ‘aggregate data’, e.g., the mean of all of the laboratory values, then statistically combining these values from multiple data sources. While the EHDS also facilitates accessing pseudonymised individual level data in TRE, federated analysis provides benefits e.g. where datasets are very large or very sensitive.

TREs also help ensure ethical and lawful data use. In Europe, GDPR governs compliance with national health data access laws, while the upcoming EHDS will create a unified legal framework for secure health data use across member states. In the US, TREs must adhere to HIPAA regulations to uphold patient privacy. Meeting such strict security requirements of SPEs means that using a commercial Software-as-a-Service (SaaS) provider, such as BC Platforms, can be much more cost-efficient and reliable than building an in-house system, whether it’s on the Cloud or a bespoke, internal system. This can also remove the burden of the continuous audits and security monitoring processes required for in-house systems, delivering further cost savings.

Establishing a trusted space within organizations for health data use

Organizations and individuals benefitting from TREs include:

• Healthcare institutions: Hospitals, research centres, and public health organizations use TREs to analyse patient data securely, supporting clinical research, epidemiological studies, and evidence-based decision-making.
  
• Pharmaceutical companies: TREs allow pharma to conduct real-world evidence studies, identify potential clinical trial participants, and gain insights into drug efficacy without compromising patient privacy. Unfortunately, the available open-access, public solutions might not meet all of pharma’s needs in the most resource-efficient way. As SaaS is very popular tool in pharma research, and at BC Platforms, we provide optional SaaS-support for researchers to use their existing and proven scripts for data analyses.
  
• Researchers: Universities and independent research bodies use TREs to access high-quality datasets for clinical, genomics, epidemiology, and personalized medicine studies. In collaborative projects, or when providing access to pharmaceutical companies, hospitals, or other external collaborators, Cloud-based TREs can also be used to record used record computing resource consumption at the project level, for billing purposes.
  
• Government and regulatory agencies: National and regional agencies leverage TREs to monitor public health trends, evaluate healthcare policies, and improve patient outcomes.

BC Platforms’ TREs provide unmatched access to global, research-ready, regulatory-grade patient data

We are a pioneer in real-world data and federated architecture solutions. Our TRE solutions, used by leading research organizations around the world, are designed to provide seamless, privacy-preserving access to global, research-ready, regulatory-grade patient data in compliance with GDPR, HIPAA, and ISO 27001. The EU is currently defining technical specifications for SPEs where approved, pseudonymised data can be stored for data analysis. Being Cloud and hardware agnostic, we are confident in deliver our software to SPEs, including Sovereign Cloud systems. Sovereign Cloud means that the operator is an European company – located and operated entirely within the EU, providing more stringent data residency, operational autonomy, and resiliency requirements.

With access to over 130 million patient lives, of which 90% is ex-US data, we offer RWD spanning clinical data, EMRs, eCRFs, labs, multi-omics, and imaging across oncology, neurology, immunology, and rare diseases. RWD is delivered via our TREs, which have proven global scalability across the life sciences and healthcare. With automated data ingestion and curation, and advanced AI capabilities, we can help researchers to perform their analyses and collaborate with other researchers, while reducing the burden on internal IT resources and preventing typical internal bottlenecks and delays.

Our experience includes a global track record of excellence, working in close collaboration with a network of world-leading researchers, developers, and major industry partners, including:

• University of Nottingham and Nottingham University Hospitals NHS Trust, one of the biggest and busiest NHS Trusts in the UK. An extended, joint partnership was announced in late 2024 to continue to provide TREs to accelerate dialogue and data sharing between clinicians and basic researchers.
  
• The FinnGen project, a large public-private partnership that analyzed 500,000 Finnish biobank participants. BC Platforms delivered a secure, audited system for performing clinical and genomic data queries at scale.
  
• The Southampton Clinical Trials Unit, a Cancer Research UK core-funded trials unit serving over 4 million patients across the south of England. Their iDx Lung study has been applying BC Platforms’ technology and was awarded the ‘Further, Faster, Together’ Award for industry-academia collaboration at the 2022 Cancer Research Horizons Innovation and Entrepreneurship Awards.
  
• Helsinki University Hospital (HUS), its European consortium project termed ONCOVALUE, was awarded EUR 7 million. As a key partner, BC Platforms will provide sophisticated, trusted collaborative environment solutions for healthcare data management and analytics in this European Commission project that is expected to recruit 40,000 European patients annually.
  
• Lee Kong Chian School of Medicine, NTU Singapore (HELIOS Study): BC Platforms supports the SG100K precision medicine initiative by managing genotypic and phenotypic data from a large Asian cohort. Our role in this project demonstrates our platforms’ global scalability, with the capacity to support population-scale research.

References

1. World Economic Forum (2019). 4 ways data is improving healthcare. Available at: https://www.weforum.org/stories/2019/12/four-ways-data-is-improving-healthcare.
2. Park, E. & Lim, J.H. (2025). The impact of healthcare data breaches on patient hospital visit behavior. International Journal of Research in Marketing. https://doi.org/10.1016/j.ijresmar.2025.01.004.
3. Health Data Research UK. Trusted Research Environments. Available at: https://www.hdruk.ac.uk/access-to-health-data/trusted-research-environments.