Publication date: 30th June 2023
Author: Hadley E. Sheppard, PhD
Trusted Research Environments (TREs), also known as “Data Safe Havens” or “Secure Data Environments”, are highly secure and controlled computing environments that allow approved researchers from authorised organisations a safe way to access, store, and analyse sensitive data remotely. TREs provide access to data while keeping it safe, secure and accessible, while also promoting collaboration and driving innovation.
TREs are being widely adopted across the world by organisations such as biobanks, governments and health providers, to provide both data accessibility and security. In the UK, for example, the government’s public sector research endeavour, Genomics England, has benefited from the adoption of TREs during the COVID-19 pandemic, where approved researchers could securely access the clinical and genomic data of over 135,000 patients in a secure, cloud-based TRE.
This article focuses on use cases of TREs and potential opportunities for TREs within the biobanking, research and health sectors of countries in the Nordic region as a means to achieve both data accessibility and security. It also highlights the guidance and regulation in establishing these critical data access and compute spaces.
The Nordic region, composed primarily of Denmark, Estonia, Finland, Iceland, Norway and Sweden, have all made significant contributions to population sequencing and genomics research. Having shared ancestry and highly homogenous populations makes it easier to study disease-associated genetic variants and rare genetic conditions in these populations. Due to this, there has been a high appetite for large-scale population sequencing to inform on personalised medicine in the Nordic countries. Most importantly, there are national strategies, funding initiatives and collaboration initiatives to foster sharing of this data within the Nordics.
An example of the Nordic region’s aim to position itself as a leader in research cooperation and infrastructure was the creation of NordForsk, by the Nordic Council of Ministers in 2005. One of the outcomes from NordForsk was investing NOK 165 million (about USD 15 million) into research efforts in personalised medicine. This effort was in collaboration with national funding agencies from Sweden, Iceland, Denmark, Finland and Norway. Awarded projects from this investment include using personalised medicine in a range of diseases, such as prostate cancer, sleep apnea, inflammatory bowel disease, ischemic heart disease, severe infectious diseases, rheumatoid arthritis, and also generation of new health economic evidence to address important health care decisions.
Being at the forefront of precision medicine is a shared goal of the Nordic countries, and has resulted in the formation of the Nordic Precision Medicine Initiative (NPMI) and development of a roadmap for the precision medicine initiative in this region. These initiatives and strategies have fostered collaboration and data sharing between governments, universities, research organisations and the private sectors. However, sharing of this data poses challenges and considerations, such as having the infrastructure to securely store and share information safely. The combination of wanting to foster collaboration and sharing of data, while keeping data safe and secure, has resulted in the adoption of Trusted Research Environments (TREs) across the Nordics.
With the increase in genomic research and data, some Nordic countries have already adopted Trusted Research Environments and similar models to be able to securely store the data, while promoting research collaboration. Listed below are some examples:
The Nordic countries have well-established healthcare systems, biobanks, universities and support from private companies to drive population-level studies. Listed below are national strategies and funding initiatives to further promote personalised medicine in the Nordic regions, resulting in generation of more genomics data that will need to be hosted and shared safely and securely, for example in a TRE.
When establishing a TRE within the Nordic region, there are a number of key considerations to ensure that data is safely stored and utilised. Providers of TREs should also be aware and be compliant with region-specific and national legislations relating to health and genomic data.
As described above, the use of TREs and Data Safe Havens in the Nordic region has increased in recent years, however, there is scope for continued adoption with the rollout of several precision medicine initiatives and funding. Increased data access and usage of health data from Nordic populations will not only help people and the health and care system in these countries, but will also benefit international research collaborations. Virtually connecting these sensitive datasets, enabling research studies without compromising security, can lead to greater research insights for the benefit of local, national and international populations.
Moving forward, if an organisation is endeavouring to establish a TRE for efficient and secure data access, they will need a well-defined security-by-design and governance framework in place to ensure compliance, in addition to wide-ranging technology capabilities.
Lifebit works proactively with clients, including Genomics England, the Danish National Genome Centre, Boehringer Ingelheim, NIHR Cambridge Biomedical Research Centre, and others to comply with sensitive data requirements. We ensure that organisations can meet and exceed industry standards amidst the changing regulatory and regional landscape - enabling valuable research at scale to improve patients’ lives.
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