Patient data is fundamentally special and requires sensitive handling within cyber secure software environments, especially when it is being used for research, diagnostics and treatment. But that’s much easier said than done, as Timo Kanninen, CSO at BC Platforms (BCP), explained in a keynote presentation at BIO-Europe about new legislation for enabling access to harmonized real-world data from hospitals across Europe. The challenge in accessing harmonized data

The difficulty comes in part as ‘data’ covers such a wide range of potential sources. There’s a myriad of health data types, from comparatively simple things such as a patient’s age, weight, and height, to much more complicated variables such as the results of blood and tissue tests, through to high-information density visual data provided by medical imaging systems from X-Rays through to MRIs and CT scans. Different hospitals may also annotate patient data differently (e.g. using different medical vocabularies and data structures of the medical data), and, in Europe, many different languages are used in the notes of a patient’s medical record. For research to drive forward, patients to benefit, and healthcare systems to thrive, this data needs to be efficiently harmonized for use between healthcare institutions, life sciences companies, and across international borders without compromising patient privacy.

Finland is leading the way with its pilot study

To provide a solution to these pain-points, BC Platforms has been collaborating with other leading deep-tech data integrators in Finland to jointly publish, as partners, the ‘reference architecture’ that has been designed to underpin the foundations of harmonizing health-data in Europe. Just like architectural plans in the real world are used by a wide variety of sophisticated organizations with highly skilled employees to produce beautiful buildings, in software it’s essentially the same approach to making the best use of real-world data. Here, the software architects and data integrators working together are BC Platforms, Modirum Platforms, VEIL.AI and Productivity Leap, each providing a superior set of software-savvy skills, coupled with a large dose of Finnish ‘Sisu’: the grit and determination to get something difficult done, and done well.

These four companies have long been providing innovative software solutions for data access and data analysis to support medical research and the efficient running of healthcare systems. In this case they were spurred to come together with Helsinki University to support compliance with looming European legislation, designed to create a unified digital health ecosystem. This legislation, called the European Health Data Space secondary framework (EHDS2) will make data readily available from hospitals and is expected to drastically increase the number of data enquiries to process information. See press release here.

New software tools needed to support the delivery of EHDS2

By way of example, Finland’s Care Helsinki University Hospital typically receives around 800 data requests annually (around 95% internal) leading to around 200 projects with granted data access. Both data queries and data access application processing are mostly manual process. This will simply be impossible to deal with using existing healthcare human resources and software systems and hence BCP is employing an AI supported software platform to help enable rapid access to healthcare data under EHDS2 regulation. This platform provides solutions for Data Discovery, Data Access Application Management and Data Release and a Secure Processing Environment for Federated Analyses in a synthetized or anonymized format.

The goal of the new legislation

EHDS2 is anticipated to impact hundreds of European hospitals, and thousands of organizations with healthcare data. The goal of this legislation is to:

• facilitate access to different sources of health related data across the EU for research
• provide a consistent, trustworthy, and efficient system for reusing health data for research, innovation, policy-making, and regulatory activities without compromising patient privacy
• foster research and innovation activities in the EU for better global competitiveness and improved patient care

By doing so, the EHDS should enable Europe to fully benefit from the potential offered by a safe and secure exchange, use and reuse of health data to benefit patients, researchers, innovators, and regulators. It is estimated that the implementation of EHDS will generate €5.5 billion in savings for the EU over ten years through better access and exchange of health data in healthcare. However, enabling EHDS across the entire EU will require a significant investment of time, resources, and technology to enable fast and fair data access and sharing.

BCP’s role in supporting EHDS

BCP’s goal is to support this initiative by providing a platform helping researchers to access data for research and innovation. For streamlining and automating data access processes, vast data lakes must be harmonized to structured standard formats with acronymized names such as OMOP CDM and FHIR. A carefully curated software system, enhanced with AI-based tools, is needed to process growing amount of data queries and data access applications, and join the digital dots to enable rapid data discovery, informed clinical decision making, and advance medical research and personalized medicine.

The goal is to use BCP’s market-leading EHDS-ready Trusted Research Environment* Technology to facilitate the transition from current, mostly manual systems serving internal researchers, to automated EHDS compatible systems serving all researchers across the EU. Ultimately this means speeding up ‘data request’ tasks currently taking months to years to complete, due to the complexity of application processing for data access and the logistics of working with non-harmonised data, to one that could be done in days or weeks. Finland is leading the way in this initiative and is the first country to have secondary and biobank laws, official HDAB as well as major role in TEHDAS projects shaping the EHDS framework. In addition to the Finnish initiative, BCP’s software has also been used to implement the HDR-UK real-time data availability query service, which combines 11 NHS Trusts in one federated platform. This example provides a benchmark and validation of the technology and underlines the importance of fast access to data.

By automating internal systems and harmonizing healthcare data now, using European and government reserved funds for EHDS implementation, hospitals can use their enhanced digital capabilities to focus on delivering high quality patient care, healthcare cost savings for payers and advancing new diagnostics and medicines for researchers.

EU-wide data access enabled by EHDS is expected to fuel annual growth in the global RWD market by 15-20% and increasing demand for AI. University hospitals need to take decisive action today to start optimizing their RWD access processes to drive competitiveness in research and development as well as pricing and reimbursement.

For more information about EHDS check here.

*Trusted Research Environments (TREs) can also be referred to as ‘Secure Data Environments’ (SDEs) or ‘Secure Processing Environments’ (SPEs). See here for more information.