A vision of a Europe where health data can be smoothly and efficiently transferred from one researcher or clinician to each other, with patient’s informed consent, to treat patients rapidly and to find better and more accurate therapies faster – that is what the European Health Data Space (EHDS) strives to achieve.
However, the road towards this ideal is long and there may be many bumps along the way. At the moment, European health records are not interoperable – data are collected in various ways that differ from hospital to hospital, in many languages and using diverse terminologies and methodologies for recording and organising data. In addition to health records there are also many other valuable sources of data for health research: registries, clinical trials, cohort studies and real-world data studies.
This means that before the data can be compared and used to find bigger patterns that could unveil more information about the diseases that we face, it needs to be found, harmonised and standardised. The data also needs to be accessible for research. Though it may sound simple, this is more difficult than it seems. There are legal, technical, ethical, data protection and sometimes intellectual property rights challenges involved.
That is where IHI and IMI comes in – under the framework of an IHI or IMI project, everyone can work together in a trusted environment, which has enabled access to a large amount of high quality data sequestered by individual private companies to further precompetitive health research.
IHI leads the way
A suite of new IHI projects will smooth the way towards the European Health Data Space. One of those is IDERHA, a project that aims to set up a federated health data space that will facilitate the integration and analysis of diverse types of health data, using lung cancer as a case study. Lung cancer is responsible for some 400 000 deaths in Europe every year, around 20 % of all cancer deaths. IDERHA is not only concerned with the technical aspects of creating such a health data space, but also with a strategic focus on the needs of regulatory authorities and health technology assessments, so that product research that may be conducted using the health data space will have regulatory requirements built-in from the get-go.
IDERHA has already taken steps to harmonise its objectives with the goals of the European Health Data Space. The project carried out a mapping first, examining the main EHDS initiatives and projects on primary and secondary use of data and comparing them to IDERHA’s plan of work. IDERHA then investigated existing initiatives on using data to drive personal health management – including, for instance, IMI project Gravitate-Health, which is developing an app to allow people to more easily read the most relevant parts of an electronic product information leaflet. The project also mapped ongoing initiatives using AI or machine learning to standardise health data regarding cancer, including the IMI Optima project, which is building a federated network of data providers on cancer. Other IMI projects like EHDEN, FAIRplus and H2O were also flagged by IDERHA in their mapping exercise. Terminology is also extremely important, and IDERHA endeavoured to ensure that the language that will be used during the project matches the terms used by the EU when talking about the EHDS.
In January, we also released our call for proposals on how the EHDS can enable the use of secondary health data for innovation while safeguarding intellectual property. Here, we are looking for project proposals that can balance the societal benefits of data-driven innovation in healthcare against the interests of public and private sector innovators. Applicants will need to explain how they plan to enable the harmonised and efficient sharing of IP-protected data – for instance, by developing frameworks and guidelines. You can read more about this topic here.
IMI sets the scene
IMI has already been addressing the goals of the EHDS for many years. IMI projects such as EHDEN took the first steps towards harmonising and standardising public-private health datasets, successfully harmonising and standardising more than 400 million anonymous electronic health records into a common data model, delivering a vital resource to health researchers, in a first step towards the vision of the European Health Data Space.
Another IMI project, H2O, is examining how patients can retain control of their data throughout the research pipeline, a factor which is very important for the European Health Data Space. To do this, the project provided patients with digital tools, including an app, to report their health outcomes in a standardised way. The data are then anonymised and tracked so that individual patients and their clinicians can compare their progress with other patients with similar health issues.
A third IMI project, Optima, is building the first interoperable, large-scale oncology data and evidence generation platform, containing data from over 200 million people. The platform, which will be compliant with the General Data Protection Regulation, will host data sets, data analysis tools, federated learning tools, and artificial intelligence (AI) tools. Optima is focusing on three main types of cancer: prostate, breast, and lung.
The BIGPICTURE project is investigating whether image data, which comprises more than 90% of health data, could be scanned and analysed by AI, and then place in a repository for scientists to use. The project is creating the infrastructure needed to store, share and process millions of (often heavy) image files and will investigate the legal and ethical concerns related to patient privacy and data confidentiality. The project intends to include 3 million digital slides from human and animal samples in the repository.
“Data-driven research in the health sciences rests on the trust from research participants, patients, regulators and society at large. IHI’s public-private partnerships, with their broad cross-sectorial involvement, are ideal platforms to advance Europe’s innovation potential,” says Niklas Blomberg, IHI Executive Director.
“All of these ongoing projects will pave the way towards the EU’s vision for an interoperable and connected European health data space, with all the benefits for society that it will bring.”
EHDEN, H2O, Optima, FAIRplus, Gravitate Health and BIGPICTURE are supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.