The secure and efficient sharing of data has changed how we live. From entertainment and communication to travel and financial services, the world have become more connected. Healthcare has been slow to embrace the digital revolution, but collaboration between public and private partners across Europe is helping to change that.  

The Innovative Medicines Initiative (IMI) has supported 17 consortia which aim to standardise the way data are collected and recorded. The overarching goal is to ensure that health data are FAIR: findable, accessible, interoperable and reusable.  

This requires a significant effort and investment, but the prize is priceless. Data sharing benefits health research and drives innovation in healthcare. Ultimately, if Europe can accelerate the development and uptake of digital health, patients and society will benefit.  

Connecting healthcare  So, how can the potential of health data be unleashed, while ensuring privacy and security for individuals? Several IMI projects have taken on this task while others are using large datasets to unblock bottlenecks in health research.  

For example, FairPlus is ensuring that IMI and EFPIA data meet the FAIR principles, while EHDEN is helping to create a distributed network that allows researchers to mine the data of 100 million EU citizens – while complying at all times with GDPR.     

By supporting the health data ecosystem, researchers are working to improve outcomes in people with blood cancers (HARMONY), testing real-world evidence in Alzheimer’s disease (ROADMAP), and harnessing big data to advance the treatment of prostate cancer (PIONEER).  

Large datasets can also help to identify causes of dementia and obesity (EMIF) and to share toxicology data used in early medicines development (Safe-T).  

Patient-centred trials 

Digital tools are changing how clinical research is conducted. Not only can trials be brought closer to patients (Trials@Home) and made more patient-friendly (EU-PEARL), clinical researchers and industry can provide regulators with the reliable data needed to assess the impact of new medicines. The use of artificial intelligence tools in histology (BIGPICTURE) and real-world data in drug development (GetReal) promise further advances in research and care.   

In all of these collaborations, patients are centre stage. For example, digital measurements of how well people with Parkinson’s disease can walk, provide valuable and precise feedback on patients’ ability to carry out daily tasks (MOBILISE-D). Digital tools can also track quality of life indicators, such as sleep, in people with inflammatory diseases (IDEA-FAST).  

Keeping patients safe and healthy remains a priority. New technologies are paving the way for earlier detection of medication safety issues (WEB-RADR) and detect early warning signs of illness using remote monitoring (RADAR-CNS).   

Building trust 

Taken together, these digital technologies can drive long-term transformation of health systems, making them more efficient and focused on outcomes that matter to patients. To ensure the full potential of digital health is realised, public trust is vital. Patient engagement helps researchers to understand patient expectations and any concerns about how data is used. 

All IMI projects ensure that data collection, analysis and sharing are conducted to the highest legal, ethical and privacy standards. As researchers are often working at the cutting edge of their field, best practices or guidelines are not always available. When this is the case, IMI consortia develop new standards which can be used by others.  

For example, researchers have pioneered robust consent methodology (DO->IT), developed blockchain (PharmaLedger) and machine learning platforms (MELLODDY), built registries for collecting data on pregnancy and medications (ConcePTION), and worked to reduce variability in how data is used in clinical studies (EQIPD).  

Digital futures 

IMI projects are leading the co-creation of trustworthy data governance frameworks and are striving to share best practice. These bold collaborations will shape the digital future of healthcare by balancing the needs of healthcare systems treating today’s patients and researchers seeking tomorrow’s therapies.  

In isolation, each project offers pragmatic solutions to a great challenge. In combination, they have the potential to contribute to paradigm shifts in research that will have a lasting impact.