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Regulators need solid evidence that new technologies are reliable. IMI can provide it

Innovation, meet regulation: oversight of the technosphere will be greatly helped by a neutral go-between

By Pierre Meulien, IMI Executive Director

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Image by WNGSTD/Shutterstock


The technological breakthroughs that made the human genome project possible were, for me, the starting point of a major acceleration in the way healthcare has converged with information technology. An unprecedented collaborative effort sped up the sophistication and power of sequencing and genotyping technologies, and heralded advances in analytical tools and imaging methods, among others. The human genome took several billion euro and over a decade to sequence for the first time; now it can be done in a day or two for a few thousand euro. In what other field has the technology accelerated so quickly?

Right treatment, right patient, right time

The push for personalised medicine has hastened this acceleration further, because understanding a patient profile and tailoring treatments for them requires better diagnostics. Digital tools can give a very holistic view of someone’s health, and merging metabolic, genomic, and physiologic parameters collected thanks to innovative devices can give doctors and patients a zoomed-out view of the state of someone’s of health.  

IMI projects have been on the front lines of this evolution. We have been building informatics platforms and bringing diverse big data sources and formats together and harmonising and standardising them (the IMI BD4BO programme), and even training and certifying people on how to do it (EHDEN). While some projects are experimenting with different data capture methods, using sensors and devices to measure things like gait and other movements as signs of a person’s wellbeing (MOBILISE-D, RADAR-CNS), others are running clinical trials completely remotely (Trials@Home), making scientific data accessible and interoperable (FAIRPlus), and even using social media to help monitor adverse reactions (WEB-RADR). PharmaLedger is bringing blockchain into drug development, while MELLODDY uses advances in machine learning to leverage the combined proprietary data of pharma partners in early drug development, while keeping if fully confidential.


Health is different

Every sector is seeing this technological transformation; smart devices and apps can be programmed for many tasks, they are relatively easy to commercialise, and new versions come out every few months. The difference with healthcare is the time it takes for these innovations to filter down to the health system. Before any regulatory body will allow the use of a new digital health technology, whether it be an app, a device, or an artificial intelligence algorithm to monitor and give readouts of blood glucose levels or any other health parameters, they have to be ‘validated’ – meaning, they need to be proven to be reliable.

It turns out that IMI is not only useful for helping pharmaceutical companies develop new medicines; others, in the medtech and IT domains, like GE Healthcare, Siemens and Nvidia have come on board in recent years, eager to understand how they can make sure their innovations can be used by health providers. This is new territory for everyone, and we need to understand the interplay between the regulatory requirements (medicinal products vs devices) and build new frameworks for how these innovations get qualified. IMI can facilitate the discussions between these technology companies and regulators, the pharma companies and scientists, as well as those who are going make decisions about reimbursement. Conversations with regulators are already underway because we encourage all of our research project consortia to build interactions with them from very early on, turning our projects into a kind of testing ground for the regulatory frameworks to come.

We make it possible for competitors to work together to set the standards that can be applied across the industry, thereby avoiding a piecemeal approach resulting from bilateral dialogue between a particular company and a particular health provider about a particular technology. The inclusion of health technology assessment bodies (HTAs) and payers in the discussions is of course, vital; with a plethora of different platforms, apps and gadgets out there, how can HTAs understand which one is going to be worthy of informing reimbursing decisions? We saw what happened with the COVID-19 testing technologies: some of the early ones turned out not to be very accurate. A diagnostic test that's only 50% accurate is of little use to anyone. The business case has to be very clear for any new innovation. What kind of economic models will be convincing?

Understanding the others' perspectives 

IMI is the perfect platform to convene these discussions and carry out these demonstrations. While in the past the regulatory authorities occupied the role of enforcer, there is widespread understanding that what’s needed is multilateral dialogue between all the groups with a stake in the outcome. The authorities need help understanding complex technological advances, while the innovators need help understanding what will make the regulators approve their application. The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) signed off on a report after a joint IMI-EMA-FDA Regulatory Summit in 2019 that stated that “collaborative mechanisms, such as IMI, are needed to create common understanding of problems, body of knowledge and proof of concepts that would inform the evolution of the regulatory practice.”

IMI can provide a transparent, neutral and, importantly, pre-competitive setting. It's one of the ideas that is driving the creation of IMI’s successor, one of Europe’s new health partnerships. The technology will move very quickly, so we should, too.

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