New White Paper calls for removal of barriers in regulatory framework to harness the power of AI, to save lives and cut costs

Press release

Brussels, 21 June 2022 - A new White paper: “Unlocking the power of data in healthcare a European vision”, presented the 21st of June 2022 in Brussels called for urgent reform to regulatory and privacy regulation. A global “Culture change” is needed to harness the power of the digital world and digital citizens, removing bottlenecks to open up new approaches to research and care. “The pace of technology development allows us to process huge amount of data in minutes, extracting exceptional knowledge and insights, where only a few years ago it would have required decades. We need to unleash this opportunity working together in for bringing benefits to all” said Andrea Pescino, Partner and founder, StratejAI, who coordinated the White Paper published by the The Healthcare Data Innovation Council.

The Paper was presented to key actors of the healthcare community from AI experts, industry and European institutions, clinicians, patients, researchers, pharma, technology providers and MedTech companies at an event in Brussels entitled: Data-driven future of Healthcare. Yiannos Tolias, Legal Officer European Commission’s DG SANTE gave the keynote address: “The abundance of health data combined with advancements in digital health including AI have created a promising potential to revolutionize healthcare. We all need to work together so patients can reap the benefits of this revolution”
“We are working to make data secure and private; we need data to be as open as possible, usable and empowering to create the value that the healthcare system needs”, said Jeff Bullwinkel, Associate General Counsel and Director of Corporate, External & Legal Affairs at Microsoft Europe.
The global impact could be enormous, with a global market valued at $8.23 billion in 2020, projected to reach $194.4 billion by 2030, growing at a CAGR of 38.1% . The Paper points to drawbacks such as the global lack of harmonization across data sharing standards and interoperability; the current regulatory framework, which is very stringent, difficult to interpret, fragmented between EU member states and even regions, and to new upcoming regulations, such as the DGA or the AI Act, that could trigger contradictory trends.
“GDPR has not adequately addressed the necessary conditions for research with health data. National legislations are not homogeneous, each data protection authority defines its own criteria and it is practically impossible to share pseudonymised data or personal data. Especially when it comes to the analysis of large volumes of data,” said Ricard Martinez Martinez, Director of the Chair of Privacy and Digital Transformation at the University of Valencia speaking at the event.
While in US health care providers gains the property right of possession of data, in the EU, healthcare data are distributed across 512 million people. This healthcare data space has the potential to become a competitive advantage for Europe with better harmonisation in regulations and standards, as consumers are becoming more and more digital users, with wearables, connected devices and mobile apps that offer direct or indirect health services, which generate huge amount of data. “We launched Pillo in the US market because it's challenging for a startup to deal with all the legal aspects required to enter the European market and every state's regulation. The cost of all the necessary legal and consulting activities and the effort to manage different solutions for every single national market is not sustainable for small companies.” Said Emanuele Baglini – CTO Pillo Health.
The White Paper highlights emerging new ways of handling data. Jeroen Tas –Director of Gaia-X, an initiative that develops a software framework of control and governance and implements a common set of policies and rules, spoke of decentralization and self-sovereignty: “Gaia-X aims to enable the future of European healthcare: federated, citizen-centric and insight-driven. We are guided by the quadruple aim: better health outcomes, better patient experiences, more efficient care and better professional experiences.”He said.
Brak opisu.

In a similar way, the MedTech and start-up ecosystem is growing rapidly, creating solutions that frequently target consumers rather than supporting providers or organizations. And all these small, consumer targeted solutions generate data, without a clear governance or model to share them, risking fragmenting the innovation in different uncoherent streams.
The transformations envisioned by systems from the new paradigm of the 4P (personalised, predictive, preventive, participatory), or with the emerging strategy of value-based healthcare, have their foundation based on data. Delegates stressed that the time to accelerate on data usage is now, and there is a global need to:
- Bring clarity and progress the legal framework on data sharing
- Facilitate and support the cultural transformation to accelerate adoption and promote the creation of centralized initiatives and data ecosystems
- Promote the adoption of National and regional strategies on data usage for healthcare to consolidate the efforts and streamline investments and transformations

Is data the new oil? The Paper asks. To find innovative approaches to critical diseases as cancer, new vaccines, or protein development, data from many patients are required, that could be gathered from many countries or regions. This is even more true for new diseases which may still be untreatable. In biomedical research, there is the need for new paradigms very different from the existing outdated ones. The advantages offered by the usage of data, especially big data and artificial intelligence, should lead to a vision not only based on individual interest but with obvious prejudice to the common good.

A cultural transformation is needed at all levels, from understanding and promoting digital literacy, to the definition of effective privacy preserving techniques, to consolidating trust while not limiting the verification of results. Data ecosystems are already being created, but they need to be promoted and supported effectively, to become a crucial part of national and regional strategies. The Paper identifies central initiatives like the “Health Outcome Observatory – H2O” created in Europe as a positive model to facilitate the transformation, accelerate innovation, and strengthening the patient voice in health care. Another model sighted in the Paper is the UK government’s draft national strategy: “Data saves lives: reshaping health and social care with data”.
Case studies were presented to showcase the benefits of data driven innovation in a wide range of applications, from improving diabetes care to early diagnosis of leprosy.

GdL 6/2022