Ugo PagalloProfessor of Philosophy of Law and Legal Informatics, wonders if, in addition to a law, there is also a duty to health, as the title of the book written for Mimesis edizioni states. His positive response and as a paradigm of this lack of duty the author brings the underuse of artificial intelligence in healthcare. In countries such as Italy, Pagallo estimates they can affect up to 2% of the gross domestic product: A tragic luxury that we cannot and should not affordwrites Pagallo.
Of the same opinion l‘Healthcare Data Innovation Council, a group representing diverse actors in the healthcare sector (clinics, patients, researchers, pharmaceutical and medical companies) and aims to advance regulatory frameworks and privacy preservation technologies for sharing and using data. The Council presented the White Paper Unlocking the Power of Data in Healthcare, a European Visionasking for one urgent reform of regulatory and privacy regulations.
Cultural change
Net of the hype that often surrounds it, that of the use of data in healthcare is a central and thorny topic, the elephant in the roomaccording to the metaphor used by Julian Islapresident and co-founder of Foundation 29 a non-profit foundation that in Spain works for a medicine in which responsible patients take control of their health through their data and they work with doctors and institutions to improve their own well-being and that of others. Patients don’t know they don’t have their medical records. Citizens need to wake up and have their data for the common good, he added.
For this reason, the European Union, on 3 May last, presented a proposal for a regulation to establish the European health data space. Now, according to the authors of the White Paper, a global cultural change is needed to take advantage of the opportunities of the digital world and digital citizens,
removing bottlenecks to open up new approaches to research and assistance.
The pace of technological development allows us to process huge amounts of data in minutesextracting exceptional knowledge and insights, which just a few years ago would have taken decades. We must unlock this opportunity by working together to benefit allhe stressed Andrea Pescino, partner and founder of StratejAI, who coordinated the White Paper published by the Healthcare Data Innovation Council. The document was presented to key players in the healthcare community by experts from Ia, European industry and institutions, doctors, patients, researchers, pharmaceutical industries, technology providers and MedTech companies in the Data-driven future of Healthcare event held at the Microsoft Executive Briefing. Center of Brussels.
Safe data
Yiannos ToliasLegal Officer DG Sante of the European Commission: An abundance of health data combined with advances in digital health, including artificial intelligence, have created promising potential to revolutionize healthcare.. We all need to work together so that patients can reap the benefits of this revolution. We are working to make the data safe and private; we now need the data to be as open as possiblethat can be used and empowered to create the value the health system needs, he said Jeff BullwinkelAssociate General Counsel and Director of Corporate, External & Legal Affairs of Microsoft Europe.
A very rigorous and fragmented regulatory framework
The global impact could be huge, with a world market valued at $ 8.23 billion in 2020, which is expected to reach $ 194.4 billion by 2030, growing at a CAGR of 38.1%. The document highlights disadvantages such as the global lack of harmonization between data sharing standards and interoperability; the current regulatory framework, which is very strict, difficult to interpret, fragmented between EU Member States and even regionsand upcoming new regulations, such as the Dga
or theAi Act
which could trigger contradictory trends.
The GDPR did not adequately address the conditions necessary for research through health data. National laws 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 analyzing large volumes of data, he was keen to clarify Ricard Martinez MartinezDirector of the Chair of Privacy and Digital Transformation at the University of Valencia.
The health data space
While in the United States, health care providers gain ownership of data possession, in the EU health data is spread across 512 million people. This health data space has the potential to become a competitive advantage for Europe with better harmonization of regulations and standards, as consumers are increasingly becoming digital users, with wearables, connected devices and mobile apps that offer direct or indirect health services, which generate huge amounts of data. The White Paper highlights the new emerging ways of managing data.
Jeroen TasDirector of Gaia-X, an initiative that develops a data governance and control framework, and implements a common set of policies and rules, he spoke of decentralization and self-sovereignty: Gaia-X aims to enable the future of European healthcare: federated, citizen-centered and guided by intuition. We are driven by the fourfold goal: better health outcomes, better patient experiences, more efficient care and better professional experiences.
There is no precise guide
Similarly, the‘MedTech ecosystem and start-ups is growing rapidly, creating solutions that often appeal to consumers rather than supporting suppliers or organizations. And all these small consumer-focused solutions they generate data, without precise guidance or a clear model to share it, risking to fragment innovation into different inconsistent flows. The transformations imagined by the systems starting from the new 4P paradigm (personalized, predictive, preventive, participatory)or with the emerging Value-based healthcare strategy, find their foundation in the use of data.
The proposals
Delegates stressed that time to speed up data usage now and there is a global need for: bring clarity and advance the legal framework on data sharing; facilitate and support cultural transformation to accelerate adoption and promote the creation of centralized initiatives and data ecosystems; promote the adoption of national and regional strategies on the use of data for health care to consolidate efforts and simplify investments and transformations.
Application of AI to critical illnesses
It is often said that data is the new oil. Effectively p
Andr Finding innovative approaches to critical diseases such as cancer, new vaccines or protein development, data from many patients is needed, which could be collected from many countries or regions. This is even more true of new diseases which may still be incurable. According to the Council, in biomedical research there is a need for new paradigms that are very different from the existing obsolete ones. The application of artificial intelligence to medicine is a great challenge – he says Elisa Ficarrafull professor of the Engineering Department “Enzo Ferrari” – DIEF University of Modena and Reggio Emilia, called by the Council to participate as an external expert – because the extremely complex medicine and therefore it is necessary to model a system of enormous complexity. And he adds: Undoubtedly the Covid-19 experience has promoted various appreciable local initiatives in the regulation of data sharing and processing. However, these local movements and projects are a substantial limitation in the definition of a common European strategy and, consequently, in the implementation of common regulations, standards and best practices.
The benefits of using data, especially big data and artificial intelligence, should lead to a vision that protects individual rights but does not prejudice the common good. a cultural transformation is needed at all levels, from understanding and promoting digital literacy, the definition of effective techniques for the protection of privacy, the consolidation of trust without limiting the verification of the results, is emphasized in the document.
Virtuous models
Data ecosystems are already being created, but they need to be effectively promoted and supported to become a crucial part of national and regional strategies. The document identifies central initiatives such asHealth Outcome Observatory – H2O created in Europe as a positive model to facilitate transformation, accelerate innovation and strengthen the patient’s voice in healthcare.
Another model highlighted in the document the national strategy of the British government: Data Saves Lives: Reshaping Healthcare and Social Care with Data. Case studies were presented to show the benefits of data-driven innovation across a wide range of applications, from improving diabetes care to early diagnosis of leprosy.
June 21, 2022 (change June 21, 2022 | 13:04)
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