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Artificial intelligence (AI) is changing the world we live in, and it has the potential to transform struggling healthcare systems with new efficiencies, new therapies, new diagnostics, and new economies. Already, AI is having an impact on healthcare, and new prospects of far greater advances open up daily. This paper sets out how AI can bring new precision to care, with benefits for patients and for society as a whole. But it also sets out the conditions for realizing the potential: key issues are ensuring adequate access to data, an appropriate regulatory environment, action to sustain innovation in research institutes and industry big and small, promotion of take-up of innovation by the healthcare establishment, and resolution of a range of vital legal and ethical questions centred on safeguarding patients and their rights. For Europe to fulfil the conditions for success, it will have to find a new spirit of cooperation that can overcome the handicaps of the continent's fragmented technical and legal landscape. The start the European Union has made shows some ambition, but a clearer strategic vision and firmer plans for implementation will be needed. The European Alliance for Personalised Medicine (EAPM) has listed its own priorities: data, integrating innovation into care, building trust, developing skills and constructing policy frameworks that guarantee infrastructure, equitable access, and legal clarity.

Artificial intelligence (AI) is changing the world we live in, and it has the potential to transform struggling healthcare systems with new efficiencies, new therapies, new diagnostics, and new economies. Already, AI is having an impact on healthcare, and new prospects of far greater advances open up daily. This paper sets out how AI can bring new precision to care, with benefits for patients and for society as a whole. But it also sets out the conditions for realizing the potential: key issues are ensuring adequate access to data, an appropriate regulatory environment, action to sustain innovation in research institutes and industry big and small, promotion of take-up of innovation by the healthcare establishment, and resolution of a range of vital legal and ethical questions centred on safeguarding patients and their rights. For Europe to fulfil the conditions for success, it will have to find a new spirit of cooperation that can overcome the handicaps of the continent's fragmented technical and legal landscape. The start the European Union has made shows some ambition, but a clearer strategic vision and firmer plans for implementation will be needed. The European Alliance for Personalised Medicine (EAPM) has listed its own priorities: data, integrating innovation into care, building trust, developing skills and constructing policy frameworks that guarantee infrastructure, equitable access, and legal clarity.

Artificial intelligence (AI) is changing the world we live in, and it has the potential to transform struggling healthcare systems with new efficiencies, new therapies, new diagnostics, and new economies. Already, AI is having an impact on healthcare, and new prospects of far greater advances open up daily. This paper sets out how AI can bring new precision to care, with benefits for patients and for society as a whole. But it also sets out the conditions for realizing the potential: key issues are ensuring adequate access to data, an appropriate regulatory environment, action to sustain innovation in research institutes and industry big and small, promotion of take-up of innovation by the healthcare establishment, and resolution of a range of vital legal and ethical questions centred on safeguarding patients and their rights. For Europe to fulfil the conditions for success, it will have to find a new spirit of cooperation that can overcome the handicaps of the continent's fragmented technical and legal landscape. The start the European Union has made shows some ambition, but a clearer strategic vision and firmer plans for implementation will be needed. The European Alliance for Personalised Medicine (EAPM) has listed its own priorities: data, integrating innovation into care, building trust, developing skills and constructing policy frameworks that guarantee infrastructure, equitable access, and legal clarity.

INTRODUCTION: Digital therapeutics (DTx) can be a valuable contribution to the successful scale up of P5 Medicine (personalized, participatory, predictive, preventive, precision medicine) as they offer powerful means of delivering personalization and active patient participation in disease self-management. We investigated how the approval and adoption of DTx within health systems have been approached in five selected European countries and regions, with a view to proposing success factors scaling up their adoption. METHODOLOGY: Preliminary research established best countries or region candidates as being Germany, UK, France, Belgium, and the Spanish Region of Catalonia. The research was informed by a literature review, interviews with public bodies and industry, and a multi-stakeholder workshop to validate the findings and fill in existing gaps. RESULTS: To authorize the use of digital technologies, the countries and regions passed legislation and developed policy instruments, appointed bodies to assess and certify the products and formalized mechanisms for permitting reimbursement. While DTx is not a commonly used nomenclature, there are digital health technology types defined that have similar requirements as DTx. Assessment and certification frameworks are usually built around the Medical Device Regulation with additional criteria. Reimbursement considerations often observe reimbursement of therapeutic devices and/or medicines. To be integrated into reimbursement systems, countries require manufacturers to demonstrate clinical value and cost-effectiveness. As there are currently very few DTx approved in practice, there is resistance toward clinical acceptance and organizational change, and change management is highly needed to integrate DTx into healthcare systems. The integration and secondary use of DTx data is not encountered in daily practice. Although some enablers exist, there remain technical and legal barriers. DISCUSSION: DTx strategies should be considered as an integral part of digital health ...

The European Medical Information Framework (EMIF) project, funded through the IMI programme (Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115372), has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice (ECoP) to ensure the privacy protection of data subjects, protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board (EAB), to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes (kinds of research) for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources.

The scope and potential of personalised health care are underappreciated and underrealised, often because of resistance to change. The consequence is that many inadequacies of health care in Europe persist unnecessarily, and many opportunities for improvement are neglected. This article identifies the principal challenges, outlines possible approaches to resolving them, and highlights the benefits that could result from greater adoption of personalised health care. It locates the discussion in the context of European policy, focusing particularly on the most recent and authoritative reviews of health care in the EU Member States, and on the newly acquired spirit of readiness and pragmatism among European officials to embrace change and innovative technologies in a new decade. It highlights the attention now being given by policymakers to incentives, innovation, and investment as levers to improve European citizens' prospects in a rapidly evolving world, and how these distinct and disruptive themes contribute to a renaissance in thinking about delivering optimal health care in Europe. It explores the chances offered to patients by specific initiatives in health domains such as cancer and antimicrobial resistance, and by innovative science, novel therapies, earlier diagnosis tools, and deeper understanding of health promotion and prevention. And it reflects on how health care providers could benefit from a shift towards better primary care and towards deploying health data more effectively, including the use of artificial intelligence, coupled with a move to a smoother organisational/regulatory structure and realigned professional responsibilities. The conclusion is that preparing Europe's health care systems for the inevitable strains of the coming years is both possible and necessary. A more courageous approach to embracing personalised health care could guarantee the sustainability of Europe's health care systems before rising demands and exponential costs overwhelm them - an exercise in future-proofing, in ensuring that they are equipped to withstand whatever lies ahead. A focus on the potential and implementation of personalised care would permit more efficient use of resources and deliver better quality health-preserving care.

Introduction The European medical information framework (EMIF) was an Innovative Medicines Initiative project jointly supported by the European Union and the European Federation of Pharmaceutical Industries and Associations, that generated a common technology and governance framework to identify, assess and (re)use healthcare data, to facilitate real-world data research. The objectives of EMIF included providing a unified platform to support a wide range of studies within two verification programmes-Alzheimer's disease (EMIF-AD), and metabolic consequences of obesity (EMIF-MET). Methods The EMIF platform was built around two main data-types: electronic health record data and research cohort data, and the platform architecture composed of a set of tools designed to enable data discovery and characterisation. This included the EMIF catalogue, which allowed users to find relevant data sources, including the data-types collected. Data harmonisation via a common data model were central to the project especially for population data sources. EMIF also developed an ethical code of practice to ensure data protection, patient confidentiality and compliance with the European Data Protection Directive, and GDPR. Results Currently 18 population-based disease agnostic and 60 cohort-based Alzheimer's data partners from across 14 countries are contained within the catalogue, and this will continue to expand. The work conducted in EMIF-AD and EMIF-MET includes standardizing cohorts, summarising baseline characteristics of patients, developing diagnostic algorithms, epidemiological studies, identifying and validating novel biomarkers and selecting potential patient samples for pharmacological intervention. Conclusions EMIF was designed to provide a sustainable model as demonstrated by the sustainability plans for EMIF-AD. Although network-wide studies using EMIF were not conducted during this project to evaluate its sustainability, learning from EMIF will be used in the follow-on IMI-2 project, European Health Data and Evidence ...

Background: C3-Cloud is an integrated care ICT infrastructure offering seamless patient-centered approach to managing multimorbidity, deployed in three European pilot sites. Challenge: The digital delivery of best practice guidelines unified for multimorbidity, customized to local practice, offering the capability to improve patient personalization and benefit. Method: C3-Cloud has adopted a co-production approach to developing unified multimorbidity guidelines, by collating and reconciling best practice guidelines for each condition. Clinical and technical teams at pilot sites and the C3-Cloud consortium worked in tandem to create the specification and technical implementation. Results: C3-Cloud offers CDSS for diabetes, renal failure, depression and congenital heart failure, with over 300 rules and checks that deliver four best practice guidelines in parallel, customized for each pilot site. Conclusions: The process provided a traceable, maintainable and audited digitally delivered collated and reconciled guidelines.

Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. This paper sets out the potential of biomarker testing, the unfolding precision and range of possible diagnosis and prediction, and the many obstacles to adoption. It offers case studies of biomarker testing in breast, ovarian, prostate, lung, thyroid and colon cancers, and derives specific lessons as to the potential and actual use of each of them. It also draws lessons about how to improve access and alignment, and to remedy the data deficiencies that impede development. And it suggests solutions to outstanding issues − notably including funding and the tangled web of obtaining reimbursement or equivalent coverage that Europe's fragmented health system implies. It urges a European evolution towards an initial minimum testing scenario, which would guarantee universal access to a suite of biomarker tests for the currently most common conditions, and, further into the future, to an optimum testing scenario in which a much wider range of biomarker tests would be introduced and become part of a more sophisticated health system articulated around personalised medicine. For exploiting genomics to the full, it argues the need for a new policy framework for Europe. Biomarker testing is not an issue that can be treated in isolation, since the purpose of testing is to improve health. Its use is therefore always closely linked to specific health challenges and needs to be viewed in the broader policy context in the EU and more widely. The paper is the result of extensive engagement with experts and decision makers to develop the framework, and consequently represents a wide consensus of views on how healthcare systems should respond from push and pull factors at local, national and cross-border and EU level. It contains strong views and clear ...

Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. This paper sets out the potential of biomarker testing, the unfolding precision and range of possible diagnosis and prediction, and the many obstacles to adoption. It offers case studies of biomarker testing in breast, ovarian, prostate, lung, thyroid and colon cancers, and derives specific lessons as to the potential and actual use of each of them. It also draws lessons about how to improve access and alignment, and to remedy the data deficiencies that impede development. And it suggests solutions to outstanding issues - notably including funding and the tangled web of obtaining reimbursement or equivalent coverage that Europe's fragmented health system implies. It urges a European evolution towards an initial minimum testing scenario, which would guarantee universal access to a suite of biomarker tests for the currently most common conditions, and, further into the future, to an optimum testing scenario in which a much wider range of biomarker tests would be introduced and become part of a more sophisticated health system articulated around personalised medicine. For exploiting genomics to the full, it argues the need for a new policy framework for Europe. Biomarker testing is not an issue that can be treated in isolation, since the purpose of testing is to improve health. Its use is therefore always closely linked to specific health challenges and needs to be viewed in the broader policy context in the EU and more widely. The paper is the result of extensive engagement with experts and decision makers to develop the framework, and consequently represents a wide consensus of views on how healthcare systems should respond from push and pull factors at local, national and cross-border and EU level. It contains strong views and clear recommendations springing from the convictions of patients, clinicians, academics, medicines authorities, HTA bodies, payers, the diagnostic, pharmaceutical and ICT industries, and national policy makers.