Upcoming and open funding calls

We're continuously updating this page with calls relevant to biomedical imaging

Below are the full call texts for open and forthcoming calls relevant to biomedical imaging. This includes information on the budget and prospective estimates on how many projects will be funded. You can scroll down, or use the quick menu on the right side of the screen to navigate.

HORIZON-HLTH-2021-STAYHLTH-01-02

Towards a molecular and neurological understanding of mental health and mental illness for the benefit of citizens and patients

Indicative budget: 60 million (6 projects at 10 million per project)
Opening: 26 May 2021
Deadline: 21 September 2021

Keywords: novel tools for prevention/treatment of mental illness; improved diagnosis and therapy; validated biomarkers; access to clinical trial data; artificial intelligence

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several impacts of destination “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to one or several of the following expected outcomes:

  • Researchers, health care professionals and developers of medical interventions have a much better understanding of how genetic, epigenetic and environmental risk and resilience factors interact to drive or prevent the transition from mental health to mental illness throughout the life course. Developers of medical interventions make use of this understanding to develop novel classes of medications and non-pharmaceutical interventions for the prevention and treatment of mental illnesses (including relapse prevention).
  • Mental health professionals have access to different types of validated biomarkers for making more accurate diagnoses (beyond current symptom-based criteria) and for optimising and personalising preventive and therapeutic treatment decisions. As a result, patients receive more targeted therapies, relapse less frequently and experience less stigma, due to more accurate and objective diagnoses and increased public awareness about the molecular and neurobiological basis of mental health and mental illness.
  • Citizens have the possibility to undergo laboratory testing for assessing their mental health and their predisposition to mental illnesses, and are given timely evidence-based guidance on personalised preventive measures that underpin their active engagement and adherence to effective strategies for promoting their mental health.
  • Public health authorities and policy makers have access to comprehensive clinical trial data on the effectiveness of different types of pharmacological and non-pharmacological strategies for the promotion of mental health and prevention of mental illnesses, helping them draft evidence-based clinical guidelines and best practices as well as design tailor-made prevention policies and campaigns.

Scope

Mental illnesses represent a huge and growing burden for Europe, both at individual and societal level. There is an enormous stigma and they often remain undetected as diagnoses largely depend on symptom-based criteria without any biological markers linked to causative mechanisms. Currently available medications are primarily used by trial and error (rather than in a targeted and personalised manner) and they are all very similar in their mechanisms of action with rather little breakthrough innovation in the last few decades. There is further a lack of evidence base on the optimal use of different pharmacological and non-pharmacological prevention strategies. A deeper molecular and neurobiological understanding of the interplay between genetic, epigenetic and environmental risk and resilience factors, including neural circuit alterations, is critical for the development of objective biomarkers and evidence-based interventions that will significantly improve mental health outcomes.

Accordingly, the proposed research is expected to deliver on several of the following:

  • Significantly advance the molecular and neurobiological understanding of how genetic, epigenetic and environmental risk and resilience factors (including psychosocial experiences, diet, sleep, natural and artificial light, use or abuse of drugs, infections and other exposures) interact to drive or prevent the transition from mental health to mental illness throughout the life course as well as how such molecular and neurobiological changes could be reversed. The use of computational modelling and/or artificial intelligence tools is encouraged for the analysis of big, complex and heterogeneous data.
  • Develop relevant predictive models through federated analysis of large European cohorts of psychiatric disorders and investigate the biological and neural basis of pathogenetic mechanisms and symptoms shared by different disorders. If relevant to the disorders studied, develop neurobiologically-grounded models of cognition and social behaviour and apply these models and their simulation potential to the understanding and improved management of mental health conditions associated with behavioural or emotional dysfunction.
  • Identify, validate and document different types or combinations of biomarkers for all of the following purposes:
    • development of robust quantitative, clinical measures of mental health;
    • identification of signatures, for example genetic and epigenetic blueprints, conferring susceptibility to and protection against mental illnesses;
    • establishment of more objective diagnostic and monitoring criteria (complementing current symptom-based criteria) to improve patient outcomes and reduce the stigma associated with mental illness;
    • prediction of treatment response and risk of relapse for better, more scientifically-guided and targeted use of currently available preventive and therapeutic interventions for different population groups.

For biomarker discovery, applicants are encouraged to take stock of advances in disciplines such as for instance neuropsychology, neurophysiology, neuroendocrinology, neuroimaging, electrophysiological monitoring, e-health/m-health, -omics (genomics, epigenomics, transcriptomics, proteomics, metabolomics, lipidomics, exposomics, microbiomics including the role of the microbiota-gut-brain axis), optogenetics, nanomedicine, stem cell biology, neuroimmunology and immunopsychiatry.

  • Discover new disease pathways and drug targets (including pathways involved in maintaining mental health) to boost the development of new (or repurposed) classes of safer and more effective medications for the prevention and treatment of mental illnesses (including relapse prevention).
  • Establish the molecular and neurobiological effects as well as cognitive and psychological consequences of both pharmacological and non-pharmacological prevention strategies (for example: neurostimulation, neurofeedback, psychotherapy and other psychological/behavioural interventions, light therapy, diet, exercise, lifestyle, mindfulness or a combination of them) and assess their efficacy and side effects as part of clinical trials (also determining windows of opportunity when preventive actions are most effective throughout the life course).

Proposals may cover different stages in the continuum of the innovation cycle (from basic and translational research to the validation of findings in real-world settings) and should ensure strong involvement of end-users, including citizens and patients. Sex and gender differences and the effects of age should be duly taken into account. International cooperation is encouraged and the proposed research is expected to be multidisciplinary, including through the involvement of medical sciences, psychological sciences, social sciences and the humanities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

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HORIZON-HLTH-2021-CARE-05-01

Enhancing quality of care and patient safety

Indicative budget: 25 million (5 projects at 5 million per project)
Opening: 26 May 2021
Deadline: 21 September 2021

Keywords: recommendations/clinical guidelines for improved patient care and safety; harmonised evidence-based interventions.

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 4 “Ensuring access to innovative, sustainable and high-quality health care”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Health policymakers use context specific knowledge and evidence to develop inclusive, effective and affordable interventions ensuring patient safety;
  • Health care professionals know how to prevent, identify, evaluate and address risks for patient safety, and use harmonised or standardised patient-centred procedures and practice guidelines for improving patient safety developed in partnership with empowered patients;
  • Health care providers integrate harmonised and standardised practices with personalised treatment schemes;
  • Health care providers use quality assured processes to bridge inter-sectorial gaps in the clinical pathways of patients to improve patient safety;
  • An increased number of health care professionals and patients/citizens adhere to recommendations for improved patient safety.

Scope

Patient safety remains an issue of increasing concern for EU health systems. The Commission estimates that between 8% and 12% of patients admitted to hospitals in the EU suffer from adverse effects of health care.

Overall, the most common types of in-hospital adverse effects are operative/surgical related, medication or drug related, and health care associated infections, half of them being preventable. According to the Organisation for Economic Co-operation and Development (OECD), more than 7 million admissions in the OECD countries result from safety lapses in primary and ambulatory care. Diagnostic errors persist throughout all settings of care and contribute to increased risks and harms from the treatment. Therefore, it is necessary to develop and implement coherent quality improvement and patient safety strategies in Europe. Harmonisation and standardisation of health care processes (Guidelines and Standard Operating Procedures) along the continuum of care contribute to improve quality and safety of health services, minimise the risk of errors and at the same time ensure the quality and comparability of health data. It is also a mean to address inequities in health care delivery. The proposals should take into consideration the already existing EU-funded initiatives in this area and must address in a coherent manner at least three of the following items, but may also contain other research and innovations activities for improving patient safety:

  • Fill knowledge and practice gaps in quality of care and patient safety, including through harmonisation and standardisation of health care delivery, optimizing inter-sectoral clinical pathways and decision-making processes and tools across regions and countries.
  • Development and piloting of harmonised evidence-based interventions in a uniform and structured way in health care institutions of different EU regions and countries. This should be addressed in case studies at hospital, primary and outpatient care levels, and it should also take into consideration the diverse health care landscape across European Union and Associated Countries.
  • Research on translation of international standards and clinical guidelines into national practice for improved quality of care and patient safety.
  • Provide context-specific evidence on facilitators and barriers for transferring identified good practices across regions and countries.
  • Comprehensive comparison of practices related to clinical guidelines in European Union and Associated Countries, including the regulatory basis underpinning guidelines in each health system, the guideline development process, mechanisms of quality control, implementation modalities, and evaluation of produced recommendations.
  • Development of innovative approaches for the integration of harmonised and standardised practices with personalised treatment plans.

Proposals should consider a patient-centred approach that empowers patients/citizens, promotes a culture of dialogue and openness between health professionals and citizens/ patients, and unleashes the potential for social innovation.

The proposals should contribute to improved patient safety along the continuum of care in European Union and Associated Countries. The proposal should present a clear strategy for empowering and involving patients and caregivers in addressing the selected item(s), giving attention to both PROMs (Patient-Reported Outcome Measures) and PREMs (Patient-Reported Experience Measures). The research design, including the expected results, should carefully analyse and tackle the sex and gender dimension. The proposed evidence-based interventions, including clinical guidelines and standards, should meet health care providers’ needs and goals to increase patient safety and health care quality.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

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HORIZON-HLTH-2021-CARE-05-02

Data-driven decision-support tools for better health care delivery and policy-making with a focus on cancer

Indicative budget: 40 million (4 projects at 10 million per project)
Opening: 26 May 2021
Deadline: 21 September 2021

Keywords: artificial intelligence solutions for decision-making; evidence-based decision support tools; Standards for interoperability; improved health outcomes and quality of life

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 4 “Ensuring access to innovative, sustainable and high-quality health care”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Health care organisations and policymakers adopt robust and transparent modelling (including data collection, storage and analysis), planning algorithms and artificial intelligence (AI) solutions in support of health care decision-making processes;
  • Health care providers, caregivers (formal and informal), citizens, and other relevant stakeholders take better informed decisions about their health or the health of persons they are responsible for and/or about the organisation of the health care service or system they are involved in or in charge of;
  • Health system owners are provided with evidence-based participative decision-making processes that take into consideration all relevant values, needs and perspectives, enabling to deliver health care services to patients in the most suitable and efficient manner;
  • Policymakers access evidence-based decision support tools for public health policymaking and health care delivery.

Scope

This call topic will contribute to Europe’s Beating Cancer Plan. For this reason, proposals must focus on one or more of the cycle of the disease, starting from prevention and early diagnosis to treatment and quality of life of patients and survivors.

An ever-increasing amount of data is at the disposal of decision- and policy-makers, which, if analysed, pooled and used, could lead to novel data-driven approaches in health care delivery and policy-making, thus improving quality of life, health equity and producing better health outcomes. The collection, access, processing, and (primary and secondary) use of data is still very fragmented across national health systems. The availability and use of structured and unstructured health data represents an opportunity for the implementation of data-driven innovation and it provides new opportunities for developing, monitoring, evaluating decisions and feedback into decision-making processes and policy strategies.

In this topic, research and innovation actions should aim at optimising and/or transforming health care delivery decision-making processes, supporting policy-making, and/or empowering citizens and cancer patients. The development of innovations, including tools, processes and services, should be done together with end-users (i.e. citizens, health professionals and policymakers), and represent both a support-base and scientific evidence for data-driven innovation. Design thinking and other relevant design methodologies should be considered.

The proposals should adhere to the FAIR data principles and adopt data quality standards, data integration operating procedures and GDPR-compliant data sharing/access best practices developed by the European research infrastructures, if relevant. In addition, the proposals are encouraged to adopt best practices of international standards used in the development of computational models.

Data-driven algorithms should be explainable, unbiased and inclusive. Caution needs to be paid to systematically control for gender and racial bias and/or discrimination bias, when developing and using data and algorithms. The actions should ensure that the novel ideas are accompanied by frameworks/guidelines for new forms of collaboration and incentivising mechanisms/tools in order to support implementation of the innovations in the public sector. The tools should aim to improve health outcomes and quality of life, not only to lower health care costs.

Actions should pursue a multi-disciplinary and multi-stakeholder approach to integrate health care research, health services research, innovation, health economics, implementation science, operations management/research, data science and other relevant disciplines (i.e. sociology and anthropology) to ensure more equitable, innovative and sustainable health care systems.

Applicants should propose activities underpinned by health care data in one or more of the following areas:

  • The development of data-driven, interactive policy and visualisation tools (i.e. through creation of digital twins/virtual models) bringing novel insights on populations, systems and services as a whole, to help policymakers make data-driven decisions. These can be foreseen to be used solely for health care decisions or constitute health-relevant inputs for other sectorial approaches, and promote multi-disciplinary knowledge exchange;
  • The development of data-driven solutions (i.e scenario-building tools and models) helping health care organisations take evidence-informed decisions on cancer care delivery processes such as logistics planning and management, capacity, utilisation of health services and allocation of resources and infrastructures (i.e. human resources, health goods, etc.), and availability of and access to health care technologies (i.e. pharmaceuticals, vaccines, medical devices, etc.) and interventions;
  • The development of data-driven solutions empowering citizens and cancer patients interaction with the health care systems, including feedback mechanisms, guidance on health care pathways and on managing health care data, supporting patients in making health care decisions and treatment adherence;
  • The development of digital toolkits and indicators to improve the reporting and assessment of outputs from end-user involvements including of patient-reported outcomes measures (PROMs) and patient-reported experience measures (PREMs), and help gauge the actual impact in health care (including interaction between patients and health care providers).

Applicants are encouraged to establish dynamic relations and synergies with the following areas, where applicable:

  • Decision-making processes and tools, including social innovation;
  • Monitoring and evaluating budgetary impact of health care interventions (i.e. innovative solutions, digital services and health care models);
  • Health technology assessment and cost-effectiveness analysis;
  • Artificial intelligence/deep learning tools in social medicine to determine causal factors of disease/conditions and develop interventions;
  • Data sharing between different institutions;
  • European Health Data Space (EHDS);
  • Open source and/or common building blocks used in Connecting Europe Facility (CEF) (e.g. eDelivery, eID);
  • Standards and mechanisms to allow for interoperability between primary and secondary use of data;
  • Privacy-preserving protocols for secondary use of data for public health policy-making and research;
  • Federated/distributed access or data processing protocols for data-driven decisionsupport tools for better health care delivery and policy-making.

Proposals should adopt a patient-centred approach that empowers patients, promotes a culture of dialogue and openness between citizens/patients, caregivers, health care providers and other relevant stakeholders, and unleashes the potential for social innovation.

If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).

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HORIZON-HLTH-2021-TOOL-06-01

Smart medical devices and their surgical implantation for use in resource-constrained settings

Indicative budget: 25 million (4 projects at 6 million per project)
Opening: 26 May 2021
Deadline: 21 September 2021

Keywords: smart medical devices, smart active implants, medical device design, surgical interventions, minimally invasive surgical implantation

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes.

  • Medical device developers provide sustainable and affordable smart active implants validated in the operational environment.
  • Medical professionals in resource-constrained clinical settings use sustainable and affordable surgical procedures for smart active implants.
  • Patients have access to sustainable and affordable smart medical devices suitable for minimally invasive surgical implantation through further clinical studies.

Scope

“Smart” technologies, i.e. micro-electronic sensor/actuator systems provide novel functionalities to surgically-implanted active medical devices. “Smart” active implants involve microelectronic components and are placed inside the body of the patient to achieve the desired physiological response. They open up therapeutic avenues for a wide range of medical handicaps, complex chronic conditions and lesions, thanks to their integrated diagnostic capabilities, and may help addressing hitherto unmet medical needs. Challenges involved in the development of these devices include but are not limited to miniaturization, sensor robustness, wireless power supply, etc. Such devices require specific surgical implantation procedures, dependant on the type of device and on the intended use, with the successful surgical implantation and activation of such smart medical implants, being crucial steps for their functioning. The device targeted and its intended use is open for applicants to choose (e.g. orthopaedic, neural, cardiovascular, metabolic, etc.), but should at the start of the proposed work be at a TRL of minimum four and will necessitate appropriate tailored surgical procedures and interventions. Surgical conditions account for approximately 30% of the global burden of disease and have a huge social and economic impact. However, of the 300 million surgical interventions undertaken globally every year only around 6% occur in low-income countries, where a third of the world’s population lives. There is therefore a strong need for high-quality, affordable surgical interventions for implanting “smart” active medical devices suitable for resource-limited or -constrained clinical settings. Resource-constrained settings are clinical environments that are affected by limitations such as lack of medical staff, scarcity of medical equipment or medicines supply, etc. To address this gap, the sustainability of both the medical device and the applied surgical intervention, including the necessary equipment and operating skills, are essential elements. Implantation procedures should be fully compatible with resource-constrained environments and minimally invasive approaches should be favoured. Hence, research and innovation activities should comprise medical device design, regulatory work, clinical stages and developmental iterations, reaching a TRL of at least seven, and involve key medical specialists (e.g. surgeons) and/or other health care professionals, developers, patients and relevant regulatory bodies as appropriate. The work proposed should take into account the new EU legal framework on medical devices with the targeted implants meeting all the essential requirements as defined therein.

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HORIZON-HLTH-2021-TOOL-06-03

Innovative tools for use and re-use of health data (in particular of electronic health records and/or patient registries)

Indicative budget: 30 million (4 projects at 8 million per project)
Opening: 26 May 2021
Deadline: 21 September 2021

Keywords: health data, electronic health records, patient registries, interoperability, data management and analytics, AI, machine learning, natural language processing

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to all of the following expected outcomes:

  • Novel solutions improve quality, ensure interoperability and enable re-use of health data, data analytics and metadata from different repositories across countries by health professionals, researchers and health authorities, in compliance with FAIR data management principles as well as national and EU legal and ethical requirements (in particular with regard to personal data protection).
  • Health professionals, researchers and health authorities make effective use of tools enabling them to exploit unstructured and heterogeneous data from different sources to improve the delivery of care and advance health research.
  • Increased use and valorisation of health data by patients, researchers and clinicians thanks to better data portability due to the standardization of meta knowledge (meta data, ontologies and reference repositories) and clinical data, especially health data coming from different clinical services and sites, and/or from multiple countries.
  • Health care professionals use more efficient and cost-effective health care procedures and workflows that contribute to improved disease prevention, early detection/diagnosis and more effective treatment.

Scope

Health data exists in many forms and multiple fragmented repositories; there is still significant room for improvement in the way both structured and unstructured health data is stored, analysed and interpreted. Sharing and analysing data from multiple countries in a safe and legally compliant manner (in particular with regard to personal data protection) remains a challenge. Powerful analytic tools are already helping providers to use structured data in increasingly impactful ways. On the other hand, the heterogeneity, diversity of sources, quality of data and various representations of unstructured data in health care increase the number of challenges as compared to structured data.

Advances in AI and machine learning, however, have the potential to transform the way clinicians, providers and researchers use unstructured data. Furthermore, developing data interoperability standards, trust and harmonization of GDPR’s interpretation across the EU for the sharing and processing of personal health data will support establishing a sound health data culture in view of the European Health Data Space.

Proposals should address all of the following aspects:

  • Developing robust novel solutions compliant with legal requirements (in particular concerning personal data protection) that will improve the quality, interoperability, machine-readability and re-use of health data and metadata in compliance with FAIR data management principles, making these data more accessible to clinicians, researchers and citizens. The focus should be on data in electronic health records (EHRs) and/or patient registries, taking into account the Commission Recommendation on a European Electronic Health Record exchange format.
  • Developing innovative natural language processing tools, including computational semantics, ontologies, text mining, associated machine learning and deep learning, to improve accessibility, interoperability, translation, transcription, and analysis of health data (e.g. to predict risks). Tools should extract health information from unstructured data in different clinical and medical sources, and bring that data into EHRs/patient registries in a structured form. The innovative solutions should also address missing data in EHRs and/or patient registries and their related metadata, to reduce bias and improve the quality of conclusions.
  • Developing and piloting AI-powered virtual assistants that will utilise the tools and solutions developed (as mentioned above) in order to demonstrate improved usability of health data for end-users.

Proposals are expected to build on and contribute to existing European and international data standards, specifications and schemas for health data. The use of open standards should be considered and interactions with relevant ongoing research infrastructure efforts are encouraged. Applicants should focus on health data coming from a number of EU Member States and EEA countries, constituting as much as possible a representative sample of the European healthcare landscape, so as to contribute to the work on the creation of the European Health Data Space.

To guarantee their adoption, the developed solutions should be quick and easy to use by researchers and clinicians. Therefore active involvement of end-users from the onset is encouraged. In particular, patient advocacy groups and citizens should be involved to ensure adequate consideration of diverse patient needs, with respect to their gender, ethnicity, age, ability, and socio-economic background, to underpin acceptance by patients and other data subjects. SMEs participation is also encouraged.

The proposals should duly take into account requirements stipulated in the relevant European regulations (Data protection, in vitro diagnostics and medical devices) and must meet appropriate ethical standards.

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HORIZON-HLTH-2022-STAYHLTH-02-01

Personalised blueprint of chronic inflammation in health-to-disease transition

Indicative budget: 50 million (7 project at 7 million per project)
Opening: 6 October 2021
Deadline: 21 April 2022

Keywords: chronic disease, chronic inflammation, personalised prevention, personalised diagnosis, patient-centred approach, omics, biomarkers

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to several of the following expected outcomes:

  • Researchers and medical professionals understand the chronic inflammation factors triggering the health-to-disease transition and subsequently provide optimal counselling to citizens for improving their health.
  • Health care professionals have access to and employ objective health indicators of chronic inflammation for monitoring the health status, establishing personalised prevention measures and improving the health outcomes for citizens.
  • Health care professionals have the scientific evidence and understanding of health-todisease transition to develop and use improved guidelines for personalised prevention strategies to tackle chronic diseases.
  • Citizens are better informed to actively manage their own health, have the tools to maintain their healthy status, improve their health and reduce their risk for developing chronic diseases.

Scope

Personalised approaches for disease prevention seek to determine the predisposition to disease and deliver timely and targeted prevention measures. Understanding the risk factors that trigger the health-to-disease transition is essential for delivering personalized prevention measures or reducing the burden of chronic diseases.

A large body of clinical evidence has accumulated over the past decade demonstrating that chronic inflammation is a process implicated in chronic diseases/disorders. Inflammatory response is a physiological process helping the body to heal against harmful entities, but when dysregulated it could lead to unresolved chronic local or systemic inflammation. The later in combination with the person’s genotype, phenotype, medical history, nutritional and well-being status, life-style and/or occupational/environmental/life stressors is likely to be involved in driving the health-to-disease transition, leading to the onset of chronic diseases.

Proposals should be of multidisciplinary nature involving all relevant stakeholders and may cover several different stages in the continuum of the innovation path (from translational research to validation of the findings in human studies etc.), as relevant.

Proposals are expected to develop and implement data-driven, personalised approaches to identify the drivers of chronic inflammation that may determine the transition from health to pre-symptomatic and early stages of chronic diseases/disorders. The topic does not exclude any diseases/disorders. The human studies and human data utilised/generated should be compatible to an age range as representative as possible to the pre-disease phase and onset of the disease to be studied, in order to boost the fast translation of the research results into proof-of-concept studies.

Proposals should develop personalised diagnosis and/or prevention strategies linked to chronic systemic/local inflammation and assess the effects of different types of interventions and/or their combinations i.e. pharmacological, non-pharmacological, nutritional supplements, diet and life-style modifications, as relevant. Sex and gender differences should be investigated, wherever relevant.

The proposals should address several of the following areas:

  • Integrate state-of-the-art knowledge and data from suitable human studies (i.e. medical/clinical, well-being, life-style etc.) to identify actionable factors linking chronic systemic and/or local inflammation to the health-to-disease transition. Take stock of omics (i.e. genomics, metabolomics, nutrigenomics, microbiomics etc.), of dynamic measurements of the health and well-being status, and of data-driven analytical tools in order to identify biomarkers and other health indicators linked to the health-to-disease transition.
  • Understand at the systems-level the human biology and physiology underlying chronic inflammation in connection to the tissues/organ dysregulation, organ cross-talk and homeostasis breakdown triggering the health-to-disease transition, taking into account the person’s genotype, phenotype, medical history, nutritional and well-being status, lifestyle and/or occupational/environmental/life stressors.
  • Develop and utilize robust sensors, devices and/or mobile apps and other innovative technologies to monitor dynamically the individual’s health status and to identify objective indicators of chronic inflammation correlative to the health-to-disease transition.
  • Implement proof-of-concept human studies to assess the beneficial effect of diverse prevention and/or interventions strategies with the aim to demonstrate improved health outcomes.
  • Test suitable interventions with the aim to demonstrate the reduction and/or reversion of the pre-disease state linked to chronic systemic and/or local inflammation.

Proposals should adopt a patient-centred approach to inform and empower patients, promote a culture of dialogue and openness between health professionals, patients and their families, and unleash the potential for social innovation.

The proposals should adhere to the FAIR data principles and adopt wherever relevant, data standards and data sharing/access good practices developed by existing European health research infrastructures.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

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HORIZON-HLTH-2022-IND-13-02

Scaling up multi-party computation, data anonymisation techniques, and synthetic data generation

Indicative budget: 30 million (4 projects at 7 million per project)
Opening: 6 October 2021
Deadline: 21 April 2022

Keywords: multi-party computation, health data anonymisation and de-identification techniques, AI-based and distributed data analytics, synthetic data generation

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • The EU contributes strongly to global standards for health data through enhancement of common European standards for health data (including medical imaging data) by researchers and innovators. Researchers and innovators contribute to GDPR compliant guidelines and rules for data anonymisation.
  • Innovators have access to advanced secure data processing tools to test and develop robust data-driven digital solutions and services in response to the needs of researchers, clinicians and health systems at large.
  • Cross-border health data hubs further facilitate the innovation process by providing secure, trustable testing environments for innovators.
  • Clinicians, patients and individuals use a larger variety of high quality data tools and services for wellbeing, prevention, diagnosis, treatment and follow-up of care.
  • Researchers and innovators have more opportunities for testing and developing GDPR compliant data driven solutions based on actual needs of the health care environments.

Scope

It is essential to speed up and facilitate innovations in the field of data-driven tools and services for wellbeing, prevention, diagnosis, treatment and follow-up of care, among others. However, limited access by developers to health data and secure testing environments hinder the development of innovative data-driven digital health products and services.

Therefore, the proposals are expected to scale up multi-party computation, data anonymisation techniques and synthetic data generation. To ensure privacy, the data analytics should be conducted in a distributed way among processors that grant third parties access to analysis outcomes but not to the underlying data. The developers should have access to distributed testing data sources at large scale, with a view to improving the speed and robustness of multi-party computation solutions for innovators. The aim is to allow secure GDPR-compliant data processing for research, and clinical purposes.

The proposals should consider the use of synthetic, i.e. artificially generated, data as they allow researchers and developers to test, verify and fine-tune algorithms in large-scale data experimentations without re-identifiable personal data.

In addition, the proposed anonymisation techniques will have to be sophisticated and robust enough to tackle the challenge of anonymised data sets that still make it possible to trace back to individuals.

The proposals are expected to foster the development of secure, interoperable, transparent – and therefore trustable – cross-border health data hubs that can facilitate the provision of the required testing environments for innovators. This will support the uptake of new data tools, technologies and digital solutions for health care.

To this end, integration of national/regional health data hubs/repositories/research infrastructures is appropriate to achieve the scope of the topic. The proposals are expected to address all of the following areas:

  • Consolidate and scale up multi-party computation and data anonymisation techniques and synthetic data generation to support health technology providers, in particular SMEs.
  • Support the development of innovative unbiased AI based and distributed tools, technologies and digital solutions for the benefit of researchers, patients and providers of health services, while maintaining a high level of data privacy.
  • Advance the state-of-the-art of de-identification techniques, to tackle the challenge of anonymised datasets that can be traced back to individuals.
  • Develop innovative anonymisation techniques demonstrating that effective data quality and usefulness can be preserved without compromising privacy.
  • Explore and develop further the techniques of creating synthetic data, also dynamically on demand for specific use cases.
  • Widen the basis for GDPR-compliant research and innovation on health data.
  • Ensure wide uptake and scalability of the methodologies and tools developed, promote high standards of transparency and openness, going well beyond documentation and extending to aspects such as assumptions, architecture, code and any underlying data.

In this topic the integration of the gender dimension (sex and gender analysis) in research and innovation content is not a mandatory requirement.

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HORIZON-HLTH-2022-TOOL-11-01

Optimising effectiveness in patients of existing prescription drugs for major diseases (except cancer) with the use of biomarkers

Indicative budget: 60 million (6 projects at 10 million per project)
Opening: 6 October 2021
Deadline: 21 April 2022

Keywords: effectiveness of existing pharmaceuticals, clinical biomarker validation, personalised medicine, common (cardiovascular) diseases

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to all of the following expected outcomes:

  • Diagnostics industries move towards market approval for companion diagnostics.
  • Regulatory authorities approve companion diagnostics and make recommendations for the prescription of existing drugs.
  • Health care providers use biomarkers with existing pharmaceuticals to treat more efficiently and cost-effectively patients, with less adverse effects.

Scope

The applicants should perform the clinical validation of qualified biomarkers (not limited to molecular biomarkers) that will enable the identification of appropriate patients to ensure an effective and efficient use of existing pharmaceuticals in the treatment of major diseases and conditions. The relevant biomarkers should allow providing the right medicinal product, at the right dose and the right time, according to the concept of personalised medicine, taking into account, among others, differences of sex, age, ethnicity and gender identity. This topic refers to medicines that are already on the market and not to the validation of biomarkers for the development of new medicinal products. It addresses broadly prescribed medicines for major diseases and conditions, including but not limited to cardiovascular diseases. A condition is that preliminary studies or publications have demonstrated that the pharmaceuticals considered are efficient in less than 50% of the population treated. This topic excludes cancer and rare disease treatments. The applicants should consider existing guidelines, standards and regulations, as appropriate. Synergies with relevant European Research Infrastructures are encouraged.

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HORIZON-HLTH-2022-IND-13-05

Setting up a European Electronic Health Record Exchange Format (EEHRxF) Ecosystem

Indicative budget: 2 million (1 project)
Opening: 6 October 2021
Deadline: 21 April 2022

Keywords: cross-border interoperable digital health solutions , heath data portability, sustainable public infrastructure for digital health innovation, establishment of Pan-European stakeholder ecosystem

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • Individuals, researchers, health services and the workforce across borders in the EU Digital Single Market use significantly improved and interoperable cross-border digital health solutions thanks to sophisticated ICT toolbox, representative use case applications, a Pan-European ecosystem of early adopters, and a framework for sustainability and exploitation. These will also contribute to the European Health Data Space.
  • Individuals have an improved level of accessibility, control and portability of health data, including donation for research across Europe and jurisdictions.
  • Policy makers and members of the eHealth Network are better informed and advised regarding potential evolutions of the EEHRxF and its extension to other uses cases.
  • Different target populations such as designers, developers, health care professionals, and individuals have access to exploitation and capacity building support, such as training material, dedicated tools, guidelines, mentorship and collaboration programs.

Scope

Interoperability of Electronic Health Record is key for the exchange and the portability of health data in view of better health outcomes and treatments. The EU has supported projects to ensure cross-border sharing of health data and, in 2019, adopted a Recommendation on EEHRxF. There is a need to continue supporting the uptake of new use cases (i.e. laboratory results, medical imaging and reports, and hospital discharge reports) and take on board possible new requirements, and ultimately to bring together policy actors and stakeholders.

Applicants should propose activities in all of the following areas:

  • Building on the outcomes of activities and projects related to the EEHRxF Recommendation, establishing and sustaining a scalable public infrastructure for digital health innovation based on the EEHRxF principles and the functional and technical specifications of its information domains (i.e. medical imaging, discharge letters, laboratory results, etc.). This infrastructure must provide a REST API to third-party developers, which should comprise a coherent set of functionality that significantly improve the development and deployment of interoperable cross-border digital health solutions. It should specifically allow individuals accessing and providing their own (electronic) health records across national borders. The infrastructure must ensure compliance with the General Data Protection Regulation, the Network and Information Systems Directive and the operation in a European Digital Single Market.
  • Demonstrating feasibility of real-life interoperable digital solutions for use by individuals, researchers, health services and the workforce across borders in the EU Digital Single Market by leveraging the above EEHRxF-based infrastructure. Emphasis should be given to specific fields of high societal relevance and high prevalence. Omics type of information associated to the use and exchange of health datasets and artificial intelligence should be strongly considered with special regard to analysis and corresponding further health-related data. Integration with population-based patient registries such as cardiovascular disease, congenital anomalies, diabetes, rare diseases, and cancer are highly recommended. Relevant activities of the eHealth Network should be taken into account. For all relevant data (e.g. from hospitals, doctors or user-generated) ethics and legal issues should be considered appropriately. Local, regional, national and cross-border aspects (to cover e.g. differences in languages and terminologies) should be given adequate consideration.
  • Establishing and sustaining a Pan-European ecosystem of digital health stakeholders by promoting and ensuring adoption of the EEHRxF-based infrastructure, involving both supply and demand sides, reinforcing collaboration and networking between the different actors working on digital health innovation across Europe around that infrastructure, and more particularly ensuring strong involvement and coordination at the governance level with the national authorities and Ministries represented in the eHealth Network and the eHealth agencies underneath it. The latter should include innovation initiatives related to a coherent selection of the following: clinical research, clinical trial integration, outcomes-based research, monitoring or decision aids for individuals, and business analytics, as well as application designers and developers, SMEs, innovation hubs, professionals networks e.g. rare disease network, health professionals and patient associations, and standardisation bodies.
  • Creating and validating a framework for enabling further exploitation of the public infrastructure for digital health innovation, including its terms of reference, governance and operations rules and procedures, as well as support for capacity building such as training material, guidelines, mentorship and collaboration/twinning programs for designers, developers, health care professionals, policymakers, SMEs, etc.

In this topic the integration of the gender dimension (sex and gender analysis) in research and innovation content is not a mandatory requirement.

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HORIZON-HLTH-2022-STAYHLTH-01-05-two-stage

Prevention of obesity throughout the life course

Indicative budget: 60 million (6 projects at 10 million per project)
Opening: 6 October 2021
Deadline: 01 Feb 2022 (First Stage), 06 Sep 2022 (Second Stage)

Keywords: obesity, biological pathways and pre-obesity markers, environmental, socio-economic and lifestyle factors, prevention, evidence-based guidelines, recommendations

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several impacts of destination “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Researchers, developers of medical interventions, and health care professionals have a much better understanding of basic biological pathways (genetic and epigenetic blueprints) conferring susceptibility to and protecting against overweight/obesity, i.e. how genetic, epigenetic, environmental, socio-economic and lifestyle factors interact to drive or prevent the transition from normal weight to overweight/obesity throughout the life course.
  • Health care professionals, national/regional/local public authorities and other relevant actors (e.g. schools, canteens, hospitals, work places, shopping malls, sport centres):
    • Have access to, adopt and implement evidence-based clinical guidelines, best practices, coordinated, pan-European, multidisciplinary preventive strategies, policy recommendations and/or new policies to fight overweight/obesity and their co-morbidities throughout the life course.
    • Have access to and make use of a robust outcomes framework and tool-kit for standardised collection of economic and cost data related to the prevention and treatment of overweight/obesity and its co-morbidities at population level across European regions and countries.
    • Adopt and implement tailor-made prevention campaigns to tackle overweight/obesity, including campaigns for improving integration of health education into academic learning and raising awareness of health care providers and citizens.
  • Citizens have access to and make use of new tools and services to make informed decisions about lifestyle choices that will prevent them from becoming overweight/obese.

Scope

Obesity is one of the most serious public health challenges of the 21st century. Although health has improved in the EU over the last decades, the prevalence of obesity has tripled in many countries of the EU. It is known that once individuals become overweight or obese, they also develop related diseases (diabetes, cardiovascular diseases, cancer). Overweight and obesity are largely preventable. In the current pandemic, the issue of overweight/obesity has become even more prominent, highlighting the need for prevention of overweight/obesity.

Increased efforts in research and innovation are critical for developing and testing the impact of tools, initiatives, interventions, strategies, programmes, policies and their implementation to prevent overweight/obesity. The use of best practices, harmonisation guidelines and/or standard operating procedures, developed at various levels (from local to national) in the EU and beyond, will be the foundation for new research.

Cultural diversity, urban/rural dichotomy, socio-economic status, age groups, sex and gender differences should be investigated, where relevant. Strong collaborations across sectors and with other European projects dealing with issues such as agriculture, aquaculture, food, environment, etc. are welcome. Proposals should engage citizens, civil society organisations (e.g. employers/employee organisations, charities), authorities (e.g. municipalities and health authorities) and institutions (schools, canteens, hospitals, work places, shopping malls, sport centres), local producers, etc. in the development of their actions to ensure acceptability and deployment. Proposals should aim to develop scientifically robust and transparent methodologies, building on achievements from previous research activities.

Proposals should address several of the following research bottlenecks:

  • A comprehensive understanding of biological pathways (genetic, epigenetic, molecular, microbiome, and/or neuroimmune) conferring susceptibility to and protecting against uncontrolled “weight gain”.
  • Identification of socio-economic and lifestyle factors influencing consumer behavior and their association to overweight/obesity prevention.
  • Identification of pre-obesity biomarkers (genetic, laboratory, imaging, etc.) and their association to lifestyle and environmental interventions aiming at obesity prevention and tailored to specific target populations.
  • Mapping existing implementation research activities to prevent overweight/obesity, outcome analyses and identification of best practices.
  • Conducting a thorough meta-review of information from available scientific literature and identification of the relationship between the risk for overweight/obesity and the biology of obesity, lifestyle habits, exposures, susceptibility to co-morbidities and/or all of their combinations.
  • Developing recommendations and guidelines for what constitutes an appropriate healthy diet for different age and health groups.
  • Understanding the casual links between overweight/obesity and sedentary behaviour, quality and quantity and types of food/drinks, physical activity, and personality traits.
  • Designing a creative and engaging programme to reach the optimal balance between diets and physical activity for the prevention of overweight/obesity.
  • Analysing obesity stigma, stress and work-life balance, circadian rhythm disruption, mental health (including psychological problems), screen-time dependency, drugs and side effect of drugs, for the prevention of overweight/obesity.
  • Addressing inequality aspects of overweight/obesity at multiple levels, taking into account vulnerable groups, gender and socio-economic factors.
  • Setting up pilots to assess the effectiveness of obesity management strategies, including cost-effectiveness, and analyse the impact of inactions, taking into account comorbidities and value-based care system.
  • Developing a system for monitoring population indicators relevant to overweight/obesity by extending European Core Health Indicators.

Proposals should adopt a patient-centred approach that empowers patients, promotes a culture of dialogue and openness between health professionals, patients and their families, and unleashes the potential of social innovation.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

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HORIZON-HLTH-2022-DISEASE-06-04-two-stage

Development of new effective therapies for rare diseases

Indicative budget: 60 million (8 projects at 8 million per project)
Opening: 6 October 2021
Deadline(s): 01 Feb 2022 (First Stage), 06 Sep 2022 (Second Stage)

Keywords: novel therapy, rare diseases, multidisciplinary, novel preclinical models/tools, verification of therapeutic targets, proof-of-concept clinical studies

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to some of the following expected outcomes:

  • Researchers and developers make the best use of the state-of-the-art knowledge and resources for a fast and effective development of new therapies for rare diseases.
  • Researchers and developers increase the development success rate of therapies for rare diseases by employing robust preclinical models, methods, technologies, validated biomarkers, reliable patient reported outcomes and/or innovative clinical trials designs.
  • Developers and regulators move faster towards market approval of new therapies for rare diseases (with currently no approved treatment option) due to an increased number of interventions successfully tested in late stages of clinical development.
  • Healthcare professionals and people living with a rare disease get access to new therapeutic interventions and/or orphan medicinal products.

Scope

Despite the considerable amount of knowledge that has been accumulated and the new orphan medicines developed in recent years, the number of available therapies for rare diseases remains low, as fewer than 6% of rare diseases have an approved treatment option.

The joint evaluation of the regulations on orphan medicinal products and paediatric medicines concluded that those regulations have boosted the development for new therapies for rare diseases but have not yet adequately managed to direct research and innovation in areas of greatest unmet medical need. Actually, there is an urgent unmet medical need for the development of therapies for rare diseases, where there is still no approved therapeutic option available.

Therefore, proposals should aim to develop therapies for rare diseases with no approved therapeutic option. Proposals should focus on group(s) of rare diseases with commonalities, such as shared biological features, possibly within the same and/or across different medical areas within the rare diseases landscape. Thus, proposals should not address a single disease only (for example with an Orphacode representing a single disease).

The therapies to be developed may include a broad family of therapeutic interventions such as small molecule(s), advanced therapy medicinal products, repurposing of existing medicinal products, including non-pharmacological interventions and/or their combinations, as relevant. Sex and gender aspects should be considered, where relevant. To ensure that the needs of people living with a rare disease are adequately addressed, the involvement of patient representatives in all phases of the research and development process is strongly encouraged. Rare infectious diseases and rare cancers are excluded from this topic and will not be considered.

The topic will support proposals covering several different stages in the continuum of the innovation pathway (i.e. translational, preclinical, clinical research, validation in the clinical and/or real-world setting etc.), as relevant. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations for the benefit of people living with a rare disease.

The proposals should address most of the following research activities:

  • Establish multidisciplinary collaborations between all relevant stakeholders by integrating disciplines, technological developments and existing knowledge. Integrate harmonised data from multiple sources (i.e. natural history studies/clinical trials, multiomics, medical imaging, registries etc.) by utilising data analytics and/or other suitable methods, with the aim to understand the pathophysiology/heterogeneity of the rare diseases concerned and to identify therapeutically actionable mechanisms.
  • Develop and utilise relevant preclinical models and/or innovative tools/technologies to: verify molecular/cellular pathways/genes that can be therapeutically targeted, increase the confidence in the targets selection and/or perform toxicity studies. When using disease models the applicants should describe how well the model replicates the pathology or the human condition.
  • Develop and/or execute innovative clinical trials designs for small populations and novel approaches to assess and monitor the safety and efficacy of the proposed interventions. Such approaches may include but are not limited to: biomarkers defining robust surrogate and clinical endpoints; artificial intelligence tools/medical devices/biosensors/ companion/ complementary diagnostics for defining reliable patient reported outcomes; modelling and simulation and in-silico trials methodologies.
  • Carry out preclinical proof-of-concept (PoC) studies and/or multinational interventional clinical studies to demonstrate the safety and efficacy of the therapeutic interventions under study. Preclinical PoC studies should include late-stage preclinical studies (i.e. toxicological properties, adverse effects etc.). Clinical studies may cover all necessary development stages. Applicants should propose a clear exploitation pathway through the different necessary steps (research, manufacturing, regulatory approvals and licensing, IP management etc.) in order to accelerate marketing authorisation and uptake by the health systems.

Proposals should involve group(s) of rare diseases (i.e. a rare disease being individually defined in the European Union as affecting not more than five in 10.000 persons). Proposals that plan to run clinical trials should demonstrate that they have already taken into account scientific advice or protocol assistance from EMA. In particular, proposals planning the clinical development of orphan medicinal products should demonstrate that they have been granted approval for an orphan designation at the latest on the date of the call deadline.

Proposals should adhere to the FAIR data principles and take stock, wherever relevant, of data standards, harmonisation guidelines and data sharing/access good practices developed by existing European health research infrastructures (i.e. ESFRI infrastructures). Proposals should take stock, where relevant, of the FAIR guidance, of good practices for analytical methods and preclinical models, and of good exploitation strategies for the translation of research results into high impact interventions, developed by the European Joint Programme on Rare Diseases (EJP RD) and other relevant EU-funded projects. Proposals utilising data from registries may adopt, where relevant, the European standards such as the “set of common data elements” developed by the European Platform on Rare Disease Registration. In addition, synergies should be sought with the European Reference Networks, where relevant.

Projects funded under this topic will contribute towards the goals of the International Rare Diseases Research Consortium (IRDiRC) that supports the development of 1000 new therapies for rare diseases by 2027 and may take stock of the IRDiRC Orphan Drug Development Guidebook, where relevant.

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HORIZON-HLTH-2022-STAYHLTH-01-04-two-stage

Trustworthy artificial intelligence (AI) tools to predict the risk of chronic non-communicable diseases and/or their progression

Indicative budget: 60 million (6 projects at 10 million per project)
Opening: 6 October 2021
Deadline(s): 01 Feb 2022 (First Stage), 06 Sep 2022 (Second Stage)

Keywords: trustworthy AI tools, risk prediction, chronic non-communicable diseases, evidence-based recommendations and guidelines

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Staying healthy in a rapidly changing society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes.

  • Clinicians, medical professionals and citizens have access to and use validated AI tools for disease risk assessment. Hence, citizens are better informed for managing their own health.
  • Health care professionals utilise robust, trustworthy and privacy-preserving AI tools that help them to assess and predict the risk for and/or progression of chronic noncommunicable diseases. Hence, citizens benefit from improved health outcomes.
  • Health care professionals develop evidence-based recommendations and guidelines for the implementation of AI-based personalised prevention strategies. Hence, citizens benefit from optimized health care measures superior to the standard-of-care.
  • Health care professionals employ quantitative indicators in order to identify and followup on individuals with high risk for the development and/or risk for the progression of chronic non-communicable diseases.

Scope

It is widely recognised that health systems must put more emphasis on prevention and adopt a person-centred approach. Artificial intelligence (AI) along with the increased availability of health data hold great potential to pave the way for personalised prevention and enable progress towards risk prediction and early detection of chronic non-communicable diseases.

This topic will support multidisciplinary research, build on broad stakeholder engagement and support proposals developing novel robust and trustworthy AI tools to enable timely personalised prevention approaches for chronic non-communicable diseases/disorders. The topic does not exclude any diseases/disorders.

Proposals are expected to develop and test AI tools for assessing and predicting the risk of developing a disease and/or the risk of disease progression once it is diagnosed, taking into account the individuals’ (or groups) genotypes, phenotypes, life-style, occupational/environmental stressors and/or socio-economic and behavioural characteristics, as necessary. Sex and gender aspects should be considered, wherever relevant.

The AI tools may include a broad range of technological solutions on their own and/or in combination with other relevant state-of-the-art technologies (i.e. AI algorithms, mobile apps and sensors, robotics, e-health tools, telemedicine etc.)

Proposals should implement proof-of-concept studies to test and validate the performance of their AI tools in the real-world setting and compare their performance to the established practice.

The applicants should ensure that the AI tools developed are driven by relevant endusers/citizens/health care professionals needs. Therefore, the proposals are expected to introduce concrete measures for the involvement of the end-users throughout the AI development process and not only in the last phases of development. SME(s) participation is encouraged with the aim to strengthen the scientific and technological basis of SME(s) and valorise their innovations for the people’s benefit.

Proposals should address all of the following:

  • Leverage existing high-quality health-relevant data from multiple sources (i.e. cohorts, electronic health records and registries, taking into account the individual’s genotypic/phenotypic, medical, life-style, socio-economic, behavioural data etc.) and/or generation of new high-quality health data necessary for the rigorous development of the AI disease-risk tools.
  • Develop the adequate performance metrics to assess the technical robustness of the developed AI tools for risk assessment of disease and/or disease progression and in particular their accuracy, reliability, reproducibility and generalisability. Proposals should assess the possible inherent bias introduced to the AI tools originating from the data quality used for their development.
  • Develop the criteria to assess the effectiveness of the AI tools for disease risk assessment in terms of improving health outcomes and enabling personalised prevention strategies.
  • Implement proof of concept and/or feasibility studies to validate the AI tools for risk assessment of disease and/or disease progression in a relevant end-users environment and/or real-world setting and assess their performance in comparison to the standard-ofcare

Proposals should adhere to the FAIR data principles and apply good practices for GDPR compliant personal data protection. Proposals are encouraged to implement international standards and best practices used in the development of AI solutions.

Integration of ethics and health humanities perspectives to ensure an ethical approach to the development of AI solutions. In relation to the use and interpretation of data, special attention should be paid to systematically assess for gender and ethnic bias and/or discrimination when developing and using data-driven AI tools.

To ensure citizens’ trust, wide uptake by user communities and scalability of the solutions across clinical contexts, actions should promote the highest standards of transparency and openness of the AI tool, going well beyond documentation and extending to aspects such as assumptions, architecture, code and underlying data.

Applicants are highly encouraged to deliver a plan for the regulatory acceptability of their technologies and to interact at an early stage with the regulatory bodies, whenever relevant.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

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HORIZON-HLTH-2022-TOOL-12-01-two-stage

Computational models for new patient stratification strategies

Indicative budget: 60 million (10 projects at 6 million per project)
Opening: 6 October 2021
Deadline(s): 1 February 2022 (First Stage), 6 September 2022 (Second Stage)

Keywords: patient stratification, health data integration, data-driven computational tools, evidence-based guidelines

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to some of the following expected outcomes:

  • Clinical researchers use effective health data integration solutions for the classification of the clinical phenotypes.
  • Researchers and/or health care professionals use robust and validated data-driven computational tools to successfully stratify patients.
  • Regulatory bodies approve computer-aided patient stratification strategies to enable personalised diagnosis and/or personalised therapy strategies.
  • Health care professionals adopt evidence-based guidelines for stratification-based patient management superior to the standard-of-care.

Scope

In the era of big and complex data, the challenge remains to make sense of the huge amount of health care research data. Computational approaches hold great potential to enable superior patient stratification strategies to the established clinical practice, which in turn are a prerequisite for the development of effective personalised medicine approaches.

The proposals may include a broad range of solutions, such as computational disease models, computational systems medicine approaches, machine-learning algorithms, Virtual Physiological Human, digital twin technologies and/or their combinations, as relevant. The topic covers different stages in the continuum of the innovation path (i.e. translational, preclinical, clinical research, validation in the clinical and real-world setting, etc.), as relevant to the objectives of the proposals.

The topic will support the development of the computational models driven by the end users’ needs.

Proposals should address several of the following areas:

  • Establish interdisciplinary research by bridging disciplines and technologies (disease biology, clinical research, data science, -omics tools, computational and mathematical modelling of diseases, advanced statistical and/or AI/machine learning methods, Virtual Physiological Human and/or digital twin technologies).
  • Develop new computational models for the integration of complex health data from multiples sources, including structured and unstructured data.
  • Develop and optimise robust, transparent and accurate computational models to guide patient stratification strategies for improving clinical outcomes.
  • Demonstrate, test and clinically validate such models with respect to their utility to realistically stratify patients with the aim of improving the standard-of-care.
  • The development of new patient stratification strategies guided by computational models and the validation of the new concepts of stratification in pre-clinical and/or clinical studies.

The proposals should adhere to the FAIR data principles, adopt data quality standards, data integration operating procedures and GDPR-compliant data sharing/access good practices developed by the European research infrastructures, wherever relevant. In addition, proposals are encouraged to adopt good practices of international standards used in the development of computational models, and make available the tools and solutions developed early. Proposals aiming to develop computational models of high technology readiness level are encouraged to deliver a plan for the regulatory acceptability of their technologies. Early interaction with the relevant regulatory bodies is recommended (i.e. the EMA qualification advice for new technologies, etc.) for the proposals contributing to the development of new medicinal products, improvement of the effectiveness of marketed products and the development of medical devices. The proposals aiming to validate their models as high-risk medical devices in the relevant clinical environment are encouraged to deliver a certification implementation plan.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider to cover the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate. In addition, the proposals will be encouraged to exchange with other successful proposals developing AI algorithms and in silico models under other relevant topics.

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