Periodic Reporting for period 2 - COVID-X (COVID eXponential Programme)
Periodo di rendicontazione: 2021-11-01 al 2022-10-31
The world has faced multiple waves of the COVID-19 pandemic. According to the World Health Organization, Europe has been the most affected zone in the number of cases. EU/EEA fully vaccinated 86.3% of their population, but COVID-19 continues to affect all EU countries and pressure the healthcare system. We are just starting to understand this pandemic's health, economic and social impact in the medium and long term. This crisis knows no borders and demands, causing similar challenges to first and third countries worldwide. Europe must stand out as a union and face this threat jointly.
COVID-X brings together startup and SME providers of digital health solutions and healthcare systems. Solution providers are developing innovative eHealth solutions using artificial intelligence and big data but need help entering the healthcare market dominated by large companies. Healthcare providers are collecting massive amounts of data when diagnosing and treating patients. COVID-X bridges these two communities to validate innovative solutions in European clinical scenarios to support the diagnosis, treatment, and recovery of COVID-19 patients.
COVID-X brings together startup and SME providers of digital health solutions and healthcare systems. Solution providers are developing innovative eHealth solutions using artificial intelligence and big data but need help entering the healthcare market dominated by large companies. Healthcare providers are collecting massive amounts of data when diagnosing and treating patients. COVID-X bridges these two communities to validate innovative solutions in European clinical scenarios to support the diagnosis, treatment, and recovery of COVID-19 patients.
The project ran for two intense and challenging years through five waves of COVID-19, achieving significant results.
Two open calls during 2021 looking to fund EU Companies and Healthcare Providers to boost data-driven solutions to overcome diagnosis, prognosis, and follow-up challenges. The project focused on products with TRL 7+ and CE marking (or in the process of achieving it). We covered two profiles: single players (technology provider SMEs and startups) validating their solutions at one of the COVID-X clinical partners; and team players (technology providers SMEs working with their healthcare provider to validate the solution). We received over 190 applications in the two open calls, selecting 29 solutions.
The ethical and legal framework is a reference guide on personal data privacy, including strategies and techniques to ensure accountability and safeguard patients’ rights. First, we developed a process to anonymise personal data, preserving the confidentiality and privacy of patients and eliminating the possibility of reidentification. Secondly, we specified information security guidelines to ensure compliance with international standards (ISO / IEC 27001: 2005) and GDPR. This result helps hospitals, data holders, and operators who want to provide their data to third parties but don’t understand the road to system creation by drawing aspects to consider when beginning the journey.
Policy recommendations outline the critical legal and ethical issues hindering a faster uptake of digital health solutions and provide considerations for health authorities and other stakeholders. This result serves as a reference point and action plan for policymakers on a national and European level and advises on future steps to better facilitate the implementation of novel medical solutions. The key challenges identified in the regulatory domain are associated with understanding and interpreting the Medical Device Regulation, the shortage of notified bodies and the fragmentation of the local regulations regarding health technology assessment and reimbursement paths.
Sandbox is an infrastructure to store, process and manage data. It can be used as a local or cloud deployment and includes a security layer. The Sandbox is a layered and modular architecture with a collection of core services to ingest, manage, annotate and store healthcare data. It also offers multiple services covering data management, security, data visualisation (e.g. creating dashboards), and federated learning of models using dispersed data sources. This last service allows providers to train and validate their models faster and more robustly, using additional data sources when their access to data is limited.
COVID-X Programme accelerates the final steps towards the market uptake of top-rated data solutions. The programme provided financial support to the technology providers and healthcare partners, access to the Sandbox as technical infrastructure, and business, clinical and ethical support. The business support programme covered eight topics, offering general and individual sessions with topic-specific mentors and accompaniment from general mentors. The programme also included a clinical monitoring framework to monitor all pilots to ensure a high clinical impact and rapid response to achieve better patient outcomes, avoiding overtreatment and under-treatment conditions.
COVID-X accelerated 29 data-driven solutions, covering six challenges: early detection, innovative diagnosis, personalised care, remote care, healthcare continuity and recovery. We had six single solutions and 23 team solutions, representing 29 technology provider SMEs and 23 healthcare providers, supported by the COVID-X consortium.
Two open calls during 2021 looking to fund EU Companies and Healthcare Providers to boost data-driven solutions to overcome diagnosis, prognosis, and follow-up challenges. The project focused on products with TRL 7+ and CE marking (or in the process of achieving it). We covered two profiles: single players (technology provider SMEs and startups) validating their solutions at one of the COVID-X clinical partners; and team players (technology providers SMEs working with their healthcare provider to validate the solution). We received over 190 applications in the two open calls, selecting 29 solutions.
The ethical and legal framework is a reference guide on personal data privacy, including strategies and techniques to ensure accountability and safeguard patients’ rights. First, we developed a process to anonymise personal data, preserving the confidentiality and privacy of patients and eliminating the possibility of reidentification. Secondly, we specified information security guidelines to ensure compliance with international standards (ISO / IEC 27001: 2005) and GDPR. This result helps hospitals, data holders, and operators who want to provide their data to third parties but don’t understand the road to system creation by drawing aspects to consider when beginning the journey.
Policy recommendations outline the critical legal and ethical issues hindering a faster uptake of digital health solutions and provide considerations for health authorities and other stakeholders. This result serves as a reference point and action plan for policymakers on a national and European level and advises on future steps to better facilitate the implementation of novel medical solutions. The key challenges identified in the regulatory domain are associated with understanding and interpreting the Medical Device Regulation, the shortage of notified bodies and the fragmentation of the local regulations regarding health technology assessment and reimbursement paths.
Sandbox is an infrastructure to store, process and manage data. It can be used as a local or cloud deployment and includes a security layer. The Sandbox is a layered and modular architecture with a collection of core services to ingest, manage, annotate and store healthcare data. It also offers multiple services covering data management, security, data visualisation (e.g. creating dashboards), and federated learning of models using dispersed data sources. This last service allows providers to train and validate their models faster and more robustly, using additional data sources when their access to data is limited.
COVID-X Programme accelerates the final steps towards the market uptake of top-rated data solutions. The programme provided financial support to the technology providers and healthcare partners, access to the Sandbox as technical infrastructure, and business, clinical and ethical support. The business support programme covered eight topics, offering general and individual sessions with topic-specific mentors and accompaniment from general mentors. The programme also included a clinical monitoring framework to monitor all pilots to ensure a high clinical impact and rapid response to achieve better patient outcomes, avoiding overtreatment and under-treatment conditions.
COVID-X accelerated 29 data-driven solutions, covering six challenges: early detection, innovative diagnosis, personalised care, remote care, healthcare continuity and recovery. We had six single solutions and 23 team solutions, representing 29 technology provider SMEs and 23 healthcare providers, supported by the COVID-X consortium.
First, COVID-X contributed to public health preparedness and response to the COVID-19 pandemic. COVID-X funded solutions for all stages of pandemic preparedness and response: early detection, innovative diagnostics, personalised care, remote care, healthcare continuity and recovery. The Sandbox integrates five public datasets, providing 13 services and a unified data model to support interoperability.
Secondly, the project contributed to the acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, coverage, and sustainability of diagnosis and clinical management of patients and survivors of COVID-19. COVID-X supported the successful validation of 28 solutions in hospitals. The solutions contributed to reducing diagnosis time by 21-96%, improved prognosis by more than 50% and reduced the number of tests by at least 30%. In addition, the solutions improved the specificity of diagnosis by 30%, reduced hospital visits by 60% and reduced recovery time by 20%.
Thirdly, COVID-X accelerated the deployment and market uptake of mature health technologies to prevent COVID-19 and optimise its treatment by delivering results within 3-24 months to end-users at scale. The project developed individual business roadmaps for all the solutions, supporting them in the next steps after the programme. Fourteen solutions have already acquired CE marking, and another eight expect to have it during 2023. The solutions plan revenues of over EUR 1.5 million for 2023 and EUR 4.4 million for 2024.
Finally, COVID-X proposed changes for a fast recovery and better preparedness for future health emergencies, including in the healthcare systems. The project engaged 26 healthcare providers, directly validating new digital solutions and exchanging valuable information on dealing with the COVID-19 pandemic. COVID-X provided recommendations to the healthcare systems on the best actions for a fast recovery, preparedness and prevention of the effects of the pandemic, with a set of measures considering the value of healthcare and costs for effective implementation.
Secondly, the project contributed to the acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, coverage, and sustainability of diagnosis and clinical management of patients and survivors of COVID-19. COVID-X supported the successful validation of 28 solutions in hospitals. The solutions contributed to reducing diagnosis time by 21-96%, improved prognosis by more than 50% and reduced the number of tests by at least 30%. In addition, the solutions improved the specificity of diagnosis by 30%, reduced hospital visits by 60% and reduced recovery time by 20%.
Thirdly, COVID-X accelerated the deployment and market uptake of mature health technologies to prevent COVID-19 and optimise its treatment by delivering results within 3-24 months to end-users at scale. The project developed individual business roadmaps for all the solutions, supporting them in the next steps after the programme. Fourteen solutions have already acquired CE marking, and another eight expect to have it during 2023. The solutions plan revenues of over EUR 1.5 million for 2023 and EUR 4.4 million for 2024.
Finally, COVID-X proposed changes for a fast recovery and better preparedness for future health emergencies, including in the healthcare systems. The project engaged 26 healthcare providers, directly validating new digital solutions and exchanging valuable information on dealing with the COVID-19 pandemic. COVID-X provided recommendations to the healthcare systems on the best actions for a fast recovery, preparedness and prevention of the effects of the pandemic, with a set of measures considering the value of healthcare and costs for effective implementation.