This project is developing solutions to enable routinely collected hospital EHR data to be directly reused within the conduct of clinical trials, if trial subjects have given their consent for this. The project is designing and implementing a platform to enable the reuse of EHR data within a trial, which has been piloted in four European hospitals. Discover the challenges, results, validation ...
i~HD leads a work package on governance, especially compliance with the GDPR, and has developed a code of practice covering this aspect of EHR reuse. i~HD also leads the task on discussions with regulatory bodies on the acceptability criteria for EHR data acting as a source of information into regulated clinical trials (eSource). i~HD is developing a new Quality Seal for research platforms contributing eSource data. We will also contribute to the work package on semantic interoperability and develop an extension to the Data Quality Seal for the EHR2EDC context. During 2020 the project will enrich the data set to be communicated between EHR and EDC systems in the domains of cardiovascular medicine and oncology. Follow on grant applications are being submitted to EIT Health for 2021.
EIT Health, Assistance Publique - Hôpitaux de Paris, TriNetX, Hospital 12 de Octubre, Hannover Medical School, ICON, i~HD, Inserm, IRST, AstraZeneca, Janssen, Sanofi, UCB
Conception is developing an ecosystem for generating and disseminating real world evidence on the use of medicines in pregnancy and during breastfeeding, the effectiveness and safety of these medicines. The evidence will be generated through a network of women’s health databases held by consortium partners and third parties, and published for access by women, healthcare providers and other decision makers including medicines regulators. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, pregnant women and their children through a large network. i~HD is a partner and leads a work package on multi-stakeholder engagement and consensus building on the acceptance of real-world evidence, in particular interacting with medicines regulators such as EMA. It also leads a task on information governance and GDPR compliance. The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Consortium partners: Novartis, UMC Utrecht, Ulster University, Uppsala Universitet, BBMRI-ERIC, Alma Mater Studiorum Università Di Bologna, i~HD, KU Leuven, Medicines & Healthcare products Regulatory Agency, Netherlands Pharmacovigilance Centre Lareb, Ars Toscana, Karolinska Institutet, The Newcastle Upon Tyne Hospitals, University of Kwazulu-Natal, University of Oslo, St George’s University of London, Eurohealth, UMCG, Orcion, Inserm, BioNotus, Hôpitaux de Toulouse, Università Degli Studi di Ferrara, Prifysgol Abertawe Swansea University, Université de Genève, EFCCP, The Synergist, Entis, The University of Manchester, Region Stockholm, Elevate, Finnish Institute for Health and Welfare, IFC, FISABIO, Ttopstart, European Medicines Agency, RIVM, Janssen, Sanofi, Takeda, GSK, Lilly, Pfizer, Bristol-Myers Squibb Company, Merck, Novo Nordisk, UCB, Abbvie, Ellegaard, Covance, Teva
Health data LInkage for ClinicAL benefit is a training network comprising 17 academic and 9 non-academic/industry partners for early stage researchers in the field of Healthcare Data Linkage in the GDPR era. HELICAL will link research datasets with longitudinal healthcare records, based on a robust ethical foundation required for linkage studies using near-patient data, to address key experimental questions, using autoimmune vasculitis as a paradigm. Fifteen PhD studentships will be funded through this network. i~HD will host one fully funded PhD to conduct research to work for 3 years into the implications of GDPR for biomedical research using personal and genetic data, the role of consent in rare disease research and the appropriate safeguards for the pseudonymisation of genetic data. This project is funded through the European Union’s Horizon 2020 research and innovation programme (Marie Skłodowska-Curie grant).
Consortium partners: Adapt Centre, IBM, Trinity College Dublin, University of Glasgow, Kantonsspital St. Gallen, ISGlobal Barcelona, Instituto de Parasitología y Biomedicina "López - Neyra", Consejo Superior de Investigaciones Científicas, University of Leeds, Anaxomics, IDIBAPS, Medizinische Universität Wien, TissueGnostics, KTH Royal Institute of Technology, Firalis, i~HD
EU-PEARL has the ambition of transforming the current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), taking into consideration both patients’ interests and the opportunities from novel molecules for addressing medical needs. Patient-centric data and knowledge sharing have the potential to accelerate the development of new treatments and reduce the operational costs of clinical trials. EU-PEARL will improve clinical effectiveness, patients’ satisfaction and societal access to timely and affordable medicines, and it will shape the clinical trials of the future. This will change the industry paradigm from competition to cooperation in four disease areas and provide the framework for designing IRPs in other disease areas. EU-PEARL will create a reusable, accessible and sustainable modular IRP for the design and execution of patient-centric, cross-company IRP in any disease area with unmet needs. This will take into account the appropriate regulatory, ethical, legal, statistical and data utilisation requirements. The IRP design will deliver trial-ready IRP networks in the four disease areas of Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis and Neurofibromatosis. EU-PEARL receives funding from the Innovative Medicines Initiative 2 Joint Undertaking. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
i~HD leads the main governance work package of the project, and so will play a leading role in ensuring the project meets its objectives. It has specific responsibilities in information governance and GDPR compliance, interoperability and data quality, platform certification, and contributes to other sustainability actions.
Consortium partners: Fundació Hospital Universitari Vall d'Hebrón – Institut de Recerca, EATRIS ERIC, SYNAPSE Research Management Partners SL, Medizinische Universitӓt Wien, Katholieke Universiteit Leuven, King’s College London, Universita Vita-Salute San Raffaele, Erasmus Universitair Medisch Centrum Rotterdam, Ludwig-Maximilians-Universitaet München, Charité - Universitaetsmedizin Berlin, Assistance Publique - Hôpitaux de Paris, Custodix, i~HD, Berry Consultants, ECRIN European Clinical Research Infrastructure Network, European Patients’ Forum, University of Newcastle upon Tyne, EUROSCAN International Network, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, The Chancellor, Masters and Scholars of the University of Oxford, Università degli Studi di Milano, DocuMental OÜ, The University of Manchester, Janssen Pharmaceutica, Novartis Pharma, Allergan, AstraZeneca, Novo Nordisk, Otsuka Novel Products, Pfizer, Sanofi-Aventis Research & Development, Institut de Recherches Internationales Servier, Teva Pharmaceutical Industries, Children’s Tumor Foundation, SpringWorks Therapeutics, Global Alliance for TB Drug Development
This innovation action will give a powerful impulse to implementation of ISO IDMP (ID of Medicinal Products) standards in EU Member States drug databases, supporting safe cross-border ePrescription/ eDispensation and effective pharmacovigilance. Once EU-interoperable data on medicines taken by patients become available, further benefits will accrue through better health data for improved clinical decision support, patient empowerment, public health and clinical research. New opportunities will arise for pharma industry, software developers, SMEs providing smart apps and others, thereby fostering their innovation capacity and competitiveness.
The project ambition centres on conversion of key regulatory and clinical processes to use IDMP. These information value chains must be converted over their full length from data input to data repositories to data usage. The project will mainly focus on the implementation of EU and national SPOR (substances, products, organisations, referentials) data bases, including establishing an EU Substance Reference System (EU-SRS). Such information is fundamental to cross-border ePrescription where safe dispensation may require reliable identification of substances in available products. 19 countries are represented, including 26 national Drug and eHealth Agencies. Stakeholders are involved through their associations. This project is funded through the European Union’s Horizon 2020 research and innovation programme.
i~HD leads work packages on the delivery of enhanced medicines information to patients, pharmacists and clinicians, its use in pharmacovigilance and in personalised medicine, and the incorporation of IDMP medicines identification standards into healthcare provider and pharmacy systems including decision support.
Consortium partners: AEMPS, AFMPS, AGES, ARIA, BFARM, BIDMC, CGB, COCIR, Datawizard, EESAM, EHTEL, ELGA, EMPIRICA, FIMEA, FOUND, GNOMON, HALMED, HL7, HPRA, Croation Health Insurance Fund, IDIKA, IDMP1, IEDOH, i~HD, IHE Europe, ILIM, INDRA, INFARMED, KELA, MHRA, NICTIZ, NOMA, REGLOMB, SAS, SEMPA, SPMS, VIDAL, ZINDEX
m Health Hub is a project funded by the EC through the WHO and ITU. Its goal is to develop a web platform of knowledge to enable mHealth to be more widely and successfully deployed in national and regional level health services, and for mHealth to deliver large scale benefits. The platform aims to become the focal point for expertise on mHealth in the EU, identifying and highlighting trends and gaps in policies, standards, regulations, etc. and best practices and barriers to the creation of consistent mHealth infrastructure and strategy. i~HD is responsible for threads of work relating to stakeholder engagement, contributing to the structure and content of mHealth knowledge frameworks and for charting the innovation landscape of mHealth.
Consortium partners: Campania Region, Ehtel, Empirica, Ericsson Nikola Tesla D.D., Foundation Tallinn Science Park Tehnopol – Connected Health Cluster, European Society of Cardiology (ESC), Health Care Centre Zagreb, Hl7 International Foundation, i~HD, International Telecommunication Union (ITU), Junta de Andalucia, Mdog, Spanish Ministry of Health, Osakidetza (Basque Health Service), PCHA, Promis, Jämtland Härjedalen Region, SPMS, University of Agder, University of Applied Sciences Technikum Wien, WHO
The conect4children (collaborative network for European clinical trials for children (c4c)) consortium aims to enhance the competitiveness of Europe, as a critical region for developing medicines for children. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
i~HD plays an advisory role as a third party in this IMI project, providing expertise in semantic interoperability and the development of a standardised paediatric data dictionary.
Consortium partners: Fondazione PENTA Onlus, The University of Liverpool, Ospedale Pediatrico Bambino Gesù, EURORDIS–Rare Diseases Europe, European Cystic Fibrosis Society, Radboud University Medical Centre, Swiss Clinical Trial Organisation, Associação para Investigação e Desenvolvimento da Faculdade de Medicina, Istituto Giannina Gaslini, University College London, The European Society for Paediatric Oncology (SIOP Europe), University of Tartu, Okids, Newcastle University, Universiteit Gent, Universitaetsklinikum Heidelberg, Aristotelio Panepistimio Thessalonikis, Instytut “Pomnik-Centrum Zdrowia Dziecka”, Helse Bergen HF*Haukeland University Hospital, ECNP, Robert Bosch Gesellschaft für medizinische Forschung, University College Cork, Karolinska Institutet, Fundació Sant Joan de Deu, Servizo Galego de Saude, Gyermekgyógyászati Klinikai Vizsgálói Hálózat, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, ECRIN European Clinical Research Infrastructure Network, The Hospital District of Helsinki and Uusimaa, Institut National de la Santé et de la Recherche Médicale, Helios Dr. Horst Schmidt Kliniken Wiesbaden, ARSENAL.IT-Centro Veneto Ricerca e Innovazione per la Sanità Digitale, Univerzita Karlova, Janssen Pharmaceutica, Bayer, Sanofi-Aventis Research & Development, Eli Lilly, UCB Biopharma, Novartis Pharma, Institut de Recherches Internationales Servier, GlaxoSmithKline Research and Development, Pfizer
Due to population ageing and advances in medical science, people with chronic diseases – including advanced severe life-threatening chronic diseases - live longer. Challenges are how to sustain quality independent living for the patient; support caregivers facing an increasing burden; create sustainable healthcare and social care systems with limited resources. ADLIFE aims to provide a solution for the integration of therapies and approaches targeting early detection and assessment of deterioration, advanced and well-coordinated care planning and integrated supportive care to enhance quality of life, reduce suffering and accelerate recovery for these patients and their families. It will deploy developed and validated personalised digital solutions for integrated supportive care based on H2020 projects C3-Cloud and Power2DM, previously tested in two health systems. The ADLIFE Toolbox solutions include: a Personalised Care Plan Management Platform, Clinical Decision Support Services; Interoperability Solutions and Patient Empowerment Platform with Just-In Time Adaptive Intervention Delivery Engine.
The ADLIFE Project has received funding from the European Union under the Horizon 2020 Programme, and started on 1 January 2020. i~HD will be a partner and lead work on data management and GDPR compliance, the communication of the project results to patients, the public and to healthcare systems, and contributes to the business plans for sustainability.
Consortium partners: Asociación Centro de Excelencia Internacional en Investigación sobre Cronicidad (KRONIKGUNE), University of Strathclyde, The University of Warwick, Odense University Hospital, Falkiewicz Specialist Hospital, OptiMedis, Region Jämtland Härjedalen, Assuta Ashdod Hospital, Software Research & Development Consultancy (SRDC), EVERIS, i~HD, Osakidetza, Maccabi Healthcare Services
i~HD has been a partner in this Horizon 2020 Co-ordination and Support Action which ran from January 2017 to June 2019. Trillium II has co-ordinated and supported efforts towards an interoperable international patient summary. The consortium comprised EU and US partners. i~HD led a work package to promote successful patient summary adoption, focusing on a strategy for identifying success factors including education for a range of stakeholders, those who will implement or use patient summaries, or those who will benefit from access to aggregated patient summary information. An additional goal was to promote the social value of international patient summary standards. This work package produced its deliverables at the end of 2018, on the potential contribution of the international patient summary in disaster response situations, to improve child immunisation rates, as well as for emergency care in emergency departments, on the critical success factors for adoption, and on the educational requirements for patients and healthcare professionals to make best use of patient summaries.
Consortium partners: MedCom, HL7 International Foundation, CEN/Stichting Nederlands Normalisatie-Instituut, Integrating The Healthcare Enterprise, i~HD, Empirica, Gnomon Informatics, Reseau Phast Association, SRDC, Offis, Lombardia Informatica, Terveyden Ja Hyvinvoinnin Laitos, Agence e-Santé, Fundacio Ticsalut Social, SPMS, ECH Alliance, Advanced Digital Innovation, Reliant Medical Group, Lantana Consulting Group, Healthcare Services Platform Consortium, Prosocial Applications, Healtheway, inc. DBA The Sequoia Project, Kaiser Foundation Hospitals