European Health Data Space: the way ahead

Background: The European Health Data Space (EHDS) promises a paradigm shift transformation in healthcare across Europe. EHDS will foster improved care coordination, facilitate groundbreaking research, and empower patients by enabling secure exchange of patient data across borders. Recent public-private partnership EU-funded projects, like IDERHA and H2O projects will not only be aligned with the EHDS technical requirements and organizational requirements but also will play an active role in shaping the EHDS. In this session, the coordinators of both projects will highlight these aspects with emphasizing on how the two projects can accelerate the EHDS implementation in Austria.

Chair: Dr. Rada Hussein PhD, FIAHSI

Speakers:

• Dr. Christian Muehlendyck
  IDERHA Project Lead and Scientific Partnerships Lead for Europe Middle East and Africa (EMEA) region | Johnson & Johnson MedTech
• Dr. Philip Gribbon
  Coordinator of IDERHA and Head of Discovery Research | Fraunhofer Institute for Translational Medicine and Pharmacology, Hamburg, Germany

Abstract:

IDERHA (Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance) is a European public-private partnership launched in April 2023 (https://www.iderha.org/). This pioneering project addresses the obstacles in accessing, integrating and analyzing health data to maximize their value for patient care and medical research. IDERHA is one of the first implementations of the pan-European Health Data Space starting with a pilot in a lung cancer. 

Christian Muehlendyck will address the opportunities that arise from developing the IDERHA’s pan-European health data space while highlighting the imperative necessity to address the challenges associated with using Real World Data (RWD) in generating Real World Evidence (RWE) for Health Technology Assessment (HTA) acceptance. He will explore the planned IDERHA’s four selected clinical use cases in lung cancer using AI tools, and personalized remote monitoring applications

Philip Gribbon will highlight the role of data FAIRness in paving the way toward the secondary use of health data. He will elaborate on the health data governance framework in IDERHA and IDERHA’s approach in synchronizing the Data Management Plan (DMP) with the Data Protection Impact Assessment (DPIA), and the Data Sharing Agreements (DSA).

Speaker Bios:

• Christian Muehlendyck is the Scientific Partnerships Lead for Johnson & Johnson MedTech in the Europe Middle East and Africa (EMEA) region. In this role, he focuses on the various Innovative Health Initiative (IHI) activities of J&J MedTech. This includes the establishment and industry leadership of IDERHA, one of the first IHI public-private partnerships. Furthermore, he is a member of the IHI Science & Innovation Panel and Co-Chair of the MedTech Europe Research & Innovation Committee.
  Within Johnson & Johnson he has held a series of local, regional and global roles of increasing responsibility spanning from Medical Training as well as commercial positions to Health Economics & Market Access across the surgical and orthopedic spectrum. Within those roles he worked closely with physicians, patients & health authorities and acquired a broad expertise in health care innovation and research incl. value-based healthcare and healthcare digitalization such as robotic surgery.
  He began his career as a physician in Orthopedic and General Surgery and obtained his MD/PhD while co-leading the development of an innovative Medical Device. He subsequently transitioned into the MedTech industry to further pursue his passion for medical innovation. 
• Philip Gribbon is the coordinator of IDERHA and Head of Discovery Research at the Fraunhofer Institute for Translational Medicine and Pharmacology in Hamburg, Germany. In February 2024, he was appointed as the Director General of the EU-OPENSCREEN. Philip is involved in several national and European consortia working on FAIR data strategies which help promote cloud deployment of analysis workflows and therefore achieve greater reuse of data by the wider scientific community  (eg., EOSC-LIFE, FAIRplus, BY-COVID). Previously, Philip was Chief Scientific Officer of the European ScreeningPort GmbH, which provided drug discovery and translational research services. Between 2005 and 2007, Philip was a manager at GlaxoSmithKline Ltd, Stevenage, providing support for the development of Drug Development technologies. In the period 2000 to 2005 he was a Principle Scientist at Pfizer working across multiple therapeutic areas. Between 1995- 1999, Philip was at the University of Manchester studying molecular interactions governing the function of connective tissues.  He received his PhD in Biophysics from Imperial College London in 1995 and has MSc and BSc degrees in Physics.

Speaker:

• Univ.-Prof. Dr. Tanja Stamm, PhD
  Coordinator of H2O and Head of the Institute for Outcomes Research | Center for Medical Data Science | Medical University Vienna & Head of the Ludwig Boltzmann Institute for Arthritis and Rehabilitation

Abstract:

H2O is a strategic partnership between the public and private sectors to create a robust data governance and infrastructure model to collect and incorporate patient outcomes at scale into healthcare decision-making at an individual and population level. The H2O approach gives patients ultimate control of their health data and ensures that only they exercise this control. H2O developed and implemented core outcome sets in diabetes, Crohn’s disease and breast and lung cancer in Germany, Netherlands, Spain and Austria. H2O’s patient consent, data collection infrastructure and governance model could be scaled up to more countries and diseases. 

Speaker Bio:

• Tanja Stamm is Full Professor and Head of the Institute for Outcomes Research, Deputy Director of the Center for Medical Statistics, Informatics and Intelligent Systems at the Medical University of Vienna and Head of the Ludwig Boltzmann Institute for Arthritis and Rehabilitation. Her research focuses on patient-reported outcomes, arthritis, occupational health, psychometrics, assistive technologies, and the use of real-world data. Tanja Stamm combines clinical expertise with other advanced research skills and professional competence in data science. She has pioneered work in various medical fields, such as rheumatology, musculoskeletal health, rehabilitation, public health, diabetes, dietetics, and oral health. She has also been involved in the development of complex multi-center drug studies and registries, including their digital infrastructure and patient-centered approach. Until June 2020, Tanja Stamm was Vice President of the European League Against Rheumatism. Since October 2020, she coordinates the Innovative Medicines Initiative (IMI) Health Outcomes Observatories H2O Project (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0146). Since March 2021, Tanja Stamm chairs the outcomes task force of the European University Hospital Alliance, a network of 9 leading university hospitals in Europe (https://www.euhalliance.eu/).