Objective of the CRT meeting
Trustworthy Implementation of AI in Clinical Practice
Overall objective
To establish a comprehensive and actionable roadmap for the trustworthy integration of AI into clinical practice within cardiology, ensuring that AI tools are reliable, evidence-based, and contribute to improved patient outcomes. This roadmap will be developed through collaboration between the medical industry, regulators, notified bodies, professional societies, policy makers, payers and patient representatives.
Specific objectives
- Developing an AI Implementation Roadmap:
- Identify key stakeholders involved in AI implementation.
- Outline the phases of implementation, from pilot projects to full integration.
- Establish milestones and timelines for each phase.
- Objective: To create a clear, step-by-step plan for the adoption of AI technologies in clinical practice.
- Discussion points:
- Ensuring Data Quality and Integrity:
- Identify key data sources and types of data required for AI algorithms.
- Develop strategies to minimise bias in data collection and processing.
- Discuss data governance and management practices, including patient privacy concerns.
- Address data harmonisation, common data models, federated learning and synthetic data generation for data sharing and evaluation of AI algorithms.
- Objective: To define standards and protocols for ensuring the quality, consistency, and reliability of data used in AI systems.
- Discussion Points:
- Creating a Framework for AI Evaluation:
- Define criteria for evaluating AI algorithms, including accuracy, transparency, and fairness.
- Discuss the role of independent third-party evaluations and certifications.
- Explore methods for continuous monitoring and post-market surveillance of AI tools within network of centres.
- Objective: To establish a robust framework for evaluating the safety, efficacy, and ethical considerations of AI tools before and after their deployment in clinical settings.
- Discussion Points:
- Defining Computable Disease Definitions and Outcomes:
- Identify diseases and outcomes that require standardised definitions.
- Harmonisation with existing definitions and deposit in centralised ESC phenotype platform.
- Discuss how these definitions can be used to support clinical decision-making and research.
- Objective: To develop standardised, computable definitions for diseases and clinical outcomes that can be consistently used across AI tools, guidelines, and clinical trials.
- Discussion Points:
- Establishing Evidence Requirements for AI in Clinical Trials:
- Discuss the need for rapid-cycle trials embedded within routine clinical care.
- Explore short-term outcome definitions that are suitable for AI validation.
- Identify the balance between rigorous evidence requirements and the need for timely innovation.
- Discuss the role of HTA.
- Objective: To determine the appropriate levels of evidence needed to validate AI tools in clinical trials, ensuring that these tools are both (cost-)effective and safe for patient care.
- Discussion Points:
- Engaging with Stakeholders:
- Facilitate dialogue between cardiologists, AI developers, and patient representatives.
- Address regulatory and policy challenges and opportunities related to AI in healthcare.
- Discuss the role of professional societies in guiding the ethical and effective use of AI.
- Objective: To ensure that the perspectives of all relevant stakeholders, including regulators, policy makers, payers, professional societies, patients, notified bodies and industry, are incorporated into the roadmap.
- Discussion Points:
- Planning Future Collaborations:
- Set the agenda for the next CRT meetings, focusing on unresolved issues and new developments.
- Identify working groups or committees to continue work on specific objectives.
- Discuss potential partnerships or funding opportunities to support the roadmap’s implementation.
- Objective: To outline the next steps and future meetings required to continue progress on the AI implementation roadmap.
- Discussion Points:
Final Programme
Academic Chairpersons
- Prof. Folkert Asselbergs
- Prof. Ruben Casado Arroyo
- Prof. Cecilia Linde (ESC President-Elect and ESC Chair of the CRT)
Industry Chairpersons
- Dr. Katarzyna Markiewicz (Philips)
- Prof. Rodolphe Katra (Medtronic)
- Dr. Tamara Krcmar (Servier International)
- Prof. Alexandra Goncalves /(BMS) (Industry Chair of the CRT)
Time |
Session |
Speaker |
---|---|---|
12:00 |
Arrival and Buffet Lunch |
|
13:15 |
Welcome from the CRT Chairpersons |
Alexandra Goncalves (BMS) Cecilia Linde |
13:20 |
SESSION 1.1 – The road towards an ESC computable phenotype and outcome definition library Moderated by: Folkert Asselbergs and Katarzyna Markiewicz (Philips) |
|
13:20 |
Health Systems of the next 25 years: How do we harness AI innovation to improve performance? |
Martin McKee (European Observatory on Health Systems & Policies) recording |
13:40 |
Health Data Research UK and the British Heart Foundation (HDR UK/BHF) data science center phenotype library |
Angela Wood |
14:00 |
Data standards: EuroHeart perspective |
Stefan James |
14:20 |
How to leverage European Health Data Space(EHDS) and other regulatory initiatives to build computable phenotype and common outcome library? |
Andrzej Ryś (European Commission) via ZOOM |
14:40 |
PANEL DISCUSSION |
|
15:00 |
Coffee Break |
|
15:30 |
SESSION 1.2 – Stakeholders perspective on AI adoption and implementation Moderated by: Ruben Casado Arroyo and Tamara Krcmar (Servier International) |
|
15:30 |
Unmet needs in the clinical setting in the era of AI and Decision Support Systems. |
Carlos Pena |
15:50 |
AI In Healthcare - Yes, No and Maybe |
Richard Stephens (ESC Patient Forum) |
16:10 |
Clinical and patient requirements for trustworthy AI: results of co-creation workshops of Trustworthy Artificial Intelligence for Personalized Risk Assessment in Chronic Heart Failure (AI4HF) European Union program |
Carina Dantas (SHINE) |
16:30 |
European Medicines Regulatory Network. Key initiatives to adopt AI in Health Care |
Florian Lasch (European Medicines Agency : EMA) via ZOOM |
16:50 |
Accelerating clinical value through engagement with big tech and startups: how the ESC can make a difference? |
Guy Spigelman (Amazon Web Services) |
17:10 |
Coffee Break |
|
17:20 |
SESSION 1.3 – New solutions from the start-up world Moderated by: Cecilia Linde and Alexandra Goncalves (BMS) |
|
17:20 |
AI impact on patient awareness, engagement and recruitment in routine care and clinical trials: the Elfie case (mobile intervention) |
Jean François Legourd (Elfie) Otavio Berwanger via ZOOM (Elfie) |
17:30 |
How is EIT Health supporting AI integration into the health innovation ecosystem? |
Jérôme Fabiano (EIT-European Institute of Innovation and Technology ) |
17:40 |
Generative AI in Healthcare: From (unstructured) data to insights & workflow automation - the HealthSage AI case. |
Marcel Alberti (Healthsage AI) |
17:50 |
Transforming Frontline Cardiovascular Patient Detection and Referral: PMcardio AI-powered ECG Platform |
Robert Herman (Powerful Medical) |
18:00 |
Image-based home monitoring for the early detection of post surgical infection with AI | Simone Bottan (Hylomorph) |
18:10 |
PANEL DISCUSSION | |
18:30 |
Wrap-up and Summary Day 1 – Outlook to Day 2 |
Alexandra Goncalves (BMS) Cecilia Linde |
END OF DAY 1 |
||
19:30 |
APERITIF + DINNER |
Day 2: 14 November 2024 08:30–12:30 CEST
Time |
Session |
Speaker |
---|---|---|
08:30 |
Summary of day 1 |
Folkert Asselbergs Katarzyna Markiewicz (Philips) |
08:40 |
SESSION 2.1: The road to Evidence-based AI driven software Moderated by: Thomas F. Lüscher and Rodolphe Katra (Medtronic) |
|
08:40 |
AI Trials: Landscape |
Tor Biering-Sorenson |
09:00 |
Notified body view on evidence generation software |
Richard Holborow |
09:20 |
AI act |
Piotr Szymanski |
09:40 |
ESC Guidelines for AI driven software |
Anja Hennemuth |
10:00 |
Coffee break |
|
10:20 |
BREAKOUT SESSIONS: What are the boundaries & limitations for AI successful implementation? |
|
Group 1: Regulatory perspective |
Lead: Ruben Casado Arroyo Rapporteur: Alan Fraser |
|
Group 2: Clinical researchers and patient perspective |
Lead: Richard Stephens (ESC Patient Forum) Rapporteur: Filippo Crea |
|
Group 3: Industry perspective |
Lead: Piotr Szymański Rapporteur: Monika Gratzke (Daiichi Sankyo) |
|
11:10 |
Report from breakout session 1 |
|
11:20 |
Report from breakout session 2 |
Rapporteur: Filippo Crea |
11:30 |
Report from breakout session 3 |
Rapporteur: Monika Gratzke (Daiichi Sankyo) |
11:40 |
PANEL DISCUSSION and NEXT STEPS |
|
12:20 |
Wrap-up, conclusions |
Alexandra Goncalves (BMS) Cecilia Linde |
END OF DAY 2 |
||
12:30 |
Buffet Lunch and Departures |
Biographies
- Prof. Cecilia LINDE, Sweden
- Prof. Alexandra GONCALVES, BMS
- Marcel ALBERTI, Netherlands
- Prof. Folkert ASSELBERGS, Netherlands
- Prof. Tor Biering-Sørensen, Denmark
- Dr. Simone BOTTAN, Switzerland
- Prof. Ruben CASADO ARROYO,Belgium
- Prof. Filippo CREA, Italy
- Ms. Carina DANTAS, Portugal
- Deputy Director EIT Health in France. Jérôme FABIANO, France
- Dr. Josep FIGUERAS, Belgium
- Prof. Alan FRASER, UK
- Dr. Monika GRATZKE, Germany
- Prof. Anja HENNEMUTH, Germany
- Dr. Robert HERMAN, Belgium
- Dr. Richard HOLBOROW, UK
- Prof. Stefan JAMES, Sweden
- Dr. Rodolphe KATRA, Medtronic
- Ms. Tamara KRCMAR, Servier International
- Dr. Florian LASCH, Netherlands
- Mr. Jean-Francois LEGOURD, Singapore
- Prof. Thomas LÜSCHER, UK/Switzerland
- Dr. Katarzyna Markiewicz-Barreaux, the Netherlands/Poland
- Associate Prof. Carlos PEÑA GIL, Spain
- Dr. Andrzej RYS, Belgium
- Mr. Guy SPIGELMAN, Netherlands
- Mr. Richard STEPHENS, UK
- Prof. Piotr SZYMANSKI, Poland
- Prof. Angela WOOD, UK