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The program consists of eight modules relating to themes of health, law, and technology, and there will be two sessions for every module. The modules are the following:

The Modules
Monday 3/06
Tuesday 4/6
Wednesday 5/6
Thursday 6/6
Friday 7/6
1. Innovative use of AI in health-related technology

AI is presenting both new challenges and opportunities in medicine. In terms of the former these include new possibilities not only to detect and treat illness but even potentially to prevent or reduce the likelihood of it occurring in the first place. It will also hopefully permit a reorganisation of healthcare systems allowing for a more efficient use of available resources.  In terms of the latter, it will bring both new ethical and regulatory challenges. These must be addressed in order to ensure that new technological developments occur in the most patient centric way possible.

2. AI & Medical Devices

This module will introduce artificial intelligence, as applicable for a non-mathematical audience, including all approaches relevant to medical devices (with the exception of generative and large language approaches which are covered in the Module 3). The features of AI that make it ‘special’ from a regulatory perspective will be described.  The developing EU regulations for AI will be described, including how ‘vertical’ medical device regulation and guidance related to the sector, and how it will be affected by ‘horizontal’ legislation (the AI Act) and standards. Challenges and gaps in AI regualion will be considered.

3. How might Large Language Models be used in Medical Devices

Although a subset of deep learning AI, large language models (LLMs), and other transformer-based generative AI approaches bring with them larger promise and large challenge associated with their use in medicine and medical devices. These potentials and challenges will be described in detail, along with an overview of the current state of development of technologies on-market, and the challenge for regulators in deciding how to apply and enforce regulation in this area.

4. Health Data Governance (including EHDS)

The sharing of health data is critical to both performing good medicine and to research associated with that aim. Despite advances in the digitisation of patient dossiers (e.g. the EHR) and improved online connectivity great challenges remain. These are not only technical, but also regulatory and even in many cases cultural. Amongst initiatives to improve the sharing of data in this area is the EU’s proposal for a European Health Data Space. The aim behind it is to increase the sharing of electronic health data both for primary (i.e. the treatment of patients) and for secondary (i.e. scientific research, innovation and other) purposes.

5. Health apps, sensors, wearables and biomarkers

Medical device, pharmaceutical regulation and specific aspects of current and developing health data law will be described, as they relate to this diverse, complex and increasingly pervasive family of technologies. Groupings of these concepts in new modes of healthcare delivery will be described, alongside the unique potential and risks these advances bring with them.

6. Design thinking and medical device development

The product design process for regulated medical devices will be explored in detail, and we will examine to what degree the most creative and reactive forms of ‘design thinking; can be applied in software-based medical devices developed in quality management systems. To what degree can experimentation with design be carried out within ‘Design Control’, and how might this already complex field be further challenged by flexible aspects of design that may be brough by generative AI influence interfaces and products?

7. Health data and IP

Modern healthcare is generating enormous amounts of data. This trend will intensify further with the increasing use of AI in healthcare. AI processes not only generate enormous amounts of data, but also require such data, including during the training process. Ownership and the right to use the data generated by and required for such processes will be an important issue. The applicability of Intellectual Property framework in this area may therefore be influential to how such processes are able to evolve.

8. Patient and Healthcare Provider Perspective

At a time when new technological paradigms are offering the potential to radically reorganise how healthcare is conducted and organised, it is important not to lose sight of the healthcare provider perspective. Medical professionals often have a unique oversight that spans knowledge of patient needs and perceptions, health care organisation and best practices in terms of treatment. It is therefore essential to consider the healthcare provider perspective in order to ensure that vital requirements are not missed. This includes in the design, training, and evaluation of AI driven processes. It is also important to discern when and how they should fit into AI assisted decision making processes, something that is considered an indispensable AI requirement.

3 June 2024 at 08:30 — 3 June 2024 at 09:00
Registration and coffee
3 June 2024 at 09:00 — 3 June 2024 at 09:30
Welcome speech rector
3 June 2024 at 09:30 — 3 June 2024 at 10:45
Mod. 1 - Innovative use of AI in health-related technology
Dr. Shada Alsalamah picture
Dr. Shada Alsalamah
3 June 2024 at 10:45 — 3 June 2024 at 11:00
Break
3 June 2024 at 11:00 — 3 June 2024 at 12:45
Mod. 2 - AI & SaMDs, in the EU & US and IEC 62304:2006
Dr. Andrea Biasiucci picture
Dr. Andrea Biasiucci
3 June 2024 at 12:45 — 3 June 2024 at 13:45
Lunch Break
3 June 2024 at 13:45 — 3 June 2024 at 15:30
Mod. 2 - Health technology assessment of AI & MDs
Dr. Ruben Casado Arroyo picture
Dr. Ruben Casado Arroyo
3 June 2024 at 15:30 — 3 June 2024 at 15:45
Coffee Break
3 June 2024 at 15:45 — 3 June 2024 at 17:30
Mod. 8 – Patient and Healthcare Provider Perspective
Cátia Sousa Pinto picture
Cátia Sousa Pinto
4 June 2024 at 09:00 — 4 June 2024 at 10:45
Mod. 6 - Design Thinking, UXR
Dr. Anne Schmitt picture
Dr. Anne Schmitt
O
Oscar Freyer (Co-convenor)
4 June 2024 at 10:45 — 4 June 2024 at 11:00
Break
4 June 2024 at 11:00 — 4 June 2024 at 12:45
Mod. 3 - Law meets LLMs (their data, their use of data, liability and their 'practice of medicine'
Mindy Duffourc picture
Mindy Duffourc
4 June 2024 at 12:45 — 4 June 2024 at 13:45
Lunch Break
4 June 2024 at 13:45 — 4 June 2024 at 15:30
Mod. 4 - Health Data Governance (including EHDS)
Prof. Dr. Paul Quinn picture
Prof. Dr. Paul Quinn
H
Hannah Muti
4 June 2024 at 15:30 — 4 June 2024 at 15:45
Coffee Break
4 June 2024 at 15:45 — 4 June 2024 at 17:30
Mod. 2 - AI for pathology lab hospital use: practical considerations, implementation…
Prof. Dr. Stephen Gilbert picture
Prof. Dr. Stephen Gilbert
5 June 2024 at 09:00 — 5 June 2024 at 10:45
Mod. 5 - Apps, wearables & biomarkers
Shireen Saxena picture
Shireen Saxena
Prof. Dr. Stephen Gilbert picture
Prof. Dr. Stephen Gilbert
5 June 2024 at 10:45 — 5 June 2024 at 11:00
Break
5 June 2024 at 11:00 — 5 June 2024 at 12:45
Mod. 6 - The design intersection of personal digital twins, AI, LLMs, ethics and law
Christel De Maeyer picture
Christel De Maeyer
5 June 2024 at 12:45 — 5 June 2024 at 13:45
Lunch Break
5 June 2024 at 13:45 — 5 June 2024 at 15:30
Mod. 4 - Health Data Governance (including EHDS)
5 June 2024 at 15:30 — 5 June 2024 at 15:45
Coffee Break
5 June 2024 at 15:45 — 5 June 2024 at 17:30
Mod. 7 - Health data and IP
Séverine Bouvy picture
Séverine Bouvy
Christian Dekoninck picture
Christian Dekoninck
6 June 2024 at 09:00 — 6 June 2024 at 10:45
Mod. 3 - LLMs in MDs
Dr. Daniel Truhn picture
Dr. Daniel Truhn
O
Oscar Freyer (Co-convenor)
6 June 2024 at 10:45 — 6 June 2024 at 11:00
Break
6 June 2024 at 11:00 — 6 June 2024 at 12:45
Mod. 8 - Patient and Healthcare Provider Perspective
Dr. Teodora Lalova-Spinks picture
Dr. Teodora Lalova-Spinks
6 June 2024 at 12:45 — 6 June 2024 at 13:45
Lunch Break
6 June 2024 at 13:45 — 6 June 2024 at 15:30
Mod. 1 - Innovative use of AI in health-related technology
Dr. Liam Quinn picture
Dr. Liam Quinn
6 June 2024 at 15:30 — 6 June 2024 at 15:45
Coffee Break
6 June 2024 at 16:15 — 6 June 2024 at 18:00
Visit to EU Parliament
7 June 2024 at 10:00 — 7 June 2024 at 11:30
Presentations (4)
7 June 2024 at 11:30 — 7 June 2024 at 12:00
Break
7 June 2024 at 12:00 — 7 June 2024 at 12:45
Presentations (2)
7 June 2024 at 12:45 — 7 June 2024 at 13:45
Lunch Break
7 June 2024 at 13:45 — 7 June 2024 at 15:00
Presentations (3) & Closing speech
7 June 2024 at 15:00 — 7 June 2024 at 16:15
Reception & certificates

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