ai regu
HEALTH TECHNOLOGY ROUNDTABLES
AI REGU HEALTH TECHNOLOGY ROUNDTABLES
AI Regu HealthTech Roundtables bring together health technology companies, experts, and other stakeholders to discuss current topics at the intersection of artificial intelligence and regulation. The Roundtables provide a platform for sharing knowledge, learning from real-world experiences, and collaboratively developing solutions to key challenges in the field.
The series consists of three expert formats designed to address current questions related to AI, health technology, and regulation. Each format serves a distinct purpose: one helps participants stay informed about the latest developments, another deepens understanding through shared experiences, and the third focuses on co-creating solutions to important challenges.
LEARN
SHARE
CREATE
Stay up to date.
Short, interactive webinars offering the latest insights into developments in health technology, artificial intelligence, and regulation.
Discussion-based sessions where participants exchange practical experiences, lessons learned, and perspectives from across the sector.
Collaborative workshops where participants build shared understanding and develop solutions to key questions in health technology and AI regulation.
UPCOMING EVENTS
26.11.2026 SHARE | Part 1/4:
GENAI AND SENSITIVE DATA IN HEALTHCARE – WHAT DOES REGULATION REQUIRE OF DEVELOPERS?
Sandra Liede
Leading Expert
Health Technology Sailab – MedTech Finland
Kirsi Talman
Health Tech. and Life Sciences Legal Expert
Laissa Oy
AI Regu, LUMI AI Factory and FAIR EDIH are launching a four-part Health Technology Roundtables SHARE event series focusing on the development of GenAI solutions using sensitive data in healthcare. The first event will provide an overview of the regulatory framework affecting GenAI development in healthcare and its implications for practical development work.
Topics include:
- Key regulatory frameworks relevant to GenAI development in healthcare
- The significance of a GenAI solution’s intended purpose in determining applicable requirements
- Risk classification and risk assessment
- Legal considerations related to the use of sensitive data
- How to incorporate regulatory requirements into the design and development of GenAI solutions
Experts:
Sandra Liede, Leading Expert, Health Technology Sailab – MedTech Finland
Kirsi Talman, Health Tech. and Life Sciences Legal Expert, Laissa Oy
Spaces are limited. Register by 22 November 2026 via the link below!
3.12.2026 | LEARN Interactive webinar:
AI ACT AND STANDARDS: WHERE ARE WE NOW?
A STATE OF PLAY
Alpo Värri
Research Director
Decision Support for Health Research Group
Faculty of Medicine and Health Technology,
Tampere University
In this AI Regu Health Technology Roundtables LEARN webinar, participants will explore the harmonised standards being developed under a mandate from the European Commission for providers of high-risk AI systems as defined by the EU AI Act. By complying with a harmonised standard, a provider may presume conformity with the essential requirements covered by that standard.
In his presentation, Research Director Alpo Värri will review the harmonised standards currently under development, their level of maturity, and their anticipated role in supporting compliance with the AI Act. The session will also provide an overview of other key AI standards that have already been published or are currently being developed.
Expert: Alpo Värri, Research Director, Decision Support for Health Research Group, Faculty of Medicine and Health Technology, Tampere University, and CEN-CENELEC/JTC 21.
3.12.2026 | CREATE – Building a Shared Understanding: AI IN MEDICAL DEVICES
What Is Required to Demonstrate Compliance?
Seppo Vahasalo
Person Responsible at Notified Body NB0598, SGS Fimko Oy
Nelli Karhu
Lead Expert, HealthTech Finland
Haaga-Helia University of Applied Sciences, Pasila Campus.
At this AI Regu in-person event, Seppo Vahasalo from notified body NB0598 SGS Fimko and Nelli Karhu from HealthTech Finland will discuss how compliance can be established in a regulatory environment where best practices are still evolving.
The discussion will explore the compliance of AI-enabled medical devices, clinical evidence, and technical documentation from a practical perspective. In addition to the expert discussion, participants will have the opportunity to apply the insights gained through an interactive group exercise and exchange experiences and ideas with other attendees.
Topics include:
- Demonstrating compliance of AI-enabled medical devices in practice
- Clinical evidence, technical documentation, and transparent, traceable verification of performance and safety
- Expert perspectives, peer discussion, and practical application through an interactive group exercise
Experts:
Seppo Vahasalo, Person Responsible at Notified Body NB0598, SGS Fimko Oy
Nelli Karhu, Lead Expert, HealthTech Finland
Spaces are limited. Register by 29 November 2026 via the link below!
PAST EVENTS AND PRESENTATION MATERIALS
To ensure that valuable insights remain accessible beyond the live event, we record our webinars and make the presentation materials available in one convenient place.
These resources allow you to explore the topics at your own pace and revisit expert insights, additional explanations, and practical tips even after the event.
Explore the webinar recordings, presentations, and other materials below!
30 October 2026 | LEARN Interactive webinar: MEDICAL DEVICE USABILITY – WHEN THE USER INTERFACE BECOMES A SAFETY ISSUE
Terhi Holappa
Development Manager
UNA Oy
The webinar examines the specific characteristics and considerations that shape user interface and usability design in health technologies, highlights the concepts and topics that industry professionals should understand, and discusses the practical usability requirements from a regulatory perspective.
Expert: Terhi Holappa, Development Manager, UNA Oy.
Materials will be published shortly.
22 September 2026 | Interactive webinar: AI ACT TRANSPARENCY OBLIGATION ARE NOW IN FORCE – ARE YOU READY?
Mari Rupponen
Legal Counsel
Traficom
How do these requirements affect AI system providers and deployers?
This interactive webinar explores the transparency obligations set out in Article 50 of the AI Act, which have now become applicable. These requirements cover, among other things, the disclosure of AI-human interaction, the labeling of deepfakes, and the technical detectability of certain types of AI-generated content.
The expert presentation will provide an overview of the key principles behind these transparency obligations and explain what they mean in practice for both AI system providers and deployers.
Expert: Mari Rupponen, Legal Counsel, Finnish Transport and Communications Agency Traficom
Avoimuusvelvoitteet ovat täällä, oletko valmis?
The transparency obligations are here, are you ready?
Webinaaritallenne
AI Regu Terveysteknologian Pyöreät Pöydät OPI -webinaari 22.9.2026.
Puhuttu ja tekstitetty suomeksi.
Webinar recording
AI Regu HealthTech Roundtable LEARN Webinar 22 Sept 2026.
Spoken in Finnish, with English subtitles.
Esitysmateriaali
AI Regu Terveysteknologian Pyöreät Pöydät OPI -webinaari 22.9.2026.
Keskustelutiivistelmä
AI Regu Terveysteknologian Pyöreät Pöydät OPI -webinaari 22.9.2026.
25 May 2026 | Interactive Webinar:
MEDICAL DEVICE QUALIFICATION AND CLASSFICATION
Nelli Karhu
This interactive webinar explored the qualification and classification of medical devices, with a particular focus on software, digital services, and AI-enabled solutions.
The expert presentation examined why intended purpose, product claims, and risk classification are key factors in determining whether a product falls within the scope of medical device regulation and how it should be classified. Participants were invited to discuss practical questions related to borderline cases, development-stage decisions, and the implications of classification for regulatory strategy and market access.
This webinar was conducted in Finnish. The recording is available with English subtitles.
Expert: Nelli Karhu, Senior Advisor, HealthTech Finland
Lääkinnällisen laitteen määrittely ja luokittelu
Qualification and Classification of Medical Device
Webinaaritallenne
AI Regu Terveysteknologian Pyöreät Pöydät OPI -webinaari 25.5.2026.
Puhuttu ja tekstitetty suomeksi.
Webinar Recording
AI Regu HealthTech Roundtable LEARN Webinar 25 May 2026.
Spoken in Finnish, with English subtitles.
Esitysmateriaali
AI Regu Terveysteknologian Pyöreät Pöydät OPI -webinaari 25.5.2026.
Keskustelutiivistelmä
AI Regu Terveysteknologian Pyöreät Pöydät OPI -webinaari 25.5.2026.
28 May 2026 | Interactive Webinar:
INTENDED PURPOSE AT THE CORE OF MEDICAL DEVICE DEVELOPMENT
Kirsi Talman
Johtava asiantuntija
Sailab – MedTech Finland
Kirsi Korhonen
Toimitusjohtaja, konsultti
Korsi Key Oy
This interactive webinar explored the role of intended purpose in the development of health technology and AI-based solutions.
The expert presentation examined intended purpose from a practical perspective: what should be described, how appropriate boundaries can be defined, and why an unclear intended purpose can create challenges for product development and regulatory compliance. Participants were invited to share their perspectives and discuss practical questions related to defining intended purpose and its implications for product development and market access.
Experts:
Kirsi Talman, Senior Advisor, Sailab – MedTech Finland
Kirsi Korhonen, CEO and Consultant, Korsi Key Oy
11 May 2026 | Interactive Webinar:
INTRODUCING THE AI & MDR/IVDR REGULATORY PATHAWAY TOOL AND OTHER AI REGU TOOLS
Elisa Laatikainen
Project manager
AI Regu
How do the AI Act and the MDR/IVDR regulatory frameworks interact?
What does the regulatory pathway look like for manufacturers of AI-powered medical devices?
This interactive webinar introduced the new AI Regu tool, “AI & MDR/IVDR Regulatory Pathway for Medical Devices.” The tool has been developed through expert collaboration to support manufacturers of AI-based medical devices in navigating regulatory requirements.
The session also showcased other free and publicly available AI Regu tools and resources designed to support regulatory compliance and innovation in health technology.
This webinar was conducted in Finnish. The recording is available in Finnish.
Expert: Elisa Laatikainen, Project manager, AI Regu
THREE DISTINCT ROUNDTABLE FORMATS,
DESIGNED FOR YOU
The Health Technology Roundtables offer three ways to stay up to date, deepen your understanding, and gain practical insights into the regulation of artificial intelligence and health technologies.
These formats complement one another: you can participate in individual sessions based on your specific interests and needs, or follow the entire series to gain a broader perspective on current developments and key challenges in the field.
Health Technology Roundtables LEARN
Interactive Webinar
When you need a clear overview of a current topic.
The Interactive Webinar combines expert insights with participant discussion. You will gain a concise overview of the topic, hear different perspectives, and have the opportunity to reflect on its relevance to your own work or organisation.
Ideal for you if you want to:
• quickly understand the key issues behind a current topic
• hear expert perspectives without extensive preparation
• gain clarity on how the topic relates to health technology development, regulation, or implementation
Health Technology Roundtables SHARE
Two Perspectives and a Discussion
When you want to learn from real-world experiences and compare different perspectives.
In this format, two different experiences, case examples, or viewpoints serve as the starting point for discussion. Participants have the opportunity to explore how a similar issue may be experienced from different roles, organisational contexts, or stages of development.
Ideal for you if you want to:
• hear practical experiences from the intersection of health technology and regulation
• learn from the successes, challenges, questions, and interpretations of others
• identify what feels familiar, new, or requires further consideration in your own situation.
Participation in this workshop may constitute De minimis aid.
Health Technology Roundtables CO-CREATE
Building Answers to Important Questions Together
When you want to make sense of a complex issue and identify practical ways forward.
This format focuses on collaborative problem-solving. Participants and experts work together to explore a pre-selected topic of high relevance, building a clear and actionable understanding through participant questions, expert insights, and practical examples.
Ideal for you if you want to:
• bring structure to a challenging or unclear topic
• understand the different options, considerations, and implications related to the issue
• leave the discussion with practical takeaways and a concise summary that you can apply in your own work.
Participation in this workshop may constitute De minimis aid.