LSA 2022: Review
Regulatory affairs for medical devices
The EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are being implemented. We discussed the state of play, and give an outlook on further upcoming regulations, in particular for the use of health data. The session is organised by Life Science Nord’s Working Group on Regulatory Affairs.
Health data, interoperability, and data exchange
We also highlighted technological aspects of the exchange and use of health data in various environments: Medical devices linked in a 5G network or in an innovation hub for robotic surgery, and data collected in the European Health Data Space or an AI sandbox for the German Research Data Centre.
LSA2022 was an online conference and took place on 23th June 2022, 9 am to 4 pm.
Programme
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08.50
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Attendees‘ login
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09.00
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Welcome
Folker Spitzenberger, Conference chair, Centre for Regulatory Affairs in Biomedical Sciences (CRABS), Technische Hochschule Lübeck / Lübeck University of Applied Sciences & Fraunhofer IMTE, Lübeck
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Session I: Regulatory Affairs
Session chair: Folker Spitzenberger |
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09.10
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Keynote 1: Status of MDR and IVDR Implementation
Ortwin Schulte, Head of Unit “Medical Device Safety”, Federal Ministry of Health, Berlin |
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09.50
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LIROS – Lübeck Innovation Hub for Robotic Surgery
Svenja Ipsen, Head of Business Unit “Operating Theatre Technology”, Fraunhofer IMTE, Lübeck |
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10.20
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Ten-minute break
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10.30
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Regulatory Approach for Data Exchange, Distributed Alerting, and External Control of Medical Devices
Stephan Klöckner, OR.NET e.V., Herzogenrath and KEYMKR GmbH, Lübeck |
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11.00
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Sustainable AI: The next big leap in quality and efficiency of radiology services
Naglis Ramanauskas, Chief Medical Officer, Oxipit, Vilnius, Lithuania |
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11.30
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Ten-minute break |
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11.40
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Panel discussion (I)
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12.15
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Bring your own lunch
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Session II: AI & Deep Learning
Session chair: Dirk Hermsmeyer |
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13.00
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Keynote 2: Giga for Health: Saving lives with 5G
Falko Schmid and Hug Aubin, Digital Health Lab, University Hospital Düsseldorf |
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13.40
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AI / ML-based Tools in Radiology: A User's Point of View
Jörg Barkhausen, Director of Radiology, University Hospital Schleswig-Holstein, Lübeck |
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14.10
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Ten-minute break
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14.20
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User Research: Expectations regarding an AI Sandbox for health claims data analyses
Markus Wenzel, Key Scientist Cognitive Computing, Fraunhofer MEVIS, Bremen
Presentation avaialable upon request. Please contact dirk.hermsmeyer@luebeck.ihk.de
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14.50
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European Data Act and the European Health Data Space (EHDS): Opportunity or Threat for MedTech?
Pia Maier, Governmental Affairs Specialist, Medtronic GmbH, Berlin |
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15.20
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Ten-minute break
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15.30
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Panel discussion (II)
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16.00
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End
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