Title of the panel IEEE BHI – BSN 2021 “Regulatory issues for medical devices”  
Description Medical devices similar as drug in the pharmaceutical industry play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. Regulatory issues impact on the whole cycle of the innovation for medical device.
We are in a stage of transition as artificial intelligence (AI) is increasingly being used in healthcare across the world. Regulatory bodies have to understand that software itself could be the software as a medical device (SaMD). Artificial intelligence is already used in the medical sector, although currently sporadically. We are aware that benefits of AI could be delayed if slow, expensive clinical trials are necessary for each application of AI. According to the requirements defined in the Medical Device Regulation, any medical device, including those incorporating AI, must be designed in such a way as to ensure repeatability, reliability and performance according to its intended use.
The manufacturer of medical device must implement measures to minimize unacceptable risks and reduction of the performance of the medical device. This requires validation and verification of the AI model. Many of the AI models used are “black-box” models. It can make a problem where interpretability and trustworthiness of the systems are concerned. In order to avoid the current error in the pre-clinical applications of AI explainable and approvable AI decisions are necessary for the safe use of AI in the real patients. Also all producers of AI application in the health care must satisfy high level of protection of personal data according to The General Data Protection Regulation. Regulation of artificial intelligence is still at the beginning of development. All major regulatory bodies around the worlds have defined or just starting to define requirements for AI in medical devices.
This panel will discuss many of the above mentioned issues and open the new pathways for regulatory issues and using AI in the medical device sector.
Chair Nenad Filipovic
affiliation University of Kragujevac, Serbia
email address fica@kg.ac.rs
Andreas Melzer, University of Leipzig, Germany

Title of Presentation: To be announced

Biosketch: To be announced

Kevin Fu, Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), U.S. Food and Drug Administration

Title of Presentation: Medical Device Security

Biosketch: Kevin Fu is Associate Professor of EECS at the University of Michigan where he direct the Security and Privacy Research Group (SPQR.eecs.umich.edu). During 2021, Fu is also Acting Director of Medical Device Cybersecurity at FDA’s Center for Devices and Radiological Health (CDRH) and Program Director for Cybersecurity, Digital Health Center of Excellence (DHCoE). He is most known for the original 2008 cybersecurity research paper showing vulnerabilities in an implantable cardiac defibrillator by sending specially crafted radio waves to induce uncontrolled ventricular fibrillation via an unintended wireless control channel. https://www.secure-medicine.org/hubfs/public/publications/icd-study.pdf The prescient research led to over a decade of revolutionary improvements at medical device manufacturers, global regulators, and international healthcare safety standards bodies just as ransomware and other malicious software began to disrupt clinical workflow at hospitals worldwide.

Kevin was recognized as an IEEE Fellow, Sloan Research Fellow, MIT Technology Review TR35 Innovator of the Year, Fed100 Award recipient, and recipient of an IEEE Security and Privacy Test of Time Award. Fu has testified in the U.S. House and Senate on matters of information security and has written commissioned work on trustworthy medical device software for the U.S. National Academy of Medicine. He co-chaired the AAMI cybersecurity working group to create the first FDA-recognized standards to improve the security of medical device manufacturing. He founded the Archimedes Center for Healthcare and Device Security (secure-medicine.org). He is a founding member of the N95decon.org team for emergency reuse decontamination of N95 masks during PPE shortages. Fu served as a member of the U.S. NIST Information Security and Privacy Advisory Board and federal science advisory groups. Eleven years ago, Fu served as a visiting scientist at the U.S. Food & Drug Administration. Fu received his B.S., M.Eng., and Ph.D. from MIT. He earned a certificate of artisanal bread making from the French Culinary Institute and is an intermediate level salsa dancer.

Nicholas Petrick, U.S. Food and Drug Administration, Center for Device and Radiological Health

Title of Presentation: A brief introduction to medical device regulation

Biosketch: Nicholas Petrick is Deputy Director for the Division of Imaging, Diagnostics and Software Reliability at the Center for Devices and Radiological Health, U.S. Food and Drug Administration and is a member of the FDA Senior Biomedical Research Service.  The Division of Imaging, Diagnostics and Software Reliability Division conducts regulatory research in medical imaging physics and image analysis techniques to optimizing medical image interpretation.  Dr. Petrick received his Ph.D. from the University of Michigan in Electrical Engineering-Systems and is a Fellow of the Americana Institute of Medical and Biomedical Engineering and SPIE.  His current research focuses on quantitative imaging, medical artificial intelligence and the robust assessment methods for a range of medical imaging hardware systems and medical artificial intelligence tools.

Yiannos Tolias, Legal Lead AI and AI liability in healthcare, DG SANTÉ, European Commission

Title of Presentation: Challenges in developing and deploying AI in healthcare

Biosketch: Yiannos is a legal lead on AI liability and AI in healthcare in DG SANTE (Health and Food Safety) in the European Commission. He was a Senior Emile Noel Fellow at NYU Law School working on a project on machine learning in medicine and law. Prior to joining the European Commission, he was an Assistant Professor of EU law at the Universities of Edinburgh and Dundee. He holds a Ph.D. in EU Constitutional law from the University of Edinburgh and was a Post-doctoral Research Fellow at the Institute for Advanced Studies in the Humanities (Edinburgh University).

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