Yale Certificate in Medical Software and Medical AI: Guest Experts

Our guest is Prof. Anat Lior (https://drexel.edu/law/faculty/fulltime_fac/Anat%20Lior/) who is an assistant professor at Drexel University’s Thomas R. Kline School of Law, an AI Schmidt affiliated Scholar with the Jackson School at Yale and an affiliated fellow at the Yale Information Society Project. Her research interests include AI governance and liability, quantum computing policy, and the intersection of insurance and emerging technologies. The interview was recorded on Dec 5, 2023. Further Reading: EU AI Act: https://artificialintelligenceact.eu/the-act/ Biden AI Executive Order: https://www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence/ Lior A. Insuring Ai: The role of insurance in artificial intelligence regulation. Harv J Law Technol. 2002;35(2):467–530. Available from: https://jolt.law.harvard.edu/assets/articlePDFs/v35/2.-Lior-Insuring-AI.pdf

Our guest is Mr. Oleg Yusim (https://www.linkedin.com/in/olegyusim/) who is a currently vice-president and Chief Product Security Officer at Illumna. At the time we recorded this video, he was Senior Director of Information Security at Edwards Lifesciences. He has many years of experience in the area cybersecurity in medical devices. This video was recorded Dec 11, 2023. Further Reading: U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cybersecurity in Medical Devices: Quality Systems and Premarket Submissions. Sep 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions Healthcare Vulnerability Scoring System (HVSS) Version 1.0 Calculator: https://hvss.online/

Our guest is Elad Walach (https://www.linkedin.com/in/elad-walach/) who is a founder and CE of AIDoc (https://www.aidoc.com/) Based in Tel Aviv, Aidoc is a leading provider of medical AI solutions. It has 13 algorithms cleared by the U.S. Food and Drug Administration, with over 1,000 hospitals using its products across the globe. Further Reading: Elad Walach. An AI model is NOT An AI Product. January 31, 2024 https://www.linkedin.com/pulse/ai-model-product-elad-walach-abemf AIDoc. Understanding Recent AI Regulations and Guidelines. January 29, 2024. https://www.aidoc.com/blog/ai-regulations-guidelines/

Our guest is Dr. Andrea Biasiucci (https://www.linkedin.com/in/andreabiasiucci/) who is the CEO of confinis (https://www.confinis.com/), a worldwide medical device regulatory consulting company based in Switzerland. Dr. Biasiucci received his Ph.D. in Brain-Computer Interfaces from EPFL in Lausanne, and has been an AI-based neurotech innovator for over a decade. The video was recorded on Nov 22, 2023. This is a follow up interview to a previous discussion recorded with Dr. Biasiucci for the Yale Medical Software Coursera Class: https://www.youtube.com/watch?v=OhK6AQ3Qyfk (June 2021). Further Reading: EU AI Act: https://artificialintelligenceact.eu/the-act/ Gilbert S, Harvey H, Melvin T, Vollebregt E, Wicks P. Large language model AI chatbots require approval as medical devices. Nat Med [Internet]. Nature Publishing Group; 2023 Jun 30. Available from: https://www.nature.com/articles/s41591-023-02412-6

Our guest is Mr. Korey Johnson (https://www.linkedin.com/in/koreyrjohnson/), Managing Partner at Bold Insight (https://boldinsight.com/), which is a consulting company focusing on User Experience and Human Factors research. The interview was recorded on Dec 15, 2023. Further Reading/watching: International Electrotechnical Commission (IEC). IEC 62366-1 Medical devices – Part 1: Application of usability engineering to medical devices. Geneva, CH; 2015. Available from: https://www.iso.org/standard/63179.html International Electrotechnical Commission (IEC). IEC 62366-2 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices. Geneva, CH; 2016. Available from: https://www.iso.org/standard/69126.html U.S. Food and Drug Administration (FDA): Center for Devices and Radiological Health. Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff. 2016. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices U.S. Food and Drug Administration. FDA; 2023[Office of the Commissioner. Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/application-human-factors-engineering-principles-combination-products-questions-and-answers American National Standards Institute. ANSI/AAMI HE 75:2009 (r2018). 2018. Report No.: 75. Available from: https://webstore.ansi.org/standards/aami/ansiaamihe752009r2018?gad_source=1 Lew G, Schumacher RM Jr. AI and UX: Why Artificial Intelligence Needs User Experience. 1st ed. Apress; 2020. Available from: https://www.amazon.com/AI-UX-Artificial-Intelligence-Experience/dp/148425774X/ U.S. Food and Drug Administration (FDA) Center for Devices, Radiological Health. Digital Health Software Precertification (Pre-Cert) Pilot Program. 2023 May. Available from: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program

Randy Horton, Chief Solutions Officer of Orthogonal and co-chair of AAMI SW WG-10 Cloud Computing, discusses the benefits and challenges of cloud computing in medical devices. They also talk about creating guidelines for cloud use in the medical technology industry and the importance of developing a certificate in medical software and AI. Being a deep generalist in medical software and AI is emphasized as crucial for the future of connected medical devices.

Our guest is Ms. Megan Graham who is an experienced medical software quality and regulatory consultant, focusing on digital health. Ms. Graham also serves on a number of international standards committees including most recently AAMI SW WG-10 Cloud Computing. She is also an adjunct faculty member at the University of Minnesota where she teaches in the Master of Science Software Engineering Program. This interview was recorded Dec 14, 2023. Further Reading: Good Machine Learning Practice for Medical Device Development: Guiding Principles (ÒGMLPÓ). October 2021, Food & Drug Administration, Health Canada, and Medicines and Healthcare Products Regulatory Agency. Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles ISO 13485:2016, Medical devices – Quality management systems – requirements for regulatory purposes. March 2016, International Organization for Standardization. Available from : https://www.iso.org/standard/59752.html ISO 14971:2019, Medical devices – Application of risk management to medical devices. December 2019, International Organization for Standardization. Available from: https://www.iso.org/standard/72704.html AAMI TIR 34971:2023, Application Of ISO 14971 To Machine Learning In Artificial IntelligenceÑGuide. March 2023, Association for the Advancement of Medical Instrumentation. Available from: https://doi.org/10.2345/9781570208669.ch1 NIST Risk Management Framework. National Institute of Standards and Technology. Available from: https://csrc.nist.gov/projects/risk-management NIST Secure Product Development Framework. National Institute of Standards and Technology. Available from: https://csrc.nist.gov/projects/ssdf Overgaard SM, Graham MG, Brereton T, Pencina MJ, Halamka JD, Vidal DE, Economou-Zavlanos NJ. Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions. NPJ Digit Med. Nov 25;6(1):218. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10676432/ This interview is also available in video form on YouTube: https://youtu.be/POd0LQ80t4w

Our guest is Attorney Bradley Merrill Thompson RAC (https://www.linkedin.com/in/bradleymerrillthompson/) who is a partner at Epstein Becker and Green P.C. At the firm, he leads the AI practice and serves in the medical device, digital health, and combination product practices. This video was recorded on Nov 28, 2023. Further Reading: Thompson BM, Snyder LS. FDA Oversight of AI Software Developed by Health Care Providers . Epstein, Becker and Green. 2023. Available from: https://www.healthlawadvisor.com/2023/08/10/fda-oversight-of-ai-software-developed-by-health-care-providers/ Thompson BM. FDA’s Final Guidance on Clinical Decision Support Violates the Law. LinkedIn. 2022. Available from: https://www.linkedin.com/pulse/fdas-final-guidance-clinical-decision-support-law-thompson-rac/?trackingId=K7vHT91EEExEN%2BqrezASkg%3D%3D U.S. Food and Drug Administration (FDA) Center for Devices, Radiological Health. Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff. 2022. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software This episode is also available to watch on Youtube: https://www.youtube.com/watch?v=58-2IG9aY2U

Our guest is Dr. Kicky van Leeuwen, who is the founder of AIforRadiology.com, a webpage providing objective insights into what AI products for healthcare professionals are on the market. She is also a cofounder and consultant at Romion Health, a company that aids AI procurement and implementation. This video is part of a series of guest expert interviews that we recorded for the new Yale Certificate Program on Medical Software and Medical AI. The interview was conducted on Nov 30, 2023. For more information about the Yale Certificate Program in Medical Software and Medical AI please visit https://online.yale.edu/medical-software-ai-program