Category: Yale Certificate in Medical Software and Medical AI: Guest Experts

This is a set of interviews that were recorded as supplementary teaching material for both our new online Yale Certificate Program in Medical Software and Medical AI, and the original Yale/Coursera Class Introduction to Medical Software. The topics cover issues important to medical software and medical artificial intelligence, ranging from regulatory issues, to algorithm development and software engineering, to clinical implementation, and other related areas. We try to keep most of the material at the introductory to intermediate level. We hope that you feel them useful and educational.

These interviews are also available in video form on YouTube. .

For more information on the certificate program see: online.yale.edu/medical-software-ai-program

The audio theme is excerpted from the song “Opening” by Magiksolo.

Quality Systems and Risk Management with Megan Graham

Quality Systems and Risk Management with Megan Graham

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Podcast: Play in new window | Download (Duration: 24:49 — 34.1MB) | Embed

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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

Regulatory Issues, Clinical Decision Support and AI with Bradley Merrill Thompson

Regulatory Issues, Clinical Decision Support and AI with Bradley Merrill Thompson

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Podcast: Play in new window | Download (Duration: 29:32 — 40.6MB) | Embed

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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

Healthcare and AI with Dr. Kicky Van Leeuwen

Healthcare and AI with Dr. Kicky Van Leeuwen

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Podcast: Play in new window | Download (Duration: 24:03 — 33.1MB) | Embed

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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