Yale Certificate in Medical Software and Medical AI: Guest Experts

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Yale Certificate in Medical Software and Medical AI: Guest Experts

Yale Biomedical Informatics & Data Science

19 episodes

10 hours ago

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 -- https://www.youtube.com/watch?v=aeyYc9hCFLE&list=PLF8QgN7ybSHzDGDIPYbQwwdcK9Tqa3Lh7. .

For more information about the Yale Certificate Program in Medical Software and Medical AI please visit https://online.yale.edu/medical-software-ai-program

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

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All content for Yale Certificate in Medical Software and Medical AI: Guest Experts is the property of Yale Biomedical Informatics & Data Science and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

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 -- https://www.youtube.com/watch?v=aeyYc9hCFLE&list=PLF8QgN7ybSHzDGDIPYbQwwdcK9Tqa3Lh7. .

For more information about the Yale Certificate Program in Medical Software and Medical AI please visit https://online.yale.edu/medical-software-ai-program

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

Show more...

Episodes (19/19)

Yale Certificate in Medical Software and Medical AI: Guest Experts

The FDA and Software: A Historical Overview with Dr. Donna-Bea Tillman

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Donna-Bea Tillman, a principal consultant at Biologics Consulting Group. She has 30 years of medical device regulatory experience. Prior to joining Biologics Consulting she … Read More Read More

9 months ago

38 minutes 25 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

The Current State of Medical Device AI Regulation with Eric Henry

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Eric Henry. Mr. Henry is the Senior Quality Systems & Compliance Advisor at the Law Firm King & Spalding and works from his home … Read More Read More

11 months ago

40 minutes 54 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Medical Devices, Cloud Services and Regulatory Compliance with Ian Sutcliffe

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Ian Sutcliffe, who is Principal Solutions Architect at AWS. Prior to that he has many years in the health sciences and tech industry in … Read More Read More

1 year ago

26 minutes 48 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

In Silico Trials of Medical Devices with Professor Alejandro Frangi FREng

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Prof Frangi is the Bicentennial Turing Chair in Computational Medicine at the University of Manchester, Manchester, UK, with joint appointments at the Schools of … Read More Read More

1 year ago

51 minutes 36 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Integrating AI into a Healthcare Practice with Dr. Vishishit Mehta

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Dr. Vishisht Mehta who is the Director of Interventional Pulmonology at the Lung Center of Nevada, a division of Comprehensive Cancer Centers and also … Read More Read More

1 year ago

36 minutes 46 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Global Health, Digital Health and AI

Our guest is Riccardo Lampariello, who is a statistician by training and brings almost 25 years of experience in health. He initially spent 10 years in the pharmaceutical industry and then moved into the not-for-profit sector: GAVI, UICC and Terre des hommes. In 2022 he joined D-tree as their CEO. D-tree’s mission is to expand … Read More Read More

1 year ago

43 minutes 1 second

Yale Certificate in Medical Software and Medical AI: Guest Experts

Large Language Model-based Chatbots and Medical Regulation

Our guest is Prof. Stephen Gilbert (https://www.linkedin.com/in/stephen-gilbert-31ba2587/) who is a Professor of Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden where he teaches and conducts research on regulatory science with a team of colleagues. He is also News and Views Editor, Nature Portfolio – Digital Health. He … Read More Read More

1 year ago

59 minutes 17 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

AI and Medical Software Engineering with Hirohito Okuda

Our guest is Mr. Hirohito Okuda. Mr Okuda has close to 30 years of working experience in the medical device industry. Currently he is a principal AI engineer at Konica Minolta, Japan where he directs AI engineering across the company, leads generative AI adaptation, helps to establish AI guidelines and is also a member of … Read More Read More

1 year ago

26 minutes 11 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Agile in a Regulated Environment with Bernhard Kappe

Our guest is Mr. Bernhard Kappe (https://www.linkedin.com/in/bernhardkappe/) who is the founder and CEO of Orthogonal (https://orthogonal.io/), a medical device consulting company. He is also a member of the AAMI working group AAMI SW WG-10 Cloud Computing. This interview was recorded on Nov 16, 2023. Further Reading: Kappe B. Accelerating Medical Product Development: Applying Agile Methods … Read More Read More

1 year ago

26 minutes 59 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Software Development with/and AI with Larkin Lowrey

Our guest is Mr Larkin Lowrey (https://www.linkedin.com/in/larkinlowrey/). Mr Lowrey has spent the past 30 years in the Software Engineering Product Development space building new product development organizations but also turning around organizations which had fallen into traps resulting in poor quality, execution and products which did not resonate in the marketplace. Most of his career … Read More Read More

1 year ago

36 minutes 36 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Emerging Global AI Regulations with Anat Lior

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 … Read More Read More

1 year ago

42 minutes 3 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Medical Device Cybersecurity with Oleg Yusim

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, … Read More Read More

1 year ago

34 minutes 23 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Medical AI: From Algorithms to Solutions with Elad Walach

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 … Read More Read More

1 year ago

32 minutes 12 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

The EU AI Act and Medical Device Regulation with Andrea Biasiucci

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. … Read More Read More

1 year ago

28 minutes 19 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Human Factors and Medical Software with Korey Johnson

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, … Read More Read More

1 year ago

25 minutes 46 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Cloud Computing and Medical Devices with Randy Horton

Our guest is Mr. Randy Horton, who is the Chief Solutions Officer of Orthogonal (https://orthogonal.io/), a medical device consulting company. He also co-chairs the AAMI working group AAMI SW WG-10 Cloud Computing. The video was recorded on Dec 7, 2023 Further Reading/watching: Association for the Advancement of Medical Instrumentation (AAMI). AAMI/CR510:2021; Appropriate use of public … Read More Read More

1 year ago

30 minutes 19 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Quality Systems and Risk Management with Megan Graham

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 … Read More Read More

1 year ago

24 minutes 49 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

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

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

1 year ago

29 minutes 32 seconds

Yale Certificate in Medical Software and Medical AI: Guest Experts

Healthcare and AI with Dr. Kicky Van Leeuwen

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 … Read More Read More

1 year ago

24 minutes 3 seconds