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In the first episode of the Yale Global Health Insights podcast, host Dr. Sharon Chekijian introduces the podcast and talks about her work to improve emergency care in Armenia. She is joined by Dr. Svetlana Harutyunyan, who discusses her own experiences working in Artsakh, during the 2020 war, the blockade and the forced displacement that followed in September 2023.
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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
The Yale Program for Medicine, Spirituality & Religion is founded upon the belief that healing concerns the wellness of both the body and the spirit. We seek to understand the implications of religious practice, communal support, and intrinsic belief for the health and wellness. We are scholarly in focus, seeking evidence to discern how the worlds of medicine and religion impact one another. We are collaborative in spirit, reaching across Yale University and other institutions to foster dialogue and research.
As scholars and practitioners, we recognize the deep influence that religious and spiritual commitments have in medicine and illness. Religious and spiritual beliefs inform ethical choices, attitudes concerning death and grieving, approaches to suffering and illness, and commitments to justice and fairness. We seek diverse perspectives through collaboration with colleagues from divinity, chaplaincy, public health, legal, and medical communities. This podcast is a collection of our public monthly seminar series. Enjoy!
For more information and to get on our mailing list, please check out our website: ypmsr.yale.edu
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Chris Oldfield is a Research Associate at the Faraday Institute of Science and Religion at the University of Cambridge. His talk, “The Metaphysics of Pregnancy” outlines the key issues of “Foster-Gravida Relations.” This work is based upon the working group Better Understanding the Metaphysics of Pregnancy (B.U.M.P.) based at Kings College, London. For more information, see https://bump.group.
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The Craft & Career series connects with professional creatives from the arts, entertainment, and media industries, to discuss the nuances of their craft, the reality of their careers, and how, in often surprising ways, these two concerns can work together.
We’re excited to continue our fall podcast season with Zina Ellis ’15, Brooklyn-based performer, writer, and educator, discussing the realities of the musical theater pursuit, as well as practical tips for creatives moving to New York.
More info on Zina Ellis:
IG: @abitoverzellis
OCS Craft & Career Podcast (full episode list) – https://ocs.yale.edu/podcast
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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
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For Yale Law School’s bicentennial in 2024, Sterling Professor Emeritus of Law Guido Calabresi ’58 reflects on his tenure as Dean from 1985 to 1994. He discusses his work to restore the law school building to its former glory and start the law school’s first loan forgiveness program.
Episode webpage and transcript: https://law.yale.edu/yls-today/news/podcast-even-91-students-are-everything-guido-calabresi
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In this episode of the Yale University Press podcast, we talk with Philip Freeman about Julian: Rome’s Last Pagan Emperor (Ancient Lives Series).
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In recognition of Martin Luther King Jr. Day, the Yale and Slavery Working Group’s David Blight and Charles Warner, Jr. join President Salovey to discuss their work to study Yale’s history in the service of a stronger, more inclusive university for the future.
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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