AI in Healthcare: Exploring Practical Applications and Policy Guidance
13-14th Feb 2025
Celtic Manor
Dr Joseph Alderman
BMedSc (Hons) MBChB FRCA
j [.] e [.] alderman [at] bham [.] ac [.] uk
Hi there!
I'm Joe - a clinical researcher based in Birmingham, UK.
Our team's research focuses on digital health technologies - things like predictive models, clinical calculators, and artificial intelligence.
Do they work?
Are they safe?
Are particular groups at risk of harm if things go wrong?
Clinically I'm a speciality registrar in anaesthesia and intensive care medicine. I'm also a researcher for the STANDING Togther initative, co-organiser of The Alan Turing Institute's Clinical AI interest group, and co-lead for the Participatory Research theme at DSxHE.
STANDING Together
The final STANDING Together recommendations have now been published in The Lancet Digital Health and NEJM-AI. To learn more or to read the full paper, visit www.datadiversity.org/recommendations
The Centre of Excellence for Regulatory Science & Innovation in AI & Digital Health
We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives.
Learn more at: www.cersi-ai.org
References for my talk at Celtic Manor:
U.S. Food and Drug Administration. ‘Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices’. FDA, 2023. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices.
Liu, Xiaoxuan, Livia Faes, Aditya U. Kale, Siegfried K. Wagner, Dun Jack Fu, Alice Bruynseels, Thushika Mahendiran, et al. ‘A Comparison of Deep Learning Performance against Health-Care Professionals in Detecting Diseases from Medical Imaging: A Systematic Review and Meta-Analysis’. The Lancet Digital Health 1, no. 6 (1 October 2019): e271–97. https://doi.org/10.1016/S2589-7500(19)30123-2.
Saab, Khaled, Tao Tu, Wei-Hung Weng, Ryutaro Tanno, David Stutz, Ellery Wulczyn, Fan Zhang, et al. ‘Capabilities of Gemini Models in Medicine’. arXiv, 1 May 2024. https://doi.org/10.48550/arXiv.2404.18416.
Futoma, Joseph, Morgan Simons, Trishan Panch, Finale Doshi-Velez, and Leo Anthony Celi. ‘The Myth of Generalisability in Clinical Research and Machine Learning in Health Care’. The Lancet Digital Health 2, no. 9 (1 September 2020): e489–92. https://doi.org/10.1016/S2589-7500(20)30186-2.
Van Calster, Ben, Ewout W. Steyerberg, Laure Wynants, and Maarten van Smeden. ‘There Is No Such Thing as a Validated Prediction Model’. BMC Medicine 21, no. 1 (24 February 2023): 70. https://doi.org/10.1186/s12916-023-02779-w.
Wong, Andrew, Erkin Otles, John P. Donnelly, Andrew Krumm, Jeffrey McCullough, Olivia DeTroyer-Cooley, Justin Pestrue, et al. ‘External Validation of a Widely Implemented Proprietary Sepsis Prediction Model in Hospitalized Patients’. JAMA Internal Medicine 181, no. 8 (1 August 2021): 1065–70. https://doi.org/10.1001/jamainternmed.2021.2626.
Cao, Jie, Xiaosong Zhang, Vahakn Shahinian, Huiying Yin, Diane Steffick, Rajiv Saran, Susan Crowley, et al. ‘Generalizability of an Acute Kidney Injury Prediction Model across Health Systems’. Nature Machine Intelligence 4, no. 12 (December 2022): 1121–29. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10751025/
Obermeyer, Ziad, Brian Powers, Christine Vogeli, and Sendhil Mullainathan. ‘Dissecting Racial Bias in an Algorithm Used to Manage the Health of Populations’. Science 366, no. 6464 (25 October 2019): 447–53. https://doi.org/10.1126/science.aax2342.
Seyyed-Kalantari, Laleh, Haoran Zhang, Matthew B. A. McDermott, Irene Y. Chen, and Marzyeh Ghassemi. ‘Underdiagnosis Bias of Artificial Intelligence Algorithms Applied to Chest Radiographs in Under-Served Patient Populations’. Nature Medicine 27, no. 12 (December 2021): 2176–82. https://doi.org/10.1038/s41591-021-01595-0.
Chen, Irene Y., Emma Pierson, Sherri Rose, Shalmali Joshi, Kadija Ferryman, and Marzyeh Ghassemi. ‘Ethical Machine Learning in Healthcare’. Annual Review of Biomedical Data Science 4 (July 2021): 123–44. https://doi.org/10.1146/annurev-biodatasci-092820-114757.
‘AI Act | Shaping Europe’s Digital Future’, 30 July 2024. https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai.
GOV.UK. ‘AI Airlock: The Regulatory Sandbox for AIaMD’, 9 May 2024. https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-aiamd.
U.S. Food and Drug Administration, Health Canada, and Medicines and Healthcare products Regulatory Agency. ‘Good Machine Learning Practice for Medical Device Development: Guiding Principles’. FDA, 27 October 2021. https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles.
Liu, Xiaoxuan, Ben Glocker, Melissa M. McCradden, Marzyeh Ghassemi, Alastair K. Denniston, and Lauren Oakden-Rayner. ‘The Medical Algorithmic Audit’. The Lancet Digital Health (5 April 2022). https://doi.org/10.1016/S2589-7500(22)00003-6.
Cruz Rivera, Samantha, Xiaoxuan Liu, An-Wen Chan, Alastair K. Denniston, and Melanie J. Calvert. ‘Guidelines for Clinical Trial Protocols for Interventions Involving Artificial Intelligence: The SPIRIT-AI Extension’. Nature Medicine 26, no. 9 (September 2020): 1351–63. https://doi.org/10.1038/s41591-020-1037-7.
Vasey, Baptiste, Myura Nagendran, Bruce Campbell, David A Clifton, Gary S Collins, Spiros Denaxas, Alastair K Denniston, et al. ‘Reporting Guideline for the Early Stage Clinical Evaluation of Decision Support Systems Driven by Artificial Intelligence: DECIDE-AI’. BMJ, 18 May 2022, e070904. https://doi.org/10.1136/bmj-2022-070904.
Collins, Gary S., Karel G. M. Moons, Paula Dhiman, Richard D. Riley, Andrew L. Beam, Ben Van Calster, Marzyeh Ghassemi, et al. ‘TRIPOD+AI Statement: Updated Guidance for Reporting Clinical Prediction Models That Use Regression or Machine Learning Methods’. BMJ 385 (16 April 2024): e078378. https://doi.org/10.1136/bmj-2023-078378.
Liu, Xiaoxuan, Samantha Cruz Rivera, David Moher, Melanie J. Calvert, and Alastair K. Denniston. ‘Reporting Guidelines for Clinical Trial Reports for Interventions Involving Artificial Intelligence: The CONSORT-AI Extension’. Nature Medicine 26, no. 9 (September 2020): 1364–74. https://doi.org/10.1038/s41591-020-1034-x.
‘JMIR Research Protocols - Target Product Profile for a Machine Learning–Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study’. Accessed 12 August 2024. https://www.researchprotocols.org/2024/1/e50568.
The STANDING Together Collaboration. ‘Recommendations for Diversity, Inclusivity, and Generalisability in Artificial Intelligence Health Technologies and Health Datasets’, 30 October 2023. https://doi.org/10.5281/zenodo.10048356.
‘Economic Evaluation for Medical Artificial Intelligence: Accuracy vs. Cost-Effectiveness in a Diabetic Retinopathy Screening Case | Npj Digital Medicine’. Accessed 12 August 2024. https://www.nature.com/articles/s41746-024-01032-9.
‘The Environmental Cost of AI’. Accessed 12 August 2024. https://www.ft.com/content/323299dc-d9d5-482e-9442-f4516f6753f0.