The Human Element: Ethical Guardrails for AI in Modern Medicine

Ross C Swetlitz I. IBM’s Watson supercomputer recommended “unsafe and incorrect” cancer treatments, internal documents show STAT News. Published July 25, 2018. https://www.statnews.com/2018/07/25/ibm-watson-recommended-unsafe-incorrect-treatments/

Ruamviboonsuk P Tiwari R Sayres R , et al. Real-time diabetic retinopathy screening by deep learning in a multisite national screening programme: a prospective interventional cohort study. Lancet Digit Health. 2022;4(4):e235-e244.

Henry KE Hager DN Pronovost PJ Saria S. A targeted real-time early warning system for sepsis. Sci Transl Med. 2015;7(299):299ra122.

Tomašev N Glorot X Rae JW , et al. A clinically applicable approach to continuous prediction of future acute kidney injury. Nature. 2019;572(7767):116-119.

Norori N Hu Q Aellen FM Faraci FD Tzovara A. Addressing bias in artificial intelligence for health care: challenges and opportunities. Patterns. 2023;4(10):100804.

Goodwin Procter LLP. FDA approvals of AI-enabled medical devices continue to climb in 2024. Goodwin Insights. November 1, 2024. Accessed November 1, 2024. https://www.goodwinlaw.com/en/insights/publications/2024/11/insights-technology-aiml-fda-approvals-of-ai-medical-devices

Muehlematter UJ Daniore P Vokinger KN. FDA-approved artificial intelligence and machine learning medical devices: an updated landscape in 2024. NPJ Digit Med. 2024;7(1):88.

Grand View Research. Artificial intelligence in healthcare market size worth $208.2 billion by 2030. Updated April, 2024. Accessed November 1, 2024. https://www.grandviewresearch.com/industry-analysis/artificial-intelligence-ai-healthcare-market

Globenewswire. Artificial intelligence (AI) in healthcare market size expected to reach USD 613.81 billion by 2034. August 12, 2024. Accessed November 1, 2024. https://www.globenewswire.com/news-release/2024/08/12/2928598/0/en/Artificial-Intelligence-AI-in-Healthcare-Market-Size-Expected-to-Reach-USD-613-81-Bn-by-2034.html

Wolters Kluwer. Survey: generative AI in healthcare: growing physician enthusiasm. 2024. Accessed November 1, 2024. https://www.wolterskluwer.com/en/expert-insights/generative-ai-in-healthcare-growing-physician-enthusiasm

Char DS Shah NH Magnus D. Implementing machine learning in health care—addressing ethical challenges. N Engl J Med. 2018;378(11):981-983.

Dankwa-Mullan I. Health equity and ethical considerations in using artificial intelligence in public health and medicine. Prev Chronic Dis. 2024;21:240245.

Ghassemi M Oakden-Rayner L Beam AL. The false hope of current approaches to explainable artificial intelligence in health care. Lancet Digit Health. 2021;3(11):e745-e750.

Bajwa J Munir U Nori A Williams B. Artificial intelligence in healthcare: transforming the practice of medicine. Future Healthc J. 2021;8(2):e188-e194.

World Health Organization. Key regulatory considerations on artificial intelligence for health. 2023. Accessed November 1, 2024. https://iris.who.int/bitstream/handle/10665/373421/9789240078871-eng.pdf

Dilsizian SE Siegel EL. Artificial intelligence in medicine and cardiac imaging: harnessing big data and advanced computing to provide personalized medical diagnosis and treatment. 2023.

Li F Ruijs N Lu Y. Ethics & AI: a systematic review on ethical concerns and related strategies for designing with AI in healthcare. AI. 2023;4(1):28-53.

ShiftMed. AI in healthcare: a powerful supplement, not a substitute. 2023. Accessed November 1, 2024.

American Medical Association. AMA survey of nearly 1,200 doctors offers four key insights into how physicians use and feel about augmented intelligence (AI) in medicine. 2024. Accessed November 1, 2024.

Bell Law Firm. Medical malpractice involving AI: what patients need to know. 2023. Accessed November 1, 2024.

Medtronic. New survey reveals Americans are cautiously optimistic about artificial intelligence in healthcare. 2023. Accessed November 1, 2024.

Johner Institute. Regulatory requirements for medical devices with artificial intelligence. 2023. Accessed November 1, 2024.

US Food and Drug Administration. Artificial intelligence and machine learning (AI/ML) medical devices. 2023. Accessed November 1, 2024.

Validation strategies for AI, systems in healthcare. NPJ Digit Med. 2023;6(1):15.

LinkedIn Expert Perspectives. Best practices for validating AI healthcare applications. 2023. Accessed November 1, 2024.

ArteraAI. The importance of clinical validation for AI-based predictive and prognostic tools. 2023. Accessed November 1, 2024.

van Voorst R . Challenges and limitations of human oversight in ethical artificial intelligence implementation in health care: balancing dgital literacy and professional strain. Mayo Clin Proc Digital Health. 2024;2(4):559-563. doi:10.1016/j.mcpdig.2024.08.004

Reverberi C Rigon T Solari A , et al. Experimental evidence of effective human–AI collaboration in medical decision-making. Sci Rep. 2022;12:14952.

European Commission. Proposal for a regulation of the European Parliament and of the council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act). 2021. Accessed November 1, 2024.

Mennella C Maniscalco U De Pietro G Esposito M. Ethical and regulatory challenges of AI technologies in healthcare: a narrative review. Heliyon. 2024;10(4):e26297.