Ethical challenges and emerging regulatory frameworks on artificial intelligence in biomedicine

Authors

Keywords:

artificial intelligence, biomedical research, bioethics, military medicine

Abstract

Artificial intelligence (AI) has become a fundamental tool in biomedical research, offering advanced capabilities in diagnosis, data analysis, and personalized treatment. However, its rapid advancement raises crucial ethical questions regarding the delegation of sensitive decisions, algorithmic transparency, data privacy, and bias prevention. Organizations such as the WHO and the European Commission have published frameworks for an ethical and secure digital transformation. The Cuban Journal of Military Medicine, a pioneer in this field, requires authors to declare the ethical use of AI. For legitimate integration, ethics must encompass responsibility, fairness, constant human oversight, and ensure that AI complements, never replaces, clinical judgment.

Downloads

Download data is not yet available.

Author Biographies

Jenrry Alvarez Cruz, Universidad de Ciencias Médicas de las FAR. HMC "Dr. Luis Díaz Soto"

Doctor of Medical Sciences. First and Second Degree Specialist in Pediatrics. Assistant Researcher and Titular Professor. Deputy Editor of the Cuban Journal of Military Medicine. Diploma in Research Management. Head of the Pediatric Specialty at the "Dr. Luis Díaz Soto" Central Military Hospital.

Carlos Rafael Quevedo Fonseca, Universidad de Ciencias Médicas de las FAR. La Habana, Cuba.

Doctor en Ciencias Médicas. Profesor Titular. Director de la Revista Cubana de Medicina Militar.

References

1. Feng L, Zhang Y, Wei W, Qiu H, Shi M. Applying deep learning to recognize the properties of vitreous opacity in ophthalmic ultrasound images [Internet]. Eye (Lond). 2023;38(2):380–5. DOI: 10.1038/s41433-023-02705-7

2. Mellado Raúl, Escobar E, De la Mora H, Díaz EJ, Rodríguez FL. Estudio de concordancia entre el sistema Watson for Oncology y la práctica clínica en pacientes con cáncer de mama dentro del Hospital Angeles Pedregal [Internet]. Acta méd. Grupo Ángeles. 2023;21(4):339-42. DOI: https://doi.org/10.35366/112643

3. Albisua J, Pacheco P. Límites éticos en el uso de la inteligencia artificial en medicina [Internet]. Open Respiratory Archives. Elsevier; 2025 [acceso: 25/12/2025]. Disponible en: https://www.elsevier.es/en-revista-open-respiratory-archives-11-articulo-limites-eticos-el-uso-inteligencia-S265966362400105X4

4. Howcroft A, Bennett-Weston A, Khan A, Griffiths J, Gay S, Howick J. AI chatbots versus human healthcare professionals: a systematic review and meta-analysis of empathy in patient care [Internet]. British Medical Bulletin. 2025;156(1): 1-13. DOI: 10.1093/bmb/ldaf017

5. Marwala T. The Dual Faces of Algorithmic Bias — Avoidable and Unavoidable Discrimination [Internet]. United Nations University, UNU Centre; 2024. [acceso: 29/12/2025]. Disponible en: https://unu.edu/article/dual-faces-algorithmic-bias-avoidable-and-unavoidable-discrimination

6. Seyyed-Kalantari L, Zhang H, McDermott MBA, Chen IY, Ghassemi M. Underdiagnosis bias of artificial intelligence algorithms applied to chest radiographs in under-served patient populations [Internet]. Nat Med. 2021; 27: 2176–82. DOI: https://doi.org/10.1038/s41591-021-01595-0

7. Campos Rivera G. Responsabilidad civil derivada del uso de sistemas de IA. Situación actual y retos para un futuro reglamento europeo [Internet]. Revista Jurídica Universidad Autónoma de Madrid. 2023;(46):173-215. DOI: https://doi.org/10.15366/rjuam2021.46.007

8. Hassija V, Chamola V, Mahapatra A, Singal A, Goel D, Huang K, et al. Interpreting Black-Box Models: A Review on Explainable Artificial Intelligence [Internet]. Cogn Comput. 2024;16:45–74. DOI: https://doi.org/10.1007/s12559-023-10179-8

9. World Health Organization. Ethics and governance of artificial intelligence for health [Internet]. Geneva: WHO; 2021 [acceso: 25/12/2025]. Disponible en: https://www.who.int/publications/i/item/9789240029200

10. European Commission. Research and Artificial Intelligence [Internet]. Brussels: European Research Executive Agency; 2025 [acceso: 25/12/2025]. Disponible en: https://rea.ec.europa.eu/research-and-artificial-intelligence_en

11. European Commission. Consultation on High-Risk AI Systems under the AI Act [Internet]. Brussels: European Commission; 2025 [acceso: 25/12/2025]. Disponible en: https://www.gtlaw.com/en/insights/2025/6/eu-commission-consultation-on-high-risk-ai-systems-key-points-for-life-sciences-and-health-care

12. European Commission. Research Ethics and Integrity [Internet]. Brussels: European Commission; 2025. [acceso: 25/12/2025]. Disponible en: https://research-and-innovation.ec.europa.eu/strategy/support-policy-making/scientific-support-eu-policies/research-ethics-and-integrity_en

13. Food and Drug Administration. Artificial Intelligence in Software as a Medical Device [Internet]. FDA; 2025. [acceso: 29/12/2025]. Disponible en: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device

14. European Medicine Agency. Artificial intelligence [Internet]. EMA; 2025. [acceso: 29/12/2025]. Disponible en: https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/artificial-intelligence

15. International Standart Organization. ISO/IEC 42005:2025 Information technology-Artificial intelligence (AI)-AI system impact assessment [Internet]. ISO; 2025. [acceso: 29/12/2025]. Disponible en: https://www.iso.org/es/norma/42005

16. Quevedo Fonseca CR, Corral Martín A, Vázquez Velázquez E, del Risco Valiente GI, Lozano Hidalgo Y. Nuevas instrucciones para los autores de la Revista Cubana de Medicina Militar [Internet]. Rev cuba med mil. 2024 [acceso: 26/12/2025];53(1):e34952. Disponible en: https://revmedmilitar.sld.cu/index.php/mil/article/view/34952

Published

2026-01-05

How to Cite

1.
Alvarez Cruz J, Quevedo Fonseca CR. Ethical challenges and emerging regulatory frameworks on artificial intelligence in biomedicine. Rev. cuba. med. mil [Internet]. 2026 Jan. 5 [cited 2026 Jan. 12];55(1):e026077238. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/77238