Legal and Ethical Considerations of Artificial Intelligence in Medical Imaging in India.
- 1Department of Radiodiagnosis and Interventional RadiologyAll India Institute of Medical SciencesNew DelhiIndia.
- 2Centre for Responsible AI, Indian Institute of TechnologyMadrasTamil NaduIndia.
- 3Department of Diagnostic and Interventional OncoradiologyIRCH, AIIMSDelhiIndia.
Abstract
Background
Artificial intelligence is being deployed in radiology faster than the rules and regulations required to govern it. In India, this is further complicated by disparities in access to healthcare and a data protection legal framework that is in a transition phase until it becomes fully operational on May 13, 2027. Understanding these legalities is no longer optional for doctors who are in practice, using AI in the clinic, or participating in the development of AI.Methods
This is a narrative review drawing on existing articles, Indian laws, and current national governance frameworks related to the use of AI in medical imaging in India.Results
This review discusses the ethical and legal considerations that come with using AI today. We discuss algorithmic bias, the economic divide that limits AI access, the lack of transparency and explainability of black-box models, the threat to radiology residents from automation bias, and post-deployment model drift. On the legal side, we discuss the requirements of the Digital Personal Data Protection Act, 2023, regarding informed consent and hospitals as data fiduciaries, the classification of AI tools as Software as a Medical Device (SaMD), and Indian governance frameworks, including the Indian Council of Medical Research Ethical Guidelines for AI in Biomedical Research and Healthcare, 2023, and the Strategy for Artificial Intelligence in Healthcare for India (SAHI), 2026.Conclusion
The review concludes with a practical good-practice checklist that gives radiologists an illustrative set of questions to help retain the critical mindset required at each stage of AI adoption. As AI use cases vary by context, specific guidance for your own use case is recommended.
Related
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- Introducing Artificial Intelligence into Surgical Practice for Cancer Care: Clinical Applications and Ethical Considerations
- Clinical Validation, Bias, and Ethical Deployment of Artificial Intelligence in Imaging.
- A Tale of Two Countries: Challenges in the Adoption of Artificial Intelligence in Medical Imaging in India and Singapore.
- Legal and Regulatory Considerations for Artificial Intelligence Use in Medical and Radiology Research.
BibTeX
@article{upadhyaya2026legal,
title = {{Legal and Ethical Considerations of Artificial Intelligence in Medical Imaging in India.}},
author = {Vineet Upadhyaya and Vibhav Mithal and Amit Gupta and Krithika Rangarajan and Devasenathipathy Kandasamy},
journal = {The Indian journal of radiology \& imaging},
year = {2026},
month = aug,
doi = {10.1055/s-0046-1827766},
url = {https://europepmc.org/article/MED/42921631},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Legal and Ethical Considerations of Artificial Intelligence in Medical Imaging in India.
AU - Vineet Upadhyaya
AU - Vibhav Mithal
AU - Amit Gupta
AU - Krithika Rangarajan
AU - Devasenathipathy Kandasamy
PY - 2026
DA - 2026/08/26
JO - The Indian journal of radiology & imaging
DO - 10.1055/s-0046-1827766
UR - https://europepmc.org/article/MED/42921631
AB - Background Artificial intelligence is being deployed in radiology faster than the rules and regulations required to govern it. In India, this is further complicated by disparities in access to healthcare and a data protection legal framework that is in a transition phase until it becomes fully operational on May 13, 2027. Understanding these legalities is no longer optional for doctors who are in practice, using AI in the clinic, or participating in the development of AI.Methods This is a narrative review drawing on existing articles, Indian laws, and current national governance frameworks related to the use of AI in medical imaging in India.Results This review discusses the ethical and legal considerations that come with using AI today. We discuss algorithmic bias, the economic divide that limits AI access, the lack of transparency and explainability of black-box models, the threat to radiology residents from automation bias, and post-deployment model drift. On the legal side, we discuss the requirements of the Digital Personal Data Protection Act, 2023, regarding informed consent and hospitals as data fiduciaries, the classification of AI tools as Software as a Medical Device (SaMD), and Indian governance frameworks, including the Indian Council of Medical Research Ethical Guidelines for AI in Biomedical Research and Healthcare, 2023, and the Strategy for Artificial Intelligence in Healthcare for India (SAHI), 2026.Conclusion The review concludes with a practical good-practice checklist that gives radiologists an illustrative set of questions to help retain the critical mindset required at each stage of AI adoption. As AI use cases vary by context, specific guidance for your own use case is recommended.
SN - 0971-3026
SN - 1998-3808
ER -