ICMR has released Ethical Guidelines for AI in Healthcare and Biomedical Research. These guidelines apply to AI-based tools for all biomedical and health research and applications involving human participants and/or their biological data.  

Diagnosis and screening, therapeutics, preventive treatments, clinical decision-making, public health surveillance, complex data analysis, predicting disease outcomes, behavioral and mental healthcare and health management systems are among the recognized applications of AI in healthcare.  

Since AI cannot be held accountable for its decisions, an ethically sound policy framework is essential to guide AI technology development and its application in healthcare. The ICMR guiding document stated that as AI technologies get further developed and applied in clinical decision-making, it is important to have processes that discuss accountability in case of errors for safeguarding and protection. 

The document highlighted ten key patient-centric ethical principles for AI applications. These principles include accountability and liability, autonomy, data privacy, collaboration, risk minimization and safety, accessibility and equity, data quality optimization, non-discrimination and fairness, validity and trustworthiness. 

The autonomy principle stresses the need to attain the patient's consent, who must also be informed of the physical, psychological and social risks involved. In contrast, the safety and risk minimization principle prevent "unintended or deliberate misuse", anonymized data delinked from global technology to avoid cyber-attacks. 

The body is responsible for assessing the scientific rigor and ethical aspects of all health research. It will ensure that the proposal is scientifically sound and weigh all potential risks and benefits for the population where the research is being carried out. 

Informed consent and governance of AI tools in the health sector are other critical areas highlighted in the guidelines. The latter is still in the preliminary stages, even in developed countries. 

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