Dear Apollo Family, 

The Indian Council For Medical Research (ICMR) has released the  Ethical Guidelines for the application of Artificial Intelligence in  Biomedical Research and Healthcare, 2023 (‘Guidelines’) 

https://main.icmr.nic.in/content/ethical-guidelines-application-artificial intelligence-biomedical-research-and-healthcare 

With this, India gets its first ethics framework for the deployment of Artificial Intelligence (‘AI’) in healthcare and biomedical research. Although these Guidelines are only recommendatory/advisory in  nature and are not binding, they open the doors to a larger discussion  on the need for a robust regulatory regime on AI in healthcare.

The Guidelines recognize the ethical challenges in the application of AI in healthcare and biomedical research and intend to put in place  sufficient checks and balances to ensure that ethics is a cornerstone in  the decision-making process when relying on /developing AI-driven  solutions.  

The Guidelines also provide mechanisms for the delivery of healthcare services by applying AI techniques, therefore, covering a wide range of applications such as diagnostics and screening, therapeutics, drug discovery and development, clinical care, epidemiology and prevention  of disease, behavioral and mental healthcare, health management  systems using AI, medical AI software for clinic management systems,  medical AI software for hospital management systems. 

There is emphasis on effective informed consent, data privacy,  accountability and liability, and the role of Ethics Committees including  an Ethics Checklist of AI for Biomedical Research and Healthcare. 

The Guidelines highlight ethical practices in the application of AI/ Software as a Medical Device (SaMD), regulated under the Drugs and Cosmetics Act, 1940. SaMD is a medical device if it is used for  diagnosis, prevention or monitoring of any disorder or disease, is part  of or used in conjunction with a device or is capable of or assists in the  investigation of any physiological process. Such AI/SaMD must  comply with several Indian regulations and global standards applicable  to medical devices. However, while the Guidelines touch on the ethical  aspects, comprehensive laws to cover the complexities of the real-time  application of such AI/SaMD in the healthcare industry are yet to be formulated. 

Look forward to your views and feedback! 

Sincerely, 

Maimoona Badsha 

Group Legal Advisor, 

Apollo Group