The Indian Council of Medical Research (ICMR) has released the country’s first Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare, aimed at creating “an ethics framework which can assist in the development, deployment, and adoption of AI-based solutions” in the fields specified.
Through this, they hope to make “AI-assisted platforms available for the benefit of largest section of common people with safety and highest precision possible,” while also addressing emerging ethical challenges when it comes to AI in biomedical research and healthcare delivery.
The document, prepared by the Department of Health Research and ICMR Artificial Intelligence Cell, Delhi, will be updated as and when the need arises, said a senior Health Ministry official. Developed through extensive discussions with experts and ethicists, the guidelines include sections on ethical principles, guiding principles for stakeholders, an ethics review process, governance of AI use, and informed consent.
“It [the document] is intended for all stakeholders involved in research on AI in biomedical research and healthcare, including creators, developers, researchers, clinicians, ethics committees, institutions, sponsors, and funding organizations,’’ noted Dr. Rajiv Bahl, director-general, ICMR.
Development, as well as deployment of AI-based solutions in healthcare, span a number of issues, including those related to data safety, data sharing, and data privacy, say experts. The document says that as AI technologies are further developed and applied in clinical decision making, it is important to have processes that discuss accountability in case of errors. As per the guidelines, the ethical review process for AI in health comes under the domain of the ethics committee. The document notes that the regulation of AI technologies in healthcare is still in its nascent stage even in developed countries.
India already offers streamlining of AI technologies in various sectors including healthcare through the National Health Policy (2017), National Digital Health Blueprint (NDHB 2019), and Digital Information Security in Healthcare Act (2018) proposed by the Health Ministry which will pave the way for the establishment of the National Data Health Authority and other health information exchanges.