The Indian Council of Medical Research (ICMR) has released Ethical Guidelines for Artificial Intelligence 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.
The recognised applications of AI in healthcare include diagnosis and screening, therapeutics, preventive treatments, clinical decision-making, public health surveillance, complex data analysis, predicting disease outcomes, and health management systems.
To ensure the responsible development and use of AI in healthcare, it is crucial to establish an ethical policy framework that guides decision-making. The ICMR guiding document stated that as AI technologies evolve and are increasingly applied in the healthcare sector, there must be processes that discuss accountability in case of errors.
The document outlined ten ethical principles based on the well-being of patients that must be considered when applying AI technology. These principles include accountability and liability for decisions made, respecting patient autonomy, ensuring data privacy, promoting collaboration, minimising risk, and ensuring safety, striving for accessibility and equity, optimising data quality, preventing discrimination and promoting fairness, and ensuring validity and trustworthiness of AI applications.
The principle of autonomy emphasises the importance of obtaining informed consent from patients, who should also be fully informed of the potential physical, psychological, and social risks associated with AI applications. On the other hand, the principle of safety and risk minimisation aims to prevent any unintended or intentional misuse of AI technology.
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.
India has made significant strides in increasing the use of AI and other technologies in healthcare. Emerging technologies are being used to track citizens’ health statuses as well as to monitor health outcomes and identify areas for improvement. Last August, the National Health Authority (NHA) issued hardware guidelines for state and union territory hospitals, clinics, and wellness centres. The aim was to promote digitsation in healthcare institutions. The guidelines briefly describe the required infrastructure for the efficient implementation of the Ayushman Bharat Digital Mission (ABDM), with a particular focus on quality patient care and the adoption of digital initiatives.
As OpenGov Asia reported, the guidelines provide a basic framework for the planning, assessment, and procurement of the IT hardware (including IT specifications of various hardware equipment) based on the size of the healthcare facility. It enables healthcare providers to operate applications compliant with the ABDM. The document includes guidelines for desktops and laptops; printers; QR code readers; QR code printers; fingerprint scanners; uninterrupted power supply (UPS); and web cameras.
ABDM is a national-level digital health ecosystem that intends to support universal health coverage (UHC) in an accessible, inclusive, and affordable manner, through the provision of big data and infrastructure services, and by leveraging open, interoperable, standards-based digital systems. At the same time, the government is keen on ensuring the security, confidentiality, and privacy of health-related personal information.
