Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare by the ICMR

Artificial Intelligence (AI) and Machine Learning (ML) are certainly the game-changer in the space of healthcare. A wide variety of exciting and future-looking applications of AI/ML techniques and platforms are available now. Identification of disease, screening, making diagnosis, medical imaging, intelligent health operations management, personalized medicine to digital surveillance for public health, outbreak prediction, and drug discovery are only some of the emerging uses of AI/ML.

However, AI as data-driven technology has many potential ethical challenges which include algorithmic transparency and explainability, clarity on liability, accountability and oversight, bias and discrimination

The Indian Council of Medical Research (ICMR) has come up with the country’s first Ethical Guidelines for the Application of Artificial Intelligence in Biomedical Research and Healthcare to provide an ethical framework for the development of AI-based tools which will benefit all stakeholders. These guidelines apply to AI based tools created for all biomedical and health research and applications involving human participants and/or their biological data.

The purpose of the Guideline is to provide an ethics framework which can assist in the development, deployment, and adoption of AI-based solutions for biomedical research and healthcare delivery. The guidelines are intended for all stakeholders involved in research on artificial intelligence in healthcare, including creators, developers, technicians, researchers, clinicians, ethics committees, institutions, sponsors, and funding organizations.

The document includes separate sections addressing ethical principles for AI in health, guiding principles for stakeholders, ethics review process, governance of AI use for healthcare and research, and informed consent process involving human participants and their data. The guideline has been formulated after extensive discussions with subject experts, researchers and ethicists


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