In 2021, the World Health Organization issued a report about AI in Healthcare called Ethics & Governance of Artificial Intelligence for Health. It is the product of eighteen months of deliberation amongst leading experts in ethics, digital technology, law, human rights, as well as experts from Ministries of Health. While new technologies that use artificial intelligence hold great promise to improve diagnosis, treatment, health research and drug development and to support governments carrying out public health functions, including surveillance and outbreak response, such technologies, according to the report, must put ethics and human rights at the heart of its design, deployment, and use.
The report identifies the ethical challenges and risks with the use of artificial intelligence of health, six consensus principles to ensure AI works to the public benefit of all countries. It also contains a set of recommendations that can ensure the governance of artificial intelligence for health maximizes the promise of the technology and holds all stakeholders – in the public and private sector – accountable and responsive to the healthcare workers who will rely on these technologies and the communities and individuals whose health will be affected by its use.
The six principles include (1) Protecting human autonomy; (2) Promoting human well-being and safety and the public interest; (3) Ensuring transparency, explainability and intelligibility; (4) Fostering responsibility and accountability; (5) Ensuring inclusiveness and equity; (6) Promoting AI that is responsive and sustainable.
One of the organization’ss leading guidance in this area is the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators working toward harmonizing international medical device regulation (http://www.imdrf.org/). Its members currently include Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea, and the United States. The IMDRF has issued key definitions for SaMD and a common framework for regulators 31. Its guidance also recommends a continuous iterative process based on real-world performance data35. Similar to the FDA approach, the IMDRF states that low-risk SaMD may not require independent review.
