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The World Health Organization (WHO) has released a new publication listing key regulatory considerations on artificial intelligence (AI) for health. The publication focuses on establishing AI systems' safety and effectiveness, rapidly making appropriate methods available to those who need them. It fosters dialogue among stakeholders, including developers, regulators, manufacturers, health workers, and patients.
WHO recognizes the potential of AI in enhancing health outcomes by strengthening clinical trials, improving medical diagnosis, treatment, self-care and person-centered care, and supplementing health care professionals' knowledge, skills and competencies.
According to Dr Tedros Adhanom Ghebreyesus, WHO Director-General, Artificial intelligence holds great promise for health but also comes with serious challenges, including unethical data collection, cybersecurity threats and amplifying biases or misinformation. He also stated that this new guidance would support countries to regulate AI effectively to harness its potential, whether in treating cancer or detecting tuberculosis while minimizing the risks.
In response to the growing country's need to responsibly manage the rapid rise of AI health technologies, the publication outlines six areas for the regulation of AI for health:
Transparency and documentation
Risk management
Validating data
Data quality
Privacy and data protection
Fostering collaboration
AI systems are complex and depend not only on the code they are built with but also on the data they are trained on, which come from clinical settings and user interactions. Better regulation can help manage the risks of AI amplifying biases in training data. The new WHO publication aims to outline key principles that governments and regulatory authorities can follow to develop new guidance or adapt existing guidance on AI at national or regional levels.