Innovation & TechWHO Issues Guidance on Regulating AI in Healthcare for Safety and Efficacy

WHO Issues Guidance on Regulating AI in Healthcare for Safety and Efficacy

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The World Health Organization (WHO) has released a new publication, highlighting key regulatory considerations for the use of artificial intelligence (AI) in healthcare. This guidance emphasizes the significance of ensuring the safety and effectiveness of AI systems in healthcare. It emphasizes rapid access for those in need and highlights fostering collaboration among all stakeholders.
 
“Artificial intelligence holds great promise for health, but also comes with serious challenges, including unethical data collection, cybersecurity threats and amplifying biases or misinformation,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This new guidance will support countries to regulate AI effectively, to harness its potential, whether in treating cancer or detecting tuberculosis, while minimising the risks.”

To responsibly manage the rapid rise of AI in healthcare, the publication outlines six areas for AI regulation:

Transparency and Documentation: It highlighted the importance of documenting the entire product lifecycle, and tracking development processes to foster trust.
Risk Management: Comprehensive handling of issues such as intended use, continuous learning, human interventions, training models, and cybersecurity threats to mitigate risks.
External Validation: Clarity about the intended use and external validation of AI systems to assure safety and facilitate regulation.
Data Quality: Rigorous evaluation of systems pre-release to ensure AI does not amplify biases and errors.
Regulatory Challenges: Addressing complex regulations like GDPR and HIPAA with a focus on jurisdiction and consent requirements for privacy and data protection.
Collaboration: Fostering collaboration between regulatory bodies, patients, healthcare professionals, industry representatives, and government partners to ensure compliance throughout AI products’ lifecycles.

Also Read: World Health Organization launches the WHOeyes app
 
The complexity of AI systems depends on both code and training data, which may lead to biases. Regulations can help ensure that training data represents diversity, mitigating the risk of bias amplification. The new WHO publication serves as a blueprint for governments and regulatory authorities. Also, It facilitates the development of guidance at national or regional levels. This guidance helps navigate the challenges and opportunities presented by AI in healthcare.

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