The WHO recognises AI's potential to enhance health outcomes through improved clinical trials, medical diagnoses, treatments, self-care, and person-centred healthcare while also supplementing healthcare professionals' expertise.
The World Health Organization (WHO) has released a comprehensive publication outlining critical regulatory considerations for the use of artificial intelligence (AI) in healthcare.
This initiative underscores the need to prioritise AI system safety, effectiveness, and accessibility for those who require them while fostering collaboration among various stakeholders, including developers, regulators, manufacturers, healthcare professionals, and patients, according to a recent WHO statement.
Recognising the potential of AI to enhance health outcomes, the WHO highlights its role in strengthening clinical trials and improving medical diagnosis, treatment, self-care, and person-centred care. Additionally, AI can supplement the knowledge, skills, and competencies of healthcare professionals.
However, the rapid deployment of AI, including large language models, raises concerns about potential impacts on both healthcare professionals and patients. AI's access to sensitive health data necessitates robust legal and regulatory frameworks to protect privacy, security, and data integrity, a primary focus of this publication.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, acknowledged the significant promise of AI in healthcare but also emphasised the challenges it poses, such as unethical data collection, cybersecurity threats, and the risk of amplifying biases or misinformation. He noted that the new guidance aims to help countries effectively regulate AI, harnessing its potential while minimising risks.
Responding to the growing demand for responsible management of AI health technologies, the publication outlines six essential areas for regulating AI in healthcare.
These areas include transparency and documentation throughout the product lifecycle, comprehensive risk management addressing intended use, continuous learning, human interventions, model simplicity, and cybersecurity threats.
It underscores the importance of external data validation, a commitment to data quality to prevent biases, and compliance with complex regulations like GDPR and HIPAA. Collaboration among regulatory bodies, patients, healthcare professionals, industry representatives, and government partners is emphasised to ensure ongoing compliance with regulations.
The WHO publication serves as a guide for governments and regulatory authorities, offering fundamental principles to develop new guidance or adapt existing regulations at national or regional levels. It represents a crucial step in establishing a framework for the ethical and practical use of AI in healthcare, with the ultimate goal of improving patient outcomes and maintaining data security.
In another recent development, WHO launched the 'WHOeyes' App on World Sight Day in response to the growing demand for eye care services.
The newly launched app checks visual acuity, a measure of how well the eye can distinguish shapes and details at a specific distance, representing a common evaluation of visual function. Moreover, it offers a simple, non-invasive measure, which is critical to determine if someone has a vision impairment.