The World Health Organization (WHO) has unveiled a pivotal publication outlining vital regulatory considerations for artificial intelligence (AI) in the healthcare sector.
The World Health Organization (WHO) has unveiled a pivotal publication outlining vital regulatory considerations for artificial intelligence (AI) in the healthcare sector. This release underscores the imperative of establishing the safety and efficacy of AI systems, ensuring their swift availability to those in need, and promoting dialogue among stakeholders, including developers, regulators, manufacturers, healthcare professionals, and patients.
With the proliferation of healthcare data and rapid advancements in analytic techniques, AI tools hold the potential to revolutionize the healthcare landscape. WHO acknowledges the transformative impact of AI in strengthening clinical trials, enhancing medical diagnoses, treatment, self-care, and person-centered care, as well as augmenting the knowledge and skills of healthcare professionals. This technology could prove particularly invaluable in settings lacking specialized medical expertise, such as in interpreting retinal scans and radiology images.
While AI offers immense promise, its rapid deployment, sometimes without comprehensive understanding, raises concerns about potential benefits or harms to end-users, including healthcare providers and patients.
Given that AI systems may access sensitive personal information, establishing robust legal and regulatory frameworks is crucial to safeguard privacy, security, and integrity. The WHO publication aims to guide the establishment and maintenance of these essential frameworks.
Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized, “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 noted that the new guidance will empower countries to effectively regulate AI, harnessing its potential while minimizing risks.
Responding to the increasing need for responsible management of the rapid expansion of AI health technologies, the publication outlines six key areas for the regulation of AI in healthcare:
- Emphasizing transparency and documentation throughout the product lifecycle to foster trust.
- Addressing risk management aspects such as ‘intended use’, continuous learning, human interventions, training models, and cybersecurity threats.
- Externally validating data and clarifying the intended use of AI to ensure safety and facilitate regulation.
- Committing to data quality through rigorous pre-release system evaluations to prevent biases and errors.
- Navigating complex regulations like GDPR and HIPAA, focusing on jurisdiction and consent requirements to protect privacy and data.
- Encouraging collaboration between regulatory bodies, patients, healthcare professionals, industry representatives, and government partners to ensure compliance with regulations over time
The publication also highlights the significance of better regulation in managing the risks of AI amplifying biases in training data, emphasizing attributes like gender, race, and ethnicity for representative datasets. WHO’s new guidelines aim to provide governments and regulatory authorities with essential principles to develop or adapt AI guidance at national or regional levels.