Do we need prequalification of AI as a medical device to drive equitable adoption.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 41407822.
- Also identified by DOI 10.1038/s41746-025-02151-7 and PMC identifier 12738538.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
Artificial intelligence offers transformative potential for global health, yet regulatory disparities threaten equitable adoption. This brief examines whether the World Health Organization's Prequalification (PQ) framework should extend to AI. We highlight limitations of applying static product paradigms to dynamic systems, outline targeted reforms, and propose a reimagined PQ4AI that balances global technical assurance with local regulatory accountability to foster safe, effective, and equitable deployments.