Artificial intelligence will continue to make a significant contribution to the way healthcare is delivered in the UK in the coming year. The transformative potential of AI is discussed daily but is usually accompanied by the caveat that it must be designed, developed and deployed safely. To deal with these issues, the Medicines and Healthcare products Regulatory Agency launched its AI Airlock project to address the challenges involved in regulating AI as a medical device (AIaMD). The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges and the AI Airlock applies this to healthcare. The objective is to identify the issues posed by AIaMD and to work collaboratively to understand and mitigate any risks that are uncovered while ensuring the viability of the devices in the pilot. The findings from this partnership between government, regulators and industry will then inform future projects and feed into future UK and international AIaMD guidance. Other sectors will watch with interest.