The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of the AI-Airlock, a revolutionary regulatory sandbox for AI developers. This exciting initiative aims to facilitate the development and deployment of software and AI medical devices, ensuring that patients have earlier access to cutting-edge innovations that enhance healthcare.
The AI-Airlock will serve as a virtual space monitored by regulators, providing developers with the opportunity to generate robust evidence for their advanced technologies. This collaborative approach will address the challenges of testing AI-driven solutions using traditional trial techniques, ultimately expediting the availability of improved diagnostics, precision medicine, and personalized care for patients.
The partnership between the government, regulators, and industry is set to revolutionize the use of advanced AI technology in NHS settings. With stringent safety controls in place, these technologies will be utilized before obtaining regulatory approval, allowing NHS patients to benefit from emerging technologies ahead of the rest of the world.
The AI-Airlock will support innovators in navigating the current regulatory system, identifying areas where additional evidence is required for safety and efficacy assessments. By following the ‘regulatory sandbox’ model, this project ensures the safe development and deployment of software and AI medical devices, fostering a deeper understanding of the challenges and potential solutions.
The MHRA’s commitment to leveraging its regulatory expertise and building on existing capabilities is evident in this groundbreaking initiative. By accelerating the introduction of cutting-edge products to UK patients, the AI-Airlock maintains the highest standards of safety and performance.
Scheduled to launch in April 2024, the AI-Airlock is designed as a collaborative space, bringing together expertise from innovators, regulatory organizations, the government, the NHS, and academia. The development of this service is made possible through government funding from the Department of Science, Innovation and Technology and the Department of Health and Social Care.
Dr. Paul Campbell, MHRA Head of Software and AI, expressed his excitement about the AI-Airlock, stating, ‘We need to ensure that AI is safe and properly regulated, but in a way that doesn’t stifle innovation and access to the latest medical technologies. The AI-Airlock offers a unique and safe learning space for manufacturers to explore new solutions and provide safe and effective AI-driven medical devices to the NHS and patients.’
Dominic Cushnan, NHS England AI, Imaging & Deployment Director, emphasized the NHS’s commitment to testing new AI technologies and its collaboration with the MHRA. He stated, ‘We are proud to fund and collaborate on this new initiative to bring the latest state-of-the-art AI and its benefits to the NHS and patients faster.’
The AI-Airlock is set to revolutionize the healthcare industry by enabling earlier access to emerging technologies for patients. As the Airlock opens in 2024, more information will be provided on how this sandbox will benefit NHS patients without compromising safety and post-market surveillance.
For more information on the MHRA’s vision for a developing regulatory framework for AI and software as a medical device, please visit their guidance page. Media enquiries can be directed to [email protected] or by calling 020 3080 7651 (Mon-Fri 08:30-17:00).
The MHRA, an executive agency of the Department of Health and Social Care, is responsible for regulating all medicines and medical devices in the UK, ensuring their effectiveness and safety through robust and fact-based judgements.
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