The Medicines and Healthcare products Regulatory Agency (MHRA) has selected five innovative technologies for its AI Airlock pilot scheme. This initiative aims to explore how AI-powered medical devices can be regulated in a way that ensures they reach the NHS and patients quickly and safely. The chosen devices have the potential to greatly enhance the diagnosis and treatment of various conditions, including cancer, chronic respiratory diseases, and those requiring radiology services.
Before medical products can be made available to patients, evidence of their safety and effectiveness is required. However, the dynamic nature of AI technologies, which evolve as they learn, makes it challenging to generate this evidence. The AI Airlock serves as a “regulatory sandbox,” where manufacturers can test how best to gather evidence for product approval under MHRA supervision in a virtual or simulated environment. This approach will help both manufacturers and the MHRA better understand the challenges of regulating AI in medical devices, ultimately leading to a more flexible and supportive regulatory framework, clearer pathways to market, and faster access to transformative AI technologies for the NHS and patients.
The five selected technologies are:
AI to Target At-Risk COPD Patients: Lenus Stratify® uses AI to analyze health data and predict serious outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD), such as hospital admissions. By identifying high-risk patients early, care teams can intervene proactively, reduce hospital visits, and improve patient outcomes.
AI to Improve Radiology Reporting Efficiency: Philips is integrating AI into radiology workflows to automate the summarization of “Impressions” in radiology reports. This aims to enhance the efficiency, accuracy, and clarity of reports, reducing administrative burdens, errors, and miscommunications, ultimately benefiting patient care.
AI Performance Monitoring in Hospitals: Newton’s Tree’s FAMOS platform monitors AI performance in real time to identify issues like “drift,” where AI performance declines due to changing conditions or new data. By addressing these issues early, the platform ensures that AI systems remain reliable, improving the quality and consistency of patient care.
AI to Improve Cancer Care Efficiency: OncoFlow uses AI to assist healthcare professionals in creating personalized cancer treatment plans. By reducing waiting times for appointments, the platform enables earlier treatments, which can significantly improve patient survival rates. Initially focusing on breast cancer, OncoFlow can later be adapted for other cancer types.
AI for Clinician Decision-Making Support: SmartGuideline is an AI-powered tool that allows clinicians to easily access and search national guidelines, such as those from NICE, using simple language. By providing the most accurate and up-to-date treatment information, it helps doctors make informed decisions, ensuring patients receive the safest and most effective care.
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