AI-Airlock: MHRA’s new way to test and regulate AI in healthcare
AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support. However, AI also brings new challenges for regulation, as it requires a different approach to evidence generation and assessment than traditional medical devices.
That’s why the MHRA (Medicines and Healthcare Products Regulatory Agency) has announced a new initiative called AI-Airlock, which provides a ‘regulatory sandbox’ for developers to test their advanced AI technologies in healthcare. The AI-Airlock will enable innovators to work within the current regulatory system, identify and resolve the evidence gaps, and ensure the safety and performance of their products.
The AI-Airlock will also foster collaboration and learning among stakeholders, such as regulators, government, NHS, and academia. By creating a shared understanding of the benefits and risks of AI, AI-Airlock will help build trust and confidence in these technologies among patients, clinicians, and the public.
The government funds the AI-Airlock, and it will be ready to launch in April 2024. It will enable NHS patients to benefit earlier from emerging AI technologies before they are available anywhere else in the world.
How does the AI-Airlock work?
The AI-Airlock is a virtual area where developers can submit their AI products for testing and evaluation. The MHRA will provide guidance and feedback on each product's regulatory requirements and expectations, as well as access to relevant data sources and experts.
The AI-Airlock will also allow developers to monitor and update their products in real time as they learn from their performance in different settings and scenarios. This will help to address the challenge of ensuring that AI products remain safe and effective throughout their lifecycle as they adapt and evolve.
The AI-Airlock will not replace the existing regulatory pathways for medical devices but rather complement them by providing a more flexible and tailored approach for AI. The MHRA will still require developers to demonstrate that their products meet the necessary standards of safety, quality, and efficacy before they can be marketed or used in clinical practice.
What are the advantages of the AI Airlock system?
- It will provide a safe and collaborative space for developers of software and AI medical devices to generate robust evidence for their products.
- It will help innovators work within the current regulatory system and identify and resolve the evidence gaps needed for a safety and efficacy assessment.
- It will enable faster access to cutting-edge AI technologies for patients and healthcare, such as improved diagnostics or precision medicine.
- It will build on the MHRA’s regulatory expertise and ethical standards to ensure the safety and performance of AI and software as medical devices.
How can Med-Di-Dia help you?
Med-Di-Dia is a leading consultancy firm that specialises in digital health regulation. We have extensive experience and expertise in helping developers navigate the complex and evolving regulatory landscape for medical devices, including AI.
In addition to assisted incorporation of the AI-Airlock system, Med-Di-Dia can provide you with :
- A comprehensive assessment of your product’s regulatory status and requirements
- A tailored strategy and plan for evidence generation and validation
- A clear and concise documentation of your product’s design, development, testing, and performance
- A robust and transparent risk management system
- Proactive and effective communication with the MHRA and other stakeholders
We can also support you throughout your testing period in the AI-Airlock by providing you with the following:
- Continuous monitoring and evaluation of your product’s performance and impact
- A timely and appropriate update and maintenance of your product’s functionality and quality
- A prompt and accurate reporting of any adverse events or incidents
- A constructive and collaborative feedback loop with the MHRA and other stakeholders
We can help you achieve your regulatory goals faster, easier, and cheaper. Contact us today to find out how we can assist you in making your AI product a success…contact us via email – mdd@mddltd.com or by visiting https://mailchi.mp/cef1e53ebb00/digitalhealth
