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The landscape of Artificial Intelligence is continuously evolving, marked by a rising number of regulations, standards, guidance documents, technical reports, as well as emerging frameworks. Below, we outline just a few of the existing and upcoming resources in this dynamic field that we can help you expertly navigate and where appropriate comply with.

The EU Artificial Intelligence Act (EU AIA) aims to create a single set of rules that apply across all EU member states, thereby establishing a common European approach to AI. The act categorise AI systems based on their risk levels, imposing stricter regulations on high-risk AI systems; those used in critical areas like healthcare, transportation, and public services, for example.

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These high-risk AI systems are subject to rigorous assessments for safety, data governance, and transparency before entering the market. Lower-risk or minimal-risk AI technologies, such as chatbots or AI-enhanced video games, face fewer restrictions.

 

The ultimate goal of the act  is to ensure that AI technologies are developed and used in a manner that is safe and respects EU laws on fundamental rights and values, while also fostering innovation and growth in the European AI sector.

Deviceology specialises in helping businesses navigate the complex landscape of AI regulations, including the EU Artificial Intelligence Act. We offer a suite of compliance services specifically designed to assess and ensure that your AI systems meet the standards outlined in the act, particularly in the areas of safety, data governance, and transparency. For high-risk AI systems, we conduct thorough assessments to make sure they comply with the stringent requirements before they can be deployed in sectors like healthcare, transportation, and public services.

 

Even for lower-risk AI technologies, we offer consultation and auditing services to ensure that you are still in line with EU laws and guidelines. Our aim is to simplify compliance, providing you with a clear path to operate within the European market, thereby allowing you to focus on innovation and growth. With our expertise, your business can confidently demonstrate compliance with the EU AIA, mitigating risks and building trust with stakeholders.

BS 30440:2023 Validation framework for the use of artificial intelligence (AI) within healthcare. AI systems are increasingly used in the healthcare sector to support healthcare professionals and create efficiencies in the wider healthcare system.

For AI to succeed in this context, there is a need for systems to undergo rigorous evaluation to demonstrate their clinical benefits, safe and secure integration into existing clinical pathways, sufficient levels of performance, and that their use is ethical and socially equitable. BS 30440 is a standard that has been developed to serve as a guide for such evaluation, with a focus on the development process of AI systems for the healthcare sector.

Deviceology is acutely aware of the critical role that AI plays in the healthcare sector and we recognise the importance of ensuring these systems are rigorously tested, ethically sound, and seamlessly integrated. We offer a comprehensive suite of services tailored to help healthcare providers and technology developers comply with BS 30440:2023 standards. Our team of experts work with you to conduct in-depth evaluations that cover all aspects of this framework—ranging from clinical efficacy to ethical considerations.

 

We assist in documenting the developmental process of your AI system to ensure it aligns with the standards, while also conducting safety and performance assessments. Furthermore, we guide you through the intricacies of integrating these systems into existing clinical pathways, ensuring not only technical compliance but also operational harmony.

 

By leveraging our services, you can confidently demonstrate that your AI-powered healthcare solutions are up to the high standards required by BS 30440, thereby gaining the trust of healthcare professionals and patients alike.

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