Category: Regulatory Compliance

Regulating AI in Life Sciences: The UK’s Evolving Framework

The UK is working on new regulations to better govern software and AI in medical devices, with the MHRA focusing on principles that ensure safety and efficacy. As innovation accelerates, the MHRA has initiated programs like the AI Airlock pilot to streamline the path for AI medical devices to reach the market.

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Bridging the Gap: The UK’s AI Regulation Bill Unveiled

The Artificial Intelligence (Regulation) Bill seeks to introduce AI-specific legislation in the UK, reflecting ongoing concerns about AI governance and regulatory gaps. Its reintroduction highlights the tension between the government’s pro-innovation stance and calls for formal oversight mechanisms amidst evolving global regulatory landscapes.

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Understanding IP Challenges in AI Due Diligence

This post discusses the complexities of intellectual property (IP) in the context of AI solutions, emphasizing the need for a tailored due diligence approach. It highlights critical questions regarding ownership, licensing rights, and the assessment of training data to mitigate risks associated with IP infringement.

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Regulating AI in Clinical Trials: Key Considerations

The document discusses the regulatory considerations for clinical trials that utilize AI, emphasizing the importance of transparency and compliance with data standards. It outlines the necessity for a regulatory impact assessment and the thoughtful use of AI tools to ensure the integrity of clinical data and patient safety.

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Virginia’s Landmark Legislation on High-Risk AI Systems

On February 20, 2025, the Virginia General Assembly passed HB 2094, the Virginia High-Risk Artificial Intelligence Developer and Deployer Act, which awaits the signature of Governor Youngkin. If enacted, Virginia will become the second state to legislate against algorithmic discrimination, targeting high-risk AI systems that significantly impact consequential decision-making.

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Compliance Strategies for the EU AI Act

The EU AI Act establishes a regulatory framework for AI that requires businesses operating in Europe to meet new standards for transparency, data quality, and bias reduction. While compliance may seem challenging, it presents opportunities for enhanced AI literacy within finance teams, enabling better understanding and utilization of AI to support informed decision-making.

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Rethinking the EU AI Act: A Case for Simplicity

The discussion raises questions about the necessity and effectiveness of the EU AI Act, suggesting that many of its provisions may be redundant or misdirected. Key points from a recent workshop highlight the challenges of defining AI and the potential for innovation to be stifled by overly stringent regulations.

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