US Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence


On October 30, 2023, President Biden issued a landmark Executive Order aimed at ensuring that the United States leads the way in both harnessing the benefits and mitigating the risks of Artificial Intelligence (AI). This Executive Order is a significant step in the Biden-Harris Administration’s comprehensive strategy for responsible innovation in AI. It builds upon previous actions and voluntary commitments from leading companies to drive the safe, secure, and trustworthy development of AI.

Detailed Directives

New Standards for AI Safety and Security

The Executive Order mandates that developers of powerful AI systems share their safety test results and other critical information with the U.S. government. This is in line with the Defense Production Act. Specifically, companies developing any foundation model that poses a serious risk to national security, economic security, or public health and safety must notify the federal government when training the model. They must also share the results of all red-team safety tests.

Protecting Americans’ Privacy

The Executive Order calls on Congress to pass bipartisan data privacy legislation and directs federal agencies to accelerate the development of privacy-preserving techniques. This includes cryptographic tools that preserve individuals’ privacy.

Advancing Equity and Civil Rights

The Executive Order aims to combat algorithmic discrimination and ensure fairness throughout the criminal justice system. It provides clear guidance to landlords, federal benefits programs, and federal contractors to prevent AI algorithms from exacerbating discrimination.

Supporting Workers

The Executive Order focuses on mitigating the risks AI poses to jobs and workplaces. It directs the development of principles and best practices to address job displacement, labor standards, and workplace equity.

Promoting Innovation and Competition

The Executive Order aims to maintain America’s leadership in AI innovation through various actions, including the pilot of the National AI Research Resource and expanded grants for AI research in vital areas like healthcare and climate change.

Advancing American Leadership Abroad

The Executive Order directs the State Department to collaborate with international partners to establish robust frameworks for AI. This includes working on AI safety standards and promoting responsible AI development abroad.

Implications for AI-focused Medical Devices

The Executive Order’s focus on safety, privacy, and equity has significant implications for the development and deployment of AI-focused medical devices. Medical devices that leverage AI for diagnostics, treatment planning, or patient monitoring will need to adhere to stringent safety and security standards. These devices will also need to ensure that they do not inadvertently introduce biases that could affect patient care. The emphasis on privacy-preserving techniques is particularly relevant for medical devices that handle sensitive patient data. Manufacturers will likely need to invest in advanced cryptographic tools to ensure data privacy while still enabling the AI algorithms to function effectively.

How Deviceology Can Help

Deviceology, recognised as The Market Access People, is uniquely positioned to help clients navigate the complex landscape of AI regulations. Specialising in ISO 13485 for Quality Management Systems and ISO 14971 for Risk Management in Medical Devices, Deviceology provides comprehensive guidance through intricate international and local standards. Their expertise encompasses regional regulations such as Medical Devices Regulation in the UK and EU, ANVISA in Brazil, PMDA in Japan, and FDA Regulations in the US.

Deviceology is keeping a close eye on emerging regulation from the UK, EU, US, and China to help clients demonstrate compliance for new or continued market access. Their services facilitate global market access by helping clients adhere to regulatory obligations, international standards, and local market requirements. With their support, companies can confidently navigate the evolving regulatory landscape shaped by the Executive Order and other international directives.

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The Executive Order is a significant step towards a comprehensive and responsible approach to AI development and deployment. It addresses key areas of concern, including safety, privacy, equity, and international collaboration, and sets the stage for future legislative actions. More action will be required, and the Administration will continue to work with Congress to pursue bipartisan legislation to help America lead the way in responsible innovation.