In October 2022, the U.K. Medicines and Health products Regulatory Agency (MHRA) published its Guidance, Software and AI as a Medical Device Change Programme – Roadmap, setting out how it will regulate software and AI medical devices in the U.K. by balancing patient protection and providing certainty to industry.
Background to the Reforms
The MHRA initially announced the Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) Change Programme in September 2021, designed to ensure that regulatory requirements for software and AI are clear and patients are kept safe. This builds on the broader reform of the medical device regulatory framework detailed in the Government response to consultation on the future regulation of medical devices in the United Kingdom, which recently saw its timetable for implementation extended by 12 months to July 2024.
Continue reading “Update: AI Regulation in the U.K. — New Government Approach”
As of March 2022, there are more than 18,000 different crypto currencies in service for a total market capitalization of $2 trillion. In this episode of the Faegre Drinker on Law and Technology Podcast, host Jason G. Weiss chats with Faegre Drinker partner Jeff Blumberg and associate Jane Blaney, to revisit the world of crypto and not only discuss the foundations of crypto currencies, but also explore the world of blockchain and non-fungible tokens, or NFTs.
The conversation tackles a number of questions, including:
- What is blockchain and what makes it different from traditional recordkeeping processes?
- What exactly is crypto currency? What is important to understand about it?
- What exactly is an NFT? How do they work in easy-to-understand concepts?
- What uses are there for blockchain, both using crypto currencies and in uses other than crypto currency?
- Are crypto currencies considered “legal tender”? Can people use them like normal money?
- How can and will NFTs be used in other ways in our society as these concepts grow?
Continue reading “What Are Blockchain, Crypto and NFTs? A Deeper Look – Faegre Drinker on Law and Technology Podcast”
The National Institute of Standards and Technology (NIST) has released the second draft of its Artificial Intelligence (AI) Risk Management Framework (RMF) for comment. Comments are due by September 29, 2022.
NIST, part of the U.S. Department of Commerce, helps individuals and businesses of all sizes better understand, manage and reduce their respective “risk footprint.” Although the NIST AI RMF is a voluntary framework, it has the potential to impact legislation. NIST frameworks have previously served as basis for state and federal regulations, like the 2017 New York State Department of Financial Services Cybersecurity Regulation (23 NYCRR 500).
The AI RMF was designed and is intended for voluntary use to address potential risks in “the design, development, use and evaluation of AI products, services and systems.” NIST envisions the AI RMF to be a “living document” that will be updated regularly as technology and approaches to AI reliability to evolve and change over time.
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On July 18, 2022, the U.K. Government published a paper on its proposals for AI regulation “Establishing a pro-innovation approach to regulating AI” (the AI Paper). This was published alongside the Government’s AI Action Plan, the first update provided since the Government published its National AI Strategy in September 2021.
The AI Paper provides for an alternative approach to AI regulation in the U.K. when compared with the recently proposed draft legislation for AI regulation in the EU (the EU AI Act). The U.K. Government favours a more decentralised and less regimented approach: guidance, rather than legislation; sector-based, rather than cross-sector application; regulated at sector level, rather than centrally; and with a looser definition of what constitutes AI for the purposes of regulatory application. This is intended to make the U.K. an attractive environment for AI innovation, with more flexible and pragmatic regulation, although AI businesses operating in multiple sectors will potentially need to review and comply with more than one set of principles and address conflicts between them.
Continue reading “AI Regulation in the U.K. — New Government Approach”
Chances are good that your organization uses algorithms or artificial intelligence to help make business decisions — and that regulatory efforts targeting these automated decision-making systems, including their potential to produce unintended bias, have caught your attention. In this episode of the Faegre Drinker on Law and Technology Podcast, host Jason G. Weiss sits down with Bennett Borden, Faegre Drinker’s chief data scientist and co-founder of the firm’s artificial intelligence and algorithmic decision-making (AI-X) team, to discuss algorithmic bias and what companies should know about the latest regulatory developments.
Continue reading “What Is Algorithmic Bias? Why Is It Important? – Faegre Drinker on Law and Technology Podcast”
The U.K. Information Commissioner’s Office recently confirmed the options and clarified the timing of new data transfer agreements for transfers of personal data out of the U.K. The situation has been somewhat confusing, even to those relatively familiar with international data transfers. Organizations can now review their data transfer arrangements with greater certainty, and this will be a key priority for 2022.
Continue reading “International Data Transfers: Clarity on Timing of U.K. Transfer Mechanisms”