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Software Developers Regulatory Oversight

WilmerHale

AI-Powered Medical Devices Bring Patent and Regulatory Pitfalls

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Artificial intelligence and machine learning are transforming the medical device industry. Simultaneously, companies are working to gain Food and Drug Administration approval and obtain intellectual property protection for...more

White & Case LLP

Newly passed Colorado AI Act will impose obligations on developers and deployers of high-risk AI systems

White & Case LLP on

The Colorado Artificial Intelligence Act will impose mounting obligations on developers and deployers of high-risk AI systems in an effort to protect consumers from discriminatory consequential decisions by such systems....more

Venable LLP

Colorado's Landmark AI Law: Essential Insights for Businesses

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On May 17, 2024, Governor Jared Polis signed into law Colorado Senate Bill 24-205 (SB205), pioneering a comprehensive regulatory framework for artificial intelligence (AI) systems....more

Venable LLP

Preparing for the EU Cyber Resilience Act

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The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

Foley & Lardner LLP

Competing Interests: Data Ownership at the Crossroads of SaaS Stakeholders and Regulation

Foley & Lardner LLP on

Kicking off our series on topics concerning Software-as-a Service (SaaS) technology, it is important to lay a framework around the data managed by SaaS applications and issues that arise out of complex relationships among...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

Sheppard Mullin Richter & Hampton LLP

Video Games, AI, and …the Law?

Video games have come a long way. They have morphed from simulated games of ping pong to today’s fully-immersive virtual reality games that leverage biometrics and artificial intelligence (AI)...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

McDermott Will & Emery

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Emery on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Sheppard Mullin Richter & Hampton LLP

Medical Devices - Artificial Intelligence and Reactions to FDA’s Proposed Oversight

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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A recap of Friday’s GDP numbers, which featured both a strong 3.5% growth rate and early signs that “the growth could cool in coming months”...more

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