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Artificial Intelligence Regulatory Standards Medical Devices

Goodwin

How the EU AI Act Could Affect Medtech Innovation

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The EU AI Act, which went into force on August 1, 2024, introduces specific rules for artificial intelligence (AI) systems, especially those deemed “high risk.” Medtech devices, products, and services — such as...more

Gardner Law

FDA Highlights the Promise of AI in Healthcare

Gardner Law on

On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more

Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

White & Case LLP

AI Watch: Global regulatory tracker - Switzerland

White & Case LLP on

Laws/Regulations directly regulating AI (the “AI Regulations”) - Currently, there are no specific laws, statutory rules, or regulations in Switzerland that directly regulate AI. AI in Switzerland is currently subject to...more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Alston & Bird

AI Regulation in the U.S.: What’s Coming, and What Companies Need to Do in 2023

Alston & Bird on

Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...more

Faegre Drinker Biddle & Reath LLP

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

Jones Day

JONES DAY PRESENTS® Digital Health: Current Trends and Legal Issues

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The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

Hogan Lovells on

Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Hogan Lovells

An intelligent approach for regulating medical device AI

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From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

Hogan Lovells

What’s trending: The factors that can trigger supply chain disruption and litigation in the life sciences industry

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Change is coming to the life sciences industry. Price pressure, new market entrants, the emergence of personalized medicine, and even climate change are adding complexity to traditional manufacturing processes and supply...more

Hogan Lovells

Regulate Frankenstein: the European Parliament calls for new rules for robots

Hogan Lovells on

When a parliamentary report cites Mary Shelley’s Frankenstein in its recitals and proposes new regulation for robots with artificial intelligence (“AI”), one cannot be sure whether the 19th or the 21st century has inspired...more

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