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Medical Devices Algorithms

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Troutman Pepper

New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Epstein Becker & Green

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

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This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

Epstein Becker & Green

Unpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study

Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? How can that be, you might ask, for an...more

Foley & Lardner LLP

Software as a Medical Device: Challenges Facing the Industry

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Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more

MoFo Life Sciences

FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions

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On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

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Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Knobbe Martens

AI & the FDA

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The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

King & Spalding

FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?

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First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Faegre Drinker Biddle & Reath LLP

Artificial Intelligence Briefing: Senate Committee Hears Testimony on Algorithmic Transparency, Accountability

Our latest briefing dives into the Senate’s exploration of transparency and accountability to prevent bias in algorithmic decision systems, new guidance from the U.S. Copyright Office regarding works including content...more

Mintz - Health Care Viewpoints

The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?

The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their...more

Alston & Bird

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

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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

Foley & Lardner LLP

Developers Take Note: FDA Issues Clinical Decision Support Software Final Guidance

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On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more

Weintraub Tobin

Preliminary Injunction Upheld in Trade Secret Dispute Despite Prior Publication

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Publication of an algorithm prevents the algorithm from being a trade secret, right? Not necessarily. The Federal Circuit just reminded us that under certain circumstances that may not be the case. ...more

Mintz - Health Care Viewpoints

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions

In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more

Mintz - Health Care Viewpoints

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 2: FDA’s Recent Digital Health Initiatives

In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently,...more

The Volkov Law Group

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

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Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more

Proskauer - Life Sciences

Synthetic Data Gets Real

As we mentioned in the early days of the pandemic, COVID-19 has been accompanied by a rise in cyberattacks worldwide. At the same time, the global response to the pandemic has accelerated interest in the collection, analysis,...more

Rivkin Radler LLP

Smart Speakers Can Monitor Heartbeats

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Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study...more

MoFo Life Sciences

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

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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

Sheppard Mullin Richter & Hampton LLP

FDA’s Action Plan for Artificial Intelligence: Highlights and Insights for Developers

The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for...more

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