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Medical Devices › Health Technology › Algorithms

Davis Wright Tremaine LLP

CMS Launches WISeR Model to Curb Overuse of Medicare Services

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The Centers for Medicare and Medicaid Services (CMS) is looking to reduce the volume of "low value" services furnished to Original Medicare beneficiaries through the recently announced Wasteful and Inappropriate Service...more

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

Smart & Biggar on

On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Morgan Lewis

How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

Morgan Lewis on

As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

Hogan Lovells

AI Health Law & Policy: Health Tech Investment Act would create AI-enabled device Medicare payment pathway

Hogan Lovells on

U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Epstein Becker & Green

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

Epstein Becker & Green on

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

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

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 & Schulte

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Schulte 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

Arnall Golden Gregory LLP

FDA’s Steps Toward a New Review Framework for Medical Devices That Use Artificial Intelligence Algorithms

Arnall Golden Gregory LLP on

On April 2, 2019, the Food and Drug Administration issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to promote the development of medical devices that use...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

Akin Gump Strauss Hauer & Feld LLP

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

Akin Gump Strauss Hauer & Feld LLP on

• 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

Hogan Lovells

An intelligent approach for regulating medical device AI

Hogan Lovells on

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

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