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Medical Devices › Algorithms › Health Care Providers

Buchalter

Blame It on the Bot: Health Care Fraud and Compliance in theAge of AI

Buchalter on

A large health system implements an Artificial Intelligence (AI)-powered clinical decision support tool that promises to ensure “complete and accurate” diagnosis documentation. Within six months, the system’s Medicare...more

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

Hogan Lovells on

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Cooley LLP

American Medical Association Adopts Landmark Policy on Neural Data Privacy

Cooley LLP on

The American Medical Association (AMA) House of Delegates has unanimously adopted Resolution 503, “Safeguarding Neural Data Collected by Neurotechnologies.” This new policy cements the AMA’s support for comprehensive...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

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

Sheppard Mullin Richter & Hampton LLP

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

Sheppard Mullin Richter & Hampton LLP on

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

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

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

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