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Innovative Technology › Health Care Providers › Food and Drug Administration (FDA)

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

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With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

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As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

Benesch

Dental/DSO Intelligence Monthly Report: September/October 2024

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Dentologie shares thoughts on growth by building on its unique brand identity - While other DSOs have focused on growth through acquisitions, Dentologie instead builds on its unique culture, modern aesthetic, and consumer...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

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Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

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In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

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On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

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