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

Nelson Hardiman, LLP

The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges

Nelson Hardiman, LLP on

Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on

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

Goodwin on

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

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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