Device Software Functions News Today

The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on...

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many...

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning.

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance...

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth...

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global…

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated...

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in...

Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food &...

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...