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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 &...

In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy...

Welcome to the next installment of Arnold & Porter's Virtual and Digital Health Digest. This edition primarily covers March 2023 highlights across the virtual and digital health space.

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration ("FDA") issued a series of FAQs[1] and a guidance document[2] clarifying the agency's intended...

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The...

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital...

Ransomware is the “fastest growing malware threat.” In 2022, attacks in health care increased by 328%, a study found. Another recent study reports that from 2016 to 2021, the “annual...

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate...

FDA published guidance on cybersecurity requirements for certain device premarket submissions outlining implementation of new Section 524B of Federal Food, Drug, and Cosmetic Act FDCA. Manufacturers must meet cybersecurity requirements.

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released...