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OCR Issues Proposed Rule to Strengthen Cybersecurity for ePHI

The Office for Civil Rights (“OCR”) under the U.S. Department of Health and Human Services (“HHS”) recently issued a Notice of Proposed Rulemaking (the “Proposed Rule”) to modify the Health Insurance Portability and...more

OCR Settles First Phishing Cyber-Attack Investigation with a Louisiana Medical Group

On December 7, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced its first-ever settlement involving a phishing attack under the Health Insurance Portability and...more

A Midsummer’s Review – Cybersecurity Is the Word: HIPAA Enforcement and Guidance Trends

Summer is in full swing, but the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) is doing anything but taking a vacation from HIPAA. In May and June, OCR issued five resolution agreements...more

You Can Apply if You Want To: FDA’s Guidance Concerning Its Refuse to Accept Policy for Cyber Devices

Channeling Men Without Hats’ 1982 catchy (not classic) hit, “Safety Dance,” FDA told industry in a recently issued guidance that medical device companies could submit marketing applications for cyber devices if they want to...more

Upcoming Annual Deadline for HIPAA Small Breach Reporting: March 1, 2022

HIPAA-covered entities should note the quickly approaching March 1, 2022 deadline for reporting breaches of unsecured protected health information that occurred in 2021 and involved fewer than 500 individuals. This article...more

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