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Office of Civil Rights Life Sciences

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

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‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more

Vorys, Sater, Seymour and Pease LLP

Just Say No!  HIPAA and Requests for Reproductive Health Information

On April 22, 2024, the Office of Civil Rights issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Privacy Rule). Originally Published by the American Bar Association....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Jones Day

HHS Enters Into First-Ever Ransomware Resolution Agreement and Corrective Action Plan

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The U.S. Department of Health and Human Services ("HHS") Office of Civil Rights ("OCR") has entered into its first settlement of potential Health Insurance Portability and Accountability Act ("HIPAA") violations arising out...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Burr & Forman

Hot Topics in Health Care July 2023  

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Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

Morgan Lewis

How the End of the PHE Will Impact the Healthcare Industry

Morgan Lewis on

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

Orrick, Herrington & Sutcliffe LLP

What Healthcare Companies Need to Know and Do About Ad Tracking Technologies

Healthcare companies track visitors to websites and mobile apps with third-party technologies like cookies and pixels, but that widespread practice now comes with steadily growing risk. The Federal Trade Commission is...more

Orrick, Herrington & Sutcliffe LLP

Year-End Roundup for Health Data Privacy: What Life Sciences and Healthcare Companies Need to Know for 2022

We expect many of the trends of 2021 in health data privacy to continue to pick up steam this year. See below for six noteworthy trends that life sciences and healthcare companies should continue to keep an eye on in 2022: ...more

Troutman Pepper Locke

FDA Launches Digital Center of Excellence and ONC Updates HIPAA Security Risk Assessment Tool

Troutman Pepper Locke on

Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more

Troutman Pepper

De-Identifying Protected Health Information: OCR Issues Long-Awaited Guidance

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The HIPAA Privacy Rule is intended to protect individually identifiable health information by limiting its use and disclosure. But the Privacy Rule expressly permits the de-identification of that information, and in doing so...more

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