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HIPAA Reproductive Health Rule Vacated Nationally

A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Trump Administration Rescinds HHS Guidance on Privacy of Gender Affirming Care Data

On February 20, 2025, the U.S. Department of Health and Human Services (“HHS”) took action pursuant to President Trump’s Executive Order 14187 (“EO 14187”), which is aimed at ending gender affirming care for minors. EO 14187...more

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

‘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

Compliance Eve Ends with HIPAA Reproductive Health Privacy Rule Order out of Texas: But is it a Gift or Lump of Coal for Regulated...

December 23, 2024, was the compliance deadline for HIPAA covered entities and business associates to apply the protections of the HIPAA Privacy Rule to support Reproductive Health Care Privacy Final Rule—that is all covered...more

Happy Halloween: RIP to the HIPAA Privacy Rule?

As we settle into spooky season, let’s take a minute to consider a recent development in health care privacy as we ask ourselves, is this a trick or a treat?...more

HHS OCR Withdraws Tracking Technologies Appeal in AHA v. Becerra

On August 29, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) withdrew its appeal of the U.S. District Court for the Northern District of Texas’s (Court) June 20, 2024 decision in...more

HHS Tracking Technology Guidance Vacated by Federal Court

On Thursday, June 20, 2024, a U.S. District Court Judge ruled that the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) overstepped its authority to act when issuing its December 2022 bulletin...more

Friendly Reminder - Finalize and Post Your Consumer Health Data Privacy Notice Before March 31

Friendly reminder – the Washington My Health My Data Act (“WMHMDA”) compliance deadline for regulated entities to post their consumer health data privacy policy is March 31, 2024 (June 30, 2024 for small businesses). A...more

Substance Abuse Disorder Records (42 CFR Part 2) Final Rule Is Here!

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) released its anticipated Final Rule last week. The Final Rule revises...more

Never Say Never Again: HHS Signals the Return of HIPAA Audit Program

On February 12, 2024, the U.S. Department of Health and Human Services (“HHS”) published a notice in the Federal Register regarding reinstatement of the Health Information Portability and Accountability Act of 1996 (“HIPAA”)...more

Key Considerations for Healthcare Providers Responding to Law Enforcement Requests

Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more

2023 Year-End Employee Benefits Updates

This newsletter provides updates employers should be aware of heading into 2024, including an outline of the updated 2024 retirement and welfare plan limits, instructions related to the “gag order” attestation requirements...more

Diving into the Washington My Health My Data Act Part Twelve : Washington Attorney General Guidance

This is Part Twelve, the final installment of our series of legal updates on the Washington My Health My Data Act (“WMHMDA”). We are thrilled that you came along as we dove into the intricacies of WMHMDA that are creating...more

Diving into the Washington My Health My Data Act - Part Eleven: HIPAA vs. WMHMDA (for table lovers)

This is Part Eleven in a series of legal updates on the Washington My Health My Data (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Diving into the Washington My Health My Data Act - Part Ten: Operational Realities and Next Steps

This is Part Ten in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Diving into the Washington My Health My Data Act - Part Three: Broad Scope of Consumer Health Data

This is Part Three in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating tidal waves in the...more

Diving into the Washington My Health My Data Act - Part Two: Consumers Covered by WMHMDA

This is Part Two in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles is doing a deep dive into the various factors and intricacies of the Act that are shaping up to create a sea of...more

Diving into the Washington My Health My Data Act - Part One: What Regulated Entities are Subject to WMHMDA

While it is not officially summer, it is after Memorial Day, a.k.a. the perfect time to pick out your beach reads. We recommend bumping Quarles’ series on the Washington My Health My Data Act (“WMHMDA”) to the top of your...more

Washington Poised to Transform Consumer Health Data Landscape with Passage of My Health My Data Act

Effects to consumer health data collection and processing will be felt in Washington and beyond with new consumer rights and consent requirements as well as a private right of action....more

HHS Office for Civil Rights Announces Proposed Rule Increasing HIPAA Privacy Rule Protections for Reproductive Care

On April 12, 2023, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM), aimed at strengthening the Health Insurance Portability and...more

It’s the End of the PHE as We Know It

The Biden Administration announced that the federal COVID-19 Public Health Emergency (PHE) will expire at the end of the day on May 11, 2023. As we draw closer to the expiration date of the PHE, do you feel fine about your...more

“Circling Back” After the New Year: Recent Updates in Data Privacy & Security

As we settle in to 2023 and return to our “circle back in the new year” projects, it is a good time to catch up on data privacy and security updates from the end of 2022 and set priorities for 2023. To help you start the year...more

CPRA is in Effect: What Health and Life Sciences Entities Need to Know

The long-awaited January 1, 2023 effective date of the California Privacy Rights Act (CPRA) has arrived and cannot be ignored or dismissed any longer. Many health care entities are aware of the Health Insurance Portability...more

Substance Abuse Disorder Records (42 CFR Part 2) Proposed Rulemaking Works Toward HIPAA Alignment

While the federal substance use disorder regulations enjoyed decades without a single change, the federal government has been on a roll since 2017. The latest round of changes was recently announced by the U.S. Department of...more

Information Blocking Rule Expands to Full Designated Record Set

Effective today, October 6, 2022, the Information Blocking Rule will expand in scope to prohibit interfering with access or exchange of information in a designated record set. With this expansion of the Information Blocking...more

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