On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more
4/22/2025
/ Arkansas ,
Healthcare ,
Healthcare Reform ,
New Legislation ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government ,
State Attorneys General
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
2/21/2025
/ Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Executive Orders ,
Gender Expression ,
Gender Identity ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
LGBTQ ,
Patient Access ,
Patient Privacy Rights ,
PHI ,
Reproductive Healthcare Issues ,
Transgender ,
Trump Administration
It took some time, but we officially have the first complaint filed alleging violations of the Washington My Health, My Data Act (“MHMDA”). The complaint, filed February 10 in the U.S. District Court Western District of...more
2/14/2025
/ Amazon Marketplace ,
Biometric Information ,
Class Action ,
Consumer Privacy Rights ,
Data Collection ,
Data Privacy ,
Healthcare ,
PHI ,
Prior Express Consent ,
State Privacy Laws ,
Statutory Violations ,
Targeted Digital Advertising ,
Washington ,
Wiretapping
As the Trump administration stakes dramatically new positions on matters across the federal government, we are waiting to learn its view on the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule,...more
2/10/2025
/ Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Patient Privacy Rights ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
State Privacy Laws ,
Trump Administration
‘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
1/2/2025
/ Cybersecurity ,
Data Breach ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
HIPAA Security Rule ,
HIPAA Violations ,
Life Sciences ,
NPRM ,
OCR ,
PHI ,
Regulatory Agenda ,
Rulemaking Process
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
On September 18, 2024, the Attorney General (AG) of Texas announced a settlement with an artificial intelligence-focused healthcare technology company to resolve allegations of false and misleading statements about the...more
10/16/2024
/ Artificial Intelligence ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
False Statements ,
Health Care Providers ,
Health Technology ,
Life Sciences ,
Misleading Statements ,
Settlement ,
State Attorneys General ,
Texas
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
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
2/16/2024
/ Covered Entities ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Federal Register ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Audits ,
HIPAA Breach ,
HITECH Act ,
OCR ,
Patient Privacy Rights ,
PHI
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
1/12/2024
/ Data-Sharing ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Dobbs v. Jackson Women’s Health Organization ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Information Requests ,
Law Enforcement ,
Life Sciences ,
Patient Privacy Rights ,
PHI ,
Roe v Wade
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more
8/30/2023
/ Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Health and Welfare Plans ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medicare Part D ,
Patients ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Preemption
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
This is Part Six in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) in which Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the...more
Oh say, can you see, Part 5 in our Washington My Health My Data Act series? This is the fifth installment in our series on the Washington My Health My Data Act (“WMHMDA”)....more
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
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
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
3/20/2023
/ Biden Administration ,
Business Associates Agreement (BAA) ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Public Health Emergency ,
Telehealth ,
Telemedicine
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
The Massachusetts law permitting pharmacies and pharmaceutical manufacturers to offer drug discounts to consumers, which was set to expire on January 1, 2023, has recently been extended to January 1, 2026....more
Effective March 11, 2022, Ohio Board of Pharmacy (“Board”) enacted a new regulation, Ohio Admin. Code 4729:5-3-20, that creates a procedure for licensees to petition the Board for approval of pilot or research projects...more
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
In a move signaling the increasing importance of pharmacists in the overall continuum of patient care, Rhode Island (RI) recently enacted new statutory language that expands pharmacists’ ability to administer medications...more
Retail chain pharmacies should be aware of California’s recent passage of SB 362, signed into law by Governor Gavin Newson late last month, and the potential impact of the law on how chains evaluate their pharmacy staff and...more
10/22/2021
/ Business & Professions Code ,
California ,
Life Sciences ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Quotas ,
Regulatory Standards ,
Retail Market ,
Retailers