Since the Dobbs v. Jackson Women’s Health Organization decision (which overturned the landmark Roe v. Wade decision), the healthcare industry has continued to grapple with renewed concerns over patient privacy and...more
The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more
1/6/2025
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
NPRM ,
Privacy Laws ,
Proposed Rules ,
Regulatory Requirements ,
Rulemaking Process
Last week, in a significant win for the American Hospital Association plaintiff, the U.S. District Court for the Northern District of Texas issued an opinion vacating the Department of Health and Human Services’ (“HHS”)...more
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more
Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses...more
11/13/2023
/ Artificial Intelligence ,
Biden Administration ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Healthcare ,
OMB ,
Privacy Laws ,
Private Sector ,
Public Sector ,
Regulatory Agenda
On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department...more
11/8/2023
/ American Hospital Association ,
Class Action ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Privacy Laws ,
Third-Party ,
Tracking Systems ,
Web Tracking
Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors...more
In February, when the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) delivered two annual reports to Congress for the 2021 calendar year as mandated by the HITECH Act, several notable...more
Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third...more
Social media’s interplay with healthcare privacy presents a constantly evolving challenge. ICYMI (“in case you missed it”), there is an uptick in enforcement and scrutiny IRL (“in real life”) related to communications through...more
Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance...more
The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more
12/13/2022
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth
The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the...more
On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more
8/23/2022
/ Affordable Care Act ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Executive Orders ,
Gender Identity ,
Proposed Rules ,
Rulemaking Process ,
Section 1557 ,
Sexual Orientation Discrimination ,
Women's Rights