On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an opinion that vacates the 2024 final rule that enhanced privacy protections for protected health information (PHI) related to reproductive...more
6/23/2025
/ Attestation Requirements ,
Business Associates ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Judicial Authority ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Vacated
On January 6, the Department of Health and Human Services Office for Civil Rights (OCR) published a notice of proposed rulemaking (Proposed Rule) that would strengthen the requirements of the security rule promulgated...more
In response to the number of successful, large-scale ransomware attacks affecting healthcare organizations nearly tripling since 2018, the Department of Health and Human Services (HHS) has released guidance outlining its...more
1/30/2024
/ Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
New Guidance ,
Popular ,
Regulatory Agenda
On December 13, the Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services (HHS), finalized changes to the information blocking rules by...more
In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more
11/2/2023
/ 21st Century Cures Act ,
ACOs ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Clinics ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Information Blocking Rules ,
OIG ,
ONC ,
Proposed Rules
On April 13, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a Notice of Proposed Rulemaking (NPRM) to amend the HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subparts A...more
4/18/2023
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
NPRM ,
OCR ,
Patient Privacy Rights ,
PHI ,
Public Comment ,
Reproductive Healthcare Issues
On April 28, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) entered into a resolution agreement with Peachstate Health Management, LLC, doing business as AEON Clinical Laboratories...more
5/27/2021
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Due Diligence ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Privacy Rule ,
Holding Companies ,
Noncompliance ,
OCR ,
PHI ,
Private Equity Firms ,
Settlement ,
Telehealth
The Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS) recently issued a Joint Cybersecurity Advisory in light of...more
12/23/2020
/ Coronavirus/COVID-19 ,
Cyber Crimes ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Breach ,
Department of Health and Human Services (HHS) ,
FBI ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Ransomware
On March 9, 2020, the U.S. Department of Health and Human Services (HHS) published final rules to implement the information blocking prohibitions of the 21st Century Cures Act (Information Blocking Rules). The Information...more
Following President Trump’s proclamation on March 13, 2020, that the COVID-19 pandemic in the United States constitutes a national emergency, the Department of Health and Human Services (HHS) issued a Waiver or Modification...more
Responding to the COVID-19 national public health emergency, on March 13, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) exercised the authority granted by Section 1135 of the Social Security...more
3/18/2020
/ Coronavirus/COVID-19 ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Employee Privacy Rights ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Patient Privacy Rights ,
PHI ,
Popular ,
State of Emergency ,
Telehealth ,
Waivers
On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more
9/4/2019
/ Comment Period ,
Confidential Information ,
Consent ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Health Care Providers ,
Information Sharing ,
Medical Records ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Proposed Rules ,
Public Comment ,
SAMHSA ,
Substance Abuse
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
9/7/2018
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Commercial Reasonableness ,
Cost-Sharing ,
Cybersecurity ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
EHR ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Incentives ,
Medicare Shared Savings Program ,
OIG ,
Physicians ,
Public Comment ,
Request For Information ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care ,
Waivers
The Centers for Medicare & Medicaid Services (CMS) started the year with a bang, issuing guidance on January 11, 2018, in support of Medicaid demonstration projects that condition coverage on beneficiary participation in work...more
1/19/2018
/ 1115 Waivers ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health and Welfare Plans ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
Medicaid Work Requirements ,
New Guidance ,
Social Security Act ,
Trump Administration
On January 18, 2017, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule (the Final Rule) modifying the federal regulations governing the...more
1/24/2017
/ Confidentiality Policies ,
Data Security ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Drug & Alcohol Abuse ,
Electronic Medical Records ,
Final Rules ,
Mental Health ,
Patient Privacy Rights ,
SAMHSA ,
Substance Abuse
On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more
12/19/2016
/ 21st Century Cures Act ,
Barack Obama ,
Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
EHR ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
National Institute of Health (NIH) ,
New Legislation ,
OCR ,
OIG ,
Patient Access ,
PHI ,
Privacy Policy