On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder...more
On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more
4/18/2023
/ Abortion ,
Biden Administration ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
New Guidance ,
Patient Access ,
Patient Privacy Rights ,
PHI ,
Pregnancy ,
Reproductive Healthcare Issues ,
SCOTUS ,
Women's Rights
On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more
4/17/2023
/ Abortion ,
Biden Administration ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
NPRM ,
Patient Privacy Rights ,
PHI ,
Pregnancy ,
Proposed Rules ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
SCOTUS ,
Women's Rights
The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently issued new guidance (Guidance) on the use of remote communication technologies to deliver audio-only telehealth in accordance with...more
6/28/2022
/ Coronavirus/COVID-19 ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
HIPAA Security Rule ,
Infectious Diseases ,
New Guidance ,
OCR ,
Patient Access ,
Relief Measures ,
Remote Proceedings ,
Telehealth ,
Telemedicine
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The...more
6/16/2022
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medical Reimbursement ,
Medicare ,
Medicare Act ,
Prescription Drugs ,
SCOTUS ,
Section 340B ,
Statutory Interpretation
On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity...more
2/1/2021
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Liability ,
Medical Malpractice ,
Patient Access ,
Public Health Emergency ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Vaccinations
On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit overturned a $4.348 million penalty for alleged HIPAA violations assessed by the U.S. Department of Health & Human Services (HHS) against the University of...more
HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations -
On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...more
On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the...more
On June 12, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued timely HIPAA guidance (Guidance) regarding solicitations of blood and plasma donations from recovered COVID-19 patients....more
On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced that it would distribute up to $25 billion of CARES Act Provider Relief Funds to safety net hospitals and state Medicaid and Children’s Health...more
On May 22, 2020 the U.S. Department of Health and Human Services (HHS) issued a 45-day extension of the deadline for providers who receive payments from the CARES Act Provider Relief Fund to accept the Terms and Conditions...more
On April 9, 2020 the Department of Health & Human Services Office for Civil Rights (OCR) issued another Notification that it will exercise its enforcement discretion and not impose penalties for HIPAA violations in connection...more
On March 20, the U.S. Department of Health and Human Services (HHS) issued additional guidance in the form of Frequently Asked Questions (FAQs) on HIPAA and telehealth services to help providers furnish care during the...more
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more
3/17/2020
/ Acute Facilities ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
Coronavirus/COVID-19 ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Emergency Management Plans ,
Health Care Providers ,
HIPAA Privacy Rule ,
Infectious Diseases ,
Public Health ,
Relief Measures ,
Secretary of HHS ,
Skilled Nursing Facility ,
Social Security Act ,
Waivers
On February 3, 2020, the U.S. Department of Health and Human Services (HHS) issued a bulletin (the Bulletin) to remind covered entities and business associates of how patient information may be shared under HIPAA in the event...more
2/10/2020
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Disclosure ,
Electronic Medical Records ,
Emergency Management Plans ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Infectious Diseases ,
New Guidance ,
Patient Privacy Rights ,
PHI ,
Popular
Researchers at Sentinel One and Dragos have detected malicious code, called EKANS or Snake, that has been designed specifically to target industrial control systems (ICS), including those of oil refineries, manufacturing...more
2/7/2020
/ China ,
Critical Infrastructure Sectors ,
Cyber Attacks ,
Cyber Crimes ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Drones ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Identity Theft ,
Infectious Diseases ,
Malware ,
Medical Records ,
OCR ,
Personally Identifiable Information ,
Point of Sale Terminals ,
Public Health ,
Retailers ,
Tax Fraud ,
Vulnerability Assessments
On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions to the federal Physician Self-Referral Law (the Stark Law), the...more
On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual...more
On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more
9/4/2019
/ Comment Period ,
Confidentiality Policies ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medical Monitoring ,
NPRM ,
Opioid ,
Pain Management ,
Patients ,
Prescription Drugs ,
Public Comment ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
SAMHSA ,
Substance Abuse
In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share...more
6/6/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the Health and Human Service’s (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct...more
According to a recent survey of cybersecurity professionals by AT&T Cybersecurity entitled “Confidence: the perception and reality of cybersecurity threats,” phishing and cloud security threats are keeping them up at...more
5/3/2019
/ Best Practices ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Drones ,
Federal Aviation Administration (FAA) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Limitation of Liability Clause ,
Phishing Scams ,
Popular ,
Unmanned Aircraft Systems
On April 26, 2019, the U.S. Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion (Notice) regarding imposition of Civil Money Penalties (CMPs) under HIPAA. ...more
4/30/2019
/ Civil Monetary Penalty ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HITECH Act ,
Personally Identifiable Information ,
PHI ,
Security Standards
According to Hiscox’s Third Cyber Readiness Report, which surveyed 5,400 firms in the U.S. and the E.U., cyber threats have “become the unavoidable cost of doing business today.” The Report notes that for the first time, “a...more
4/29/2019
/ Charitable Donations ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Personally Identifiable Information ,
Popular ,
Scams ,
Vulnerability Assessments