Big Picture -
Last week, Texas AG Ken Paxton (R) sued the Department of Health and Human Services (HHS), alleging that the new HHS final rule amending HIPAA regulations to strengthen protections for reproductive health...more
This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal...more
6/26/2024
/ Breach Notification Rule ,
Code of Federal Regulations (CFR) ,
Consumer Privacy Rights ,
Continuing Legal Education ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Priorities ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Medical Records ,
Patient Privacy Rights ,
PHI ,
Popular ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Substance Abuse ,
Web Tracking ,
Webinars
On March 18, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its December 2022 guidance for HIPAA-regulated entities regarding the use of online tracking technologies...more
3/25/2024
/ Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
Mobile App Privacy Guidelines ,
OCR ,
PHI ,
Web Tracking
This week, the U.S. Department of Health and Human Services (HHS) took its first step in actually regulating the use of artificial intelligence (AI) in health care. Through its Office of the National Coordinator for Health...more
The Big Picture -
Many health care stakeholders have long relied on the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) guidance regarding an effective compliance program when...more
On July 20, 2023, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and the Federal Trade Commission (FTC) sent a joint letter to approximately 130 hospital systems and telehealth...more
7/24/2023
/ CIPA ,
CMIA ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Mobile Apps ,
OCR ,
PHI ,
Technology ,
Tracking Systems ,
Web Tracking
After a COVID-19-related delay, on June 27, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a long-awaited final rule that establishes monetary penalties for violations of health...more
The Big Picture -
On April 12, 2023, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking to address the privacy of protected health information (PHI) related to reproductive health...more
4/17/2023
/ Biden Administration ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
New Guidance ,
PHI ,
Proposed Rules ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Women's Rights
The Big Picture -
On February 24, the Drug Enforcement Administration (DEA), in consultation with the Department of Health and Human Services (HHS), issued two proposed rules that address the prescribing of controlled...more
3/2/2023
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Distribution ,
Healthcare ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Public Health Emergency ,
SAMHSA ,
Substance Abuse ,
Telehealth ,
Telemedicine
In the wake of the Supreme Court’s decision overturning Roe v. Wade, the Centers for Medicare & Medicaid Services (CMS) issued guidance to health care providers on July 11, 2022, underscoring that the federal Emergency...more
In the two weeks following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the Biden Administration has taken several actions to provide clarity about women’s access to reproductive health...more
7/11/2022
/ Abortion ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Equal Protection ,
Healthcare ,
Healthcare Reform ,
New Guidance ,
OCR ,
Patient Access ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS
The Big Picture -
On June 24, the Supreme Court of the United States issued a far-reaching decision, Dobbs v. Jackson Women’s Health Organization, that repudiates nearly 50 years of precedent on a woman’s right to abortion...more
6/28/2022
/ Abortion ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Counsel ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
First Amendment ,
Healthcare ,
HIPAA Security Rule ,
Patient Access ,
Planned Parenthood of Southeastern Pennsylvania v Casey ,
Popular ,
Pregnancy ,
Professional Liability ,
Professional License ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS
On November 20, 2020, the Department of Health and Human Services (HHS) finalized a set of sweeping changes to the regulatory framework that governs fraud and abuse in the Medicare and Medicaid programs. Among other changes,...more
Caring for Recipients, Protecting the Workforce and Supporting Provider Sustainability -
Examine the Immediate Issues and Opportunities Facing Long-Term Care Providers—and Look Ahead at How to Build a Stronger Future—at a...more
5/26/2020
/ Assisted Living Facilities (ALFs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Elder Care ,
Executive Orders ,
Final Rules ,
FMAP ,
Funding Opportunities ,
Health Care Providers ,
Healthcare Workers ,
Home Healthcare Workers ,
Inpatient Rehab Facilities ,
Long Term Care Facilities ,
Long-Term Care ,
Medicaid ,
Medicare ,
New Guidance ,
Nursing Homes ,
Patients ,
Regulatory Burden ,
Relief Measures ,
Sustainability ,
Telehealth ,
Waivers ,
Webinars
Editor’s Note: Earlier this year, the federal Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) issued proposed rules implementing the information...more
Editor’s Note: Earlier this year, the federal Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) issued proposed rules implementing the information...more
On September 10, 2019, the Office of Inspector General (OIG) of the federal Department of Health and Human Services posted OIG Advisory Opinion 19-04 (the Opinion), which addressed two proposed arrangements between providers...more
Earlier this year, the federal Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) issued proposed rules implementing the information blocking...more
Section 1332 Waivers: Will We See More State Innovation? -
Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more
8/25/2016
/ 1332 Waiver ,
Assisted Suicide ,
Customer-Loyalty Programs ,
Department of Health and Human Services (HHS) ,
Discounts ,
Dispute Resolution ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Long Term Care Facilities ,
Medicaid ,
Off-Label Promotion ,
Patient Privacy Rights ,
PHRMA ,
Prescription Drug Coverage ,
Section 340B ,
Unfair or Deceptive Trade Practices
The Vulnerability of Healthcare Information -
According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more
7/28/2016
/ Abortion ,
Affordable Care Act ,
Anti-Steering Rules ,
Antitrust Violations ,
Attorney's Fees ,
Bad Faith ,
Brandt Fees ,
Children's Health Insurance Program (CHIP) ,
Compensatory Damages ,
Contraceptive Coverage Mandate ,
Cybersecurity ,
Data Protection ,
Denial of Benefits ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
Employee Retirement Income Security Act (ERISA) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Gobeille v Liberty Mutual Insurance Com. ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Justice Scalia ,
Market Power ,
Materiality ,
Medicaid ,
Medical Devices ,
Medicare ,
Nurses ,
OCR ,
Patient Privacy Rights ,
PHI ,
Preemption ,
Punitive Damages ,
Religious Institutions ,
Right to Privacy ,
SCOTUS ,
Undue Burden ,
Universal Health Services Inc v United States ex rel Escobar ,
Wearable Technology ,
Whole Woman's Health v Hellerstedt ,
Zubik v Burwell
Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal -
Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more
12/22/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Contraceptive Coverage Mandate ,
Department of Health and Human Services (HHS) ,
Freedom of Religion ,
Hospital Mergers ,
IRS ,
Long-Term Care ,
Medicare ,
Medicare Part B ,
OIG ,
Prescription Drugs ,
Public Health Insurance Marketplace ,
SCOTUS ,
Section 340B ,
Split of Authority ,
Stark Law ,
Waivers