On August 29, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) withdrew its appeal of the US District Court for the Northern District of Texas’s June 20, 2024, decision in American...more
9/4/2024
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Cookies ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
OCR ,
Technology Sector ,
Tracking Systems ,
Web Tracking ,
Websites
On August 19, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) filed a notice of appeal of the US District Court for the Northern District of Texas’s June 20, 2024, decision in American...more
8/28/2024
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Cookies ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
OCR ,
Technology Sector ,
Tracking Systems ,
Web Tracking ,
Websites
The Supreme Court of the United States’s (SCOTUS’s) unanimous decision in Food and Drug Administration v. Alliance for Hippocratic Medicine (FDA v. AHM) on June 13, 2024, articulated a much more absolute view of the...more
In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more
Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including:
- The EU’s new Unified Patent Court...more
6/17/2024
/ Artificial Intelligence ,
EU ,
Financial Regulatory Reform ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Unified Patent Court
On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and...more
3/22/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Enforcement Priorities ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
PHI ,
Tracking Systems ,
Web Tracking ,
Websites
Several federal laws protect the “rights of conscience” of federally funded healthcare entities and healthcare providers and prohibit recipients of federal funds from requiring individuals to participate in actions that they...more
Data governance is a mission-critical issue for every company and institution in the United States.
GCs face a host of pressing cybersecurity concerns. Triaging them requires time, attention, and a well-rounded strategy...more
8/18/2023
/ Cookies ,
Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Disclosure Requirements ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Legislative Agendas ,
Mobile Apps ,
New Legislation ,
New Rules ,
OCR ,
Personal Information ,
Regulatory Agenda ,
Risk Factors ,
Risk Management ,
State Privacy Laws ,
Technology Sector ,
Tracking Systems
On Thursday, July 20, 2023, the Federal Trade Commission and HHS Office for Civil Rights issued a rare joint press release announcing that approximately 130 hospital systems and telehealth providers received a letter alerting...more
7/24/2023
/ Data Collection ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Joint Statements ,
Mobile Apps ,
OCR ,
Telehealth ,
Tracking Systems ,
Websites
The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and...more
7/11/2022
/ Abortion ,
Biden Administration ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Electronic Protected Health Information (ePHI) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Pregnancy ,
Privacy Concerns ,
Roe v Wade ,
SCOTUS
On June 24, 2022, the Supreme Court of the United States issued its decision in Dobbs v. Jackson Women’s Health Organization (Dobbs), overturning Roe v. Wade (Roe) and upending 50 years of precedent protecting a woman’s right...more
6/29/2022
/ Abortion ,
Continuing Legal Education ,
Dobbs v. Jackson Women’s Health Organization ,
Employee Benefits ,
Family Planning Clinics ,
Health Care Providers ,
Health Plan Sponsors ,
Pregnancy ,
Roe v Wade ,
SCOTUS ,
Webinars
June 24, 2022, the Supreme Court of the United States issued its decision in Dobbs v. Jackson Women’s Health Organization (Dobbs), overturning Roe v. Wade (Roe) and upending 50 years of precedent protecting a woman’s right to...more
Sometime in the next several weeks, the Supreme Court of the United States will issue its decision in Dobbs v. Jackson Women’s Health Organization (Dobbs). Based on the draft majority opinion authored by Justice Samuel Alito...more
6/14/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Employee Benefits ,
Employer Liability Issues ,
Family Planning Clinics ,
Health Care Providers ,
Healthcare ,
Insurance Industry ,
Planned Parenthood ,
Pregnancy ,
Roe v Wade ,
SCOTUS ,
State and Local Government
Stay current on the healthcare enforcement issues impacting your business’ compliance strategies. In this installment of the Healthcare Enforcement Roundup, we address:
• Key areas of enforcement scrutiny in 2021,...more
4/2/2021
/ 1135 Waivers ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Orders ,
False Claims Act (FCA) ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Regulatory Oversight ,
Revocation ,
Telehealth ,
Telemedicine
As the largest corporate relief package in US history, the CARES Act likely will produce an unparalleled number of government investigations in the months and years to come. Companies that receive assistance should be...more
As healthcare providers face surging demand for services arising out of the COVID-19 pandemic, they are simultaneously dealing with related equipment, space and workforce limitations. In this environment, the US Department of...more
4/1/2020
/ Anti-Discrimination Policies ,
Best Practices ,
Business Continuity Plans ,
Coronavirus/COVID-19 ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Disability Discrimination ,
Infectious Diseases ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law
The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more
1/28/2020
/ Anti-Kickback Statute ,
Continuing Legal Education ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Healthcare Fraud ,
Hospitals ,
Investors ,
Medical Necessity ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Private Equity ,
Proposed Rules ,
Stark Law ,
Webinars
In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts...more
8/16/2019
/ Acquisitions ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Home Health Agencies ,
Mergers ,
New Guidance ,
New Rules ,
OCR ,
OIG ,
Opioid ,
Pharmaceutical Industry
Frequent regulatory and policy changes, increasing government scrutiny and private whistleblower activity pose greater risks to health care organizations more than ever before. McDermott’s Q2 Health Care Enforcement Roundup...more
7/30/2019
/ Compliance ,
Continuing Legal Education ,
Cooperation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Freedom of Religion ,
Health Care Providers ,
Home Health Agencies ,
Home Health Care ,
Hospitals ,
Opioid ,
Opt-Outs ,
Physicians ,
Stark Law ,
Statute of Limitations ,
Telemedicine ,
Webinars ,
Whistleblowers
On April 26, 2019, the US Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties (the Notice) to inform the public...more
5/10/2019
/ Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Eighth Amendment ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HITECH Act ,
OCR ,
Regulatory Agenda ,
Settlement Negotiations
Lack of a sufficient risk analysis continues to be one of the most commonly alleged violations in Office for Civil Rights (OCR) HIPAA enforcement actions, appearing in half of all OCR settlements announced in the last 12...more
With no Congressional consensus to adopt a federal data privacy and breach notification statute, states are updating and refining their already-existing laws to enact more stringent requirements for companies. Two states...more
7/21/2015
/ Breach Notification Rule ,
Credit Monitoring ,
Cybersecurity ,
Data Breach ,
Data Breach Plans ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Breach Notification Standard ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Identity Theft ,
New Legislation ,
Personally Identifiable Information ,
Policies and Procedures ,
Popular
In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission...more
12/11/2014
/ Africa ,
Anti-Spam Legislation ,
Canada ,
China ,
Cybersecurity ,
Data Protection ,
EU ,
EU Data Protection Laws ,
Federal Trade Commission (FTC) ,
Latin America ,
Legislative Agendas
The Supreme Court of the United States released a unanimous decision last week barring law enforcement from searching the mobile phones of individuals placed under arrest without first obtaining a search warrant or the...more