On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more
1/14/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Prescription Drugs ,
Telehealth ,
Telemedicine ,
Time Extensions
In a recent settlement, the Texas attorney general resolved allegations that Pieces Technologies, Inc. (Pieces), a healthcare generative AI company, misrepresented the hallucination rate of its generative AI product to...more
12/4/2024
/ Artificial Intelligence ,
Compliance ,
Enforcement Actions ,
Health Care Providers ,
Healthcare Facilities ,
Misrepresentation ,
Risk Assessment ,
Risk Management ,
Settlement ,
Software ,
State Attorneys General
On April 26, 2024, almost a year after issuing a notice of proposed rulemaking to modify the Privacy Rule, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized the HIPAA Privacy Rule to...more
6/19/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Popular ,
Reproductive Healthcare Issues
On March 31, 2024, the Washington My Health My Data Act (MHMDA), a comprehensive consumer health privacy law, will come into force. Small businesses – defined as those processing consumer health data of fewer than 100,000...more
3/29/2024
/ Advertising ,
Consent ,
Consumer Privacy Rights ,
Data Privacy ,
Exemptions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Notice Requirements ,
Patient Privacy Rights ,
Personal Data ,
PHI ,
Popular ,
Small Business ,
State Privacy Laws ,
Wellness Programs
On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (HHS-OCR) revised its controversial December 2022 bulletin (the December 2022 Bulletin) regarding the use of tracking technologies by...more
3/28/2024
/ 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) ,
OCR ,
PHI ,
Tracking Systems ,
Web Tracking ,
Websites
On May 3, 2022, the New York Legislature passed legislation to regulate certain “material transactions” involving healthcare providers and others who provide administrative or management services to other healthcare...more
5/22/2023
/ Acquisitions ,
Affiliated-Business Arrangements ,
Corporate Practice of Medicine ,
Covered Transactions ,
FOIA ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Mergers ,
New Legislation ,
Notice Requirements ,
Physicians ,
State Health Departments
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
5/19/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
NPRM ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those...more
Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced...more
3/24/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more
2/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
State and Local Government ,
Telehealth ,
Telemedicine ,
Waivers
Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations.
The metaverse uses technologies such as...more
1/27/2023
/ Artificial Intelligence ,
Blockchain ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Corporate Practice of Medicine ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Licensing Rules ,
Life Sciences ,
Metaverse ,
Popular ,
Regulatory Requirements ,
Regulatory Standards ,
Telehealth ,
Telemedicine ,
Virtual Reality
The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more
11/17/2022
/ Controlled Substances Act ,
Corporate Practice of Medicine ,
DEA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Clinics ,
Informed Consent ,
Licensing Rules ,
Mental Health ,
Mental Illness ,
Prescription Drugs ,
Public Health Emergency ,
Regulatory Requirements ,
Telehealth
On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional...more
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated...more
2/23/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Medicare ,
Medicare Beneficiaries ,
Mental Health ,
Physicians ,
Public Health Emergency ,
Reimbursements ,
Telehealth ,
Telemedicine
The Department of Justice recently announced the launch of its new Civil Cyber-Fraud Initiative (the “Initiative”) which intends to use the False Claims Act to pursue “cybersecurity-related fraud by government contractors and...more
12/7/2021
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Department of Justice (DOJ) ,
Due Diligence ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Incident Response Plans ,
PHI ,
Popular ,
Privacy Laws ,
Risk Assessment
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of...more
On October 1, 2021, Nevada became the latest of a small but growing number of states extending regulatory oversight of healthcare transactions involving physician practices. Over the past decade, several states have passed or...more
10/5/2021
/ Acquisitions ,
Attorney General ,
Department of Health and Human Services (HHS) ,
Filing Requirements ,
Health Care Providers ,
Hospitals ,
Joint Venture ,
Mergers ,
Notification Requirements ,
Physicians ,
Regulatory Oversight ,
Reporting Requirements
The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more
9/13/2021
/ Artificial Intelligence ,
Business Associates ,
Business Associates Agreement (BAA) ,
Corporate Practice of Medicine ,
Data Privacy ,
Data Protection ,
Data Security ,
Disparate Impact ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Medical Malpractice ,
PHI ,
Physicians ,
Professional Liability ,
Telehealth
The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more
7/28/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Delays ,
Health Care Providers ,
Open Payments ,
Ownership Interest ,
Physician Fee Schedule ,
Physician-Owned Distributors ,
Physicians ,
Proposed Rules ,
Public Comment ,
Short-Term Loans ,
Sunshine Act ,
Teaching Hospitals
On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more
7/14/2021
/ Biden Administration ,
Biosimilars ,
Competition ,
Drug Pricing ,
Executive Orders ,
Generic Drugs ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Hospitals ,
Industry Consolidation ,
Life Sciences ,
Medical Equipment ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency
The U.S. Congress passed the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) because of “the increasing use of prescription controlled substances by adolescents and others for non-medical...more
On December 27, 2020, former President Trump signed the Consolidated Appropriations Act, 2021 (H.R. 133) (the “Consolidated Appropriations Act”), an appropriations and stimulus package that includes changes to the Public...more
On Wednesday, September 30, 2020, the Department of Justice (DOJ), along with the Federal Bureau of Investigation (FBI), Department of Health and Human Services Office of Inspector General (HHS-OIG), and the Drug Enforcement...more