DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
1/31/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Cannabis Products ,
Clinical Trials ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
Hart-Scott-Rodino Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Marijuana ,
Marketing ,
Medical Devices ,
Medical Marijuana ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B ,
Technology Sector ,
Telehealth ,
Telemedicine
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
1/9/2025
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Technology ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
National Security ,
Public Health
On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable...more
On June 27, 2024, the U.S. Supreme Court dismissed Idaho v. United States on procedural grounds and sent the case back to the Ninth Circuit. By doing so, the Supreme Court reinstated the preliminary injunction issued by the...more
Almost 40 years after its passing, the Emergency Medical Treatment and Active Labor Act (EMTALA) remains not only a key consideration for hospitals with emergency departments, but also a significant federal enforcement...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department...more
11/8/2023
/ American Hospital Association ,
Class Action ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Privacy Laws ,
Third-Party ,
Tracking Systems ,
Web Tracking
On May 1, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced two investigations of hospitals that failed to offer necessary stabilizing care to a pregnant individual experiencing an emergency medical...more
5/17/2023
/ Abortion ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Health Care Providers ,
Hospitals ,
Investigations ,
Medicare ,
Pregnancy ,
State of Emergency
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
3/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Hospice ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Public Health Emergency ,
Reasonable Expectation of Coverage ,
Regulatory Requirements ,
Rural Health Care Providers ,
Telehealth ,
Vaccinations ,
Virus Testing ,
Waivers
The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid...more
Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third...more
Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance...more
Introduction On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic initiatives, including certain...more
1/6/2023
/ Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
New Legislation ,
Physician Medicare Reimbursements ,
Rulemaking Process ,
Telehealth
The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more
12/13/2022
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth
The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and...more
9/14/2022
/ Abortion ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
Emergency Medical Services (EMS) ,
Emergency Rooms ,
EMTALA ,
Health Care Providers ,
Hospitals ,
Reproductive Healthcare Issues