The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more
7/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Patent Quality Metrics ,
Patient Access ,
Physicians ,
Regulatory Reform ,
Trump Administration ,
Value-Based Care
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
6/4/2025
/ Artificial Intelligence ,
Clinical Trials ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
Executive Orders ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Telehealth
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the first of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding health care...more
6/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Government Agencies ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Regulatory Reform ,
Value-Based Care
The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more
While hospitals will no longer be formally considered sensitive locations under new immigration directives, health care facilities and providers maintain responsibility to protect access to patient care and confidentiality....more
1/27/2025
/ Data Privacy ,
Department of Homeland Security (DHS) ,
EMTALA ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Immigration and Customs Enforcement (ICE) ,
Immigration Enforcement ,
Patient Access ,
Patient Privacy Rights
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
12/16/2024
/ Artificial Intelligence ,
Breach Notification Rule ,
Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Data Breach ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Telehealth ,
Telemedicine
In Short -
The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more
12/1/2023
/ Anti-Kickback Statute ,
Compliance Management Systems ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Physicians ,
Stark Law
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more
9/15/2023
/ Artificial Intelligence ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
End-Users ,
EULA ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
OIG ,
Popular ,
Software ,
Telehealth
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more
Note From the Editors -
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
5/15/2023
/ Clinical Trials ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
OIG ,
Popular ,
Substance Abuse ,
Telehealth
Lawyer Spotlight:
Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health. This month, we highlight two lawyers who help clients...more
Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more
3/9/2022
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Digital Health ,
Enforcement Actions ,
Federal Taxes ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
HIPAA Breach Notification Rule ,
Income Taxes ,
Life Sciences ,
Pharmaceutical Patents ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
State Taxes ,
Telecommuting ,
Telehealth ,
Telemedicine ,
USPTO
In support of the American Telemedicine Association's Telehealth Awareness Week (September 19-25, 2021), Jones Day's Digital Health team shared key insights on various legal topics applicable to telehealth. Jones Day's...more
9/27/2021
/ Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medical Reimbursement ,
Patient Access ,
Patient Privacy Rights ,
Rate Parity Agreement ,
Relief Measures ,
Rural Health Care Program ,
Taxable Income ,
Telehealth ,
Telemedicine
The COVID-19 pandemic has raised concern among health care leaders about the preparedness of acute care systems to adapt to and manage large-scale environmental disruptions. Current physician compensation models do not align...more
The Situation: As the outbreak of the novel coronavirus disease (COVID-19) continues, telemedicine platforms are ideally situated to coordinate care and minimize exposure, while advancing access to care.
The Action:...more
The Situation: States have historically required close physician supervision of physician assistants, including, among other things, onerous chart review requirements, co-location of physicians on-site where physician...more
The Issue: On June 24, 2019, President Trump signed an executive order, which instructed the Department of Health and Human Services to publish rules requiring hospitals to publicly disclose their negotiated rates for...more
With the passage of the Eliminating Kickbacks and Recovery Act in October 2018, Congress took aim at the ongoing opioid crisis threatening communities across the U.S. This new criminal statute targets healthcare providers...more
3/25/2019
/ ACOs ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Exceptions ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse