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
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more
6/6/2025
/ AI Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Comment Period ,
Digital Health ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Mobile Apps ,
Patient Access ,
Regulatory Reform ,
Telehealth ,
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 Center for Medicare and Medicaid Services ("CMS") has announced significant changes to its value-based payment model portfolio projected to save $750 million as part of a shift in the agency's refocused strategy toward...more
4/16/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Government Agencies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
Physicians ,
Regulatory Reform ,
Value-Based Care
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more
1/29/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Incentives ,
Medicare ,
Organ Transplant Centers ,
Penalties ,
Regulatory Requirements ,
Value-Based Care
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
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
7/22/2024
/ Algorithms ,
Artificial Intelligence ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Digital Health ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Personal Data ,
Pharmacies ,
Popular ,
Telemedicine
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
3/20/2024
/ Consent ,
Data Privacy ,
Data Security ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
OCR ,
Personal Information ,
Popular ,
Risk Management ,
Telehealth
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, our lawyers describe the increasingly common regulation of...more
11/27/2023
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Privacy ,
Data Security ,
DEA ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Popular ,
Public Health ,
Telehealth
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
9/25/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Supply Chain ,
Tracking Systems
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