2025 was an incredibly busy year for digital health, and 2026 is likely to be no different. This edition of Vital Signs covers numerous developments, along with a look to 2026 in Industry Insights. Thank you to our Jones Day...more
2/10/2026
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicare ,
New Legislation ,
Request For Information ,
State and Local Government ,
Telehealth
On December 23, 2025, the U.S. Department of Health and Human Services ("HHS") issued a request for information ("RFI") seeking input on ways it could accelerate the adoption and use of AI as a part of clinical care,...more
2/10/2026
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emerging Technologies ,
Health Care Providers ,
Healthcare ,
Innovation ,
Payment Systems ,
Regulatory Reform ,
Regulatory Requirements ,
Request For Information ,
Research and Development
The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical decision support ("CDS") software, reflecting a pro-innovation and risk-based regulatory...more
1/28/2026
/ CDS ,
Digital Health ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Innovation ,
Medical Devices ,
Medical Software ,
New Guidance ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Wellness Programs
A new Food and Drug Administration ("FDA") pilot opens the door for digital health devices without FDA premarket authorization to be used to provide care paid under the Center for Medicare and Medicaid Innovation ("CMMI")...more
12/19/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Digital Health ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medicare ,
Pilot Programs ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of modern analytical methods to accelerate...more
12/4/2025
/ Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
New Guidance ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
With the aim of accelerating approval of biosimilars, the U.S. Food and Drug Administration ("FDA"), in its draft guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated...more
11/4/2025
/ Biosimilars ,
Clinical Trials ,
Draft Guidance ,
Efficacy Claims ,
FDA Approval ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences industry.
...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational New Drug Application (IND) ,
Judicial Review ,
Life Sciences ,
Mandamus Petitions ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Statutory Deadlines ,
Statutory Interpretation ,
Trump Administration
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
7/29/2025
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Medicare ,
New Legislation ,
One Big Beautiful Bill Act ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Trump Administration
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
6/13/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Data Collection ,
Data Management ,
Digital Health ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Value-Based Care
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
4/28/2025
/ Administrative Procedure Act ,
Appeals ,
Clinical Laboratories ,
Constitutional Challenges ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Authority
California Assembly Bill 1264 reflects continued state interest in restrictive legislation directed at the food and beverage industry and, in particular, food additives. ...more
3/31/2025
/ California ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Safety ,
Legislative Agendas ,
Proposed Legislation ,
Public Health ,
Public Schools ,
School Lunch Programs ,
State and Local Government ,
Students
Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....more
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
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
12/27/2024
/ Artificial Intelligence ,
FDA Approval ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Post-Market Approval ,
Regulatory Agenda
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
Food chemical safety is among Food and Drug Administration ("FDA") top priorities as it rolls out a new Human Foods Program, amid a flurry of federal and state legislation addressing food additive safety, resulting in a...more
The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Canada ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Supply Chain
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
5/2/2024
/ Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Orange Book ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Teva Pharmaceuticals
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more