New CMS program, WISeR, will leverage third parties to screen prior authorization requests using technologically enhanced processes....more
8/7/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Medicare ,
Medicare Advantage ,
Prior Authorization ,
Regulatory Requirements ,
Technology-Assisted Review
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
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
Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
4/9/2025
/ Artificial Intelligence ,
Drug Pricing ,
Earn-Outs ,
Federal Funding ,
Foreign Aid ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Private Equity ,
Trump Administration ,
USPTO
State attorneys general ("AGs") have long had unique police powers over a variety of health care providers in their states. Recently, AGs in several states have used this authority to scrutinize consolidation and corporate...more
4/4/2025
/ Acquisition Agreements ,
Competition ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Merger Agreements ,
New Legislation ,
Private Equity ,
Quality of Care Standards ,
Regulatory Oversight ,
Regulatory Requirements ,
State Attorneys General
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
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
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
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
The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more
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
New, first-of-their-kind consumer health data privacy laws in Washington and Nevada are designed to provide state-level protections for personal health data not covered by the Health Insurance Portability and Accountability...more
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
DOJ, FTC, and HHS jointly announced the launching of a cross-government public inquiry into increasing private equity and corporate involvement in health care, the latest announcement in a string of public statements from the...more
The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more
2/19/2024
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Popular ,
Proposed Regulation ,
Public Health
The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more
1/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Popular ,
Proposed Rules ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation
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
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
Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more
8/19/2019
/ Artificial Intelligence ,
CLS Bank v Alice Corp ,
Digital Health ,
Healthcare ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Patent Applications ,
Patent-Eligible Subject Matter ,
Patents ,
Section 101 ,
Technology ,
USPTO