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 June 20, 2024, a U.S. federal district court held, in a suit brought by Jones Day, that the Department of Health and Human Services ("HHS") had misapplied the Health Insurance Portability and Accountability Act ("HIPAA")...more
8/2/2024
/ Confidential Information ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Medical Records ,
New Guidance ,
PHI
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Draft Guidance ,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
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
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
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