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
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
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Draft Guidance ,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
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
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...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