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
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
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
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Draft Guidance ,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, 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
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
Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more
3/9/2022
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Digital Health ,
Enforcement Actions ,
Federal Taxes ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
HIPAA Breach Notification Rule ,
Income Taxes ,
Life Sciences ,
Pharmaceutical Patents ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
State Taxes ,
Telecommuting ,
Telehealth ,
Telemedicine ,
USPTO
Note from the Editors -
Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more
1/29/2021
/ Artificial Intelligence ,
Asia Pacific ,
CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emergency Use Authorization (EUA) ,
European Commission ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
HIPAA Privacy Rule ,
Machine Learning ,
Popular ,
Telehealth ,
Telemedicine
Note From the Editors -
With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
7/21/2020
/ Acquisitions ,
Buyouts ,
CARES Act ,
Coronavirus/COVID-19 ,
Digital Health ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Foreign Direct Investment ,
Global Dealmaking ,
Investors ,
Life Sciences ,
Market Participants ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Popular ,
Private Equity ,
Public Health Emergency ,
Regulatory Requirements ,
Startups ,
Telehealth ,
Telemedicine ,
Venture Capital
Top News -
FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions -
On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
1/16/2018
/ Amended Regulation ,
Animal Food ,
CGMP ,
ECHA ,
EU ,
European Food Safety Authority (EFSA) ,
Farms ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Proposed Rules ,
Public Meetings ,
REACH ,
USDA ,
Wetlands
USDA Inspector General Recommends Reform of AMS Organic Program for Imports -
The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more
11/21/2017
/ Additive Manufacturing ,
APHIS ,
Draft Guidance ,
EU ,
European Food Safety Authority (EFSA) ,
Exports ,
Federal Register ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
France ,
Grain & Feed Commoditites ,
Imports ,
Interim Final Rules (IFR) ,
Lumber Industry ,
Menu-Labeling ,
Natural Products ,
Nutrition Facts Labels ,
Organic ,
Safety Training ,
Supply Chain ,
USDA
TOP NEWS -
FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule -
On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more
9/30/2017
/ Agricultural Sector ,
APHIS ,
Bioengineering ,
Crop Insurance ,
EU ,
European Commission ,
European Food Safety Authority (EFSA) ,
Farms ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Organic ,
Pesticides ,
Product Packaging ,
Regulatory Standards ,
UK Brexit ,
USDA
On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing additional time for implementation. The rules were finalized in May 2016 and...more
7/6/2017
/ Agricultural Sector ,
APHIS ,
China ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
FSVP ,
Harmonization Rules ,
Imports ,
Menu-Labeling ,
Nutrition Facts Labels ,
Poultry Products Inspection Act (PPIA). ,
Regulatory Standards ,
Risk Assessment ,
USDA
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
6/30/2017
/ Canada ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Imports ,
Legislative Agendas ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OMB ,
Pharmacies ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more
5/19/2017
/ Amended Regulation ,
Australia ,
Dairy Farmers ,
European Commission ,
European Food Safety Authority (EFSA) ,
FDA Commissioner ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
FSVP ,
GMO ,
Italy ,
Organic ,
Pesticides ,
Senate Confirmation Hearings ,
USDA
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and was...more
FDA Amends Waivers to Sanitary Transportation Rule -
On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more
4/13/2017
/ Animal Food ,
Annual Reports ,
Chemicals ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Imports ,
National Security ,
Pesticides ,
Sanitary Food Transportation Act (SFTA)