This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
8/12/2024
/ Artificial Intelligence ,
Competition ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Regulatory Agenda ,
Regulatory Oversight ,
State Aid
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
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...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
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Draft Guidance ,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
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
1/15/2024
/ Competition ,
Crisis Management ,
Cybersecurity ,
Data Collection ,
Data Management ,
EU ,
European Commission ,
Export Controls ,
Foreign Subsidies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
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 regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more
In Short -
The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
11/13/2023
/ Burden of Proof ,
Damages ,
Distributors ,
EU ,
European Commission ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Proposed Regulation ,
Regulatory Agenda ,
Retail Market ,
UK
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more
10/4/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Regulatory Agenda ,
State Aid
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more
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
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats.
...more
7/21/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Emergency Response ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Medical Devices ,
State Aid
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more
6/15/2023
/ Anti-Corruption ,
Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EDPS ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
State Aid
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...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
This alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide an...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.
This COVID-19 Update...more
4/17/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
Medical Devices ,
State Aid ,
UK
This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
3/22/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
State Aid