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
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
6/3/2025
/ Competition ,
Cyber Threats ,
Cybersecurity ,
Data Protection ,
Economic Sanctions ,
EU ,
European Commission ,
Export Controls ,
Geopolitical Risks ,
Healthcare ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Russia ,
State Aid ,
Trade Policy ,
Ukraine
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
4/7/2025
/ Competition ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Exports ,
Geopolitical Risks ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Russia ,
State Aid ,
Ukraine
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
2/12/2025
/ Competition ,
Cybersecurity ,
Data Protection ,
Economic Sanctions ,
EU ,
Export Controls ,
Geopolitical Risks ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Russia ,
State Aid ,
Ukraine
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
1/3/2025
/ Competition ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
Export Controls ,
Foreign Trade Regulations ,
Geopolitical Risks ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
11/21/2024
/ Competition ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
Export Controls ,
Foreign Trade Regulations ,
Geopolitical Risks ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
9/25/2024
/ Artificial Intelligence ,
Competition ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Geopolitical Risks ,
Joint Statements ,
Medical Devices ,
Russia ,
State Aid ,
Ukraine
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
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
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
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
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
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