EMA and FDA have jointly issued guiding principles for the safe and responsible use of AI across the medicines life cycle, aiming to harmonize the path for drug developers using AI-driven programs to advance innovation that...more
The German Financial Supervisory Authority ("BaFin") has issued non-binding guidance ("Guidance") clarifying how financial institutions should manage Information and Communication Technology ("ICT") risks arising from...more
1/12/2026
/ Artificial Intelligence ,
BaFin ,
Cloud Computing ,
Cloud Service Providers (CSPs) ,
Cybersecurity ,
Data Security ,
Digital Operational Resilience Act (DORA) ,
EU ,
Financial Institutions ,
Financial Services Industry ,
Information and Communication Technology (ICT) ,
Machine Learning ,
New Guidance ,
Outsourcing ,
Regulatory Requirements ,
Risk Management ,
Third-Party Risk
On November 19, 2025, the European Commission published two "Digital Omnibus" proposals as part of a wider Digital Package: (i) a Digital Legislation Omnibus that amends and consolidates large parts of the European Union's...more
12/19/2025
/ AI Act ,
Artificial Intelligence ,
Compliance ,
Cookie Banners ,
Cookies ,
Cyber Incident Reporting ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Digital Operational Resilience Act (DORA) ,
EU ,
European Commission ,
General Data Protection Regulation (GDPR) ,
Network and Information Security Directive ,
New Legislation ,
Proposed Legislation ,
Regulatory Reform ,
Reporting Requirements
This update (No. 123 | 8 October 2025) 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...more
12/1/2025
/ Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cyber Threats ,
Cybersecurity ,
Economic Sanctions ,
ENISA ,
EU ,
European Commission ,
Export Controls ,
Foreign Policy ,
Geopolitical Risks ,
Healthcare ,
International Trade ,
National Security ,
Public Health ,
Public Health Emergency ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Russia ,
Supply Chain ,
Ukraine
Italy is the first EU Member State to enact national legislation on Artificial Intelligence ("AI"), thereby positioning itself as a frontrunner in shaping AI rule-making within the European Union....more
10/16/2025
/ AI Act ,
Artificial Intelligence ,
Data Centers ,
Data Privacy ,
Data Protection ,
EU ,
General Data Protection Regulation (GDPR) ,
Healthcare ,
Information Technology ,
Intellectual Property Protection ,
Italy ,
Machine Learning ,
New Legislation ,
Popular ,
Regulatory Reform ,
Regulatory Requirements
Artificial intelligence (“AI”) is a global subject of intense focus by governments, research institutions, investors, and corporations, ranging from start-ups to well-established industry leaders. As technology and regulatory...more
On July 9, 2025, the European Parliament's Committee on Legal Affairs ("JURI") published a study examining how generative artificial intelligence ("AI") interacts with European Union copyright law....more
8/14/2025
/ AI Act ,
Artificial Intelligence ,
Copyright ,
Court of Justice of the European Union (CJEU) ,
Data Mining ,
EU ,
Innovative Technology ,
Intellectual Property Protection ,
IP License ,
Machine Learning ,
Regulatory Reform ,
Training
The European Union's Artificial Intelligence Act ("AI Act") establishes a comprehensive, risk-based regulatory framework including provisions relating to general-purpose AI ("GPAI") models that apply as from 2 August 2025. In...more
8/6/2025
/ Artificial Intelligence ,
Copyright ,
EU ,
European Commission ,
Innovative Technology ,
Machine Learning ,
New Legislation ,
Popular ,
Regulatory Requirements ,
Risk Management ,
Transparency
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
The European Union's Artificial Intelligence Act ("AI Act"), the world's first comprehensive legal framework on AI, entered into force on August 1, 2024. The AI Act sets out staggered compliance deadlines for the various...more
The European Commission has released a new template for summarizing training data used in general-purpose artificial intelligence ("AI") models, as part of its broader AI regulatory framework....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 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
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
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
On October 3, 2023, the European Commission ("Commission") unveiled a list of 10 technology areas qualified as "critical" to the European Union's ("EU") economic security, out of which four (Semiconductors, AI, Quantum...more
10/17/2023
/ 5G Network ,
Artificial Intelligence ,
Biotechnology ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Economic Reform ,
EU ,
European Commission ,
Export Controls ,
Foreign Direct Investment ,
Foreign Investment ,
Investment Controls ,
Risk Assessment ,
Semiconductors
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
On July 21, 2023, the White House announced that seven leading technology companies—Amazon, Anthropic, Google, Inflection, Meta, Microsoft, and OpenAI—voluntarily committed to mitigating the risks posed by artificial...more
7/25/2023
/ Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Innovative Technology ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Oversight ,
Risk Mitigation
Across multiple continents and industries, artificial intelligence ("AI") is a topic of intense focus by governments, research institutions, investors, and corporations—from start-ups to well-established industry players. As...more
On September 28, 2022, the European Commission published two proposals—the Revised Product Liability Directive and the AI Liability Directive—aimed at adapting liability rules to the green and digital transition within the...more
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
On February 23, 2022, the European Commission ("Commission") published a proposal for a Data Act which aims at enhancing data access and use within the European Union ("EU")....more
2/24/2022
/ Artificial Intelligence ,
Data Collection ,
Data Privacy ,
Data-Sharing ,
EU ,
European Commission ,
Information Governance ,
International Data Transfers ,
Internet of Things ,
Personal Data ,
Personally Identifiable Information ,
Proposed Regulation ,
Regulatory Agenda ,
Small and Medium-Sized Enterprises (SMEs)
NOTE FROM THE EDITORS -
The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more
8/13/2021
/ Artificial Intelligence ,
Clinical Trials ,
Connected Items ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Digital Health ,
Health Information Technologies ,
Infectious Diseases ,
Information Blocking Rules ,
International Tax Issues ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Medicare ,
Physician Fee Schedule ,
Popular ,
Public Health Emergency ,
Telehealth ,
Vaccinations
The Development: On 21 April 2021, the European Commission ("Commission") unveiled a proposal for a "Regulation laying down harmonized rules on Artificial Intelligence" ("AI Regulation"), which sets out how AI systems and...more