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
11/21/2024
/ Competition ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
Export Controls ,
Foreign Trade Regulations ,
Geopolitical Risks ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid
As the national implementation deadline for the NIS 2 EU Directive is over, businesses in scope should ensure they will soon be ready to comply with the strengthened cybersecurity requirements....more
On October 10, 2024, the EU Cyber Resilience Act ("CRA") was adopted by the Council of the European Union....more
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
CISA's proposed rules will require organizations operating in U.S. critical infrastructure sectors to report cyber incidents within 72 hours and ransom payments within 24 hours. ...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
Chinese authorities issued new regulations and guidance governing cross-border transfers of data and personal information, which will significantly reduce procedural and compliance burdens for many multinationals....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
On 22 December 2023, the Regulation on harmonized rules on fair access to and use of data ("Data Act") was published in the EU's Official Journal. The Data Act lays down rules on fair access to and use of personal and...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
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
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
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
Beginning October 12, 2023, the UK-U.S. Data Bridge will allow UK companies to transfer personal data to the United States using the new EU-U.S. Data Privacy Framework....more
10/17/2023
/ Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
EU ,
EU Data Protection Laws ,
Information Technology ,
International Data Transfers ,
Personal Data ,
Personally Identifiable Information ,
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
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