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
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Draft Guidance ,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
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
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 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
This regular update (no. 96 | 27 January 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
2/14/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
State Aid
This regular update (no. 94 | 19 December 2022 ) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
1/19/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
Medical Devices ,
Popular ,
State Aid
This regular update (no. 93| 1 December 2022 ) 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
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
COMPETITION & STATE AID -
State Aid-
Fit for Future Platform pursues simplification of EU law, including Opinion on State aid -
On 28 January 2022, the Fit for Future Platform, a high-level expert group to assist the...more
2/23/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
State Aid
COMPETITION & STATE AID -
State Aid -
European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI).
On 25 November 2021, the Commission published a...more
12/9/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Foreign Direct Investment ,
Infectious Diseases ,
International Trade ,
Pharmaceutical Industry ,
Popular ,
Regulatory Agenda ,
State Aid ,
Vaccinations
This regular update (no. 59 | 16 August 2021) 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
8/23/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
State Aid
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
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.
LATEST KEY DEVELOPMENTS...more
7/14/2021
/ Antitrust Provisions ,
Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
Dawn Raids ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
State Aid
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission publishes proposed Regulation on foreign subsidies distorting the internal market
• EU approves new and amended Member State measures to support the...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic
• EU approves new...more
3/17/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Personal Protective Equipment ,
Popular ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• Use of EU COVID-19 recovery funds to roll out very high capacity telecoms networks must adhere to State aid rules
• EU approves new and amended Member State measures to...more
The Situation: The health care sector is currently going through a digital transformation phase with the promise of achieving improved patient care and higher efficiency—and the implementation of cloud-based services is a...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.
LATEST KEY DEVELOPMENTS -...more
2/24/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid ,
State of Emergency
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
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• European Commission launches public consultation on fair taxation in the digital economy
• European Commission proposes to further prolong and adjust State aid...more
1/25/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Personal Protective Equipment ,
Popular ,
Relief Measures ,
State Aid ,
State of Emergency
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
• Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more
12/2/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid
This regular update (no. 24 | 13 October 2020) 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
10/22/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid
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