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
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Draft Guidance ,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
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
9/25/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Supply Chain ,
Tracking Systems
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
Lawyer Spotlight:
Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health. This month, we highlight two lawyers who help clients...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
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
Technology -
Japan Ministries Support Expansion of E-Signature Use -
On September 4, 2020, the Japanese Ministry of Internal Affairs and Communications, the Ministry of Justice, and the Ministry of Economy, Trade and...more
11/19/2020
/ Anti-Monopoly ,
Authentication ,
Competition ,
Digital Signature Standards ,
E-Signatures ,
Electronic Communications ,
Encryption ,
Financial Markets ,
Fund Managers ,
Intellectual Property Protection ,
Japan Fair Trade Commission (JFTC) ,
Monopolization ,
Patent Infringement ,
Private Equity ,
Vendors ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
Investigations & White Collar Defense -
Amendment to Whistleblower Protection Act -
On June 8, 2020, the Japanese Diet passed a bill to amend the Whistleblower Protection Act ("Act"). The bill was introduced amid a...more
8/17/2020
/ Anti-Harassment Policies ,
Compliance ,
Copyright ,
Coronavirus/COVID-19 ,
Corporate Culture ,
Cybersecurity ,
Data Protection ,
Employer Liability Issues ,
Ethics ,
Financial Services Industry ,
FinTech ,
Foreign Direct Investment ,
Intellectual Property Protection ,
Internal Reporting ,
National Security ,
Personal Information ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
On June 15, 2020, the Japanese government implemented new regulations that designate the manufacture of pharmaceuticals for infectious diseases and the manufacture of highly-controlled medical devices (medical devices that...more
7/14/2020
/ Coronavirus/COVID-19 ,
FEFTA ,
Foreign Acquisitions ,
Foreign Direct Investment ,
Foreign Investment ,
Infectious Diseases ,
Japan ,
Life Sciences ,
National Security ,
New Regulations ,
Notification Requirements
Amendment to the Civil Code Will Come Into Effect in April -
On April 1, 2020, the Act to Partially Amend the Civil Code ("Amendment") will come into effect, with some exceptions. The Amendment will fundamentally change...more
Corporate Governance -
Companies Act Amendments to Enhance Corporate Governance - The Companies Act of Japan was amended on December 4, 2019 ("Amended Companies Act"), based on the Interim Proposal and the Outline...more
1/16/2020
/ Acquisitions ,
Companies Act ,
Controlled Foreign Corporations ,
Corporate Bonds ,
Corporate Governance ,
Executive Compensation ,
Foreign Investment ,
Intellectual Property Protection ,
Japan ,
Legislative Amendments ,
Life Sciences ,
Shareholder Meetings ,
Shareholders ,
Subsidiaries
Projects and Infrastructure -
Ministry Releases Draft Basic Policies for IR Act -
On September 4, 2019, the Ministry of Land, Infrastructure, Transport and Tourism ("MLIT") released a draft Basic Policy ("Basic...more
10/30/2019
/ Anti-Monopoly ,
Competition ,
Draft Guidance ,
Infrastructure ,
Intellectual Property Protection ,
Japan ,
Japan Fair Trade Commission (JFTC) ,
Land Developers ,
Public Comment ,
State and Local Government ,
Tax Treaty ,
Tourism
Corporate -
Japanese Government Issues M&A Guidelines -
On June 28, 2019, Japan's Ministry of Economy, Trade and Industry issued the "Fair M&A Guidelines: Enhancing Corporate Value and Protecting Shareholders'...more
Finance -
Amendment to the Payment Services Act Tightens Regulation of Crypto Assets -
The Payment Services Act ("PSA") and the Financial Instruments and Exchange Act ("FIEA") were amended on May 31, 2019...more
6/28/2019
/ BEPS ,
Cryptoassets ,
Cryptocurrency ,
Digital Assets ,
Financial Instruments and Exchange Act of Japan (FIEA) ,
Initial Coin Offering (ICOs) ,
International Tax Issues ,
Investors ,
Japan ,
New Regulations ,
OECD ,
Virtual Currency
Japanese Cabinet Submits Bill to Amend Antimonopoly Act to Diet -
On March 12, 2019, the Japanese Cabinet approved and submitted to the Diet a bill ("Bill") to amend the Act on Prohibition of Private Monopolization and...more
4/25/2019
/ Administrative Fines ,
Anti-Monopoly ,
Antitrust Violations ,
Attorney-Client Privilege ,
Criminal Investigations ,
Driverless Cars ,
Intellectual Property Protection ,
Japan ,
Japan Fair Trade Commission (JFTC) ,
Leniency Programs ,
Transportation Industry
Finance -
Cabinet Office Ordinance on Corporate Disclosure Requirements Amended -
On January 31, 2019, the Financial Services Agency of Japan published amendments to the Cabinet Office Ordinance on the Disclosure of...more
Global Disputes -
JCAA Establishes New "Interactive Arbitration Rules"
Effective January 1, 2019, the Japan Commercial Arbitration Association ("JCAA") modified the choices of rules available to the parties to an...more
3/6/2019
/ Arbitrators ,
Commercial Arbitration ,
Corporate Governance ,
Critical Infrastructure Sectors ,
Cybersecurity ,
International Arbitration ,
International Data Transfers ,
International Labor Laws ,
Japan ,
UNCITRAL ,
Water Supplies
Labor -
Amendment to Immigration Control Act Introduces New Visa Categories -
As of April 1, 2019, most provisions of the "Immigration Control and Refugee Recognition Act," which was amended in part on December 8,...more
2/4/2019
/ BEPS ,
Cybersecurity ,
Energy Sector ,
EU ,
Immigration Procedures ,
International Labor Laws ,
Japan ,
Natural Resources ,
OECD ,
Partnerships ,
Tax Reform ,
Trans-Pacific Partnership
Energy -
Proposed Revision to Japanese Renewable Energy Act Would Have Major Industry Impact -
On October 22, 2018, the Agency for Natural Resources and Energy ("Agency") published an "Overview on Draft Ministerial...more
Japan's Personal Information Protection Commission Publishes Rules for Handling Personal Data Transferred from EU to Japan -
Following the agreement between Japan and the European Union regarding personal data protection...more