The Trump Administration has not slowed down in its rollout of wide-sweeping technology policy changes with potentially significant impacts to be felt throughout the country and around the globe...more
The EU AI Act, which went into force on August 1, 2024, introduces specific rules for artificial intelligence (AI) systems, especially those deemed “high risk.”
Medtech devices, products, and services — such as...more
The new EU Artificial Intelligence Act (“AI Act”) is a risk-based framework, ranging from outright prohibitions on certain types of systems to light regulation of others. The AI Act sets out to define AI systems, their levels...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biden Administration ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Clinical Trials ,
Cybersecurity ,
Drug Pricing ,
EU ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
NIST ,
Pharmaceutical Industry ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Reform ,
Research and Development ,
Sensitive Personal Information ,
UK
Yesterday, March 13, 2024, the European Parliament approved the EU Artificial Intelligence Act (“AI Act”), a sweeping AI governance framework which presents the first comprehensive law in the world aimed at ensuring AI...more
3/15/2024
/ Artificial Intelligence ,
Compliance ,
Compliance Dates ,
Digital Services ,
EU ,
European Commission ,
European Parliament ,
Exceptions ,
General Data Protection Regulation (GDPR) ,
Machine Learning ,
Member State ,
Multinationals ,
Penalties ,
Regulatory Authority ,
Risk-Based Approaches ,
Technology
The EU Parliament’s committees for internal market and civil liberties overwhelmingly adopted the final text of the Artificial Intelligence Act (AI Act). The European Parliament will now vote on the AI Act in a formality that...more
Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more
1/17/2024
/ Artificial Intelligence ,
Authors ,
Authorship ,
Copyright ,
Copyright Infringement ,
Data Privacy ,
EU ,
General Data Protection Regulation (GDPR) ,
Innovative Technology ,
Inventors ,
Investors ,
IP License ,
Machine Learning ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Privacy Concerns ,
Regulatory Oversight ,
Software ,
Technology Sector
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
1/4/2024
/ Advertising ,
Biosimilars ,
Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Compliance ,
Draft Guidance ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicare ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Standards ,
Research and Development ,
UK
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
10/2/2023
/ Biologics ,
Clinical Trials ,
Compliance ,
Diagnostic Tests ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Public Consultations ,
Regulatory Oversight ,
Regulatory Requirements ,
UK
The European Union Artificial Intelligence Act, or EU AI Act, is expected to pass this year. It will come into force about two years after it is approved, potentially at the end of 2025 or early 2026....more
On July 10, 2023, the European Commission adopted an adequacy decision for the new EU-US Data Privacy Framework (“DPF”), the revamped transatlantic framework designed to support transfers of personal data from the EU to...more
7/19/2023
/ Adequacy Requirement ,
Binding Corporate Rules ,
Certification Requirements ,
Data Privacy ,
EU ,
Executive Orders ,
Framework Agreement ,
International Data Transfers ,
Personal Data ,
Privacy Framework ,
Standard Contractual Clauses ,
Switzerland ,
UK
On June 4, 2021, the European Commission (the “EC”) abolished the old Standard Contractual Clauses (the “Old SCCs”) and published a new more flexible set of clauses (the “New SCCs”) for companies that wish to export personal...more
On October 7, 2022, President Biden signed an Executive Order on “Enhancing Safeguards for United States Signals Intelligence Activities,” establishing new privacy safeguards and oversight mechanisms for foreign intelligence...more
10/10/2022
/ Administrative Review Board ,
Biden Administration ,
Civil Liberties ,
Court of Justice of the European Union (CJEU) ,
Data Privacy ,
EU ,
EU-US Privacy Shield ,
Executive Orders ,
Foreign Intellgence ,
International Data Transfers ,
National Intelligence Agencies ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses ,
Surveillance
On 25 March 2022, President Biden and the President of the European Commission (“EC”) von der Leyen announced that the U.S. and EU reached an agreement in principle on a new Trans-Atlantic Data Privacy framework for...more
3/30/2022
/ Court of Justice of the European Union (CJEU) ,
Data Protection ,
EU ,
EU-US Privacy Shield ,
European Commission ,
European Court of Justice (ECJ) ,
European Data Protection Board (EDPB) ,
International Data Transfers ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses