For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
3/11/2025
/ Certification Requirements ,
Data Protection ,
EU ,
Food and Drug Administration (FDA) ,
Health & Safety Standard ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Popular ,
Regulatory Requirements
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
11/4/2024
/ Artificial Intelligence ,
Data Privacy ,
Innovative Technology ,
Intellectual Property Protection ,
Investment Opportunities ,
Life Sciences ,
Machine Learning ,
Med Tech ,
Medical Devices ,
Open Source Software ,
Patents ,
Research and Development ,
Risk Management ,
Software ,
Technology ,
Technology Sector ,
Trade Secrets ,
USPTO
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing back to 1995....more
States are stepping in to regulate AI amid an absence of federal legislation to address fast-changing developments with the technology.
This spring, Colorado became the first state to pass a comprehensive piece of AI...more
9/13/2024
/ Artificial Intelligence ,
Complex Corporate Transactions ,
Consumer Protection Laws ,
Corporate Counsel ,
Health Care Providers ,
Insurance Industry ,
Intellectual Property Protection ,
Legislative Agendas ,
New Legislation ,
Privacy Laws ,
State Legislatures ,
Technology
On October 30, 2023, President Biden issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO establishes sweeping directives and priorities for federal...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Civil Rights Act ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Procurement Systems ,
Intellectual Property Protection ,
Legislative Agendas ,
National Security ,
NIST ,
Popular ,
Proposed Legislation ,
Public Agencies ,
Regulatory Agenda ,
Semiconductors ,
Technology Sector
The answer seems to be yes — but only when ‘authorship’ of the work can be attributed to a human.
In August 2023, the US District Court for the District of Columbia ruled that an AI-generated work “absent any guiding human...more
10/4/2023
/ Artificial Intelligence ,
Artistic Works ,
Artists ,
Authors ,
Authorship ,
Copyright ,
Copyright Office ,
Copyright Registration ,
Intellectual Property Protection ,
Machine Learning ,
Multi-Factor Test
On August 18, 2023, the US District Court for the District of Columbia (the Court) ruled in Thaler v. Register of Copyrights that an AI-generated work “absent any guiding human hand” is not protected by copyright, explaining...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for...more
5/26/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Information Blocking Rules ,
Intellectual Property Protection ,
Med Tech ,
Medical Devices ,
Patent-Eligible Subject Matter ,
Popular ,
Safe Harbors ,
Software
Users probably own the outputs from GenAI tools but it is unlikely that they will be able to prevent others from copying them with patent or copyright protection....more
Artificial intelligence (AI) has revolutionized many technology areas. As a few examples, it has already been instrumental in improving and enabling voice recognition algorithms, digital assistants, advertisement...more
2/26/2021
/ Artificial Intelligence ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
Machine Learning ,
Open Source Software ,
Patent Applications ,
Patents ,
Popular ,
Research and Development ,
Software Patents ,
Technology Sector ,
USPTO