On December 11, 2024, the French High Council for Literary and Artistic Property ("CSPLA") published a report on the implementation of the European regulation on artificial intelligence ("AI"), focusing on the transparency of...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 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
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
On September 19, 2024, California adopted the California AI Transparency Act ("SB 942") to create transparency mechanisms that allow consumers to determine whether an "image, video, or audio content, or content that is any...more
The USPTO has extended the public comment deadline in order to afford all stakeholders an opportunity to weigh in on the subject matter eligibility of AI inventions....more
9/23/2024
/ Artificial Intelligence ,
Comment Period ,
Deadlines ,
Innovative Technology ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Machine Learning ,
Patent Applications ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Public Comment ,
USPTO
The Situation: In early 2023, the U.S. Copyright Office ("Office") launched a new initiative to examine the intersection of copyright law and artificial intelligence ("AI"). Later that year, the Office issued Registration...more
The Situation: Concerns that uncertain and unpredictable patent subject matter eligibility jurisprudence thwarts U.S. economic and technological advancements are especially acute in the fast advancing AI space. Stakeholders...more
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
Following similar decisions in other countries, a Japanese court held for the first time on May 16, 2024, that an inventor in the Patent Act is limited to a natural person and does not include an artificial intelligence...more
On May 17, 2024, Colorado enacted S.B. 24-205 (the "Act"), which imposes a duty of reasonable care on developers and deployers of high-risk artificial intelligence ("AI") systems to protect consumers from risks of algorithmic...more
The USPTO is seeking public input on whether prior art must be authored by humans and how, if at all, AI-generated disclosures should be treated differently from non-AI generated disclosures....more
The USPTO's April 11, 2024, guidance clarifies how existing USPTO rules apply to the use of AI by practitioners when interacting with the USPTO....more
The Background: In response to the Biden administration's "Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence" on October 30, 2023, the U.S. Patent and Trademark Office...more
2/19/2024
/ Artificial Intelligence ,
Biden Administration ,
Executive Orders ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Joint Inventors ,
New Guidance ,
Patent Act ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Public Comment ,
USPTO
USPTO Director Katherine K. Vidal issued guidance on February 6, 2024 regarding the use of AI in drafting materials submitted to the USPTO’s administrative boards, including the PTAB. Of biggest concern in the guidance is...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
A federal district court held in Thaler v. Perlmutter that an AI-generated image, "A Recent Entrance to Paradise," cannot be copyrighted due to the lack of sufficient human contribution to its creation. Jones Day partners...more
On October 30, 2023, President Biden signed a first-of-its-kind executive order entitled, "Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence" ("AI")....more
11/1/2023
/ Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Machine Learning ,
Regulatory Reform ,
Security Standards
The United States Patent and Trademark Office, along with the U.S. Departments of State and Commerce, sought initial public comment last week on draft guidelines entitled "International Guiding Principles for Organizations...more
10/31/2023
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Copyright ,
Copyright Litigation ,
Cybersecurity ,
Intellectual Property Protection ,
Machine Learning ,
Technology ,
U.S. Commerce Department ,
USPTO
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
In Short -
The Background: Generative artificial intelligence ("GenAI") tools allow individuals to readily generate content, including works that traditionally would be copyrightable if authored by a human being, such as...more
8/31/2023
/ Artificial Intelligence ,
Authorship ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Copyright Office ,
Intellectual Property Protection ,
Inventors ,
Machine Learning ,
The Copyright Act ,
Work Made For Hire Doctrine
In Short -
The Background: The prevalence of generative artificial intelligence ("GenAI") is rapidly expanding, providing vast opportunities for efficiency and innovation, while also creating new risks....more
8/7/2023
/ Algorithms ,
Artificial Intelligence ,
Confidentiality Agreements ,
Data Privacy ,
End-Users ,
EULA ,
Innovation ,
Liability ,
License Agreements ,
Machine Learning ,
Popular
On July 21, 2023, the White House announced that seven leading technology companies—Amazon, Anthropic, Google, Inflection, Meta, Microsoft, and OpenAI—voluntarily committed to mitigating the risks posed by artificial...more
7/25/2023
/ Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Innovative Technology ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Oversight ,
Risk Mitigation
The Situation: The U.S. Supreme Court recently denied certiorari in Thaler v. Vidal, leaving intact the Federal Circuit's ruling that only human beings, and not artificial intelligence ("AI") systems, can be inventors under...more
6/23/2023
/ Algorithms ,
Artificial Intelligence ,
Denial of Certiorari ,
Intellectual Property Owner’s Association (IPO) ,
Intellectual Property Protection ,
Inventors ,
Machine Learning ,
Patent-Eligible Subject Matter ,
Patents ,
SCOTUS ,
USPTO
In Short -
The Background: In recent months, artificial intelligence ("AI") platforms have taken the world by storm, introducing new, powerful tools for generating original and useful content based on training data and user...more
6/12/2023
/ Algorithms ,
Artificial Intelligence ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Defend Trade Secrets Act (DTSA) ,
EULA ,
Machine Learning ,
Popular ,
Third-Party ,
Trade Secrets
In Short -
The Situation: Rapid advances in generative artificial intelligence ("AI") have galvanized bipartisan support for a new U.S. legal framework to regulate AI, potentially including creation of a new federal...more