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Draft Guidance ,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
The Patent Trial and Appeal Board (PTAB) in Videndum Production Solutions, Inc. v. Rotolight Limited (IPR2023-01219), recently denied a petition for inter partes review (IPR) of a patent on a lighting system and control for...more
Recently, the Court of Appeals for the Federal Circuit reversed one and vacated another Patent Trial and Appeal Board (“PTAB”) final written decision in which the PTAB determined that Weber Inc. (“Weber”) failed to...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
On November 16, 2023, USPTO Director Kathi Vidal ordered a Delegated Rehearing Panel (“DRP”) to review whether the PTAB misapprehended or overlooked certain issues when denying challenger SynAffix B.V.’s petition for inter...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
The Federal Circuit in Sisvel International S.A. v. Sierra Wireless, Inc. (Fed. Cir. Sept. 1, 2023) (Prost, Reyna, and Stark) affirmed a PTAB decision finding anticipated and/or obvious certain claims of two patents directed...more
10/31/2023
/ Claim Construction ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Litigation Strategies ,
Patent Infringement ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Standard of Review ,
Trial Practice Guidance
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 an effort to shed light on the practice of filing multiple petitions under the America Invents Act (AIA) at the Patent Trial and Appeal Board (PTAB), the United States Patent and Trademark Office (USPTO) recently released...more
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
In Short -
The Background: The Supreme Court reviewed a Second Circuit decision holding that the Andy Warhol Foundation had impermissibly licensed a portrait of musician Prince that was created by Andy Warhol but based on...more
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
In DynaEnergetics Europe GmbH et al v. QinetiQ Limited (PGR2023-00003), the petitioner filed its petition on the last possible day in the 9-month statutory period to timely file a petition for post-grant review (PGR). The...more
In Short -
The Situation: Workforces are increasingly using generative artificial intelligence ("AI") platforms to generate diverse content ranging from marketing materials, translations, source code, and more....more
As technology and regulatory frameworks evolve, artificial intelligence ("AI") legal issues have emerged as a key topic in transactional, litigation, and regulatory compliance contexts. Jones Day partners Laurent De Muyter,...more
The U.S. Copyright Office published new guidance on the registration of works containing artificial intelligence ("AI")-generated material and announced public roundtables on the intersection of AI and copyright....more