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Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

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The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Cozen O'Connor

OSHA Clarifies That Alternative Digital Recordkeeping is Permissible

Cozen O'Connor on

A recent standard interpretation letter dated April 29, 2025, addressed whether employers may use software-generated documents in place of the OSHA-required injury and illness recordkeeping forms, specifically Forms 300...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Update on Significant Change Process and Assessment Scope Standards

Last month, the federal government announced a major overhaul of the Federal Risk and Authorization Management Program (“FedRAMP”) called “FedRAMP 20x”. FedRAMP 20x is moving forward fast – with new authorizations, community...more

BakerHostetler

[Podcast] Making Moves: The USPTO Provides Guidance, Proposes Changes

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The U.S. Patent and Trademark Office had a busy summer in 2024. Businesses and individuals with AI and software-based inventions paid particularly close attention to the agency when, in July, it released updated guidance on...more

Orrick, Herrington & Sutcliffe LLP

EU Commission Clarifies Definition of AI Systems

The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

King & Spalding

NIST Releases Series of AI Guidelines & Software in Ongoing Response to AI Executive Order

King & Spalding on

The U.S. Department of Commerce’s National Institute of Standards and Technology (“NIST”) recently announced the publication of three AI guidelines as well as its release of a software package aimed at helping organizations...more

WilmerHale

NIST Issues New AI Risk Mitigation Guidelines and Software

WilmerHale on

On July 26, 2024, the National Institute for Standards and Technology (“NIST”), part of the Department of Commerce, released guidelines, a global engagement plan, and software covering various aspects of AI technology...more

WilmerHale

USPTO Issues Guidance Update on Subject Matter Eligibility of Artificial Intelligence

WilmerHale on

On July 17, 2024, the United States Patent and Trademark Office (USPTO) published guidance regarding the patent subject matter eligibility of claims concerning technology applicable to artificial intelligence (AI)....more

BakerHostetler

USPTO AI Examination Update Provides New Example Cases Analyzing Subject Matter Eligibility Under §101

BakerHostetler on

In a July 16 press release, The U.S. Patent and Trademark Office (USPTO) announced that it issued a guidance update on “patent subject matter eligibility to address innovation in critical emerging technologies including...more

Fitch, Even, Tabin & Flannery LLP

IP Alert: USPTO Issues Guidance for Examining Means-Plus-Function and Step-Plus-Function Claim Limitations

On March 18, the USPTO issued a guidance document on how to examine claims that recite functional limitations without necessarily using the term “means” under 35 U.S.C. § 112. The guidance document aims to improve clarity,...more

McDermott Will & Emery

CMS Issues Guidance on Usage of AI in Making Coverage Determinations

McDermott Will & Emery on

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Form I-9 Software: Avoiding Unlawful Discrimination When Selecting and Using I-9 and E-Verify Software Systems

A recent employer fact sheet from the U.S. Department of Justice (DOJ) and U.S. Department of Homeland Security (DHS) provides guidance for avoiding unlawful discrimination and other violations when using private software...more

Spilman Thomas & Battle, PLLC

Promissory Notes - Banking & Finance Insights: V 4, Issue 1, January 2024

OCC Issues Guidance on ‘Buy Now, Pay Later’ Lending - “The guidance notes that banks should maintain underwriting, repayment terms, pricing, and safeguards that minimize adverse customer outcomes and should ensure that...more

Bodman

New Patent Office Guidance Clarifies Application Requirements for Design Patent Protection of Computer-Generated Images, Icons and...

Bodman on

The U.S. Patent and Trademark Office published new guidance in the Federal Register on November 17, 2023, that clarifies the requirements for design patents of computer-generated images, icons, and graphical user interfaces. ...more

Sheppard Mullin Richter & Hampton LLP

USPTO Guidance on Design Patents Including a Computer-Generated Electronic Image

The USPTO has prepared soon to be published supplemental guidance for design patent examination for computer-generated electronic images. This guidance relates to determining whether a design patent claim including a...more

Bradley Arant Boult Cummings LLP

Alabama Department of Revenue Panel Discusses Key Administrative Developments

As part of the annual meeting of the Alabama State Bar Tax Section held in Montgomery on August 16, representatives from the Alabama Department of Revenue (ALDOR) provided a helpful update on some key legislative and...more

Saiber LLC

EEOC Issues New Guidance on the use of Software, Algorithms, and Artificial Intelligence on Employment Selection Procedures

Saiber LLC on

The new technical assistance document is focused on preventing discrimination against job applicants and employees with respect to employment decisions made with the assistance of automated systems - By now, most people...more

King & Spalding

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

King & Spalding on

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more

Sheppard Mullin Richter & Hampton LLP

EEOC Issues Guidance Regarding How Employer Software and Artificial Intelligence May Discriminate Against Individuals With...

On May 12, 2022, the Equal Employment Opportunity Commission (“EEOC”) issued guidance addressing the application of the Americans with Disabilities Act (“ADA”) to employers utilizing software, algorithms, and artificial...more

Mintz - Employment Viewpoints

EEOC Issues Guidance Addressing How the Use of Artificial Intelligence in Employment Decisions Could Violate the ADA

As employers continue to introduce a variety of software, algorithmic and artificial intelligence (“AI”) based tools into the workplace to assist and support employment-based decisions, there is an increasing concern that...more

Robinson+Cole Data Privacy + Security Insider

NIST Releases Guidance on Supply Chain Security

The National Institutes of Science and Technology (NIST) Information Technology Laboratory recently released guidance entitled “Software Supply Chain Security Guidance,” in response to directives set forth in President...more

Sheppard Mullin Richter & Hampton LLP

NIST Releases New Guidance on Software Security and Cybersecurity Consumer Labeling Programs

NIST recently released several key deliverables relating to cybersecurity. These focus on secure software development and new consumer labeling programs as contemplated by President Biden’s Executive Order 14028, which seeks...more

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