News & Analysis as of

Software Final Rules

Proskauer - Regulatory & Compliance

U.S. Department of the Treasury issues final regulations implementing Executive Order 14105 Targeting Tech Investment in China

On October 28, 2024, the U.S. Department of the Treasury (Treasury) issued final regulations (“Final Rule”) implementing Executive Order 14105, which addresses investments by U.S. persons in certain identified technologies in...more

ArentFox Schiff

EPA Pumps the PFAS Brakes by Postponing the Reporting Deadline for Past PFAS Use in Consumer Products by Eight Months

ArentFox Schiff on

The US Environmental Protection Agency (EPA) has just announced an eight-month postponement of the start of a major reporting requirement for past use of per- and polyfluoroalkyl substances (PFAS) in consumer products due to...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

Venable LLP

Navigating the Future: Medicare Advantage Plan Rules on the Use of Artificial Intelligence

Venable LLP on

The use of technology in healthcare services and payment for healthcare is evolving at an unprecedented pace, reshaping how medical services are delivered, managed, and paid for. The use of artificial intelligence systems...more

Ankura

Updates to the Translation and Accessibility Standards for Required Materials and Content in the Medicare 2024 Final Rule

Ankura on

Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more

Holland & Knight LLP

Snitches Don't Get Stitches: New Rule Requires Supply Chain Disclosures

Holland & Knight LLP on

The Federal Acquisition Regulatory Council (FARC) issued a new final interim rule requiring contractors to review their supply chain to ensure no companies, products or services they are providing the federal government or...more

Foley Hoag LLP

Department of Commerce Expands Export Controls Related to Certain Life Sciences Software

Foley Hoag LLP on

Effective October 5, 2021, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released a final rule applying export controls to software (a) designed for certain nucleic acid assemblers and synthesizers...more

Fenwick & West LLP

New Controls on Biotech Software May Restrict Exports, Trigger CFIUS Filings

Fenwick & West LLP on

On October 5, 2021, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published a final rule amending the Export Administration Regulations (EAR) to include new controls on genetic editing software and...more

ArentFox Schiff

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

ArentFox Schiff on

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...more

Goodwin

Spring Cleaning: U.S. Department of Commerce Eliminates Certain Reporting Requirements for Encryption Software

Goodwin on

In a well-received “spring cleaning,” the U.S. Department of Commerce’s Bureau of Industry & Security (BIS) has decluttered the thicket of regulations governing the export of encryption software and hardware. Among the...more

McDermott Will & Emery

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

Hogan Lovells

U.S. imposes strict export controls on certain artificial intelligence software for automating the analysis of geospatial imagery

Hogan Lovells on

The U.S. Department of Commerce's Bureau of Industry and Security (BIS) published an interim final rule on 6 January 2020 imposing licensing requirements on certain artificial intelligence software specially designed to...more

Sheppard Mullin Richter & Hampton LLP

From CFIUS, With Love: The FIRRMA Regulations

The most pressing question around the new FIRRMA regulations is “Will my transaction be covered?” To provide a bit of guidance on that point, we present an illustration from our upcoming Second Edition of The CFIUS Book due...more

Bradley Arant Boult Cummings LLP

Changes to Taxation of Software to Apply Prospectively and Challenges to Eliminating Alabama's Controversial Grocery Tax - SALT...

As previously reported, in Ex parte Russell County Community Hospital, the Alabama Supreme Court announced that all software, including customized software created for a particular user, is "tangible personal property" and...more

Goodwin

Important Changes to Export Administration Regulations Affecting Software Industry

Goodwin on

On September 20, 2016, the Department of Commerce’s Bureau of Industry and Security (BIS) issued a Final Rule, revising 58 Export Classification Control Numbers (ECCNs), adding two ECCNs, and updating technical definitions in...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Expansion of Military End-Use Controls Creates Potential Pitfalls for Exporters"

On November 7, 2014, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) announced a final rule implementing controls on exports, re-exports and transfers of a variety of goods, software and technologies for...more

Skadden, Arps, Slate, Meagher & Flom LLP

"US Government Announces Reforms to Space and Satellite Systems Export Controls"

On May 13, 2014, the U.S. State Department’s Directorate of Defense Trade Controls (DDTC) and the U.S. Commerce Department’s Bureau of Industry and Security (BIS) issued interim final rules amending the U.S. export controls...more

17 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide