News & Analysis as of

Software Comment Period

Foley Hoag LLP - Security, Privacy and the...

Deadline to Comment on Proposed Rules Impacting Infrastructure as a Service Providers Approaching

On January 29, 2024, BIS proposed a rule that would impose new requirements for U.S. providers of Infrastructure as a Service (“IaaS”) products and their foreign resellers. The proposed rule would require U.S. IaaS providers...more

Hinch Newman LLP

FTC Order Will Ban U.K.-Based Software Provider from Selling Browsing Data for Ad Purposes and Require It to Pay $16.5MM Over...

Hinch Newman LLP on

On February 24, 2024, the Federal Trade Commission announced that it will require software provider Avast to pay $16.5MM and prohibit the company from selling or licensing any web browsing data for advertising purposes to...more

Sheppard Mullin Richter & Hampton LLP

Update: CISA Seeks Additional Input from Software Providers on Security Attestation Form

The Cybersecurity and Infrastructure Security Agency (“CISA”) recently revised its Secure Software Development Attestation Common Form (after receiving over 110 comments on the initial draft), and is seeking additional...more

Holland & Knight LLP

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

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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

Paul Hastings LLP

“FAR” Reaching Consequences: Proposed FAR Cybersecurity Requirements Will Add New Obligations for Contractors

Paul Hastings LLP on

Earlier this month the Federal Acquisition Regulation (“FAR”) Council released two draft rules which would impose new cybersecurity requirements for federal contractors. The proposed rules, Cyber Threat and Incident Reporting...more

Sheppard Mullin Richter & Hampton LLP

Two New Cybersecurity Proposed Rules Mean Big Changes for Federal Contractors

On October 3, 2023, the FAR Council released two long-awaited proposed rules for federal contractor cybersecurity stemming from the Biden Administration’s Cybersecurity Executive Order from May 2021 (Executive Order 14028)....more

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

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After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Paul Hastings LLP

IRS Issues Proposed Regulations for Digital Asset Reporting

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The Internal Revenue Service and Treasury Department have issued long-awaited Proposed Regulations for parties that will be required to report transactions involving digital assets. These newly identified parties will need to...more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Goodwin on

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Barnea Jaffa Lande & Co.

How to Maintain Patient Privacy when Digitally Transferring Medical Information

Barnea Jaffa Lande & Co. on

The Israeli Privacy Protection Authority (PPA) recently published a document for public comments entitled, “Protecting Patients’ Privacy When Transferring Medical Information via Digital Devices and Undesignated Software.”...more

Wiley Rein LLP

Commerce Revises Export Rules on Entity List Companies Involved in Standard-Related Activities

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On September 9, 2022, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) published an interim final rule authorizing the release of certain U.S. technology and software in the context of standards-related...more

Wiley Rein LLP

Wireless Roundup (March 2022)

Wiley Rein LLP on

Key Wireless Deadlines- NIST Requests Comment on Staging Cybersecurity Risks for Enterprise Risk Management and Governance Oversight: The National Institute of Standards and Technology (NIST) seeks comment on Draft NISTIR...more

Wiley Rein LLP

Wireless Roundup (December 2021)

Wiley Rein LLP on

Key Wireless Deadlines- FCC Requests Comment on Implementation of PSAP Do-Not-Call Registry: The Federal Communications Commission (FCC or Commission) seeks comment on a Further Notice of Proposed Rulemaking (FNPRM) intended...more

Husch Blackwell LLP

BIS Imposes New Export Restrictions on Software for Biological Equipment

Husch Blackwell LLP on

On October 5, 2021, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) published a final rule in the Federal Register that places new controls on software and technology that can potentially be used for...more

Holland & Knight LLP

Thinking Outside the Box: Last Call for Input Regarding DoD's Evaluation and Valuation of IP

Holland & Knight LLP on

Late last year in the Holland & Knight blog post, "DOD's New IP Rules May Impact Contractors' Rights in Computer Software and Technical Data," the firm reported on new intellectual property (IP) rules proposed by the U.S....more

Husch Blackwell LLP

BIS Requests Comments On Proposed Controls For Certain Software

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Under the Export Control Reform Act of 2018 (“ECRA”), the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) is authorized to establish controls on the export, reexport or in-country transfer of “emerging...more

Goodwin

Commerce Department Proposes New Export Controls On Gene-Editing Software That Will Also Expand The Scope Of Mandatory CFIUS...

Goodwin on

On Friday, November 6, 2020, the Commerce Department’s Bureau of Industry & Security (BIS) issued a Notice of Proposed Rulemaking (NPRM) seeking public comment regarding newly-proposed controls on certain software for...more

Akin Gump Strauss Hauer & Feld LLP

BIS Publishes a Temporary Unilateral Control on a Type of Machine Learning Software for Automating Analyses of Geospatial Imagery...

Key Points - On January 6, 2020, BIS published an interim final rule to add a new worldwide (minus Canada) unilateral export control on a type of geospatial imagery software specially designed for training Deep...more

ArentFox Schiff

US Issues First Unilateral Export Control on Artificial Intelligence Software

ArentFox Schiff on

This software now requires a BIS authorization to be exported or reexported to all countries except for Canada. Companies that develop or use artificial intelligence (AI) to solve geospatial problems or in geospatial...more

Akin Gump Strauss Hauer & Feld LLP

DDTC Publishes ITAR Carve-out for Encrypted Technical Data and Software, and Further Harmonizes Definitions Common to the ITAR and...

• On December 26, 2019, DDTC published an interim final rule that would allow, under certain conditions, encrypted technical data and software that is subject to the ITAR to be sent, shipped or stored outside the United...more

McDermott Will & Emery

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

McDermott Will & Emery on

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

King & Spalding

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

King & Spalding on

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

King & Spalding

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

King & Spalding on

On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more

Hogan Lovells

FDA releases working model for Software Precertification Pilot Program

Hogan Lovells on

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more

Akin Gump Strauss Hauer & Feld LLP

DDTC and BIS Solicit Comments Regarding Controls over Explosives, Personal Protective Equipment, and Military and Intelligence...

• DDTC and BIS have published concurrent NOIs requesting public comments on the controls over the export and reexport of explosives, personal protective equipment, and military and intelligence electronics. (By volume and...more

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