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Software Public Comment

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

BakerHostetler

Cloudy with a Chance of AI: Navigating the FTC’s Regulatory Forecast

BakerHostetler on

On Nov. 16, the Federal Trade Commission (FTC) held an open meeting to discuss the FTC’s new “Voice Cloning Challenge” and present public comments on business practices of cloud computing providers in response to the FTC’s...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

Foley Hoag LLP on

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Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Fenwick & West LLP

UPDATE: Secure Software Development Attestation: A(nother) Government Requirement

Fenwick & West LLP on

As follow-on guidance to Office of Management and Budget’s (OMB) September 14, 2022 memo and the associated Executive Order on Improving the Nation’s Cybersecurity from May 2021, the Cybersecurity and Infrastructure Security...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

McDermott Will & Emery

NIST Publishes Draft Security Criteria for Consumer Software

McDermott Will & Emery on

Consumer software providers will soon have the option to label their software as compliant with National Institute of Standards and Technology (NIST) standards for software security. On November 1, 2021, NIST published its...more

ArentFox Schiff

Privacy Update: FCC Seeks Public Comment on the Current and Future Regulation of the "Internet of Things"

ArentFox Schiff on

FCC Seeks Public Comment on the Current and Future Regulation of the “Internet of Things” - The FCC is requesting public comment in a proceeding that will help determine the scope and nature of regulation of the “Internet of...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

White & Case LLP

Bureau of Industry and Security Issues First "Emerging Technology" Control on Artificial Intelligence-Based Geospatial Imagery...

White & Case LLP on

On January 6, 2020, the US Department of Commerce's Bureau of Industry and Security (BIS) issued the first "emerging technology" rule to control artificial intelligence-based software specially designed to automate the...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

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

Wilson Sonsini Goodrich & Rosati

Emerging Technologies to Be Controlled for Export: Comments Due December 19, 2018

On November 19, 2018, the U.S. Commerce Department's Bureau of Industry and Security (BIS) released its advance notice of proposed rulemaking (ANPRM) to control the export of emerging technologies. Comments on the ANPRM are...more

Skadden, Arps, Slate, Meagher & Flom LLP

US Department of Commerce Solicits Comments Regarding Emerging Technologies That Are Essential to US National Security

On November 19, 2018, the Bureau of Industry and Security, U.S. Department of Commerce (BIS) published an advance notice of proposed rulemaking (ANPRM) soliciting comments on the criteria to be used to identify emerging...more

Knobbe Martens

FDA Unveils Update to Software Precertification Program

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input....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

Knobbe Martens

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

Knobbe Martens on

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

BakerHostetler

Public Comments to USPTO’s Preliminary Examination Instructions in View of Supreme Court Decision in Alice Case

BakerHostetler on

As reported here last month, the USPTO recently issued a memorandum to the Examination Corps, entitled “Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank...more

Foley & Lardner LLP

USPTO Asks for Patent Subject Matter Eligibility Comments by July 31, 2014

Foley & Lardner LLP on

In a June 30, 2014 Federal Register notice, the USPTO requested public comments by July 31, 2014 on patent subject matter eligibility under the recent Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank...more

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