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Software Developers Regulatory Requirements

Goodwin

Crossing Administrations: The Focus on Federal Cybersecurity Continues

Goodwin on

Federal contractors, including defense contractors, should prepare for the emergence of new requirements in the coming months that are designed to strengthen software supply chain security, impose more stringent cybersecurity...more

Sheppard Mullin Richter & Hampton LLP

Texas Considers Comprehensive AI Bill

Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”),...more

McDermott Will & Emery

New Fact Sheet Highlights ASTP’s Concerns About Certified API Practices

McDermott Will & Emery on

On October 29, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP) released a fact sheet titled “Information Blocking Reminders Related to API Technology.” The fact...more

Sheppard Mullin Richter & Hampton LLP

AI Summer Roundup: EU and Colorado Celebrate Summer with AI Legislation

As we enter the end of the summer, the AI regulatory steam is not slowing down. Colorado is now the first US state to have a comprehensive AI law (going into effect February 1, 2026), and the EU published its sweeping AI law...more

A&O Shearman

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

A&O Shearman on

Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

White & Case LLP

Newly passed Colorado AI Act will impose obligations on developers and deployers of high-risk AI systems

White & Case LLP on

The Colorado Artificial Intelligence Act will impose mounting obligations on developers and deployers of high-risk AI systems in an effort to protect consumers from discriminatory consequential decisions by such systems....more

Mayer Brown

Brazil Passes ‘Legal Framework for Games’ Legislation

Mayer Brown on

In early May, Brazil’s Law No. 14,852/2024 (the “Legal Framework for Games” or the “Framework”) was published. Originating as Bill No. 2796/2021, the legislation provides the necessary legal framework for the burgeoning...more

Fenwick & West LLP

Games Industry Trends as GDC 2024 Gets Underway

Fenwick & West LLP on

The Games Developer Conference (GDC) 2024 is upon us; here are four key legal and commercial trends we think will be especially salient this year. - Keeping AI in Check. Like so many other sectors, AI is quickly reshaping...more

Fox Rothschild LLP

Virginia Looks to Regulate Artificial Intelligence

Fox Rothschild LLP on

Virginia continues to charge ahead in the AI space, with Delegate Michelle Lopes Maldonado recently submitting a new “AI Developer Act. Here are some key points to know. Definitions- •AI is defined as “technology that...more

Sheppard Mullin Richter & Hampton LLP

White House Executive Order Ramps Up US Regulation of and Policy Toward AI

The US just catapulted into being the world leader on regulating AI. Bypassing Congress, the White house issued an Executive Order focusing on safe, secure and trustworthy AI and laying out a national policy on AI. In stark...more

Jones Day

Generative Artificial Intelligence and the Requirements of Open Source Software Licenses

Jones Day on

Recently filed litigation against Microsoft Corporation, GitHub, Inc., and various OpenAI entities ("Defendants") highlights new challenges that generative artificial intelligence ("AI") presents and risks associated with...more

Snell & Wilmer

Increasing U.S. Software Developers’ Global Competitive Advantage: Bureau of Industry and Security Eases Export Administration...

Snell & Wilmer on

Traditionally, United States software developers have struggled to compete globally due to strict export control and international trade laws. But since export control reform that began during President Obama’s...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more

McDermott Will & Emery

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Emery on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Akin Gump Strauss Hauer & Feld LLP

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

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