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IP|Trend: New Era in Protection of Software by Intellectual Property Law?
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
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
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
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
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
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
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
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
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
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
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
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
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
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
• 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
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
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
• 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