The SaaS Tacks – The Ins and Outs of Negotiating SaaS Contracts
Employment and Workplace Discrimination Issues In Esports With Ruth Rauls and Lisa Koblin
Software Escrow: An enterprise resiliency tool every legal department should have in their toolbox (with Don Dennis Jr.)
Industry Implications of EO on Improving the Nation’s Cybersecurity
Humanizing AI In The Energy Industry
What’s Next?: Drones and transforming policy at GE
IP|Trend: New Era in Protection of Software by Intellectual Property Law?
On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more
The Internet of Things (IoT) represents a transformative shift in how consumers interact with technology, integrating physical devices with sophisticated services to create interconnected ecosystems. As the adoption of IoT...more
The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more
On December 15, 2023, the Cybersecurity & Infrastructure Security Agency (CISA) issued a Secure by Design Alert and guidance on “How Manufacturers Can Protect Customers by Eliminating Default Passwords.”...more
The European Commission recently proposed the EU Cyber Resilience Act, a regulation on cybersecurity requirements for products with digital elements. The proposal introduces wide-ranging technical and governance measures that...more
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more
On November 3, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance, Content of Premarket Submissions for Device Software Functions, a significant publication that has the potential to impact a variety...more
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more
Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...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
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more
In a release aptly labeled “A Starting Point for IoT Device Manufacturers” the National Institute of Standards and Technology (NIST), an arm of the Department of Commerce, recently added to the discussion with the...more
The question of categorizing high-tech companies as software industry companies arises in many due diligence inquiries. The operative meaning of this categorization suggests that the application of transaction terms set in...more
Mass manufacturing set to be next step in 3D printing, experts say - There is a sense mass production is the next big thing in 3D printing and Christoph Schell, President 3D Printing & Digital Manufacturing at HP, lent...more
The American automotive industry in no longer making your father’s Oldsmobile — not by a long shot. Today, pushed by evolving consumer behaviors, transformative technologies, and global market pressures, the automobile...more
The Situation: Whether warranties accompany software used in other products turns on many factors, including whether the designer is providing a "good" or "service," statements in advertising, representations made in sales...more
Manufacturers of wireless devices used for Internet of Things (IoT) applications should take heed of new Trump Administration proposals aimed at reducing the cybersecurity threats from botnets and other automated and...more
Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more
On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert") Pilot Program. The Pre-Cert Program is an effort by FDA to develop a new, more...more
In this episode, Hogan Lovells Partner and Chair of our Unmanned Aircraft Systems group, Lisa Ellman, speaks with Michael Fitzpatrick, head of Regulatory Advocacy at GE, about drones and other innovative technologies that are...more
On March 16, 2018, the General Services Administration (“GSA”) and the Office of Management and Budget (“OMB”) released their Phase 1 Implementation Plan (the “Plan”) for “Procurement Through E-Commerce Portals” as directed...more
The Situation: New technologies incorporating AI create questions about how product liability principles will apply and adapt. The Issue: Legislatures and courts have not addressed how product liability laws apply to new...more
On August 11, 2015, the Online Trust Alliance (OTA) released an Internet of Things (IoT) Trust Framework (“the Framework”), which presents guidelines for IoT manufacturers, developers, and retailers. The Framework was...more