The USPTO’s new director has singled out AI, distributed ledger technologies and diagnostics as prime areas of innovation that merit patent protection. Companies, investors and other stakeholders are closely watching how the USPTO’s active guidance may better align patent practice with the ingenuity and societal benefits these technologies represent.
Webinar: FDA Oversight of AI and Machine Learning in Medical Devices
Duane Morris will host the third session of its Wearable Webinars Series, Product Liability and IP Strategies for Wearables, on Tuesday, November 4, 2025, 12:00 p.m. to 12:30 p.m. Eastern.
Agatha Liu, Ph.D., will cover how wearables with diagnostic, monitoring or therapeutic claims fall under the FDA’s software as a medical device framework, including predetermined change control plans, good machine learning practices and real-world performance monitoring of adaptive algorithms.
The Convergence of Artificial Intelligence & Crypto
This article, authored by Duane Morris partner Agatha Liu, was originally published by the California Lawyers Association. This article has been reprinted with permission.
The nation is well positioned to further develop artificial intelligence (AI) and promote its application, while the government renews its interest in cryptocurrency (crypto) as a significant part of digital assets. Both AI application and crypto hold huge potential to advance collective prosperity, yet they are rooted in complex, disruptive technologies that pose significant challenges for policymakers. Traditionally, the two fields have followed separate trajectories, but their convergence is increasingly evident.
Webinar: Artificial Intelligence Legal Developments Impacting Employment, Privacy, Vendor and IP Decisions
Duane Morris will present a Zoom Event, Key Federal and State AI Legal Developments Impacting Employment Decisions, Privacy Rights, Vendor Management and IP Practices, on Wednesday, April 30, 2025, at 3:00 p.m. Eastern | 12:00 p.m. Pacific.
AI Suit Illustrates Challenges for Protecting Proprietary Information
Duane Morris partner Agatha Liu is quoted in the Bloomberg Law article, “Trade Secrets Law Is Awkward Fit in AI Prompt-Hacking Lawsuit,” about a medical AI company’s novel trade secrets lawsuit that illustrates the challenges artificial intelligence presents for protecting proprietary information.
Liu said hacking AI to reveal its prompts is “not a good thing, but it’s not terribly illegal.” AI developers most likely will have to stay on top of the best practices to craft their products to save them from themselves she said.
“If you want to reduce risk, you need to up the ante and make your system more resilient and context-aware,” Liu said.
FDA Draft AI Guidance Marks a New Era for Biotech, Diagnostics and Regulatory Compliance
The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take a step in that direction by raising awareness of important questions about the future of AI innovation in life sciences. For therapeutic, medical device and diagnostics companies—whether already implementing AI or just beginning to explore its potential—the message is clear: The landscape is evolving, and future success will require thoughtful consideration of compliance, patient safety and privacy protection from the earliest stages of AI adoption.
Read the full Alert on the Duane Morris LLP website.
Next up for Medtech: Being Generative in Domain-Specific Languages
Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML).
ML, at its core, learns from training datasets to identify patterns, which can then be applied to new input data to make direct inferences. For instance, if specific body scans frequently result in a particular diagnosis, ML can be used to quickly provide that diagnosis when similar scans are encountered, thus aiding in disease diagnosis.
Read the full article by Duane Morris partner Agatha H. Liu, PhD on the MD+DI website.
The Implications of Europe’s Artificial Intelligence Act
Duane Morris partner Agatha Liu spoke with Vogue Business on the implications of Europe’s AI Act on various sectors, including the fashion industry. Read the full article on the Vogue Business website.
Common Uses for AI in Beauty & Associated Risks
Kelly Bonner and Agatha Liu of Duane Morris LLP shared their insights and experience with CosmeticsDesign on the risks of incorporating AI technology into business practices, and how can beauty companies protect themselves.
While “today’s AI technology can save a fair amount of time in not only performing conventional services, but also uncovering hidden insight into consumer motivation and behavior,” Liu noted, “on the other hand, today’s AI technology generally lacks transparency and suffers from hallucination and thus still requires a considerable amount of human review.” Therefore, she recommended that “while companies are encouraged to incorporate AI technology into their offerings, they should closely monitor how it is utilized and what it produces and make adjustments or take remedial steps as appropriate.” […]
Continue reading “Common Uses for AI in Beauty & Associated Risks”
Artificial Intelligence Compliance in the Beauty Industry
Duane Morris’ Agatha Liu and Kelly Bonner were interviewed by Personal Care Insights about the challenges and opportunities beauty companies face while using AI to appeal to younger consumer demographics. Below is an excerpt of the article.
How does the competitive landscape of the beauty industry impact businesses’ use of AI technologies, especially when it comes to targeting younger consumer segments?
Bonner: The highly competitive nature of the beauty industry, with its desire to appeal to younger consumers, is certainly a key driver in beauty brands embracing AI tools to offer enhanced customer shopping experiences.
Can you provide some context about US AI regulations that the beauty industry should know? What do you expect is coming, especially considering the AI Act in the EU?
Liu: The EU AI Act imposes specific obligations on the providers and deployers of so-called high-risk AI systems, including testing, documentation, transparency and notification duties.
To read the full interview, please visit the Personal Care Insights page.