Colorado became the first state to adopt a comprehensive AI framework when Gov. Jared Polis signed Senate Bill 205. The law, unlike the EU AI Act, does not ban certain uses of AI. Instead, Colorado focused on accountability; the law adds guardrails designed to prevent discrimination from certain high-risk AI uses and imposes transparency
Clinical Robotics Law Journal
Focusing on legal trends and developments in clinical robotics
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Latest from Clinical Robotics Law Journal
Surgical Robot End User v. Manufacturer
When most people think about product liability lawsuits involving surgical robots, they imagine the scenario where a patient undergoes an unsuccessful operation and then sues the robot manufacturer for damages. But few envision claims against robot manufacturers for injuries sustained by healthcare providers while using surgical robots. So what would such a claim look like? …
4 Common Ways That AI Driven Medical Devices Can Fail
Artificial intelligence (“AI”) will likely drive many complex medical devices in the near future. But as with all things, AI can sometimes fail. Companies relying on AI to elevate their medical devices above the competition should be mindful of four common AI failure modes: AI functional errors, software rot, unexplained programming glitches, and the ever-present…
Is Your Artificial Intelligence a Service or a Product?
Today, major healthcare companies are investing heavily into various AI-powered devices. For example, Zimmer Biomet and the New York City-based Hospital for Special Surgery recently inked a three-year deal to create the HSS/Zimmer Biomet Innovation Center for Artificial Intelligence in Robotic Joint Replacement. “The collaboration aims to develop decision support tools—powered by data collection and…
Defeat Design Defect Claims Before They’re Filed
During product development, it’s not unusual to discover certain failure points in a surgical robot’s design. For example, certain components, like nuts or bolts or screws, may become brittle when exposed to various substances or gasses commonly found in operating rooms. Similarly, prolonged use may cause cables and wires to become overstressed. Such component degradation…
Mitigating The Risks Of Training Curriculum Modification Requests
Until they become fully autonomous, surgical robots will only be as good as their human operators. Training for all surgeons, nurses, bedside assistants, and other surgical team members is critical to ensuring optimal patient outcomes. Thus, many manufacturers ask surgical staff to undergo instruction and demonstrations on how to set up, handle, and operate their…
The Risk of Clinical Data Collection Biases In Fully Autonomous Medical Robots
Recently, an artificial intelligence-guided robot successfully performed a laparoscopic surgery to connect two ends of an intestine in four pigs, without any human intervention. And according to the researchers involved, the robot surgeon produced “significantly better” results than humans. Though such an accomplishment is astonishing and signals the inevitable rise of fully autonomous medical robots,…
Europe’s New Proposed Rules for Artificial Intelligence and Robot-Assisted Surgery
This week, the European Commission unveiled new proposed rules “aiming to turn Europe into the global hub for trustworthy” artificial intelligence. The 108-page first-of-its-kind policy outlines how companies and governments should use artificial intelligence, and sets “limits around the use of artificial intelligence in a range of activities, from self-driving cars to hiring decisions, bank…
The Haptic Feedback Revolution
What is haptic feedback? And how is it revolutionizing robot assisted surgeries? Find out in this short video.
Surgical Robots Risk Greater Legal Costs Than You May Think
It’s no secret that defending against product liability lawsuits can be costly. But surgical robot manufacturers sometimes ask me to give them hard numbers. To read the tea leaves and estimate how much they’ll have to spend to resolve such claims. Unfortunately, the answer is hard to swallow.…