The artificial intelligence startup, Humane, has introduced public orders for its standalone smart assistant, the AI Pin, designed to attach to clothing using a magnet. Co-founders Imran Chaudhri and Bethany Bongiorno, both former Apple employees, expressed that this launch signifies more than just a product introduction – it marks the commencement of a new era.
During Paris Fashion Week, the fashion community got an early glimpse of the AI Pin’s appearance, though not yet its functionality. This aligns with their vision of “forward-thinking fashion,” emphasizing that the combination of design, creativity, and technology can serve as a significant catalyst and cultural force for change.
In their autumn show, Coperni designers Sébastien Meyer and Arnaud Vaillant outfitted Naomi Campbell and other models with a prototype of the AI Pin. During the show, the models didn’t engage with the device, making it challenging to assess its functionality, and it was noted that “it was impossible to judge except on its aesthetics.” Additionally, observations were made that the pin did not contribute any discernible design element to the clothing (source: “Wearables Resurface at the Paris Shows of 3 Fashion Brands”).
What does the AI Pin do?
Humane’s demo video shows use of the AI Pin to provide nutritional advice, track health goals, purchase items from retailers, make personalised dining recommendations and listen to music, all using touch, voice, hand gestures and a “laser ink” display projected onto the palm. Access to ChatGPT is also a core feature.
In the demonstration, the founders of Humane emphasize the privacy and data security features of their product, stating, “It’s not always listening or always recording. In fact, it doesn’t do anything until you engage with it… The trust light indicates when its input, optical or audio sensors are active, ensuring full transparency and data security.”
These assertions may be in response to the prevailing public sentiment regarding AI technology and the heightened scrutiny by the US Federal Trade Commission on how companies employ AI. Recent surveys conducted by The Pew Research Center reveal that a significant majority of Americans maintain a sense of caution towards AI in general, harboring mistrust towards AI companies in terms of responsible technology use and expressing skepticism that the data collected by AI tools and devices will be used as originally intended. The FTC has explicitly stated its focus on scrutinizing uses of AI that may, whether intentionally or not, lead individuals unfairly or deceptively into detrimental decisions, especially in critical areas such as finances, health, education, housing, and employment.
Could the AI Pin be regulated as a medical device in the US?
In light of the AI Pin’s health and wellness features, it is also worth considering whether it could be subject to regulation by the US Food and Drug Administration (FDA) as a “medical device”, which is defined, with limited exceptions, to include any device that is intended to assist in the diagnosis, treatment, mitigation or cure of a disease or condition or otherwise intended to affect the structure or any function of the body. Examples of regulated personalised use devices include those intended to assist users in diagnosing insomnia or obesity, as well as those intended to help users reduce high blood pressure or reduce anxiety – all of which the FDA categorises as “disease state” conditions. Medical device manufacturers and distributors are subject to a wide range of regulatory responsibilities, including those related to labelling and advertising, reporting of adverse events, good manufacturing practices and potentially pre-market notification to the FDA, among others.
For a device like the AI Pin, which primarily focuses on providing “health and nutrition” information (at this stage), it is crucial to scrutinize which claims and features would subject the product to active regulation as a device, as opposed to those falling under the “general wellness product” category, which is exempt from active FDA regulation. General wellness products include software and hardware devices that (1) pose low risks (e.g., not implanted, invasive, or otherwise presenting safety risks) and (2) make claims related to “encouraging a healthy lifestyle” without asserting the ability to treat, diagnose, or cure a disease.
For instance, if the AI Pin’s claims are solely related to assisting users with “relaxation or stress management,” the product may not be classified as a device, whereas a claim related to anxiety would trigger regulatory scrutiny. Similarly, claims involving the tracking of exercise, promoting healthy weight management, endorsing healthy nutrition, or aiding users with sleep management are considered appropriate general wellness claims. In contrast, any express or implied claims related to conditions such as obesity, diabetes, or insomnia would fall outside the scope of general wellness.
