Study Cites 47.3M Uses of 'Therapy' Chatbot in Call for Medical AI Rules
Image Credit: Jacky Lee
Researchers linked to TU Dresden and Dresden University Hospital Carl Gustav Carus are urging regulators to treat some consumer AI chatbots as medically regulated tools when they provide therapy like interactions, warning that widely available systems can mimic clinicians and shape vulnerable users’ decisions without the checks required for health products.
In a letter published on Dec 5 in NPJ Digital Medicine, the authors argue that large language models used for mental health interactions are already producing behaviour that looks like therapeutic support, while operating outside medical device frameworks that would normally require evidence, safety controls and ongoing monitoring.
Why the Issue is Surfacing Now
The letter points to a simple driver: people are using general purpose chatbots for mental health counselling because access to talking therapies is constrained, with long waiting lists even in wealthy countries, while conversational AI is immediate, private and available at scale.
TU Dresden’s summary of the work adds that young people and individuals with mental health challenges can form strong emotional bonds with humanlike chatbots, and that AI character style tools remain lightly regulated in both the European Union and the United States compared with clinical therapeutic chatbots developed and approved for medical use.
Evidence Cited and Limits
The NPJ Digital Medicine letter says harms have been documented, including suicides, and it compiles examples ranging from simulated early experiments to cases described in court filings involving minors and companion style chatbots. It also notes that courts had not yet ruled in the referenced cases at the time described.
One case study highlighted in the paper involves a custom chatbot that the authors say was later removed after attracting heavy use, and that explicitly claimed clinical credentials while offering therapy like prompts to users. The paper reports more than 47.3 million uses for that bot in July 2025 prior to removal.
Separate court actions, still contested, have also put the spotlight on chatbot behaviour in crisis settings. In one recent case, OpenAI and Microsoft were sued over allegations that ChatGPT reinforced a user’s delusions before a murder suicide, claims the companies dispute.
Why Current Rules Struggle to Fit
A central argument in the letter is that medical device regulation often hinges on a manufacturer’s stated intended purpose, while real world use can drift into health advice even when firms disclaim it. The authors propose a more pragmatic test focused on whether there is widespread or dangerous use for medical purposes, and they argue regulators should adapt to the principle that the purpose of a system is what it does in practice.
The paper also discusses how system prompts and product design choices can signal intent. It cites an example where a published system prompt instructs a model to provide emotional support alongside medical or psychological information, and argues this undermines claims that such tools are not medical devices when used in mental health contexts.
How Policy is Moving in the EU, US and Australia
In Europe, the EU AI Act includes a transparency requirement for some chatbot systems to tell users they are interacting with a machine, while a staged rollout sets different obligations across 2025 to 2027 depending on risk categories and whether AI is embedded in regulated products.
In the United States, the FDA’s Digital Health Advisory Committee has separately examined how to regulate generative AI enabled digital mental health medical devices. An FDA executive summary notes the agency has authorised over 1200 AI enabled medical devices across domains but none for mental health uses, while also highlighting risks such as confabulation, bias, worsening symptoms and the need for clear pre market and post market evidence expectations.
Also in the US, the Federal Trade Commission has launched an inquiry into consumer facing companion style AI chatbots, seeking information on how companies test and monitor harms, how they monetise engagement, and what safeguards exist for children and teens.
In Australia, the Therapeutic Goods Administration says software that incorporates generative AI can be regulated as a medical device if it meets the medical device definition, and that LLMs or chatbots with a medical purpose supplied to Australians may be subject to medical device rules, with evidence requirements comparable to other medical devices based on risk.
What the Dresden Team is Recommending
Beyond calling for medical device style oversight, TU Dresden’s summary says the researchers recommend robust age verification, age specific protections and mandatory risk assessments before market entry, and it outlines a proposed safeguard concept where a separate protective agent could detect risky conversation patterns and steer users toward support resources.
The practical policy question for regulators is how far to extend medical style requirements to general purpose systems without collapsing innovation under the weight of clinical grade trials for every conversational use. The letter itself suggests a risk based, adaptive approach that prioritises the most widely accessible systems used at moments of need.
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