Which AI decision support tools for mental healthcare are actually on the market? A product review

Fri, 06 Dec 2024 00:00:00 +0000

Many AI tools for mental healthcare are developed and patented (see our patent review), but which of them have actually obtained regulatory approval and can be used in clinical practice? Information on regulated AI-enabled clinical decision support systems (AI-CDSS) is scattered across manufacturers’ websites, regulatory databases, and scientific articles. With this review, we wanted to make the market more transparent.

What we did

We systematically searched for regulated AI-CDSS for mental healthcare, contacted vendors for missing information, and reviewed the products’ characteristics, regulatory status, and the scientific evidence on their performance. We assessed the reporting quality of the available studies with the CONSORT-AI checklist.

What we found

Of 84 potential products, seven fulfilled the inclusion criteria.
The products fall into three areas: diagnosing autism spectrum disorder based on clinical history, behavioral, and eye-tracking data; diagnosing multiple disorders based on conversational data; and medication selection based on clinical history and genetic data.
We found only five scientific articles evaluating the devices’ performance and external validity.
On average, these articles adhered to 52% of the CONSORT-AI reporting items – modest reporting quality with clear room for improvement.

Firm entry dates, dates of published scientific evidence, and certification or clearance dates of the reviewed products. Figure 2 from Kleine et al. (2025), Artificial Intelligence in Medicine, licensed under CC BY 4.0.

What this means

Regulatory approval and scientific evaluation do not always go hand in hand. Clinicians, patients, and policymakers need transparent information about which tools are approved and how well they perform. Refining regulatory guidelines and introducing effective tracking systems for AI-CDSS could improve oversight in this fast-moving field.

Read the paper

Kleine, A.-K., Kokje, E., Hummelsberger, P., Lermer, E., Schaffernak, I., & Gaube, S. (2025). AI-enabled clinical decision support tools for mental healthcare: A product review. Artificial Intelligence in Medicine, 160, 103052. https://doi.org/10.1016/j.artmed.2024.103052

regulation on Anne-Kathrin Kleine

Which AI decision support tools for mental healthcare are actually on the market? A product review

What we did

What we found

What this means

Read the paper