Digital health technologies have the potential to bring care closer to patients, reduce costs to healthcare systems and provide constant types of monitoring that are otherwise hard to come by outside of a hospital setting.
One area in which these benefits are being embraced particularly enthusiastically is mental health.
Research shows that, in the US, 19.1% of adults had an anxiety disorder and 14.5 million adults experienced a major depressive episode in the past year.
However, approximately two-thirds of adults with mental health issues were unable to access treatment.1,2
The inability to benefit from affordable and timely mental health solutions is becoming an issue as overall rates of depression and mental health disorders continue to rise globally.
Fortunately, technological innovation means that apps, wearables and AI-powered platforms are emerging as vital tools to close the treatment gap by offering more available and tailored support.
Digital mental health technologies (DMHTs) can help to manage a range of issues such as insomnia, anxiety or depression.
Their rapid growth (the global market for emerging mental health devices and platforms was valued at $3.22 billion in 2023 and is projected to reach $17.70 billion by 2031) and complexity do, however, raise urgent questions about regulation and safety, especially when large language models (LLMs) and AI are leveraged to provide diagnoses or treatment.3
Different jurisdictions are currently producing regulations and guidance to safeguard patients.
In the US, the FDA has provided guidance, such as its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, which suggests that devices will need to be evaluated on a case-by-case basis.4
The EU, by contrast, has developed a more encompassing AI Act that also covers medical devices.
Critical to businesses with a UK footprint, one such piece of guidance has been provided by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
This framework offers clarity by defining when DMHTs qualify as medical devices based on their intended purpose and functional impact.
The MHRA also importantly addresses the integration of LLMs and AI and generative models in mental health tools, making strides when it comes to tackling the regulation and classification of cutting-edge innovation.
In this new guidance, the MHRA outlines a framework to determine whether a DMHT is a medical device and should thus be regulated according to medical device standards.
The framework encompasses various elements, including design, functionality and intended use. The MHRA offers — as a starting point — the tool’s explicit claims: if a software states that it diagnoses, treats, prevents or monitors a medical condition, then it is most likely to be considered a medical device.
When it comes to functionality, the MHRA states that a DMHT with “a medical purpose but low functional impact” may not have to comply with medical device regulation as it does not provide a clinical effect or even influence patient care decisions.
In practical terms, a simple tool that tots up numbers to form a score and provides the likelihood of a result, such as a PHQ-9 Calculator, would typically be classified as low functionality.
If the patient answers a long list of AI-tailored questions, however, the tool would be highly functional. Tools that include an AI chatbot that responds adaptively based on the user’s specific queries would usually be classified as high functionality.
Finally, medical device manufacturers developing AI-powered DMHTs would do well to familiarise themselves with the MHRA’s Software and AI Change Programme Roadmap, which provides a plan of work to ensure regulatory requirements for software and AI are presented with clarity.
Keeping current with the AI and DMHT regulatory landscape is critical to the continued success of devices in their markets as regulators continue to refine their approach based on ongoing development and innovation to safeguard patients.
References
- www.nimh.nih.gov/health/statistics/major-depression.
- www.npr.org/sections/health-shots/2023/12/13/1218953789/most-americans-with-mental-health-needs-dont-get-treatment-report-finds?u.
- www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices.
- www.fda.gov/media/145022/download?attachment.
