The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK today published new guidance to help manufacturers meet UK medical devices regulations and ensure that digital mental health technologies are effective, reliable and acceptably safe.
Just as technology has become a diagnostic, clinical and administrative “partner” in medical care and healthcare, it is also being increasingly used in mental health care. A variety of mental health apps, AI-powered assesssments, virtual and augmented reality programs and wearable technologies are becoming a new array of available mental health tools.
The prime directive of digital mental health technologies that diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and acceptably safe, just like any other medical device.
Many manufacturers may be unsure how medical devices regulations apply to software, which products are regulated, how they are evaluated, and what evidence is required. The new MHRA guidance explains:
- How to define and communicate the intended purpose of a digital mental health technology
- When a digital mental health technology is considered a medical device under UK law.
- How risk classification is determined, ensuring proportionate regulation for different types of technologies.
For the end users of these mental health apps, this means greater confidence in the tools they rely on.
Development
The UK MHRA Guidance was developed over the last two years to assist in the development of digital mental health technologies (DMHT) with the goal to create safe digital and software products that support mental health and wellbeing. The types of DMHTs can take many forms or approaches including: websites, internet-based platforms or applications (apps) to be used with non-medical technology, such as computers, mobile phones, fitness wearables, and virtual reality (VR) headsets, or medical technolog y, such as transcranial direct current stimulation (tDCS) headsets. They can be available as direct-to-consumer products intended for patients and the public, often accessible through app stores for free or for a fee, or used with a referral or supervision from healthcare or educational professionals, as part of the blended delivery of mental health care.
Figure 1 from the guidance illustrates some of the key steps in developing safe and effective DMHTs and emphasizes that these steps are iterative across the lifecycle of the product.
The complete MHRA Guidance is available online.
Link to New UK Guidance For Medical Device Regulation