Ensuring the Effectiveness of Digital Mental Health Technologies

As digital mental health tools become more widely used in healthcare, understanding the latest regulatory guidelines is essential for practice managers

CREDIT: This is an edited version of an article that originally appeared on Digital Health

Earlier this year, the Medicines and Healthcare products Regulatory Agency (MHRA) issued important new guidance aimed at ensuring the effectiveness, reliability and safety of digital mental health technologies.

These technologies, which include apps, AI-powered assessments and virtual reality therapy, are increasingly being used by individuals and the NHS to support mental health care. As these tools continue to grow in popularity, it is essential for practice managers to understand the implications of this guidance.

What’s in the New Guidance?

Published on 3rd February 2025, the guidance outlines how medical device regulations apply to software-based products. It clarifies which digital mental health technologies fall under medical device regulations, how they should be assessed and the type of evidence required to meet safety and performance standards. The guidance has been developed with input from the National Institute for Health and Care Excellence (NICE), NHS experts, researchers, healthcare professionals and individuals with lived experience. Its purpose is to address the UK’s growing mental health crisis and ensure that digital tools meet both clinical and real-world needs.

For practice managers, this guidance offers clear advice on what is required from manufacturers of digital mental health technologies. Manufacturers are encouraged to review this guidance carefully to ensure compliance before bringing their products to market, which will directly impact how these technologies are used within your practice and by your patients.

What Does This Mean for GP Practices?
As digital mental health technologies are increasingly used to support patients in managing their mental health, GP practices are likely to see a rise in their adoption. It’s crucial for practice managers to stay informed about the regulatory standards these technologies must meet.

Regulatory Changes on the Horizon
Another update for practice managers is the introduction of post-market surveillance (PMS) regulations for medical devices, set to come into force on 16th June 2025. These regulations will apply across England, Scotland and Wales and will impact all medical devices, including digital health technologies. The PMS regulations will require manufacturers to monitor the performance of their devices after they are released to ensure they continue to meet safety and effectiveness standards.

For GP practices, this means that any digital mental health tools used will be subject to ongoing monitoring, which could impact their use over time. Practice managers should ensure they are aware of how these changes might affect their practice, including understanding the potential for updates or changes to the technologies you are using.

By staying ahead of regulatory updates and embracing well-regulated digital mental health solutions, practice managers can play a crucial role in improving patient care, especially as the demand for mental health services continues to grow across the UK.