New guidance issued to strengthen safety and effectiveness of digital mental health technologies
The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new guidance to ensure that digital mental health technologies are safe, effective, and reliable. As tools such as mobile applications, artificial intelligence-driven assessments, and virtual reality-based therapies become more widely used in both the NHS and private healthcare, the guidance aims to provide clarity for developers on regulatory requirements.
Rob Reid, Deputy Director of Innovative Devices at the MHRA, emphasised the growing potential of digital solutions in mental health support, stating that “effective and acceptably safe digital tools have huge potential to improve mental health support, making help more accessible than ever.” However, he also acknowledged the need for clear regulatory pathways to maintain public trust in these technologies. He explained that the guidance was developed to “support safe access to these important tools by clarifying when a product needs regulatory approval and the steps developers must take.” Ensuring transparency and consistency in regulatory standards, he added, will help to guarantee that “the public can trust these technologies and benefit from the safe, effective mental health support they can provide.”
Clarifying Regulatory Standards for Digital Mental Health Technologies
Published on 3 February 2025, the MHRA guidance sets out how medical device regulations apply to software-based mental health interventions. It provides essential information for manufacturers, detailing which products fall under regulatory oversight, how they should be assessed, and the evidence required to demonstrate their safety and efficacy.
The guidance is one of the key outputs of a three-year Wellcome-funded project launched in 2023, which explored how digital mental health products should be regulated. It was developed in collaboration with the National Institute for Health and Care Excellence (NICE), NHS specialists, researchers, healthcare professionals, and individuals with lived experience of mental health conditions. The goal, according to the MHRA, is to create a framework that balances clinical effectiveness with real-world usability, ensuring that digital mental health technologies are both accessible and safe.
Mark Chapman, Director of HealthTech at NICE, highlighted the importance of this initiative, noting that “providing more detailed guidance to the developers of digital mental health technologies helps us to ensure that technologies being considered for NICE assessments have received an appropriate level of regulatory scrutiny to assure their safety.” He stressed that, with a wide range of digital mental health products on the market, “it is important people can understand how regulations apply to different products.” The new guidance, he explained, will also help NICE refine its own evaluations: “This guidance will help inform our evaluations and ensure that NICE is able to publish useful, usable, and timely guidance that allows people with mental health conditions to access safe and effective innovations faster.”
Supporting Compliance for Market-Ready Digital Tools
The MHRA is encouraging all manufacturers of digital mental health technologies to carefully review the guidance to ensure compliance before launching their products. Regulatory approval, according to the agency, is essential not only for patient safety but also for maintaining public confidence in the effectiveness of digital mental health tools.
Professor Miranda Wolpert, Director of Mental Health at Wellcome, underlined the significance of digital solutions in addressing global mental health challenges. She pointed out that “with millions of people around the world held back by mental health problems, digital mental health therapies have huge potential to be scalable and accessible.” However, she acknowledged the difficulties in finding the right balance between ensuring safety and avoiding excessive regulation. “It is not easy to navigate between over and under regulation in this area,” she noted. Given the rapid evolution of digital mental health technologies, she described the new guidance as a practical step forward, stating that “in a fast-moving and continuously evolving digital space, these thoughtful guidelines appear well positioned to strike a pragmatic balance between making digital mental health technologies accessible to those with a range of mental health needs whilst also ensuring they are safe, effective and as transparent as possible.”
Upcoming Changes to Post-Market Surveillance Regulations
Beyond the new guidance for digital mental health technologies, the MHRA has also issued fresh regulatory directives to help manufacturers prepare for upcoming changes in post-market surveillance (PMS) regulations. These changes, set to take effect on 16 June 2025 across England, Scotland, and Wales, are intended to enhance the monitoring of medical devices after they reach the market, ensuring ongoing compliance with safety and performance standards.
As digital mental health technologies continue to play an increasingly central role in mental healthcare, the MHRA’s latest guidance represents an important step towards ensuring that individuals have access to safe, high-quality digital interventions. By clarifying regulatory expectations and reinforcing public confidence, the guidance aims to support the development of innovative, effective, and secure mental health technologies that can meet the needs of people seeking support.
