IMed Consultancy releases white paper on Digital Mental Health Technologies
Charlie Blackie-Kelly | October 20, 2025 | News story | Medical Communications | Digital Mental Health Technologies, IMed Consultancy, MHRA
IMed Consultancy, a consultancy and service provider for the medical and health technology sector, has published a new white paper titled Mental Health Goes Digital: A Blueprint for Digital Health Medical Technologies (DHMTs). The paper provides guidance on the latest regulatory frameworks shaping this fast-developing area of healthcare innovation.
According to the World Health Organization (WHO), rates of mental health disorders such as anxiety, depression and insomnia are rising worldwide. The organisation estimates that nearly 4% of the global population will experience depression at some point in their lives. As these conditions become more prevalent, demand for digital mental health solutions has grown rapidly.
The whitepaper examines new guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which clarifies when digital health tools should be regulated as medical devices. This classification can significantly influence time-to-market decisions, regulatory pathways and strategies for ensuring patient safety.
It also addresses regulatory considerations for artificial intelligence (AI) and large language models (LLMs), which are increasingly embedded in medical technologies.
“Digital mental health technologies respond to an urgent need and are reshaping how care is delivered, but innovators must navigate an increasingly complex regulatory environment,” said Jonathan Ripley, managing director at IMed Consultancy. “Our new whitepaper helps companies understand the latest MHRA guidance and prepare for successful, compliant market entry.”
Charlie Blackie-Kelly
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