One of the most common questions our clients ask us is deceptively simple: "What level of evidence do we need for regulatory approval for our AI tool?" The answer isn’t always clear…

As the use of digital tools in the mental health sector grows, so too does the need for clear and risk-proportionate regulation to ensure the safety and effectiveness of devices on the UK market. New guidance on Digital Mental Health Technologies (DMHTs), released by the MHRA in February, is a pivotal output of a 3 year collaborative project between the MHRA and NICE, funded by the Wellcome Trust.

Expertise is needed to conduct thorough due diligence in the highly regulated and evidence-based healthcare sector. Hardian covers key clinical and regulatory points when conducting DD for investors, mergers, or acquisitions of an SaMD or AIaMD company.