There has been a large increase in the number of digital mental health tools on the market in recent years. However, these products present regulatory challenges such as clarity around whether they are medical devices and, if so, which risk classification they would fall under.
Wellcome has therefore provided £1.8m of funding to help improve regulatory certainty and safety in this high growth, high impact area, focussing on producing guidance for appropriate, risk-proportionate regulation of digital mental health products.
The project will review key aspects of medical device regulations to produce guidance that will support digital mental health in several significant areas. These include determining what qualifies as a medical device, the risk classification they would fall under, as well as a review of the current evidence base for these devices…
Mark Salmon, programme director for Information Services at NICE, said:
“This work is one way both organisations can simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products into the hands of the people who need them and help ease the pressure on the NHS.”
About NICE’s Evidence standards framework for digital health technologies:
As digital health technologies (DHTs) develop at an increasing pace, we’ve worked with stakeholders, system partners and thought leaders to develop standards that ensure new DHTs are clinically effective and offer value to the health and care system: the evidence standards framework (ESF).
The ESF is a set of evidence standards for a wide range of DHTs. Evaluators and decision makers in the health and care system canconsistently use to help them identify DHTs that are likely to offer benefits to users and to the health and care system. –> Learn more HERE
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