Clinical Safety of the dGC Project¶
Clinical Safety of these clinical tools is of paramount importance to us at the RCPCH. We are a standard-setting organisation with an international reputation and as such clinical safety has been at the forefront of our minds throughout the development of the project.
England, Wales and Scotland compliance
Our primary focus has been on clinical safety certification and Medical Device regulatory compliance for the UK market and specifically England, because the initial work on the dGC platform was commissioned by NHSX, which (at the time of commissioning) was an England-only body. We do however recognise the need for the dGC Platform to be recognised as safe for use in other UK nations including Northern Ireland and this is our next most important priority for regulatory compliance.
Compliance for EU, US and other territories may follow, but will be subject to customer engagement in those countries or global regions. If you are an API consumer and you need the dGC platform to be certified in your region of operation, then please get in touch with us and we can discuss the requirements. Note that different growth chart references (eg WHO, CDC) are used in other countries, and we may need to commission further development of the API functions in order to support these. Adding new references is not technically difficult, but mandates significant testing and assurance processes.
Open Source, Transparency and Open Governance¶
In addition to the standard NHS clinical safety practices, a key aspect of the augmented clinical safety measures we have taken with the dGC platform is the open source codebase and completely open governance profile of the project.
Our entire codebase is open for inspection by other specialists, in a manner similar to the open peer review of academic publications which ensures high quality by enabling others to replicate our results and verify or challenge the veracity of the calculations independently. (Note that we do not in any way rely on such external validation or challenge - we have ourselves extensively internally tested the API and underlying calculations)
DCB0129 and DCB0160 Compliance¶
We comply with the requirements of DCB0129 and DCB0160, and for details you can go here to review our entire Clinical Safety Management File.
Our Hazard Logs are managed on GitHub in the open. Details of how this works are here.
The members of the Project Board, a clinical expert group who oversee and advise on the clinical aspects of the development and ongoing maintenance and operation of the dGC Platform, are listed here
The Project Board decided on all changes to the nature of Growth Charts which came into effect during the dGC project - such as the application of Gestational Age Correction throughout the chart (instead of stopping at either 1 or 2 years of age, depending on the degree of prematurity, as was previously the case), and the abolition of the use of the averaged Term reference between 37 and 42 weeks.
Digital Technology Assessment Criteria (DTAC)¶
DTAC is a UK(England)-only grouping of assessment criteria. It is relatively new, and aims to simply bring together and harmonise existing assessment criteria for digital technologies. More information is available on the NHSX website
DTAC incorporates the DCB0129 and DCB0160 standards for clinical safety, which the RCPCH dGC platform is compliant with.
More information on our DTAC compliance is here