I’m currently working through the process of using our integration engine to use the MESH API, and I feel like I’m stuck in a weird limbo.
Part of the onboarding relates to Clinical Safety, and the first question is “Confirm your organisation type and standard” with the option of stating I’m either a supplier or organisation, and then providing details of conformance with either DCB0160 or DCB0129.
Because I am using an Integration Engine, but developing the components within the the Integration Engine to link in with the MESH API, it’s as if I am straddling both.
Has anyone else faced this? If so, how did you complete the onboarding questions in relation to Clinical Safety?
I do appreciate the need for ensuring conformance, however it does seem like a lot of additional overhead when attempting to use the API as a drop in replacement for using the MESH Client as a NHS Trust as opposed to a 3rd party supplier.
We went down a similar route with our integration engine. For that question, we answered ‘Provider’. Luckily our Clinical Safety Officer was on hand for most responses.
In the end we abandoned our MESH API route and fell back to installing the MESH Client on the integration engine. Time and hassle were the main reasons. Do let us know how you get on though.
Based on NHS England guidance and onboarding documentation:
DCB0129 applies to the manufacturer/developer of the Health IT system. It covers the clinical risk management activities undertaken during the design, development, testing, maintenance and modification of the software.
DCB0160 applies to the healthcare organisation deploying and using the system. It covers the assessment and management of clinical risks associated with implementing and using the system within local clinical workflows.
If an NHS Trust develops the software itself
The Trust is effectively acting in two capacities:
As the developer/manufacturer of the software
The development team should comply with DCB0129.
They should produce the relevant clinical safety documentation (for example, Clinical Safety Case Report, Hazard Log, etc.).
As the deploying healthcare organisation
The Trust should also comply with DCB0160 before deploying and using the system in clinical practice.
This includes assessing local deployment risks, operational processes, user workflows and any residual risks.
…so in this case, you would need to comply with both.
As the options in the onboarding process only allow me to select either of these options or a “none of the above” which then asks me why our solution does not meet either of these options, hopefully this could be reviewed?