Back to FAQs Index

Apps and SCCI 0129

a

Do health apps need to comply with DCB 0129?

Whether the application is built for a desktop system or as a mobile app, if the product can influence care delivery then DCB 0129 applies. In other words, it’s the ability for the system to impact care which determines DCB 0129 applicability not the chosen technology.There are an increasing number of organisations who will review and endorse health apps with the intention of identifying those which are high quality, safe and effective. If the functionality within the app falls within scope of DCB 0129, it is necessary to comply to demonstrate to these organisations that the product is safe.To find out whether your app needs to comply with DCB 0129, try our DCB 0129 Decision Tree.
Category: Apps and SCCI 0129
a

I’m completing a checklist which asks about DCB 0129. I’ve not heard of this before, what should I do?

Firstly, don’t panic. Organisations who evaluate and endorse health apps (including the NHS) are becoming increasingly popular and many include the need to comply with DCB 0129 in their criteria. The important thing to do is answer honestly. If you have not considered DCB 0129 when developing your product, you should be truthful about this. Many app evaluation organisations will be to help you to decide whether DCB 0129 compliance is something you need and to obtain appropriate help. Claiming to have undertaken a safety evaluation when this has not actually been done is dishonest and likely to backfire in the long term.

Category: Apps and SCCI 0129
a

If the app is only for lifestyle and wellness purposes, does DCB 0129 apply?

Strictly speaking, apps which only provide general wellness advice or monitor fitness do not need to comply. Similarly, apps which provide simple information in essentially the form of an electronic textbook are not within scope. However, if the product might influence health professionals, is used for specific medical conditions or could affect the delivery of care then it will need to comply with either DCB 0129 or the Medical Device Regulation. In practice, apps manufacturers tend to find that the moment they attempt to penetrate the NHS market, DCB 0129 is requested, either directly or via a DTAC questionnaire.

Many apps are on the borderline and in these cases, it is largely up to the manufacturer to decide after taking advice. Remember that undertaking a safety assessment will always be of benefit and adds credibility to the product. If you are in any doubt, it is better to undertake an assessment.

Category: Apps and SCCI 0129
a

My app is consumer-facing rather than supporting healthcare professionals, does it still need to comply with DCB 0129?

Maybe. Apps which are strictly for personal wellbeing and fitness purposes and are sold directly to consumers do not need to comply but there can be a thin line.

If you intend to sell your app to the NHS, it is highly likely that you will be asked to complete a DTAC questionnaire which, in turn, requires you to comply with DCB 0129. This can be the case even if the product's functionality is largely targeted at the 'wellness' rather than 'healthcare' markets. Ultimately, failing to comply could make the NHS market difficult or impossible to access.

If you are unsure about the applicability of DCB 0129 get help.

Category: Apps and SCCI 0129