BIVDA have been approached by a member concerned about both DTAC and DCB0129. We are scoping the issue ahead of advocacy work.
The Digital Technology Assessment Criteria for health and social care (DTAC) aim to give NHS staff and patients confidence that the digital health tools they use meet NHS clinical safety, data protection, technical security, interoperability and usability and accessibility standards.
DCB0129 is the digital clinical health standard to allow manufacturers of health IT software evidence the clinical safety of their products. Any health organisation looking to implement a solution can request, and should be provided with, this documentation.
As these items are provided for medical devices at the point of regulation, BIVDA believe this is an unnecessary duplication and the documents may be commercially sensitive. A pragmatic step would be to removed certified IVDs from scope.
If you have been affected by this area, or you hold concerns, please contact paul.fisher@bivda.org.uk.
