Navigating the complexities of DCB 0129 compliance has always been a significant challenge for digital health innovators. Whether you are launching your first NHS pilot or managing multiple healthcare customers, crafting and maintaining clinical safety documentation is time-consuming yet critical. If your product features various modules, use cases, or customisations for different buyers, assembling the necessary documentation to present to Commissioners, Trusts, and CIOs can quickly become overwhelming. Outsourcing this part of your compliance often results in additional costs every time updates are required - making it a costly task.

That's why we are excited to introduce Clinical Projects - a groundbreaking feature designed to transform how you manage DCB 0129 compliance.

What Is Clinical Projects?

Naq's new Clinical Projects feature simplifies and streamlines the DCB 0129 compliance process, making it easier for digital health innovators to achieve and maintain compliance with this clinical safety standard and for the buyers of these digital health solutions to review their compliance evidence. Here's how it works:

• Tailored Documentation: Clinical Projects allows you to generate unlimited DCB 0129 documents that are perfectly tailored to your product, scope, and NHS buyer.
• Efficient Updates: Compliance is a continuous process. With Clinical Projects, you can easily update your documentation whenever there's a significant change to your solution, ensuring that your clinical safety documentation is always current.
• Standardised Documentation: Eliminate the hassle of disjointed spreadsheets by adopting a standardised, centralised approach to managing your clinical safety documentation. This unified format not only streamlines compliance for your team but also simplifies the review process for commissioners, CIOs, and ICBs, making it faster and easier for them to assess your documentation and speeding up your solution's path to market.
• Streamlined Approval: Your Clinical Safety Officer (CSO) can log in, review, and sign off on documents quickly, streamlining the approval process. And if you need a CSO, Naq offers access to one, ensuring you're always supported by the necessary experts.
• Comprehensive Compliance Management: Manage your entire healthcare compliance programme through Naq. From GDPR and Cyber Essentials to DSPT, DTAC, DCB0129, and more, our platform allows you to handle all your compliance needs in one place, ensuring nothing slips through the cracks.

Why It Matters

The DCB 0129 standard ensures that digital health technologies and IT systems have implemented the necessary risk management measures to minimise clinical risks and safeguard patient safety. Innovators must ensure that this clinical safety documentation is regularly updated to account for new risks that may arise as their innovation develops, its use cases evolve, and is rolled out across the NHS and the wider health and social care sector.

However, updating this documentation and maintaining continuous compliance is no simple task. Many organisations outsource this work, leading to increased costs whenever updates are required - whether due to a new customer, an emerging risk, or changes to the digital health solution itself. 

For ICBs, Trusts, and CIOs, reviewing DCB 0129 documentation presents a significant challenge. They face a non-standardised system, which forces them to sift through extensive documentation in various formats. This challenge extends beyond the purchasing phase, as this documentation must be reviewed at least annually. Given the demands on CIOs, this task is often unmanageable, leading them to rely on consultants to keep the documentation current and compliant - a complex, costly, and time-consuming process for a standard that is so crucial to patient safety.

Enter Clinical Projects. By streamlining the creation of a robust clinical safety management system, Clinical Projects makes it easier than ever for innovators to update their DCB 0129 documentation and generate standardised, comprehensive clinical safety documentation tailored to each specific NHS project. It ensures continuous compliance with this essential framework, simplifying the process of updating documentation as digital health solutions develop and streamlining the approval process - allowing Clinical Safety Officers to focus on reviewing critical documentation rather than getting bogged down in administrative tasks.

For those involved in purchasing digital health solutions, Naq equips ICBs, Trusts, and CIOs with complete, comprehensive, and standardised documentation that is easy to review and seamlessly updated as needed. Naq's Clinical Projects feature offers CIOs a single, unified dashboard where they can oversee not only the clinical safety documentation of their acquired health solutions but also review their entire healthcare compliance portfolio, including DTAC, NHS DSPT, Cyber Essentials, and GDPR. This streamlined process will save both innovators and commissioners time and money, while facilitating the continuous adherence to the rigorous standards that protect patient safety.

Clinical Projects is now live and available to all our DTAC and DCB 0129 customers. Ready to see how it can revolutionise your compliance process? Book a demo with our team today and take the first step towards simplifying your DCB0129 compliance.