Without formally recognised evidence to prove that your product has clinical safety measures in place and that you’re conducting ongoing risk management, the NHS will not grant you Clinical Authority to Release (CATR). Without a CATR your cannot be used in a clinical setting.
The Framework Genie service provides the two essential elements to undertake ongoing clinical risk management:
A trained Clinical Safety Officer (CSO).
A Clinical Risk Management System.
Your dedicated CSO will help you set up an effective Clinical Risk Management System compliant with the NHS’s standard DCB 0129. They will guide you through the risk management process by first identifying any gaps, then working with you to develop key documents to evidence your risk management, such as Hazard Logs, Safety Cases and Technical Files. The CSO will use these key inputs to evidence the NHS DCB 0129 compliance standard.
The CSO will then work with your NHS partner who will formally assess your solution and if satisfied, grant their CATR and hence enable your product to be used in a clinical setting.
Whilst this might sound like a complex task, Framework Genie has simplified the process by creating a rich archive of templates and software tools to rapidly compile the suite of documents you need to achieve and maintain compliance.
Meet our Clinical Safety Officer and learn more about our Clinical Risk Management Process.
Our Information Governance as a Service option will quickly set up an ISMS & QMS that includes the technical, physical and legal procedures and policies required for information risk management. This framework is ready to be integrated into your business.
Do you process NHS patient or customer data? If so, you’ll need evidence that you have systems and processes in place to protect the data, and remove it if requested. We can provide a Data Protection Officer, who will help you to identify and minimise risks and complete compulsory assessments, required on an ongoing basis.
Our IGaaS will help you comply with your data protection requirements.
The ability to sell your digital product into the NHS can mean success for your business. Yet selling into the NHS is a complex process.
Framework Genie is your guide along this journey. We help you identify a suitable framework, obtain the necessary compliances to achieving a fully validated and assessed product, and support you step by step to a successful listing.
If you hold personal information about your customers then, by law, you must protect it!
You may not have to hand an expert in data protection. Our IGaaS provides a DPO when, where and for as long as you need them.
If your product stores, collects or uses NHS data, then you need to complete a DTAC.
Like any journey, if you’ve not travelled it before, its always much easier and quicker with a guide. We will partner you along this process, we know how to get you there in the most efficient route, we speak the language of the NHS so that you don’t have to!
What do all these acronyms mean?
The two standards, DCB 0129 for manufacturers and DCB 0160 for deployment organisations, define how each party can recognise and address their statutory obligations under the Health and Social Care Act 2012, Section 250, and comply with recommended good practice.
NHS Digitial has provided a handy guide “Applicability of DCB 0129 and DCB 0160” for you to determine if you need to comply.