--- title: Congenica assures the clinical safety of NHS genomic analysis description: Congenica clinical decision support and NGS data analysis provides a complete Clinical Risk Management Process in compliance with the DCB0129 standard image: https://blog.congenica.com/hubfs/Canva%20images/DCB0129%20Clinical%20Risk%20Management%20its%20Application%20in%20the%20Manufacture%20of%20Health%20IT%20Systems.png --- - [Our Customers and Partners](http://www.congenica.com/our-customers) - [Our Product Portfolio](http://www.congenica.com/congenica-products) - **Inherited Diseases** - [Rare Disease](http://www.congenica.com/congenica-rare-disease) - [Inherited Cancer](http://www.congenica.com/congenica-inherited-cancer) - [Prenatal Health](http://www.congenica.com/congenica-prenatal) - [Carrier Screening](http://www.congenica.com/congenica-carrier-screening) - [Neurodevelopmental Disorders](http://www.congenica.com/congenica-neuro) - **Somatic Oncology** - [Solid Tumours](http://www.congenica.com/congenica-oncology) - **Pathogen** - [Pathogen Surveillance](http://www.congenica.com/congenica-pathogen-surveillance) - [Our Services](http://www.congenica.com/congenica-services) - [Clinical Interpretation Services](http://www.congenica.com/congenica-clinical-interpretation-services) - [Professional Services](http://www.congenica.com/professional-services) - [Customer Support](http://www.congenica.com/customer-support) - [Pharma Services](http://www.congenica.com/pharma-services) - Resources - [Publications](http://www.congenica.com/publications) - [Supporting materials](http://www.congenica.com/resources) - [News](https://blog.congenica.com/) - [Events and webinars](http://www.congenica.com/events-webinars) - [About us](http://www.congenica.com) - [Leadership Team](http://www.congenica.com/leadership) - [Quality](http://www.congenica.com/quality) - [Investors](http://www.congenica.com/investors) - [People and Vacancies](http://www.congenica.com/people) - [Contact us](http://www.congenica.com/contact) Login ##### Please select your location and reference genome: [America - GRCh37](https://us-37.congenica.com/) [America - GRCh38](https://us-38.congenica.com/) [Europe, Middle East, Africa - GRCh37](https://eu-37.congenica.com/) [Europe, Middle East, Africa - GRCh38](https://eu-38.congenica.com/) [Overview](https://blog.congenica.com) [Congenica assures the clinical safety of NHS genomic analysis](https://blog.congenica.com/congenica-assures-the-clinical-safety-of-nhs-genomic-analysis) ![Congenica assures the clinical safety of NHS genomic analysis](https://blog.congenica.com/hubfs/Canva%20images/DCB0129%20Clinical%20Risk%20Management%20its%20Application%20in%20the%20Manufacture%20of%20Health%20IT%20Systems.png) News # Congenica assures the clinical safety of NHS genomic analysis 4/19/2021    |    0 min read ## **![DCB0129 Clinical Risk Management its Application in the Manufacture of Health IT Systems](https://blog.congenica.com/hs-fs/hubfs/Canva%20images/DCB0129%20Clinical%20Risk%20Management%20its%20Application%20in%20the%20Manufacture%20of%20Health%20IT%20Systems.png?width=2240&name=DCB0129%20Clinical%20Risk%20Management%20its%20Application%20in%20the%20Manufacture%20of%20Health%20IT%20Systems.png)** ## **Congenica clinical decision support software complies with required DCB0129 NHS standard for Clinical Risk Management**   The provision and deployment of digital health software and IT systems within the UK National Health Service (NHS) can deliver substantial benefits to patients through the timely provision of complete and correct information to healthcare professionals. However, failure or incorrect use of such systems have the potential to cause harm to those patients that they are intended to benefit.   To assure the clinical safety of digital health IT systems and software, health organisations within the NHS are required by the NHS Digital Data Coordination Board (DCB) to ensure that software and IT systems comply with [DCB0129](https://digital.nhs.uk/data-and-information/information-standards/information-standards-and-data-collections-including-extractions/publications-and-notifications/standards-and-collections/dcb0129-clinical-risk-management-its-application-in-the-manufacture-of-health-it-systems) – a clinical risk management standard evidencing the clinical safety of software products.   |   ***In the procurement of a Health IT System the Health Organisation MUST ensure that the Manufacturer and the Health IT System complies with DCB0129*** NHS Digital - DCB0160: Clinical Risk Management   | | --- |   At Congenica, both our company and clinical decision support software comply with the DCB0129 clinical risk management standard, helping to assure the clinical safety of NHS health IT software and enable NHS organisations to achieve compliance with their required clinical risk management standards such as [DCB0160](https://digital.nhs.uk/data-and-information/information-standards/information-standards-and-data-collections-including-extractions/publications-and-notifications/standards-and-collections/dcb0160-clinical-risk-management-its-application-in-the-deployment-and-use-of-health-it-systems).   > *“As part of Congenica’s continued commitment to patient safety and product quality, our company and software now comply with the DCB0129 standard for clinical risk management of health IT systems - a requirement for digital products in the NHS.”* > > Andrea Haworth, FRCPath > Clinical Safety Officer, Lead Clinical Scientist - Rare Disease   Congenica is a global leader in the rapid analysis and interpretation of complex genomic data and is the exclusive clinical decision support services partner for the [NHS Genomic Medicine Service](https://www.england.nhs.uk/genomics/nhs-genomic-med-service/), enabling quicker diagnosis for patients with a rare disease, rather than years of uncertainty.   Congenica provides a complete Clinical Risk Management Process in compliance with the DCB0129 standard, including: - Clinical Risk Management File, Plan and Hazard Logs - Clinical Safety Case Reports and Incident Management Log - Trained clinical risk management personnel - Clinical Safety Officer who is a qualified and experienced Clinical Scientist   Compliance with the DCB0129 standard is in line with Congenica’s long term commitment to quality through certification in locally and internationally recognised standards, such as the international standards for medical device quality management systems (ISO 13485) and information security (ISO 27001).   For more information about Congenica clinical decision support software for rapid and reliable interpretation of complex genomic data visit [www.congenica.com/platform](http://www.congenica.com/platform)   [![Discover Congenica](https://no-cache.hubspot.com/cta/default/6863388/55d21c1c-7485-4473-b32b-d95e2e94a456.png)](https://cta-redirect.hubspot.com/cta/redirect/6863388/55d21c1c-7485-4473-b32b-d95e2e94a456)   ![Congenica medical device quality Genomic Data Analysis](https://blog.congenica.com/hs-fs/hubfs/Quality%20logos.png?width=960&name=Quality%20logos.png)   --- ### Related articles ![SeqOne acquires Congenica to create a global leader in AI-powered genomic medicine](https://blog.congenica.com/hs-fs/hubfs/New%20logos/Congenica%20%26%20SeqOne%20Logo%20Without%20Tagline%20RGB.png?width=320&height=192&name=Congenica%20%26%20SeqOne%20Logo%20Without%20Tagline%20RGB.png) 9/2/2025 #### [SeqOne acquires Congenica to create a global leader in AI-powered genomic medicine](https://blog.congenica.com/seqone-acquires-congenica-to-create-a-global-leader-in-ai-powered-genomic-medicine) Strategic acquisition of UK genomics leader Congenica reinforces SeqOne market position and footprint - servicing over 160 labs in 30+ countries ![Congenica showcased in Genomics Spotlight 2024 Report](https://blog.congenica.com/hs-fs/hubfs/male%20doc%20with%20child%20and%20mum%20light%20small%20.jpg?width=320&height=192&name=male%20doc%20with%20child%20and%20mum%20light%20small%20.jpg) 11/6/2024 #### [Congenica showcased in Genomics Spotlight 2024 Report](https://blog.congenica.com/congenica-showcased-in-recently-launched-genomics-spotlight-2024-report) We are thrilled to announce that Congenica is one of the companies showcased in the recently launched Genomics Spotlight 2024 report produced by the UK Department for Business and Trade (DBT). ![Congenica Named Best Genomic Data Analysis Software Company 2024 by GHP](https://blog.congenica.com/hs-fs/hubfs/Onco%20.png?width=320&height=192&name=Onco%20.png) 6/19/2024 #### [Congenica Named Best Genomic Data Analysis Software Company 2024 by GHP](https://blog.congenica.com/congenica-named-best-genomic-data-analysis-software-company-2024-by-ghp) We are thrilled to announce that Congenica has been awarded the title of "Best Genomic Data Analysis Software Company 2024" by Global Health & Pharma Magazine.  ##### Congenica is available as a CE Marked IVD clinical decision support platform for clinical diagnostic use for inherited genetic disorders in the UK and EU, Iceland, Lichtenstein, Norway, Switzerland and Turkey. In all other countries, ensuring compliance with relevant local, national and international clinical laboratory regulations is the responsibility of the laboratory. - [Privacy Policy](http://www.congenica.com/privacy-policy) - [Cookie Policy](http://www.congenica.com/cookie-policy) Log in to Congenica ##### Please select your location and reference genome: [America - GRCh37](https://us-37.congenica.com/) [America - GRCh38](https://us-38.congenica.com/) [Europe, Middle East, Africa - GRCh37](https://eu-37.congenica.com/) [Europe, Middle East, Africa - GRCh38](https://eu-38.congenica.com/) ![CE](https://blog.congenica.com/hs-fs/hubfs/CE.png?width=80&height=80&name=CE.png) ![ISO-27001](https://blog.congenica.com/hs-fs/hubfs/ISO-27001.jpg?width=80&height=80&name=ISO-27001.jpg) ![TR-Testmark_9000030872_EN_2024_CMYK](https://blog.congenica.com/hs-fs/hubfs/2023%20website%20images/TR-Testmark_9000030872_EN_2024_CMYK.png?width=80&height=80&name=TR-Testmark_9000030872_EN_2024_CMYK.png) ![HIPAA Compliant](https://blog.congenica.com/hs-fs/hubfs/HIPAA%20Compliant.png?width=80&height=80&name=HIPAA%20Compliant.png) Copyright © 2026 Congenica Ltd. 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