DCB0129 Clinical Risk Management its Application in the Manufacture of Health IT Systems


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 – 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.


“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, 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


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