# safehand.co.uk > AI-optimized mirror of safehand.co.uk containing 50 pages totalling 13,967 words of clean markdown content, structured data, and semantic HTML. Original source: https://safehand.co.uk/. Last updated: 2026-06-14T01:04:41.313Z. Each page is available as HTML (with JSON-LD structured data) and Markdown (text-only, ideal for LLMs and RAG). ## Homepage - [Regulatory consultancy, compliance & training for health IT manufacturers and healthcare organisations](/content/site-root.html): Safehand - Helping organisations to comply with DCB 0129 and DCB 0160 - the UK mandatory safety standards in health IT. (1,842 words) ## Articles & Blog Posts - [Review of the DCB 0129/0160 Standards - Part 3](/content/2025/01/24/review-of-the-dcb-0129-0160-standards-part-3/index.html): In our continuing analysis of the current DCB 0129/0160 standards in anticipation of the forthcoming review, we’ve got another couple of points to raise for discussion. In this case, we’re going to focus on governance. The current DCB 0129 and 0160 standards note a couple of requirements with regards what… (564 words) - [Blog](/content/blog/index.html): Safehand Blog - The world's only blog dedicated to managing clinical risk in health IT and DCB 0129/0160 compliance. (666 words) - [Safehand Case Study - OneLondon](/content/safehand-case-study-onelondon/index.html): Safehand Consulting worked with six mental health Trusts via the OneLondon eMHA programme to ensure that this new approach was compliant with DCB 0160. (1,151 words) - [Review of the DCB 0129/0160 Standards - Part 5](/content/2025/01/31/review-of-the-dcb-0129-0160-standards-part-5/index.html): In our continuing series where we critique the DCB 0129/0160 ahead of the proposed revision, we turn now to the subject of incident management. The DCB 0129 and 0160 standards both have requirements for addressing what is loosely referred to as ‘safety concerns’ and ‘safety incidents’. It’s here in particular… (584 words) - [ufaqs/app-lifestyle-wellness-purposes-scci-0129-apply/index.html](/content/ufaqs/app-lifestyle-wellness-purposes-scci-0129-apply/index.html) (1 words) - [ufaqs/whats-involved-becoming-compliant-standards/index.html](/content/ufaqs/whats-involved-becoming-compliant-standards/index.html) (1 words) - [Safehand Assured Library](/content/safehand-assured-library/index.html): Introducing the Safehand Assured Library - a single point of reference showcasing manufacturers and products which have successfully completed Safehand's rigorous clinical safety assurance process. Healthcare organisations implementing these systems can be confident that they will be provided with the highest quality DCB 0129 materials, carefully crafted by the UK's… (200 words) - [Review of the DCB 0129/0160 Standards - Part 6](/content/2025/01/31/review-of-the-dcb-0129-0160-standards-part-6/index.html): In this article we continue with our review of the DCB 0129/0160 standards ahead of its potential revision in 2025. In this case, we’re going to tackle a thorny subject which would appear to create much confusion in the industry (at least by our experience of running 25+ courses a… (563 words) - [Help with DTAC](/content/services/help-with-dtac/index.html): DTAC is the Digital Technology Assessment Criteria for health and social care produced by NHS England. The document asks suppliers of health IT systems to explain how they ensure that their product is safe and secure. (316 words) - [About Us](/content/about-us/index.html): Safe in our hands Safehand offers specialist consultancy and training services to help organisations manage their digital health compliance arrangements. Our expertise enables organisations to rapidly comply with mandatory standards such as DCB 0129, DCB 0160 and the Medical Device Directive/Regulation whilst driving quality, gaining clinician engagement and improving patient… (412 words) - [When systems change but safety gets left behind: the real legacy risk](/content/2026/02/13/when-systems-change-but-safety-gets-left-behind-the-real-legacy-risk.html): It can be easy to assume that a long-standing clinical system is safe simply because it has been in use for years. It’s comforting that that ‘old-faithful’ system is still around and is considered by many to be “proven in use”. But time alone is not necessarily evidence of safe… (721 words) - [Review of the DCB 0129/0160 Standards - Part 4](/content/2025/01/24/review-of-the-dcb-0129-0160-standards-part-4/index.html): In our previous blog articles, we talked about the forthcoming revision of the DCB 0129 standard and a few nuances which, in our opinion, would benefit from a refresh. Let’s turn now to a couple of other issues, this time in relation to change management. DCB 0129 contains an important… (569 words) - [ufaqs/app-consumer-facing-rather-supporting-healthcare-professionals-still-need-comply.html](/content/ufaqs/app-consumer-facing-rather-supporting-healthcare-professionals-still-need-comply.html) (1 words) - [ufaqs/hazard-log-thing-datix-project-risk-issue-log/index.html](/content/ufaqs/hazard-log-thing-datix-project-risk-issue-log/index.html) (1 words) - [ufaqs/scci-01290160-certificate/index.html](/content/ufaqs/scci-01290160-certificate/index.html) (1 words) - [ufaqs/difference-scci-0129-scci-0160/index.html](/content/ufaqs/difference-scci-0129-scci-0160/index.html) (1 words) - [ufaqs/already-compliant-iso-27001-still-need-comply-scci-01290160.html](/content/ufaqs/already-compliant-iso-27001-still-need-comply-scci-01290160.html) (1 words) - [ufaqs/template-scci-01290160-documents/index.html](/content/ufaqs/template-scci-01290160-documents/index.html) (1 words) - [ufaqs/health-apps-need-comply-scci-0129/index.html](/content/ufaqs/health-apps-need-comply-scci-0129/index.html) (1 words) - [What documents need to be written?](/content/ufaqs/documents-need-written/index.html): The DCB 0129/0160 standards require the manufacturer/healthcare organisation to produce three project-specific documents. These are often known as the ‘deliverables’. These are as follows: Clinical Risk Management Plan – A document which sets out at the start of a project what you are going to do to assure the product.… (232 words) - [Clinical Safety Training Courses](/content/services/clinical-safety-training-courses/index.html): Clinical Risk Management training with Safehand Safehand provides NHS organisations with CPD-accredited training for Clinical Safety Officers and digital health project teams. We teach you the detailed techniques of proactive clinical risk management and / compliance. Safehand’s two-day onsite clinical safety training course will teach you how to ensure that… (1,819 words) - [SCCI 0129](/content/glossary/scci-0129-2/index.html): SCCI 0129 is one of the former names for DCB 0129. For more information see DCB 0129. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160. www.safehand.co.uk. (47 words) - [Help with DCB 0129 compliance](/content/services/help-with-dcb-0129-compliance/index.html): What is DCB 0129? DCB 0129 is a mandatory UK risk management standard and all suppliers of health IT systems must comply (see NHS England page). The majority of NHS organisations will insist that suppliers provide evidence of compliance before a health IT system is implemented. The work must be… (342 words) - [ufaqs/scci-01290160-information-governance-toolkit/index.html](/content/ufaqs/scci-01290160-information-governance-toolkit/index.html) (1 words) - [NHS Digital](/content/glossary/nhs-digital/index.html): NHS Digital – The national provider of information, data and IT systems for health and social care until October 2016. Until October 2016 NHS Digital were known as The Health And Social Care Information Centre (HSCIC). Their goal is to "Improve health and social care in England by making better use of… (100 words) - [Clinical Safety Case Report](/content/glossary/clinical-safety-case-report/index.html): Clinical Safety Case Report – One of the three documents that manufacturers and healthcare organisations are required to create when they design and implement health IT systems. The Safety Case (as it is often referred to) presents the evidence and argument which justifies the claim that a system, in a… (109 words) - [ISB 0160](/content/glossary/isb-0160/index.html): ISB 0160 is one of the former names for DCB 0160. For more information see DCB 0160. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160. www.safehand.co.uk. (47 words) - [Help with DCB 0160 compliance](/content/services/help-with-dcb-0160-compliance/index.html): What is DCB 0160? DCB 0160 is a mandatory UK risk management standard and healthcare organisations implementing IT systems must comply (see NHS England page). The work must be conducted by a clinician with a current professional registration and experience in the application of risk management to clinical domains. It… (354 words) - [ufaqs/what-is-scci-0160/index.html](/content/ufaqs/what-is-scci-0160/index.html) (1 words) - [Clinical Risk Management Plan](/content/glossary/clinical-risk-management-plan/index.html): Clinical Risk Management Plan - One of the three documents that manufacturers and healthcare organisations are required to create when they design and implement health IT systems. The document (often simply called the 'Plan') sets out the activities which a manufacturer or healthcare organisation intends to undertake in order to… (105 words) - [Is my software product a Medical Device?](/content/services/software-medical-device/index.html): Is my software product a Medical Device? As a digital health manufacturer, you need to know if your digital health product should be CE Marked for UK use. (263 words) - [DCB 0129](/content/glossary/scci-0129/index.html): DCB 0129, Clinical Risk Management: its Application in the Manufacture of Health IT Systems - A mandatory UK safety standard describing a set of assurance activities for manufacturers of health IT systems to manage clinical risk. The current version of the standard was issued by HSCIC (now NHS Digital) in 2013… (158 words) - [Hazard Register](/content/glossary/hazard-register/index.html): Hazard Register – See Hazard Log. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160. www.safehand.co.uk. (36 words) - [Independent Clinical Safety Officers from Safehand](/content/services/independent-clinical-safety-officers-from-safehand/index.html): Outsource your DCB0129 and DCB0160 compliance activities to an experienced, professional and independent Clinical Safety Officer. (285 words) - [Clinical Safety Officer](/content/glossary/clinical-safety-officer/index.html): Clinical Safety Officer (CSO) – A clinician nominated by an organisation to oversee the safety assessment of a health IT system. The presence of a CSO to govern a clinical risk management project is a requirement of DCB 0129 and DCB 0160. The CSO must hold a current registration with… (115 words) - [Accredited Clinician](/content/glossary/accredited-clinician/index.html): Accredited Clinician – An individual who has attended the NHS Digital training course on clinical risk management. Attending the course is one means of evidencing that an individual is suitably qualified and experienced to undertake activities under DCB 0129 and DCB 0160. Alternative courses exist which can also be used to evidence… (81 words) - [Health and Social Care Information Centre](/content/glossary/health-social-care-information-centre/index.html): Health and Social Care Information Centre - The national provider of information, data and IT systems for health and social care until October 2016. HSCIC have now become NHS Digital. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB… (63 words) - [Clinical Safety Consulting](/content/services/clinical-safety-consulting/index.html): At Safehand we specialise exclusively in clinical safety consultancy. Why not join the growing band of over 160 organisations who already outsource DCB0129 / DCB0160 compliance to us? The UK Health and Social Care Act (2012) requires that digital health products comply with Safety Standards DCB0129 and DCB0160. Clinical risk… (361 words) - [ISB 0129](/content/glossary/isb-0129/index.html): ISB 0129 is one of the former names for DCB 0129. For more information see DCB 0129. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160. www.safehand.co.uk. (47 words) - [Are DCB 0129/0160 mandatory?](/content/ufaqs/scci-01290160-mandatory/index.html): Yes. There has been a great deal of debate in this area for some time but NHS Digital/England have confirmed that “Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012.” According to NHS England, NHS Trusts must only procure health IT systems which comply with… (159 words) - [Clinical Risk Management System](/content/glossary/clinical-risk-management-system/index.html): Clinical Risk Management System (CRMS) – A set of policies, methods and techniques developed by an organisation to specify how clinical risk will be managed in either the manufacture or implementation of a health IT system. The definition and documentation of a CRMS is a requirement of DCB 0129 and DCB… (90 words) - [Hazard](/content/glossary/hazard/index.html): Hazard – A situation which could give rise to patient harm. For example, if a health IT system were to confuse the records belonging to two different patients, a clinician could be misled and provide inappropriate clinical care. Safehand provides expert consultancy services to manage clinical risk in health IT… (67 words) - [DCB 0160](/content/glossary/scci-0160/index.html): DCB 0160, Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems - A mandatory UK safety standard describing a set of assurance activities for healthcare organisations to manage clinical risk in the health IT systems they implement. The current version of the standard was issued by HSCIC (now… (162 words) - [Adrian Stavert-Dobson](/content/glossary/adrian-stavert-dobson/index.html): Adrian Stavert-Dobson - Managing Partner of Safehand Consulting Limited and Author of Health Information Systems: Managing Clinical Risk. LinkedIn profile. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160. www.safehand.co.uk. (50 words) - [Hazard log](/content/glossary/hazard-log/index.html): Hazard Log – One of the three documents that manufacturers and healthcare organisations are required to create when they design and implement health IT systems. The document sets out the hazard, causes, controls and impacts associated with operating a health IT system. The Hazard Log is a key component of… (132 words) - [HSCIC](/content/glossary/hscic/index.html): HSCIC – The Health and Social Care Information Centre. The national provider of information, data and IT systems for health and social care until October 2016. HSCIC have now become NHS Digital. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards… (59 words) - [SCCI 0160](/content/glossary/scci-0160-2/index.html): SCCI 0160 is one of the former names for DCB 0160. For more information see DCB 0160. Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160. www.safehand.co.uk. (47 words) - [Quick guide to DCB 0129 and DCB 0160](/content/quick-guide-to-scci-0129-and-scci-0160/index.html): Safehand's quick guide to safety standards DCB 0129 and DCB 0160. The essentials, how they affect you and what you need to do to comply. 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