Safehand Case Study - EIDO Healthcare

As the market-leading medico-legal consent software manufacturer, EIDO Healthcare appreciates that regulatory compliance is of utmost importance. In June 2021, they contracted with Safehand Consulting Limited to guide them through the DCB 0129 Safety Standard compliance requirements.

“As a small business committed to maintaining a gold-standard approach, we recognised that outsourcing our DCB0129 clinical risk requirements was the most effective way to uphold our quality standards without overstretching our internal resources. Partnering with a specialist consulting firm gave us immediate access to deep expertise, ensured compliance with NHS requirements, and allowed our team to stay focused on delivering exceptional patient-facing solutions. It was a strategic decision that balanced rigour, efficiency, and sustainability.”
Matthew, MD of EIDO

Four years later, their clinical safety relationship with Safehand continues to go from strength to strength and is at the heart of everything they do. This journey includes some pivotal moments which have contributed to EIDO and the patients the Inform Consent Suite serves, continually reaping the benefits of embracing risk management.

Initially, EIDO worked with Safehand to harness their expertise in understanding how to navigate the risk assessment process required to achieve DCB 0129 compliance. This laid solid foundations in how to break down the software’s functionality into components, allowing Hazards and their Causes to be identified and the Controls required to organically emerge. Rather than take the project back in-house, EIDO Healthcare sought to build upon this foundation and retained Safehand’s ongoing Clinical Safety Officer (CSO) services.

Clinical Risk Management Process

Crucial to embedding a clinical safety culture, EIDO committed to documenting a robust Clinical Risk Management Process, which clearly outlines the Organisational roles and responsibilities required to ensure that clinical safety is at the heart of all development activity.

“Implementing a robust Clinical Risk Management Process has been transformative for our organisation. It has streamlined how we approach clinical safety, embedding clear processes that reduce ambiguity and accelerate decision-making. Most importantly, it’s fostered organisation-wide involvement. It has brought clinical, technical, and operational teams into alignment around shared safety goals. The result is a more proactive, transparent, and resilient approach to clinical risk that supports our gold-standard commitment.”
Matthew, MD of EIDO

Safety Incident Management Process

During the initial DCB 0129 risk assessment process, EIDO identified key ways in which the Organisation monitors for, investigates and, where required, remediates safety related issues. In collaboration with Safehand, EIDO undertook an activity to identify and document specific roles within the Organisation who are pivotal to triaging and managing all clinical safety related issues. Furthermore, the processes to follow, per role, were set out in a manner which allows the reader to appreciate lines of escalation, timeframes and communication considerations through to issue resolution.

“Establishing a detailed process for the management of clinical safety related issues allows EIDO’s staff to clearly understand their role and how their contribution positively impacts upon safety incident management. Additionally, it reiterates that clinical safety is everyone’s responsibility. A co-ordinated process ensures that patient safety remains the priority and instils confidence to customers that any concerns are taken seriously and dealt with in a professional manner.”
Natalie, CSO

Clinical Safety Training

In conjunction with clinical safety collaboration being set as a priority by EIDO’s Top Management, Safehand’s CSO noticed an increase in the number of EIDO staff who spontaneously reached out to discuss topics such as potential development ideas, collaborate on a customer specific development feature request, respond to a customer-raised clinical safety related question etc. The benefits of ‘looking through the lens of clinical risk’ culminated in EIDO’s Senior Managers, Development Teams and Customer Experience staff requesting dedicated clinical safety training, to further enhance understanding and empowerment across all roles and responsibilities. The CSO developed a bespoke clinical safety training course, which was recorded to facilitate re-use for new starter and refresher training purposes and which further embedded clinical safety as ‘everyone’s role’ with the Organisation.

“Safehand worked in tandem with EIDO Healthcare to fully understand their clinical safety training needs. It was important to EIDO that staff understood not only their own responsibilities but that of others, including Top Management’s commitment. The training was well received and showcased the positive benefits to both the Organisation and, crucially, the patients at the receiving end of the software.”
Natalie, CSO

Agenda driven monthly meetings

EIDO Healthcare sets aside protected time each month to meet with their Safehand CSO. This time is utilised to discuss clinical safety related aspects of product development and maintenance. The meetings are attended by relevant key stakeholders and follows a structured agenda. This allows the Organisation to discuss the wider development roadmap, current in-flight and imminent sprint content, including post-deployment monitoring observations. Critically, embedding clinical safety at the planning and design stage of the development lifecycle, enables any changes required to the DCB 0129 documentation to be made in a timely manner for Organisational review, approval and dissemination to customers to accompany any changes to live service functionality.

“Our monthly clinical safety meetings with Natalie have become a cornerstone of our development rhythm. They provide a structured space to review progress, address emerging risks, and ensure clinical safety remains front and centre in every decision we make. Natalie’s guidance brings clarity and momentum, helping us translate safety principles into practical actions across teams. These sessions have significantly accelerated our clinical safety maturity and strengthened cross-functional collaboration.”
Matthew, MD of EIDO

“Clinical safety is a marathon, not a sprint. Strong, effective clinical safety processes are achieved over time. Therefore, our monthly meetings are utilised, not only to maintain an overview of product development, but also to reflect upon what positive process changes can be made. A perfect example is EIDO’s Digital Director introducing a dedicated Hazard Log test suite. This addition to the Organisation’s existing Test Strategy ensures that all Hazard Log Test Controls are automatically re-tested prior to deploying a new release to confirm that no breaking changes have been introduced.”
Natalie, CSO

Collaboration and honesty is key

EIDO’s journey and ability to truly embed clinical safety pan-Organisation was realised through transparent collaboration and honesty, to be open and receptive to recognising where processes could be strengthened and facilitate process adaptation. Furthermore, by involving the CSO in advance of development taking place, robust clinical safety design controls can be identified and implemented proactively. This has the advantage to preventing double-handling of code changes.

“Collaborating with our CSO is a proactive, respectful partnership that enables early clinical input, streamlines development, and strengthens organisation-wide safety thinking. For EIDO, it’s become a key driver of smarter, safer design.”
Matthew MD of EIDO