Your DTAC Journey Starts Here
From Complex Requirements to Smooth Approvals.
We specialise in helping healthcare innovators get unstuck, get aligned and get through DTAC with expert-led precision
Contact usWhy us
DTAC Decoded:
Compliance
Without
Compromise
We've brought together deep expertise across Clinical Safety, Cybersecurity, Data Privacy, Interoperability and Accessibility, meaning you have one conversation across all domains, get a single integrated approach so nothing falls through the gaps and a speedy execution.
One Conversation,
All Domains
With us, you have one integrated team, one shared understanding, and one streamlined path to compliance.
Compliance Without the Silos
Our team's strength lies in our cross-functional integration. We don't approach your product as five separate audits. We view it as a living system that needs coordinated, forward-thinking alignment across disciplines.
Efficient Delivery
Our Alliance operates as a single project team across all DTAC domains, eliminating the common bottlenecks that slow others down. You'll see faster progress because the right people are already in the room.
5 Compliance Challenges.
One Smart Solution.
Our Services
A Streamlined Route to DTAC Readiness
We've brought together deep expertise across Clinical Safety, Data Privacy, and Interoperability so you don't have to coordinate with multiple consultants. With DTAC Alliance, you get one integrated team, one clear path, and full support until you're ready.
DTAC GAP Assessment
Our comprehensive DTAC Gap Assessment service thoroughly evaluates your existing documentation, records, processes, and procedures. Our experienced consultants engage closely with your key stakeholders through structured interviews and workshops, ensuring a detailed understanding of your operational practices.
This assessment meticulously covers all five DTAC domains:
- Clinical Safety
- Data Protection
- Technical Assurance
- Interoperability
- Usability and Accessibility
We pinpoint specific gaps, clearly documenting each area that requires attention to meet DTAC standards and expectations.
Action and Execution Plan
Building on insights gained from the DTAC Gap Assessment, our team develops a clear, actionable, and highly practical execution plan tailored explicitly to address identified gaps. Unlike generic advisory services, our approach delivers tangible, implementable solutions that align with your operational realities. Our proposed actions typically include:
- Developing and maintaining comprehensive Hazard Registers to ensure robust risk management
- Conducting professional penetration testing exercises to validate security and resilience.
- Achieving compliance with the Data Security and Protection Toolkit (DSPT) to meet NHS digital standards
- Ensuring standards conformance to support seamless interoperability with healthcare systems and adherence to accessibility best practices to enhance usability for all stakeholders.
Each action in our plan is supported by step-by-step guidance, clear milestones, responsibilities, timelines, and resources required for effective implementation.
Completion and Submission
We manage every aspect of your DTAC application, from completion to successful submission. Our specialists meticulously compile and organize all required evidence and documentation, presenting your application clearly and persuasively to regulatory bodies.
As your dedicated point of contact, we liaise directly with review committees and regulatory authorities, swiftly addressing any queries, clarifications, or additional requirements.
Beyond initial submission, we offer continuous support to ensure ongoing DTAC compliance. Our services extend to the periodic review and revision of your documentation, processes, and evidence, enabling your organization to effortlessly maintain compliance as your product evolves.
This lifecycle approach provides sustained peace of mind, allowing your team to focus confidently on delivering innovative, compliant, and safe healthcare solutions.
DTAC GAP Assessment
Our comprehensive DTAC Gap Assessment service thoroughly evaluates your existing documentation, records, processes, and procedures. Our experienced consultants engage closely with your key stakeholders through structured interviews and workshops, ensuring a detailed understanding of your operational practices.
This assessment meticulously covers all five DTAC domains:
- Clinical Safety
- Data Protection
- Technical Assurance
- Interoperability
- Usability and Accessibility
We pinpoint specific gaps, clearly documenting each area that requires attention to meet DTAC standards and expectations.
Action and Execution Plan
Building on insights gained from the DTAC Gap Assessment, our team develops a clear, actionable, and highly practical execution plan tailored explicitly to address identified gaps.
Unlike generic advisory services, our approach delivers tangible, implementable solutions that align with your operational realities. Our proposed actions typically include:
- Developing and maintaining comprehensive Hazard Registers to ensure robust risk management
- Conducting professional penetration testing exercises to validate security and resilience.
- Achieving compliance with the Data Security and Protection Toolkit (DSPT) to meet NHS digital standards
- Ensuring standards conformance to support seamless interoperability with healthcare systems and adherence to accessibility best practices to enhance usability for all stakeholders.
Each action in our plan is supported by step-by-step guidance, clear milestones, responsibilities, timelines, and resources required for effective implementation.
This assessment meticulously covers all five DTAC domains:
- Clinical Safety
- Data Protection
- Technical Assurance
- Interoperability
- Usability and Accessibility
We pinpoint specific gaps, clearly documenting each area that requires attention to meet DTAC standards and expectations.
Completion and Submission
We manage every aspect of your DTAC application, from completion to successful submission. Our specialists meticulously compile and organize all required evidence and documentation, presenting your application clearly and persuasively to regulatory bodies.
As your dedicated point of contact, we liaise directly with review committees and regulatory authorities, swiftly addressing any queries, clarifications, or additional requirements.
Beyond initial submission, we offer continuous support to ensure ongoing DTAC compliance. Our services extend to the periodic review and revision of your documentation, processes, and evidence, enabling your organization to effortlessly maintain compliance as your product evolves.
This lifecycle approach provides sustained peace of mind, allowing your team to focus confidently on delivering innovative, compliant, and safe healthcare solutions.
Addressing Challenges
Every DTAC Challenge,
Expertly Solved.
With clinical safety experts, we ensure your compliance with DCB0129 standards, provide accurate hazard logs, and ensure clinical risks are proactively identified and rigorously controlled—giving you peace of mind in the safety of your digital health technology.
We proactively identify and mitigate vulnerabilities through rigorous cybersecurity assessments including DSPT, Cyber Essentials & Penetration Testing. We provide tailored guidance aligned to NHS digital security standards, ensuring your technology is robust, secure, and compliant.
Our privacy specialists conduct thorough Data Protection Impact Assessments (DPIAs), implement GDPR-compliant frameworks, and provide strategic advice to safeguard patient data, maintaining full regulatory compliance, including a Virtual DPO service.
We align your product to NHS interoperability standards (FHIR, HL7, Open APIs), facilitating seamless integration with existing healthcare systems and enhancing overall operational effectiveness.
We incorporate WCAG 2.1 AA compliance into your product design and testing from the start, ensuring inclusivity and usability for all patients and healthcare providers. Usability & Accessibility aren't retrofitted—they are built-in.
FAQs
Gain more Confidence over your DTAC Concerns
It's currently not mandatory, however some private clients may still request it for additional assurance. Furthermore, standards are always being reviewed, and CQC are being advised that this should be a requirement for private providers.
Yes, all the evidence still needs to be mapped across to the DTAC process, and this may then highlight the gaps in your evidence submission.
Cyber Essentials is the default requirement. However, commissioners are requesting a higher level of risk assurance for more high risk developments, such as Ambient Scribe Technology.
The manufacturer has to complete DTAC but they can be supported.
You need to demonstrate ongoing adherence to all of these assurance measures, which requires annual renewal.
The Alliance
Trusted Experts Across Every Compliance Domain
Our alliance between RightCue, Digital Healthcare Assurance Company, and Si-Squared simplifies the process by offering a single point of contact for all five domains. You no longer need to coordinate across different providers, re-explain your product's purpose, or mediate between siloed teams. With us, you have one integrated team, one shared understanding, and one streamlined path to compliance.
Get Started on your Compliance Journey Now.
Get ready to go on a smooth compliance journey with our expert guidance. Book a no-obligation discovery call with a member of our team and get started today!
Contact us