With NHS England increasingly placing more emphasis on the need for digital health companies to be DTAC compliant, Smart Respiratory knew it was critical to address the DTAC requirements to support their growth. They partnered with 8foldGovernance to support them through this complex process allowing them to ensure commercial success and level up their understanding of national compliance requirements.
Smart Respiratory was founded in 2014 at Imperial College London with the aim of developing affordable sensors and software for monitoring chronic respiratory issues such as asthma. Their products are designed to help patients better self-manage their respiratory health as well as share data with healthcare providers to improve treatment. This mission empowers individuals with asthma to take control of their healthcare journey through the provision of accurate and timely information to improve overall disease management and quality of life.
A portable peak flow meter and app that tracks and monitors asthma symptoms, peak flow readings, and inhaler usage allows the data to be shared with the individual’s healthcare providers.
This is a device that attaches to any MDI inhaler and tracks inhaler usage, providing data on remaining doses and time of use. This utilises NFC technology to communicate with a companion app.
The Problem
Smart Respiratory understood they needed to be compliant with the Digital Technology Assessment Criteria (DTAC) to work with the NHS, but knew the company lacked the internal expertise and resources to navigate the complex DTAC process effectively.
Recognising the urgent need for specialised guidance, Thomas Antalffy, the Founder and CEO of Smart Respiratory, engaged in the Health Technology Regulatory and Innovation Programme, which was recommended by Health Innovation Network Kent, Surrey, Sussex (formerly Kent Surrey Sussex AHSN). Through this programme, Smart Respiratory successfully secured grant funding for compliance and regulatory activities to support their UK commercial activities.
As a long-term collaborator with Health Innovation Network KSS, and having seen the quality of the work produced, 8foldGovernance was recommended to Smart Respiratory as a trusted partner.
Our Clinical Safety Officer, Haniyah Khanum, took the lead on this element of the project, working with the team to ensure DCB0129 compliance, the key requirement of the Clinical Safety section of DTAC.
Haniyah began by comprehensively assessing Smart Respiratory’s current practices and understanding of DCB0129 requirements. Recognising the need for a strong foundation, she organised a series of tailored training sessions and interactive hazard workshops. These sessions served a dual purpose; of educating the Smart Respiratory team on the intricacies of DCB0129 and facilitating a collaborative environment to identify potential risks associated with their products.
The hazard workshops proved particularly valuable, as they allowed the team to engage in critical thinking about their technology’s impact on patient safety alongside their medical device registration. Through this exercise, Smart Respiratory cross-functionally gained a deeper appreciation for the importance of risk mitigation in healthcare technology and saw the real value of a Clinical Safety Officer as part of their overall risk management process.
Recognising that DCB0129 compliance is an ongoing process, Haniyah focused on empowering Smart Respiratory’s team to maintain and update their compliance status independently, using internal resources to act as the Clinical Safety Officer. As a result, Haniyah supported the regulatory and clinical team members to ensure there was a smooth handover ensuring that Smart Respiratory could adapt their compliance framework as their products evolved, maintaining the highest standards of clinical safety.
Georgina Daugherty, Information Governance Specialist at 8foldGovernance, worked closely with Antony Wilson, Head of Commercial and Bálint Baraniuk, Head Of Quality Management at Smart Respiratory to submit the Data Security and Protection Toolkit (DSPT) as well as build a DPIA template that could be used for multiple NHS engagements. These key elements form the bedrock of the Data Protection section of DTAC and are often subject to the most scrutiny by the NHS during procurement processes.
Completing the DSPT and DPIA with 8fold has allowed Smart Respiratory to engage proactively with NHS Governance teams by evidencing key documentation and being prepared to complete a DPIA, something in our experience we have seen act as a blocker to contract sign-off.
Bálint Baraniuk, Head Of Quality Management at Smart Respiratory
The 8fold team also supported Smart Respiratory in completing Cyber Essentials Certification and a CREST-accredited penetration test. These are key requirements for the Technical Security section of DTAC which focuses on assessing products to ensure they are both secure and stable.
Cyber Essentials Certification:
We guided Smart Respiratory through the process of obtaining Cyber Essentials Certification, a fundamental requirement of DTAC’s technical security section. This government-backed scheme demonstrates that businesses have implemented essential cybersecurity measures to protect against common online threats and paves the way for enhanced accreditations such as Cyber Essentials +.
CREST-Accredited Penetration Testing:
To further bolster Smart Respiratory’s security posture, we facilitated a CREST-accredited penetration test. This intensive evaluation simulated real-world cyber attacks to identify potential vulnerabilities. It also assessed the application’s resilience against the OWASP Top 10 web application security risks and provided actionable insights to enhance system security. The penetration test not only satisfied DTAC requirements but also offered valuable recommendations for ongoing security improvements to the Smart Respiratory platform.
In the current climate of escalating cyber threats, our support in achieving these security milestones has been instrumental in positioning Smart Respiratory as a trusted and compliant healthcare technology provider. This enhanced security profile not only satisfies DTAC requirements but also instils confidence in NHS decision-makers considering the adoption of Smart Respiratory’s digital health solutions.
The final component of DTAC that 8fold supported Smart Respiratory with was Section D: Interoperability, Usability and Accessibility. This is the only scored component of DTAC and focuses on ‘ ‘Key principles for success” and is an important part of ensuring that a digital product or service is suitable for use in the NHS and Social care.
8fold’s comprehensive support with these remaining elements enabled Smart Respiratory to achieve a high conformity rating, demonstrating their commitment to delivering a digital health product that is safe, effective and accessible for use within the NHS and social care systems.
Since we collaborated with Smart Respiratory, they have made remarkable strides in securing several lucrative deals with NHS trusts such as Birmingham and Solihull Integrated Care Board, Frimley Health NHS Foundation Trust and University Hospitals Bristol and Weston NHS Foundation Trust. Alongside these partnerships with acute Trusts, they now also work across 23 Integrated Care boards in England, serving thousands of patients with asthma through their technology
Antony Wilson, Head of Commercial
Improved Governance position
Implementation of robust data security processes
With their DTAC approval, Smart Respiratory is now well-equipped to continue to collaborate with Integrated Care Boards and NHS Trusts, expanding their reach across the UK healthcare landscape.
Their success has also paved the way for international growth, as evidenced by their recent approval as a digital health solutions supplier for Health Service Ireland (HSE), with implementations already underway in several Irish hospitals. This expansion showcases Smart Respiratory’s potential to make a significant impact on respiratory care beyond UK borders while maintaining the high standards of safety and efficacy required in the digital health sector.
Leverage the skills and experience of our expert team, just like Smart Respiratory, to support commercial success in the NHS.
Leverage the skills and experience of our expert team, just like Smart Respiratory, to support commercial success in the NHS.
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