Working on the NHS COVID-19 App, by Irfan Hassan
For the last three years, I have been Psephos Biomedica’s NHS COVID-19 App Regulatory Lead, Workstream Lead for Regulatory & Clinical Safety, and part of the App’s Senior Leadership Team, as part of UKHSA’s public health response to COVID-19. The NHS COVID-19 App has been successfully decommissioned and the Team and I are back working fully in Psephos.
The Regulatory Team achieved and maintained a medical device for UKHSA’s high-profile public health response to COVID-19 in England and Wales, from its inception through to successful decommission of a Software as a Medical Device (SaMD), a journey engaged, aligned and travelled with the UK’s Competent Authority, Medicines and Healthcare products Regulatory Agency (MHRA). MHRA described the regulatory aware and compliant product life-cycle through to decommission as 'a standard that others should measure themselves by'.
It was a real delight to work alongside Psephos colleagues in the Regulatory Team (subject matter experts in regulatory affairs, quality assurance, clinical assurance, clinical research and clinical safety). We had excellent stakeholder engagement across the product life-cycle including App policy, enabling greater visibility on medical device impact, and allowed us to achieve intense fortnightly release cycles in line with other App workstreams.
The App had a user centred design, available in 12 languages, and it was a privilege to lead on the Accessibility WCAG.21 audit and compliance as part of our journey. I am very proud of the extensive user feedback channels as part of vigilance and incident monitoring that were put in place.
It was significant that we were able to demonstrate that the Government’s aspiration to include cyber security, information governance measures in future Essential Requirements for SaMD are all possible, having done so for the last three-years, including harmonising the Clinical Safety standards DCB0129 and DCB0160.
It was the most downloaded app of 2020, after Zoom, with 31m downloads in total. Leading scientists estimated the App prevented around 1m cases, 44,000 hospitalisations and 9,600 people dying during its first year ‘Epidemiological impacts of the App in England and Wales throughout its first year’ https://www.nature.com/articles/s41467-023-36495-z
It has been a privilege to work in a complex and evolving collaboration, across countries, sectors and Government, and the Team and I look forward to the digital health innovation programmes and projects ahead, especially complex stakeholder management.
Please reach out if you would like to know more or discuss your Regulatory needs for Digital Health, AI and Software, including Machine Learning. Some of the services delivered by the Psephos Digital, AI and SaMD Team on the NHS COVID-19 App include but are not limited to:
Regulatory Services (including Technical Files & Quality Management System)
Post Market Surveillance
Clinical Investigations
Vigilance, incidents, and feedback
Risk Management
Software Compliance/Traceability
Decommissioning Strategy & Implementation
Clinical Safety DCB0160 and DCB0129
Digital Technology Assessment Criteria (DTAC)
Our Regulatory and Clinical Strategy for Digital Health, AI & Software, including Machine Learning, for the different jurisdictions (e.g. UK, EU and USA as well as other markets as requested) is very popular, and helps our clients understand their regulatory commitments and assists with clarifying their market access priorities.
