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  • Writer's pictureIrfan Hassan

Psephos Summer Newsletter

Irfan Hassan, Head of Digital Health, AI and Software and Anusha Venkatesan, Quality and Regulatory Consultant We are pleased to welcome Irfan and Anusha back into the fold here at Psephos. For the last three years, they have been working on the NHS COVID-19 App. We are excited to see how their experiences gained from this integrated working arrangement can be leveraged by other clients in the future. Irfan has written a piece for us below.

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’ 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.

Estimated COVID-19 cases averted and estimated percent reduction in cases in each Lower Tier Local Authority

Digital Health and AI (SaMD) Event - Thursday 12th October 2023 Psephos and SEHTA are proud to announce this event which will provide an update on the current regulatory environment for Software as a Medical Device (SaMD), Artificial Intelligence (AI) and digital health applications. With a particular focus on UK, EU and US regulations, this event will explore the current changes in the field alongside exploring practical challenges and opportunities that arise out of them. Please click below for more details and to register.

SaMD video series We will be launching a new SaMD video series, which is going to provide an overview of the Software as a Medical Device, AI and Machine Learning landscape. Keep an eye on our LinkedIn page for details...


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