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Quality and patient safety

Prioritising clinical safety and patient privacy

Visiba Triage is powered by Red Robin, a registered medical device that is also DTAC and Cyber Essentials compliant. Patient safety and privacy are paramount in all deployments and developments.

From how the product is designed, built, updated and tested to how we handle data, we guarantee the most stringent processes to safeguard you and your patients.

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Fully compliant with current legislation

Regulatory Approval:

  • CE Marked Medical Device
  • DCB 0129/0160 for deployment in NHS urgent & primary care

Additional Governance:

  • ISO27001, ISO13485 and ISO14971 compliant
  • Digital Technology Assessment Criteria (DTAC) 
  • Data Security and Protection Toolkit compliant (DSPT)
  • Cyber Essentials 

Our approach to clinical assurance

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Real-time and real-world performance monitoring

Visiba Triage uses a clinical feedback loop where  clinicians using Visiba Triage are asked for their agreement with the AI model’s urgency and differential diagnoses, in a step that takes less than 5 seconds.

This approach enables Visiba Triage to uniquely track real time performance across all deployments, and report on accuracy using clinician consensus on a mass scale. This has significant safety benefits, as it enables the Visiba clinical team to continually track the safety of the model and retrain the model immediately should adaptations be required.

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Safety netting

Visiba Triage has established safety netting in place. In the chat, when symptoms suggest a patient requires immediate medical attention they are shown an alert directing them to urgent or emergency care.

Our unique clinician in the loop model ensures that all clinical decisions are made by clinicians supported by Visiba Triage.

 

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Internal review process

In addition to rigorous Post Market Surveillance, Visiba’s clinical team has an ongoing, weekly clinical assurance rhythm. This process includes reviewing any cases highlighting potential safety concerns as well as trends from the feedback data from clinicians using the service. 

Clinically led processes exist around reviewing, agreeing and actioning any consequent changes to the model.

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External review process

Visiba’s clinical team meets with NHS partners in a mutually agreed cadence to review performance data and any flagged cases for clinical discussion.

Our team puts clinical safety first

Visiba’s Clinical Team is led by Chief Medical Officer Dr Annabelle Painter. Dr Painter is a leading academic and clinical voice on the application of Artificial Intelligence (AI) in healthcare. Within Visiba’s Integrated Urgent Care deployment, Dr Katherine Leung is the clinical lead. Dr Leung is an NHS GP, and is supported by a team of GPs based in the UK, and Nordics.

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Dr. Annabelle Painter

Chief Medical Officer

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Dr. Katherine Leung

Clinical Product Owner

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Dr. Christer Rosenberg

Senior Medical Specialist

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Dr. Joel Ellbin

Medical Specialist

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Dr Ashiv Patel

Medical Specialist

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Dr Martha Martin

Medical Specialist

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Dr Kristina Bergman

Medical Specialist

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Responsible AI

Visiba's Responsible AI Principles ensure the ethical and transparent development of our AI-enabled triage solution Visiba Triage. They focus on fairness, accountability, and safety. Emphasising human oversight, privacy protection, and continuous improvement, to deliver a trustworthy and effective AI solution.

Software that's quality assured

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Quality by design

Our product design follows a life-cycle approach, with continuous updates to meet customer needs, including post-market surveillance. Bug fixes and new features are added every 3 weeks and incorporate risk analysis, and rigorous quality assurance testing.
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Active risk mitigation

Risk mitigation is key to our products, with assessments for all updates. Post-market surveillance helps detect issues early. We have an incident team and processes for clinical safety and security events, and all staff receive training.
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Operational resilience

Ensuring operational resilience is a part of our risk mitigation. This includes, amongst other actions, processes for: business continuity, disaster recovery, managing third party risks, supplier evaluation, third party monitoring and third party off-boarding.

Want to know more about security and governance?

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Visiba Group AB
Adolf Edelsvärds Gata 11 Göteborg, 414 51
Phone: 0761993666