LUCIDA MEDICAL LTD

Pi™ (Prostate Intelligence™) for Prostate Cancer Detection and Pathway Optimisation

Pi™ is an AI-based software to assist radiologists in assessing cancer in routine MRI scans.

Features

• AI powered prostate MRI analysis
• Outputs risk calculation for clinically significant cancerous lesions.
• Development of prostate cancer imaging AI algorithms
• Prostate cancer screening
• Prostate cancer diagnosis
• Prostate cancer active surveillance and monitoring
• Prostate cancer treatment
• Prostate cancer decision support

Benefits

• Help early cancer diagnosis
• Cut costs by reducing avoidable biopsies
• Prioritising cases and reducing waiting times
• Reduces waiting times and optimising diagnostic pathway
• Potential cost reduction from reduced outsourced tele-radiology
• Improves reporting confidence and consistency across radiologists
• Can prioritise high-risk patients more effectively

• Education pricing available

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at BusinessDevelopment@lucidamedical.com. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 15

Service ID

346029326381154

Contact

Antony Rix
01223 921901
BusinessDevelopment@lucidamedical.com

About your service

• Service categories:

  Application Development and Deployment

  AI platforms

  AI life cycle

  • Trustworthy AI Software

  AI software services

  • Computer Vision AI Software Services
  • Anomaly Detection AI Software Services
• Multi cloud support: Yes

Service scope

• Software add-on or extension: Yes, but can also be used as a standalone service
• What software services is the service an extension to: PACS services, MRI imaging solutions, AI orchestration solutions, Cloud medical imaging, Clinical decision support, Clinical treatment management, Patient triage solutions, Radiology information systems, Electronic health record / electronic medical record
• Cloud deployment model:
  • Public cloud
  • Private cloud
  • Community cloud
  • Hybrid cloud
• Service constraints: There are no known hardware configuration constraints.
• System requirements: Virtual machine installation with compatible Linux OS or Docker infrastructure

User support

• Email or online ticketing support: Yes
• Support response times: 1 hour within business hours on working days in England. Next business day at weekends.
• User can manage status and priority of support tickets: No
• Phone support: Yes
• Phone support availability: 9 to 5 (UK time), Monday to Friday
• Web chat support: No
• Onsite support: Yes
• Support levels: The Lucida Standard Service Agreement includes: ; • System maintained according to support plan/SLA. ; • Planned maintenance to cover: ; ○ Evaluation of imaging protocol changes or software updates, to allow checks to be repeated and updates as necessary ; ○ Updates to the AI software ; ○ Updates to reports and other services. Service systems are planned to be updated regularly, typically weekly out-of-hours. Problems will be acknowledged within 1 hour. ; Problems are defined as follows: ; • Critical: if patient safety or integrity is endangered ; • Important: if functionality and availability of the Service is severely restricted or it severely impacts one of the customer's operations. ; • Non-Critical: all other problems are characterised as Non-Critical, including where work-arounds are available. ; We aim to solve:; - Critical problems within 8 Office hours.; - Important problems will be solved within 16 Office hours. ; - Non-Critical problems will be solved within 80 Office hours or following an alternative plan agreed with the customer. ; We operate to a minimum availability commitment of 99.9%, monitored and reported frequently. Contracts over £1M will receive dedicated account management. Premium service with improved availability and response times may be ordered according the Pricing Document.
• Support available to third parties: Yes

Onboarding and offboarding

• Getting started: The Software is installed under appropriate local information governance IT and clinical safety standards.. The clinical application training will be delivered online (remotely) by a qualified Radiologist. Lucida Medical will work collaboratively with the customer to schedule the training activities for suitable times as our commitment to every customer at no additional cost. The main objective of the training is to empower reporting clinicians on how best to interpret the Pi AI output and how to use it in different workflows. The training will also cover Pi's intended use and limitations. Supportive training materials such as quick reference guides, Instructions for Use and click-through tutorials on the standalone user interface will be made available to customers.
• Service documentation: Yes
• Documentation formats:
  • HTML
  • PDF
• End-of-contract data extraction: • Outputs from the system are typically stored within hospital PACS and do not need duplicated or backup access from the vendor. DICOM riles would need to be reset to stop data flow.; • Offboarding typically therefore consists of archiving the services for regulatory retention purposes, and then decommissioning/deleting any applicable services/systems.
• End-of-contract process: • Included as standard in Contract Price: a) Disabling the Pi service so that no further data is transferred or processed. b) Archiving logs for regulatory and contractual monitoring purposes. c) deletion of live services.; • Available at an additional cost: Professional services are available for custom offboarding where Lucida Medical provides the PACS or hosts services, and typically includes providing DICOM format data back to the customer for storage in other DICOM repository via cloud or physical media (see price list).
• Documentation accessibility standard: EN 301 549

Using the service

• Web browser interface: Yes
• Supported browsers:
  • Microsoft Edge
  • Chrome
• Application to install: No
• Designed for use on mobile devices: No
• Service interface: No
• User support accessibility: EN 301 549
• API: Yes
• What users can and can't do using the API: Software supports standard DICOM APIs. Software can be connected to 3rd clinical applications using our standard API.
• API documentation: Yes
• API documentation formats:
  • HTML
  • PDF
• API sandbox or test environment: Yes
• Customisation available: Yes
• Description of customisation: Our AI solution can be customised for users as explained below: ; - Per Trust: Adjustable Operating Thresholds for the desired level of sensitivity and specificity; - Per Trust: Configuring characteristics of DICOM output sent to PACS; - Per Trust: Configuring what fields should be included in the Pi AI template report ; - Per Trust: Enabling/disabling classes of output within the scope of the contract.

Scaling

• Independence of resources: Services are dimensioned according to hospital size to cover all normal usage requirements. Spikes in demand due to migrations or outages lead to data being queued and processed in turn.

Analytics

• Service usage metrics: Yes
• Metrics types: Number of prostate MRI exams processed over a specified period of time
• Reporting types:
  • Regular reports
  • Reports on request
• Resource tagging: No
• FOCUS resource tagging: No

Resellers

• Supplier type: Not a reseller

Staff security

• Staff security clearance: Staff screening not performed
• Government security clearance: Developed Vetting (DV)

Asset protection

• Knowledge of data storage and processing locations: Yes
• Data storage and processing locations: United Kingdom
• User control over data storage and processing locations: Yes
• Datacentre security standards: Complies with a recognised standard (for example CSA CCM version 4.0)
• Penetration testing frequency: At least once a year
• Penetration testing approach: ‘IT Health Check’ performed by a CHECK service provider
• Protecting data at rest: Encryption of all physical media
• Data sanitisation process: Yes
• Equipment disposal approach: Complying with a recognised standard, for example CSA CCM v4.0, CAS (Sanitisation) or ISO/IEC 27001
• Data sanitisation type: Deleted data can’t be directly accessed / Cryptographic Erasure

Data importing and exporting

• Data export approach: • Results are saved to PACS and can be exported either through DICOM Fields, JSON metadata or other endpoints. ; • AI results are saved as DICOM Secondary Capture (SC) output image showing Pi risk score, prostate and lesion volume measurement (alternative formats such as GSPS can also be supported) ; • AI DICOM-SC secondary capture output image showing patient risk scores and lesion detections ; • AI DICOM RT-STRUCT 3D segmentations for visualisation to support treatment and biopsy planning ; • Template output report content (note that this is configurable).
• Data export formats:
  • CSV
  • Other
• Other data export formats:
  • DICOM Secondary Capture (SC)
  • PDF
  • JSON
  • DICOM Encapsulated PDF Report
  • DICOM TID1500 compliant Structured Report
  • HTML Report
  • DICOM GSPS
  • DICOM Structured Report (SR)
  • DICOM RT-STRUCT with lesion and prostate locations
  • HL7 v2.0
• Data import formats: Other
• Other data import formats: DICOM

Data-in-transit protection

• Data protection between buyer and supplier networks:
  • Private network or public sector network
  • TLS (version 1.2 or above)
  • IPsec or TLS VPN gateway
• Data protection within supplier network:
  • TLS (version 1.2 or above)
  • IPsec or TLS VPN gateway

Availability and resilience

• Guaranteed availability: Standard SLA is 99.9% availability. Premium SLA is 99.95% availability. If availability drops below the contracted availability level, customers will be credited 1/260th of the value of their annual contract fees for each complete working day (9am-5pm) during which the service is not available. There is no refunds for parts of a working day during which the service is not available.
• Approach to resilience: The Software is typically offered in high-availability cloud platforms offering at least 99.9% uptime (Standard SLA). Redundant service is provisioned where the customer orders Premium SLA.
• Outage reporting: Email alerts

Identity and authentication

• User authentication needed: Yes
• User authentication:
  • Multi-Factor Authentication (MFA)
  • Public key authentication (including by TLS client certificate)
  • Limited access network (for example PSN)
  • Dedicated link (for example VPN)
• Access restrictions in management interfaces and support channels: Management and support interface keys are restricted to specific trained users
• Access restriction testing frequency: At least once a year
• Management access authentication:
  • Multi-Factor Authentication (MFA)
  • Public key authentication (including by TLS client certificate)
  • Identity federation with existing provider (for example Google Apps)
  • Dedicated link (for example VPN)

Audit information for users

• Access to user activity audit information: Users contact the support team to get audit information
• How long user audit data is stored for: At least 12 months
• Access to supplier activity audit information: You control when users can access audit information
• How long supplier audit data is stored for: At least 12 months
• How long system logs are stored for: At least 12 months

Security governance

• Named board-level person responsible for service security: Yes
• Security governance certified: No
• Security governance approach: Lucida’s Prostate Intelligence (Pi) AI solution is subject to cyber security and data governance standards which it already satisfies as outlined below: ; - Lucida Medical has a named DPO; - Lucida has completed its DTAC assessment for Pi™ AI; - Lucida has completed a Data Protection Impact Assessment (DPIA) for the software solution; - Lucida is Cyber Essentials and Essentials Plus Certified; - Lucida is DSP Toolkit accredited with standards exceeded; - Lucida has registered with the information commissioner’s office with reference ZA798443
• Information security policies and processes: An IT security policy framework is in place and governs both operations and R&D. Systems that may store customer and business data are protected using 2FA, strong passwords and prohibition of password sharing. All personnel are trained on IT security including monthly training and tests. The supplier follows and is certified to Cyber Essentials Plus. Customer and cloud systems are operated according to ISO 27001.
• Software Security Code of Practice: Yes

Operational security

• Configuration and change management standard: Supplier-defined controls
• Configuration and change management approach: All system software configuration is maintained using Git version control or equivalent systems, compliant with ISO 62304 and ISO 13485. Changes require approval of a subject matter expert and testing before incorporation into production.
• Vulnerability management type: Supplier-defined controls
• Vulnerability management approach: Threat risk is considered during risk assessment throughout the product lifecycle. Penetration testing is performed by contracted security specialists at least annually. Patches are deployed according to analysis of risk, in as little as 1 hour during business hours, or in the next maintenance window as appropriate. We subscribe to mailing lists and monitor industry providers including CERT to gain warning of known vulnerabilities.
• Protective monitoring type: Supplier-defined controls
• Protective monitoring approach: Services are typically installed in customer's IT environment and subject to access and monitoring in place to supplier processes. Responses include patching, disabling accounts and increasing logging if a compromise is found. Immediate action (typically within 1 hour) is taken when potential compromises are identified, for example to implement a patch, firewall rule, blacklist or whitelist, or disable compromised accounts.
• Incident management type: Supplier-defined controls
• Incident management approach: Pre-defined processes for potential data incident and security breaches. Users can report incidents through the standard support channels. Incident reports are provided by email on daily basis for serious potential breaches until resolution or closure.
• Post-quantum cryptography secure: No

Secure development

• Approach to secure software development best practice: Independent review of processes (for example CESG CPA Build Standard, ISO/IEC 27034, ISO/IEC 27001 or CSA CCM v4.0)

Public sector networks

• Connection to public sector networks: No

Pricing

• Discount for educational organisations: Yes
• Free trial available: No

Discount percentage by annual call-off contract value (excluding VAT)

• Less than £250,000: 4%
• Between £250,000 and £500,000: 8%
• Between £500,001 and £1,000,000: 10%
• Between £1,000,001 and £2,500,000: 13%
• Between £2,500,001 and £5,000,000: 13%
• Over £5,000,001: 13%

Non-mandatory Standards and certifications

• ISO/IEC 27001 certification: No
• ISO 28000:2022 certification: No
• ISO 9001 certification: No
• Quality management systems (QMS): Yes
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: Yes
• Please provide your Cyber Essentials Certificate Number: E7c940e6-1e63-49ba-9953-b7ccb26bef03
• Cyber essentials plus: Yes
• Please provide your Cyber Essentials Plus Certificate Number: 7d9cbc2f-c551-45fc-9d1a-159c5aeb09e1
• Other security certifications: Yes
• Any other security certifications: Data Security Protection Toolkit (DSP Toolkit)

Social value

• Section B - Commitment for Future: Delivery:

  • Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

    Policy Outcome 1: Fair work: That offers fair wages and good working conditions. Help people get a job, stay in work, and progress in their careers, with good employment opportunities across the country. Notes: Where there is a large proportion of labour costs in the contract, commercial teams should consider MAC in Outcome 1 as a priority

    • New or retained jobs on the contract workforce in the relevant area that meet the criteria set out in MAC 1b, 1c and 1d
    • Providing opportunities for, and measuring and monitoring of, staff workforce conditions over time, including employee engagement, involvement in decision-making and satisfaction and adapting to any changes in the results, with clear processes for acting on issues identified
    • Monitoring of employee engagement rates (by protected characteristic) and, where necessary, the development of actions to ensure all voices are heard across the diversity of the workforce
    • Payment of more than the National Minimum Wage or National Living Wage (as appropriate) to the contract workforce
    • Entitlement to sick pay for the contract workforce, with provision in place for any staff who do not meet the earnings threshold for statutory sick pay, payment of sick pay from day one of absence and payment of staff on the contract workforce who are off sick a replacement income of 100% of their usual earnings for as long as possible
    • Measures to support in-work progression to help people in the contract workforce, to move into higher paid work by developing new skills relevant to the contract
    • Understanding of the modern slavery risks and issues affecting the market, industry, sector or country (of origin or of source) relevant to the contract, and the workforce in the supplier’s own organisation and those of its key subcontractors
    • Measures to identify, mitigate and manage modern slavery risks relating to the contract and how these will be implemented

  • Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

    Policy Outcome 3: Resilient, innovative and flexible supply chains: Support economic growth through enabling resilient businesses, opportunities for small businesses and voluntary, community and social enterprises

    • Activities that demonstrate a collaborative way to work with a diverse range of businesses as part of the supply chain
    • Measures to involve local stakeholders and/or users in design (e.g. in the design of services, systems, products or buildings)

  • Mission: Make Britain a clean energy superpower: To cut bills, create jobs and deliver security with cheaper, zero-carbon electricity by 2030, accelerating to net zero

    Policy Outcome 4: Sustainable procurement practices: Reducing carbon footprints, minimising waste, and promoting the use of clean energy and green technologies.

    • Understanding of opportunities for additional environmental benefits delivery in the performance of the contract, including working towards net zero carbon emissions and use of clean energy and green technologies

  • Mission: Break down barriers to opportunity: By reforming our childcare and education systems, to make sure there is no class ceiling on the ambitions of young people in Britain

    Policy Outcome 6: Employment and training: For those who face barriers to employment

    • Understanding of the issues affecting inequality in employment, skills and pay in the market, industry or sector relevant to the contract, and in the supplier’s own organisation and those of its key sub-contractors. Measures to tackle inequality in employment, skills and pay in the contract workforce

  • Mission: Build an NHS fit for the future: That is there when people need it; with fewer lives lost to the biggest killers; in a fairer Britain, where everyone lives well for longer.

    Policy Outcome 8: Increasing productivity through physical and mental wellbeing: In the supply chain and communities in the relevant area.

    • Understanding barriers to access to health and social care services or employment opportunities e.g. digital inclusion

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at BusinessDevelopment@lucidamedical.com. Tell them what format you need. It will help if you say what assistive technology you use.