MedTech NHS Cervical Screening Digital Colposcopy Platform

Cervical screening digital pathway

• 1invitation management (automated letter generation via NHS Spine — GP practice list → eligible women aged 25–64 → invitation letter),
• 2screening result recording (cytology lab reports results to PDS FHIR R4 CancerObservation resource),
• 3colposcopy referral workflow (abnormal result → automated referral to colposcopy clinic — NHS eRS referral),
• 4colposcopy result recording (clinical result — biopsy, treatment, outcome — recorded in colposcopy platform),
• 5CSP KC66 return (quarterly NHSE data submission — colposcopy audit data for national quality assurance),
• 6failsafe recall (women who do not attend screening sent recall — failsafe system ensures no woman falls through the net).

DCB0129 Cervical Screening Clinical Safety

Cervical screening clinical safety is extremely high-stakes — failure to recall a woman with abnormal results can lead to missed cervical cancer diagnosis.

DCB0129 critical hazards

• 1failsafe failure (woman with abnormal result not referred for colposcopy) — mitigation: automated referral at result recording (eRS API), mandatory confirmation receipt, 5-day escalation if no referral confirmation;
• 2result not communicated to patient — mitigation: automated letter within 14 days (GOV.UK Notify), delivery confirmation tracking;
• 3colposcopy recall not sent — mitigation: 6-week recall trigger if colposcopy result not recorded (system assumes failure, escalates to clinic).

CSP QA

National Colposcopy QA team reviews DCB0129 hazard log.

CSP standards

minimum colposcopy result recording completeness: 95%.

CSDS and NHS Spine Integration

• CSDS (Community Services Data Set): NHS England data submission for all community-based healthcare, including colposcopy services.
• CSDS v1.5 submission: quarterly data extract (patient identifiable — NHS number, DOB, postcode) → CSDS XML → NHS Digital Submissions Portal.

NHS Spine integration

• 1PDS FHIR R4 (NHS number verification for all women on cervical screening list),
• 2CSDS submission (FHIR R4 EpisodeOfCare, Procedure, Condition resources),
• 3NHS eRS (colposcopy referral — structured FHIR R4 ServiceRequest).

NHS article 9 health data

cervical screening and colposcopy data is the most sensitive category of Article 9 health data — UK GDPR Article 9(2)(h) (healthcare treatment) as legal basis.

Data retention

cervical screening records retained 10 years post last screening (NHS Records Management Code of Practice).

Colposcopy image capture

colposcope camera output (HDMI capture → DICOM conversion → PACS integration (Sectra/Carestream — DICOM C-STORE)).

Colposcopy images stored

• PACS for long-term storage (colposcopy images retained 10 years), RIS for current episode management.
• Future AI pathway (MHRA Class IIa — planned post-launch): AI clinical decision support for colposcopy images (acetowhite change detection, CIN grading support — Class IIa SaMD, requires UKCA marking and UK Notified Body).

Current build

AI pathway designed but not implemented (MHRA regulatory pathway for Class IIa AI requires clinical performance data from real-world use — collected during initial platform operation).

AI evidence collection

colposcopy images and clinical outcomes stored (with patient consent for AI research) — training dataset for future MHRA submission.