Defined
Intended use and users
Professional evidence, regulatory and access information retrieval for clinicians, pharmacists, governance teams and health-system evaluators.
PRE-ASSESSMENT RECORD · VERSION 0.1
NICE readiness without claiming NICE endorsement.
This record makes the intended use, evidence plan, assurance gaps and regulatory boundary visible before any formal NHS or NICE engagement.
Current status
Prepared with reference to the NICE Evidence Standards Framework for digital health technologies. Peptide Intelligence has not been assessed, approved, endorsed or recommended by NICE.
READINESS WORKSTREAMS
What exists and what must still be evidenced.
The present classification hypothesis is a professional system-service and reference-information product. Final ESF tier and medical-device status depend on the precise intended purpose and actual functionality and require independent confirmation.
Defined
Clinical boundary
No patient-specific output, diagnosis, prescribing, dosing, treatment ranking or automated clinical recommendation.
Operational beta
Source and change control
Field-level sources, verification dates, source tiers, record versions, corrections and append-only status history.
Evidence required
User acceptability
Structured testing with intended UK users is scheduled for the founding professional cohort.
Evidence required
Performance evidence
Baseline and post-use task time, source verification success, answer completeness and confidence will be measured.
Evidence required
Economic case
Time-release and avoided duplicated search claims remain hypotheses until measured in a UK workflow.
Planned
NHS technical assurance
DTAC, DCB0129 applicability, DSPT scope and information-governance requirements require formal scoping before NHS deployment.
CONTROLLED VOCABULARY
Eight questions. Eight separate answers.
No composite badge is allowed to imply that authorisation, recommendation, access, evidence and exposure are interchangeable.
MHRA authorisationWhether the exact medicinal product is authorised for the relevant UK market, formulation and indication.
NICE recommendationNICE assessment and recommendation for a defined technology, population and use; it is not marketing authorisation.
NHS accessWhether a practical funded or commissioned route exists, including eligibility, implementation and local service constraints.
Private lawful useA product-, indication-, prescriber- and governance-specific position; private availability is not NICE recommendation or routine NHS access.
FDA approvalUS product and indication approval; it does not create a UK marketing authorisation.
FDA advisory reviewCommittee consideration or vote that may inform FDA action; it is not drug approval.
Evidence gradePeptide Intelligence editorial assessment of proposition-specific evidence maturity; it is not regulatory status.
Market exposureObserved availability or discussion signal; it is not evidence of quality, safety, efficacy or lawful supply.
FOUNDING COHORT EVIDENCE PLAN
Measure usefulness before claiming value.
- Capture baseline time and sources used for four representative peptide questions.
- Repeat the same tasks using Peptide Intelligence.
- Record correct status identification, successful primary-source verification and missing information.
- Collect usability, confidence and workflow-fit feedback by professional segment.
- Report results with denominators and limitations; do not convert unmeasured time into savings.