Clinical safety and governance

Operating mode: education

Education mode. Software that recommends treatment for an individual patient is likely to be a medical device under the UK Medical Devices Regulations 2002. This build has no UKCA marking and no approved clinical safety case, so it is provided for teaching and for exploring the evidence — not for individual patient decisions.

See docs/clinical-safety/README.md for intended use, the regulatory position, DCB0129/DCB0160 responsibilities and the safety-case template.

Traceability

App version

2.0.0

Knowledge base

KB-20261015-c9bb809f

Source verification

0 failed, 345 missing of 345

bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §7.5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.2: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.6: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.9: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.6: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.6: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.11: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.10: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.11: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.11: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.11: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.11: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.2: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.2: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.3.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.6: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.7: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.9: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.9: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §7.6: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.4: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.4: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §5.3.6: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §8.2: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §7.2: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §7.3: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_art §7.4: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_tb §8: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.5: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.7: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §8.7: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
bhiva_pregnancy §11.1: guideline text not downloaded (python -m tools.fetch_guidelines)
dovato §4.4: SmPC not downloaded
tivicay §4.2: SmPC not downloaded
biktarvy §4.3: SmPC not downloaded
vocabria_inj §4.4: SmPC not downloaded
tivicay §4.4: SmPC not downloaded
dovato §4.1: SmPC not downloaded
edurant §4.3: SmPC not downloaded
edurant §4.5: SmPC not downloaded
triumeq §4.1: SmPC not downloaded
triumeq §4.1: SmPC not downloaded
vocabria_inj §4.4: SmPC not downloaded
juluca §4.4: SmPC not downloaded
descovy §4.4: SmPC not downloaded
efavirenz §5.1: SmPC not downloaded
edurant §4.1: SmPC not downloaded
pifeltro §4.1: SmPC not downloaded
celsentri §5.1: SmPC not downloaded
prezista §5.1: SmPC not downloaded
biktarvy §4.2: SmPC not downloaded
biktarvy §4.2: SmPC not downloaded
biktarvy §4.2: SmPC not downloaded
descovy §4.2: SmPC not downloaded
descovy §4.2: SmPC not downloaded
odefsey §4.2: SmPC not downloaded
odefsey §4.2: SmPC not downloaded
odefsey §4.2: SmPC not downloaded
symtuza §4.2: SmPC not downloaded
symtuza §4.2: SmPC not downloaded
symtuza §4.3: SmPC not downloaded
delstrigo §4.2: SmPC not downloaded
delstrigo §4.2: SmPC not downloaded
delstrigo §4.2: SmPC not downloaded
ftc_tdf §4.2: SmPC not downloaded
ftc_tdf §4.2: SmPC not downloaded
ftc_tdf §4.2: SmPC not downloaded
ftc_tdf §4.2: SmPC not downloaded
atazanavir §4.2: SmPC not downloaded
atazanavir §4.2: SmPC not downloaded
eviplera §4.2: SmPC not downloaded
eviplera §4.2: SmPC not downloaded
efv_ftc_tdf §4.2: SmPC not downloaded
efv_ftc_tdf §4.2: SmPC not downloaded
efavirenz §4.3: SmPC not downloaded
tivicay §4.2: SmPC not downloaded
dovato §4.2: SmPC not downloaded
dovato §4.2: SmPC not downloaded
dovato §4.2: SmPC not downloaded
dovato §4.2: SmPC not downloaded
triumeq §4.2: SmPC not downloaded
triumeq §4.2: SmPC not downloaded
triumeq §4.2: SmPC not downloaded
triumeq §4.2: SmPC not downloaded
juluca §4.2: SmPC not downloaded
isentress §4.2: SmPC not downloaded
isentress_600 §4.2: SmPC not downloaded
pifeltro §4.2: SmPC not downloaded
pifeltro §4.2: SmPC not downloaded
edurant §4.2: SmPC not downloaded
rezolsta §4.2: SmPC not downloaded
rezolsta §4.2: SmPC not downloaded
prezista §4.2: SmPC not downloaded
norvir §4.3: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
combivir §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.2: SmPC not downloaded
vocabria_inj §4.4: SmPC not downloaded
vocabria_inj §4.4: SmPC not downloaded
sunlenca_inj §4.2: SmPC not downloaded
sunlenca_inj §4.2: SmPC not downloaded
edurant §4.1: SmPC not downloaded
odefsey §4.1: SmPC not downloaded
eviplera §4.1: SmPC not downloaded
pifeltro §4.1: SmPC not downloaded
delstrigo §4.1: SmPC not downloaded
juluca §4.1: SmPC not downloaded
vocabria_inj §4.1: SmPC not downloaded
efv_ftc_tdf §4.1: SmPC not downloaded
biktarvy §4.1: SmPC not downloaded
rezolsta §4.6: SmPC not downloaded
tivicay §4.6: SmPC not downloaded
biktarvy §4.6: SmPC not downloaded
pifeltro §4.6: SmPC not downloaded
efavirenz §4.6: SmPC not downloaded
efavirenz §4.6: SmPC not downloaded
edurant §4.6: SmPC not downloaded
vocabria_inj §4.6: SmPC not downloaded
isentress §4.6: SmPC not downloaded
isentress §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
vocabria_tab §4.3: SmPC not downloaded
prezista §4.3: SmPC not downloaded
atazanavir §4.3: SmPC not downloaded
descovy §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
pifeltro §4.2: SmPC not downloaded
edurant §4.2: SmPC not downloaded
vocabria_inj §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
descovy §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
vocabria_tab §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
descovy §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
vocabria_tab §4.3: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
vocabria_tab §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
descovy §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
vocabria_tab §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
biktarvy §4.3: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
prezista §4.3: SmPC not downloaded
atazanavir §4.3: SmPC not downloaded
efavirenz §4.3: SmPC not downloaded
descovy §4.5: SmPC not downloaded
atazanavir §4.5: SmPC not downloaded
atazanavir §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
isentress §4.5: SmPC not downloaded
vocabria_tab §4.5: SmPC not downloaded
edurant §4.5: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
tivicay §4.3: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
prezista §4.5: SmPC not downloaded
tivicay §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
norvir §4.5: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
norvir §4.5: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
efavirenz §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
efavirenz §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
efavirenz §4.3: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
viread §4.5: SmPC not downloaded
atazanavir §4.3: SmPC not downloaded
prezista §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
prezista §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
efavirenz §4.3: SmPC not downloaded
atazanavir §4.3: SmPC not downloaded
viread §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
descovy §4.5: SmPC not downloaded
edurant §4.3: SmPC not downloaded
pifeltro §4.3: SmPC not downloaded
vocabria_tab §4.3: SmPC not downloaded
edurant §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
biktarvy §4.5: SmPC not downloaded
atazanavir §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
rezolsta §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
efavirenz §4.5: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
prezista §4.3: SmPC not downloaded
prezista §4.5: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
prezista §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
prezista §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
atazanavir §4.3: SmPC not downloaded
norvir §4.3: SmPC not downloaded
rezolsta §4.3: SmPC not downloaded
prezista §4.5: SmPC not downloaded
norvir §4.5: SmPC not downloaded
atazanavir §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
prezista §4.5: SmPC not downloaded
pifeltro §4.5: SmPC not downloaded
ziagen §4.4: SmPC not downloaded
viread §4.4: SmPC not downloaded
efavirenz §4.4: SmPC not downloaded
edurant §4.8: SmPC not downloaded
tivicay §4.4: SmPC not downloaded
combivir §4.4: SmPC not downloaded
atazanavir §4.4: SmPC not downloaded
edurant §4.2: SmPC not downloaded
tivicay §5.2: SmPC not downloaded
biktarvy §5.2: SmPC not downloaded
pifeltro §5.2: SmPC not downloaded
edurant §5.2: SmPC not downloaded
vocabria_inj §5.2: SmPC not downloaded
rekambys §5.2: SmPC not downloaded
sunlenca_inj §5.2: SmPC not downloaded

Audit trail

One JSON line per recommendation (input hash only by default).

Source freshness

all 0 SmPCs downloaded within 180 days

Run python -m tools.check_updates to re-fetch and diff them.

Source freshness

Product	SmPC revised	Downloaded	Age (days)

The ten oldest downloads. A weekly GitHub Actions job re-fetches every SmPC and fails if one has been revised or a claim no longer matches its source.

Hazard log

Initial developer assessment using the DCB0129 risk matrix (residual risk after controls). To be reviewed and owned by a Clinical Safety Officer.

ID	Hazard	Cause	Effect	Controls	Severity	Likelihood	Risk
H01	Contraindicated regimen ranked as suitable	Interaction, renal/hepatic limit or licensing restriction missing from the knowledge base	Toxicity or loss of efficacy	Every SmPC/BHIVA statement verified against source text in CI (tools/verify_smpc.py) Interaction matrix states blank != safe; Liverpool checker linked on every page Excluded regimens shown with reasons for clinician review	Major	Low	3
H02	Outdated product information	SmPC revised after download	Recommendation based on superseded dosing or contraindications	SmPC revision date shown on every product page tools/check_updates.py re-fetches and diffs SmPCs and re-runs verification Knowledge-base version on every report	Considerable	Low	2
H03	Resistance under-estimated	Local approximate scores; archived mutations not entered; minority variants below threshold	Regimen with reduced activity chosen; further resistance	Stanford HIVdb algorithm available Cumulative genotype across all tests incl. proviral DNA Minority variants and local-mode use flagged in alerts MDT prompt for multiclass resistance	Major	Low	3
H04	Data-entry error	Wrong units (creatinine µmol/L vs mg/dL), wrong patient, mistyped mutation	Wrong renal or resistance assessment	Range validation on all numbers Mutation notation and gene positions validated Patient summary echoed on the report	Considerable	Medium	3
H05	Automation bias	Clinician accepts top-ranked regimen without review	Inappropriate regimen for factors the tool does not model	Education mode by default All reasons and citations displayed Scope and limitations stated No automatic prescribing	Considerable	Medium	3
H06	External service unavailable or returns error	Stanford HIVdb outage	Resistance not scored as expected	Automatic fall-back to local scores with a visible warning Source of scores shown on the report	Significant	Low	2
H07	Paediatric or HIV-2 patient assessed with adult HIV-1 logic	Out-of-scope use	Wrong dosing or ineffective drugs	Critical alert for age < 18 HIV-2 mode excludes NNRTIs and disables HIV-1 resistance scoring	Major	Very low	2
H08	Confidential data disclosed	Audit or case files containing clinical data; data sent to HIVdb	Information-governance breach	Audit log stores an input hash only by default HIVdb opt-in; no identifiers sent Case files saved only to the user's own device	Considerable	Low	2

DCB0129 risk matrix

Likelihood \ Severity	Minor	Significant	Considerable	Major	Catastrophic
Very high	3	4	4	5	5
High	2	3	3	4	5
Medium	2	2	3	3	4
Low	1	2	2	3	4
Very low	1	1	2	2	3