Safety-case redaction is the removal of patient and reporter IDs from a pharmacovigilance narrative. It supports EudraVigilance and ICH E2B(R3). anonym.plus runs locally and keeps the suspected medicine and the event.
When this applies
A safety narrative names the person and the one who reported it, often a doctor. Before you submit or share it, you clear those IDs but keep the signal.
How anonym.plus handles it
- Open the narrative in anonym.plus on your device.
- It scans the free text for the named people in it.
- Dates, contacts, and IDs get flagged across the entry.
- Confirm the flags; the suspected medicine is not an ID and stays.
- Swap or black out the confirmed items.
- Save the clean file. The source never leaves your machine.
What you need to provide
- The narrative (DOCX, PDF, TXT, or export).
- An operator: Redact for submissions, Replace for review.
- Optional reporter map for blinded sharing.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | Sofia Lind → [PATIENT] |
| Names | PERSON | Dr. Owusu → [REPORTER] |
| Dates | DATE_TIME | onset 02 Mar → [DATE] |
| Contact | EMAIL_ADDRESS | report@example.com → [EMAIL] |
| Location | LOCATION | Lyon clinic → [SITE] |
| Identifiers | NATIONAL_ID | case ID 9F-22 → [ID] |
Compliance achieved
- Supports EudraVigilance and ICH E2B(R3) sharing.
- Keeps the suspected medicine, since it is not patient PHI.
- Fully offline — sensitive narratives are never uploaded.
Anonymize pharmacovigilance cases offline — see plans & start free →
Limitations & cautions
A safety narrative is free text with personal clues mixed in. The suspected medicine must stay, as it carries the signal. Review the story for rare event-and-place clues that can hint at one person.
Frequently asked questions
Should the suspected medicine be removed?
No. The product name is not personal PHI and carries the safety signal, so it stays. Only the IDs of the named people are flagged for removal.
Are the reporting clinician's details PHI?
The one who reported is often a clinician, not the patient. Many teams still blind those names for sharing. The tool can flag the two roles apart or together.
Does it support the E2B(R3) free-text fields?
Yes. The narrative blocks are scanned as free text, where the personal clues hide.