Safety-case redaction is the removal of patient and reporter IDs from a pharmacovigilance narrative. Part 11 of the Human Medicines Regulations 2012 makes the marketing authorisation holder run a pharmacovigilance system and record every suspected reaction it hears of. anonym.plus runs locally and keeps the suspected medicine and the event intact.
When this applies
A safety narrative names the person and whoever reported it, often a doctor. The case goes to the MHRA in structured form, but the same text also travels to affiliates, partners, and signal reviewers who need the clinical facts only.
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.
Patient data entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | Aisha Okonkwo → [PATIENT] |
| Names | PERSON | Dr. Sharma → [REPORTER] |
| Dates | DATE_TIME | onset 02 Mar → [DATE] |
| Contact | EMAIL_ADDRESS | report@example.com → [EMAIL] |
| Location | LOCATION | Manchester clinic → [SITE] |
| Identifiers | NATIONAL_ID | case ID 9F-22 → [ID] |
Compliance achieved
- Supports the pharmacovigilance system a marketing authorisation holder must operate under Part 11 of the Human Medicines Regulations 2012, feeding the MHRA Yellow Card scheme.
- Follows MHRA-adopted GVP Module VI, which expects a narrative to carry the clinical story, not a personal dossier on the people in it.
- Processing rests on the public-health gateway in UK GDPR Art. 9(2)(i) with DPA 2018 Schedule 1, Part 1, paragraph 3 — quality and safety of medicinal products.
- Fully offline, so the case never leaves the safety unit; working copies are held under AES-256-GCM.
Anonymise 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. The tool does not replace the case-processing system your qualified person responsible for pharmacovigilance oversees; it cleans a copy for onward sharing. Review the story for rare event-and-place clues that can still hint at one person.
Frequently asked questions
Should the suspected medicine be removed?
No. The product name is not personal data 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 personal data?
Yes. The reporter is often a clinician rather than the patient, but their name and contact details are still personal data, and GVP Module VI expects reporter identity to be kept confidential. 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, which is where personal clues hide once the structured fields have been coded.