GDPR Article 9 and Manuscript Editing: Can You Send Patient Data to an Editor or an AI Tool?
Removing a patient’s name rarely makes a clinical manuscript anonymous. Before medical manuscript editing by a person or an AI tool, check identifiability, the lawful basis, the recipient’s role and the safeguards in place.

- Article 9
- Health data is special-category data
- You need
- Article 6 lawful basis plus an Article 9(2) condition
- Pseudonymised
- Still personal data
- Editors and AI
- Processor contract, security and transfer checks
Quick answer
- Sharing identifiable patient data with an editor or AI tool is processing under the GDPR.
- Health data needs both an Article 6 lawful basis and an Article 9(2) condition.
- Pseudonymised data remain personal data; only genuine anonymisation takes data outside the GDPR.
- Use an Article 28 contract for editors acting as processors, and check AI providers’ retention, training and transfer terms.
01Why patient data protection matters in manuscript editing
During medical manuscript editing, drafts pass to language editors, translators, publishers and AI writing platforms. Each handover can disclose health information. Patient data protection and medical data privacy depend on whether patients remain identifiable, whether the processing is lawful and whether the recipient offers appropriate safeguards; case reports are a common example [2].
02What does GDPR Article 9 require?
GDPR Article 9 prohibits processing special-category personal data, including data concerning health, unless one of the conditions in Article 9(2) applies [1]. Diagnoses, histories, treatment records and genetic results all qualify, which is why sensitive health data under GDPR turns up even in routine manuscript details.
Article 9 never works alone. Processing needs a lawful basis under Article 6 and an Article 9(2) condition, such as explicit consent, health care, public health or scientific research under EU or national law [1]. Consent to join a study does not automatically cover later disclosure to an external editor or AI service, and the Article 5 principles of purpose limitation, data minimisation and security still apply.
03GDPR and manuscript editing: who is responsible?
In GDPR and manuscript editing arrangements, the party that decides the purposes and means of processing is the data controller: usually the researcher’s hospital, university or sponsor. An external editor handling personal data on the controller’s documented instructions is a data processor, and Article 28 then requires a contract, often called a data processing agreement, covering instructions, confidentiality, security and sub-processors [1]. A bare confidentiality clause does not replace it, and the recipient’s actual activities, not the label “editor”, decide its role.
An AI platform’s role likewise depends on what it does with content: whether it only provides the requested service, retains submissions, allows human review or uses them to train models.
| GDPR provision | Why it matters |
|---|---|
| Article 5 | Principles: purpose limitation, data minimisation, integrity and confidentiality |
| Article 6 | A lawful basis for any processing of personal data |
| Article 9 | Additional conditions for health and other special-category data |
| Article 28 | A binding contract when a processor acts for a controller |
| Article 32 | Appropriate technical and organisational security |
| Article 35 | A data protection impact assessment where processing is likely to be high risk |
| Chapter V | Rules for transfers of personal data outside the EEA |
These provisions work together. A contract with an editor does not, on its own, establish a lawful basis.
04Anonymisation and pseudonymisation: what is the difference?
Health data anonymisation means no one is identifiable by any means reasonably likely to be used; genuinely anonymous data fall outside the GDPR (Recital 26) [1]. Pseudonymisation of patient data replaces direct identifiers with codes and keeps the key separately. It lowers risk, but pseudonymised data remain personal data: a safeguard, not an exemption [3]. The EDPB’s Guidelines 02/2026 on anonymisation are still a draft open for consultation until 30 October 2026 [4].
Clinical manuscripts are hard to anonymise because identification is often indirect: a rare diagnosis, exact age, treatment date, small locality or distinctive sequence of events, plus images, captions, supplementary files and document metadata. De-identification lowers but does not remove re-identification risk: it is very low in secure research environments [5], but de-identified notes still leak information that a less controlled setting can exploit [6]. Review the whole package and generalise unnecessary detail while keeping the scientific meaning.
05Can you upload patient data to an AI tool?
AI-assisted manuscript editing may be possible, but combining AI tools and patient data needs a deliberate assessment. Uploading personal data is processing, so it needs the same lawful basis, Article 9 condition and safeguards as any other disclosure. A provider’s promise not to train on your content does not by itself make the processing lawful. Ask:
- Is identifiable information necessary? Grammar and style correction rarely needs names, exact dates or hospital numbers.
- What happens to submitted content? Check retention, deletion, human access, reuse and model training terms.
- Who can access it, and where? Consider sub-processors, locations and whether transfer rules apply.
- Has the institution approved the tool? Research agreements and publisher policies may restrict external AI services.
- Is a DPIA needed? A data protection impact assessment under Article 35 may be required for high-risk processing.
The European Data Protection Supervisor’s guidance on generative AI is useful reading, but it is addressed to EU institutions under Regulation (EU) 2018/1725, not to every hospital, university or commercial provider [7].
| Scenario | Practical approach |
|---|---|
| The manuscript is genuinely anonymous | Outside the GDPR, but confidentiality, ethics, contract and journal duties still apply |
| Names replaced with codes; a key exists | Pseudonymised personal data: assess lawful basis, Article 9 condition and safeguards |
| Case report with a rare condition and detailed timeline | Assess whether combined details identify the patient; generalise what is not needed |
| AI tool to edit identifiable patient material | Do not upload until lawfulness, terms, security, retention and transfers are assessed |
| External editor processes personal data for a controller | Confirm the editor’s role and put an Article 28 contract in place |
06GDPR international data transfers, security and patient confidentiality
GDPR international data transfers arise when an editor or AI provider accesses personal data from outside the EEA; the provider’s headquarters alone does not settle it. Under Chapter V, a transfer can rely on an adequacy decision or safeguards such as standard contractual clauses, set out in Commission Implementing Decision (EU) 2021/914 [8]. The right module and any transfer assessment depend on the parties’ roles. Proportionate security includes restricted access, encryption, secure transfer, controlled retention and a data breach response plan.
GDPR compliance does not replace clinical confidentiality, ethics approvals, data-sharing agreements or journal rules, and consent to publish an identifiable case report is separate from the lawful basis for editing. Responsible sharing of clinical data also needs governance and clear conditions for reuse [9].
07A practical checklist before sharing a manuscript
Use this GDPR compliance checklist before sending a manuscript to an editor, translator or AI platform.
Before you share
- Identify direct and indirect identifiers in text, tables, figures, images, supplements and metadata.
- Remove details the editing task does not need, without compromising scientific accuracy.
- Assess whether what remains could identify a patient when combined with available information.
- Where personal data remain, record the Article 6 lawful basis and the Article 9 condition.
- Check the recipient’s role, privacy terms, retention, security and reuse of content.
- Put an Article 28 contract and confidentiality terms in place where required.
- Confirm whether Chapter V applies and which transfer mechanism is used.
- Check institutional, ethics, professional and publisher requirements, and document the decision.
Questions
Can I send an identifiable case report to a professional editor?
Only with a lawful basis, an Article 9 condition and, where the editor acts as a processor, an Article 28 contract. Removing unnecessary identifiers first is the safer default.
Is pseudonymised patient data still covered by the GDPR?
Yes. Pseudonymisation reduces risk, but data that can be linked back to a person remain personal data.
Does an AI provider’s no-training promise make uploads lawful?
No. It is a useful safeguard, but you still need a lawful basis, an Article 9 condition, security and transfer checks.
References
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation). Official Journal of the European Union. 2016;L119:1–88. https://eur-lex.europa.eu/eli/reg/2016/679/oj
- Roguljić M, Ščepanović R, Rees M. Writing case reports, consent for publication and General Data Protection Regulation (GDPR). Case Rep Womens Health. 2020;27:e00204. https://doi.org/10.1016/j.crwh.2020.e00204
- European Data Protection Board. Guidelines 01/2025 on pseudonymisation, version 1.0 (adopted for public consultation 16 January 2025). EDPB; 2025. https://www.edpb.europa.eu/system/files/2025-01/edpb_guidelines_202501_pseudonymisation_en.pdf
- European Data Protection Board. Guidelines 02/2026 on anonymisation, version 1.0 (adopted for public consultation 7 July 2026). EDPB; 2026. https://www.edpb.europa.eu/system/files/2026-09/edpb_guidelines_202602_anonymisation_v1_en_0.pdf
- Ford E, Pillinger S, Stewart R, et al. What is the patient re-identification risk from using de-identified clinical free text data for health research? AI Ethics. 2025;5:4441–4454. https://doi.org/10.1007/s43681-025-00681-0
- Sarkar AR, Chuang YS, Mohammed N, Jiang X. De-identification is not enough: a comparison between de-identified and synthetic clinical notes. Sci Rep. 2024;14:29669. https://doi.org/10.1038/s41598-024-81170-y
- European Data Protection Supervisor. Generative AI and the EUDPR: orientations for ensuring data protection compliance when using generative AI systems, version 2. EDPS; 28 October 2025. https://www.edps.europa.eu/system/files/2025-10/25-10_28_revised_genai_orientations_en.pdf
- European Commission. Commission Implementing Decision (EU) 2021/914 on standard contractual clauses for the transfer of personal data to third countries. Official Journal of the European Union. 2021;L199:31–61. https://eur-lex.europa.eu/eli/dec_impl/2021/914/oj
- Ohmann C, Banzi R, Canham S, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. 2017;7(12):e018647. https://doi.org/10.1136/bmjopen-2017-018647
Update log
- Published by Pubrica
How to cite this article
Vasanth. (2026, October 24). GDPR Article 9 and Manuscript Editing: Can You Send Patient Data to an Editor or an AI Tool?. Pubrica. https://pubrica.com/academy/publication-ethics/gdpr-article-9-patient-data-manuscript-editing/
This article is general information for researchers, not legal, regulatory or funding advice. Check the current requirements of your journal, funder, ethics committee or regulator before you act on it.

