- What is at stake: personal data and proprietary information
- What controls to require from a medical translation provider
- Workflows that reduce exposure
- ISO certification and audited processes: what they guarantee
- How M21Global handles confidentiality in pharmaceutical and clinical translation
- Related Services
- Frequently Asked Questions
Clinical documentation contains some of the most sensitive information an organisation handles: patient data, trial results, proprietary formulations, and regulatory submissions. When that documentation needs to be translated, it leaves the controlled internal environment and passes through an external workflow. How that transition is managed determines whether the organisation stays within its legal obligations or takes on significant, avoidable risk.
What is at stake: personal data and proprietary information
Clinical documentation rarely contains just one category of sensitive information. A clinical study report may include identifiable participant data, laboratory results, proprietary protocols, and correspondence with regulatory authorities. Each category is governed by a different legal framework.
In the European context, the General Data Protection Regulation (GDPR) classifies health data as special category data under Article 9, subject to stricter processing conditions than ordinary personal data. Any organisation that processes this data on behalf of another, including a translation provider, acts as a data processor under Article 28. This requires a Data Processing Agreement (DPA) that defines the processor's obligations, the scope of processing, and the procedures to follow in the event of a breach.
Beyond the GDPR, commercially sensitive information may be protected by non-disclosure agreements, trade secret legislation (EU Directive 2016/943), and, in the context of clinical trials, conditions imposed by ethics committees and competent authorities.
What controls to require from a medical translation provider
Evaluating a translation provider for clinical documentation goes well beyond linguistic quality. Operational and technical controls matter equally.
Data Processing Agreement (DPA). Any provider that processes personal health data as part of a translation project must be willing to sign a GDPR-compliant DPA. An inability or refusal to produce one is a clear warning sign.
Non-disclosure agreements (NDAs). For proprietary content such as investigational medicinal product dossiers, pre-clinical data, or marketing authorisation applications, a project-specific or client-specific NDA should be in place alongside the DPA.
Anonymisation before translation. Where operationally feasible, direct identifiers (patient name, date of birth, case number) should be replaced with codes before documents are shared with the translation provider. This reduces residual risk even when other controls are functioning correctly.
Secure file transfer. Sending clinical documentation by unencrypted email is not an adequate practice. The provider should offer a secure client portal, SFTP transfer, or a platform with end-to-end encryption.
Restricted internal access. A properly structured provider ensures that only the translators and reviewers assigned to a specific project can access its content. Shared translation memories without adequate client segmentation can expose fragments of sensitive text to unrelated third parties.
Retention and deletion policy. The provider's DPA or privacy policy should specify how long files are retained after project completion and how deletion is carried out. This is not a detail to leave unresolved.
Workflows that reduce exposure
Confidentiality management is not purely a contractual matter. Operational workflows have a direct bearing on risk.
Translating clinical trial protocols for regulatory submission is one context where exposure is particularly high. Documents circulate between research teams, sponsors, authorities, and translators before submission. Each transfer is a risk point.
A well-designed workflow includes: advance identification of the data categories present in the document, application of relevant anonymisation or pseudonymisation measures, secure transmission to the provider, confirmation of access restriction, and certified deletion of files after delivery.
For multilingual projects, the risk compounds because the same documents are shared with multiple translators, potentially across different countries. International transfers of personal data outside the European Economic Area require additional safeguards under the GDPR, such as Standard Contractual Clauses or verification of an adequacy decision for the destination country.
ISO certification and audited processes: what they guarantee
ISO 17100:2015 certification defines requirements for the translation process, including translator qualifications and the revision workflow. It does not, by itself, define data security requirements. However, a certified provider operates under documented and audited processes, which makes it easier for clients to verify practices.
Some providers go further and implement controls aligned with information security management standards such as ISO 27001. For high-risk clinical documentation, such as Phase III trial data or marketing authorisation applications, this additional layer of assurance may be worth requesting.
Certification of any kind does not replace contractual due diligence. A well-drafted DPA, an applicable NDA, and a clear retention policy are legal instruments that operate independently of the provider's technical certifications.
How M21Global handles confidentiality in pharmaceutical and clinical translation
M21Global has worked with clinical and pharmaceutical documentation for over 20 years, with processes certified to ISO 17100:2015 by Bureau Veritas. For projects involving personal health data, the company signs GDPR-compliant Data Processing Agreements and provides project-specific NDAs on request.
Workflows for pharmaceutical translation include project-level access controls, secure file transfer, and defined retention policies. Translation teams are composed of specialists in life sciences, with experience across regulatory, clinical, and medical device documentation.
To discuss the confidentiality requirements for a specific project, or to request a proposal that includes a DPA, contact the M21Global team directly.
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Frequently Asked Questions
Is a translation provider considered a data processor under the GDPR?
Yes. When a translation provider processes personal health data to deliver a service, it acts as a data processor under Article 28 of the GDPR. A Data Processing Agreement (DPA) is required, setting out the obligations of both parties.
Is anonymising patient data before translation legally required?
There is no universal legal obligation to anonymise before translation, but it is a widely recommended practice. Anonymisation or pseudonymisation reduces residual risk and may, in some contexts, allow data to be processed outside the stricter restrictions that apply to special category data under the GDPR.
What should an NDA with a medical translation provider cover?
The NDA should identify the categories of protected information, restrict the provider's use of that information to the specific project, prohibit inclusion in shared translation memories accessible to third parties, require deletion after project completion, and specify consequences for breach.
Does ISO 17100 certification guarantee data security in translation?
ISO 17100:2015 certifies the translation process and translator qualifications, but does not define information security requirements. For additional assurance in this area, it is worth checking whether the provider also operates controls aligned with standards such as ISO 27001.
Can clinical documentation be translated outside the EU without breaching the GDPR?
It can, but additional safeguards are required. Transfers of personal data to countries outside the European Economic Area must be covered by a mechanism such as Standard Contractual Clauses approved by the European Commission, or the destination country must have an adequacy decision in place.
