Data Processing

How we handle your data

ME-TA is a Danish data processor under the GDPR and Danish law. This page shows where your data goes, who can see it, and how AI is used on your engagement. Your DPA decides the details.

ME-TA's standard DPA. This page describes ME-TA's standard Data Processing Agreement and the architecture behind it. Each sponsor's DPA adapts it to the sponsor's procurement, regulatory and operational needs; binding terms arise only from the DPA signed with each sponsor. The AI routes below follow the editions of ME-TA's AI-usage, approved-tools and GDPR policies now in signing (P22, P16 and P21, version 03).

In short. Your data is stored in AWS eu-west-1 (Ireland) under the AWS GDPR Data Processing Addendum. ME-TA statisticians work on company-owned, encrypted PCs, and SAS runs in ME-TA's validated statistical computing environment (SCE). Storage stays in the EEA, and so does processing unless your DPA names route C; AI is used only on the route your DPA names, and AI never reads your study datasets unless your DPA releases them by name. A named ME-TA statistician or programmer signs off every program. Breach notification: within 24 hours to you.

Where your data goes

Access

Your users, your sign-in

Sign-in through your identity provider (SAML) or one-time email codes; sessions expire within 60 minutes. Your administrator grants access per study, and every action is recorded in the audit trail (P07).

Location

EU storage, EU processing

Files in AWS eu-west-1 with copies in eu-central-1; database backups kept 7 days. The only disclosed exception: an optional accelerated-upload mode, off by default, routes encrypted upload traffic over the AWS edge network.

Quality

Validated, audit-ready

22 effective policies at policy.me-ta.dk. The SCE is validated under ME-TA's Validation Master Plan; the signed 21 CFR Part 11 / EU Annex 11 mapping (1-5.4 v02) and the validation records are available under NDA or audit rights.

End of engagement

Your data is never captive

Datasets and programs can be exported throughout the engagement, with a 30-day export window at contract end. Then return or deletion on your instruction, including working copies on ME-TA's PCs.

Choosing the AI route in your DPA

The choice is between keeping everything in the EU, on ME-TA's AWS account (route A) or your own (route B), and Anthropic's business plan (route C), where your data stays stored in the EU but what the AI reads is processed outside the EEA. Name the route in your DPA; one line is enough, and ME-TA supplies the wording. Routes can be combined by content. The deliverables are the same on every route.

No AI A · EU only, ME-TA's AWS Recommended B · EU only, your own Bedrock C · EU storage, AI outside the EEA
What it is Statisticians and the SCE only Claude Code with Claude models on AWS Bedrock in an EU region, or ME-TA's own inference server in Denmark Claude Code with Claude models in your own AWS Bedrock account, on an API key you issue to ME-TA for the engagement Claude Code on ME-TA's Anthropic Team plan, under Anthropic's commercial terms
What the AI reads Nothing Restricted content: SAS jobs (program and log), metadata, reviewed documents. Study datasets only if your DPA releases them
Anthropic's role None Model author only; AWS is the sub-processor Model author only; AWS acts under your own AWS agreement Sub-processor (Anthropic Ireland, Limited), named in your DPA
Where it runs EEA EU regions; Denmark The EU region you choose in your AWS account Processed on Anthropic's infrastructure in the US, Europe, Asia or Australia; stored in the US
Transfer outside the EEA None None None EU Standard Contractual Clauses, with ME-TA's transfer impact assessment on request
Training on your content None No No No, by Anthropic's commercial terms
Retention None Bedrock keeps no prompts or completions Bedrock keeps no prompts or completions, unless you switch on invocation logging in your account ME-TA deletes conversations at engagement close; Anthropic then removes them within 30 days. Content Anthropic flags under its usage policy may be kept up to 2 years
Suits a sponsor who… does not permit AI requires EU residency wants the AI in its own AWS account, on its own bill wants Anthropic under a DPA

On every route: the AI drafts SAS programs; the SCE runs them, and they stay AI results until a named ME-TA statistician or programmer has checked and signed them off. No number in a deliverable is produced by AI, and the AI has no write access to your systems. Routes A and C can carry different prices, quoted per engagement; on route B the model use is billed to your AWS account.

Data values in SAS logs

A SAS log can carry a data value no one meant to release, for example from a put statement or an error message. Before AI processing starts, ME-TA assesses that risk for your engagement: the nature of the data (anonymized or pseudonymized), programming rules that keep values out of logs, monitoring in proportion to how independently the AI works, and when to reassess. A value found where it should not be is recorded and assessed under P11.

Claude Code: recommended and optional configurations

Recommended · route A

Claude Code on Bedrock in the EU

  • Approved Claude Opus or Sonnet models on AWS Bedrock, EU inference profile only; the model is pinned for the engagement, and other models and non-EU profiles are blocked in ME-TA's AWS account.
  • Telemetry, error reporting and feedback to Anthropic switched off; no web search, web fetch or unapproved connectors.
  • Runs on a separate ME-TA PC that holds no study datasets, and reads SAS jobs, metadata and reviewed documents.
  • Every model call recorded in AWS CloudTrail; local conversation files deleted at engagement close.

No new sub-processor, no transfer outside the EEA, nothing stored by the provider. ME-TA documents the configuration for your engagement and shows it on request.

Optional · by your choice in the DPA

More, or less, than the recommendation

  • Study datasets on route A. Same configuration, with your pseudonymized study data released to the AI. Your DPIA and your agreements with the data originators must allow it; ME-TA renews its EU AI Act assessment before use.
  • Route B, your own Bedrock. The route A configuration, on an API key from your AWS account, in the EU region you choose.
  • Route C, Anthropic's business plan. Restricted content, processed outside the EEA under the Standard Contractual Clauses.
  • No AI.

Each option is written into your DPA as release terms; nothing is released that they do not name.

Sub-processors

Your DPA's sub-processor annex lists exactly the rows that apply to your engagement. Changes to ME-TA's standing list are notified before they take effect, with a 30-day objection window.

Sub-processorRoleLocationInstrument
Amazon Web Services EMEA SARL (Luxembourg) Platform storage, database, sign-in and functions; on route A also Claude models on Bedrock, with no retention beyond the request and no training eu-west-1 (Ireland); copies in eu-central-1 (Frankfurt); Bedrock in EU regions AWS GDPR DPA
ME-TA inference server (Denmark) Route A: AI on ME-TA's own hardware. ME-TA's own processing, listed for transparency ME-TA premises, Denmark ME-TA DPA
Anthropic Ireland, Limited, route C only Claude on ME-TA's Anthropic Team plan, restricted content Processed in the US, Europe, Asia or Australia; stored in the US Anthropic DPA with the EU Standard Contractual Clauses
Microsoft Ireland Operations Ltd Workforce email and documents, device management and endpoint protection; no clinical data EU Microsoft Online Services DPA

On route B, Bedrock runs in your own AWS account under your agreement with AWS, so it is not ME-TA's sub-processor. Engagement-specific contractors, approved by you, are listed in your DPA. The live register is at policy.me-ta.dk (P21 §21.11).

What your DPA settles

ME-TA DPA

The standard DPA with the wording for your AI route and any release terms, filled in for your engagement.

contact@me-ta.dk →

Policies

P21 (GDPR, sub-processors) and P22 (AI usage), with the rest of ME-TA's QMS.

policy.me-ta.dk →

Validation package

Validation Master Plan, Validation Report and the signed Part 11 / Annex 11 mapping, under NDA or audit rights.

contact@me-ta.dk →

Regulatory conformance

Requirement by requirement: 21 CFR Part 11, EU Annex 11, the EU AI Act and the GDPR.

me-ta.dk/compliance →