> For the complete documentation index, see [llms.txt](https://opora.gitbook.io/opora-health-documentation/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://opora.gitbook.io/opora-health-documentation/technology-compliance-processes.md).

# Technology Compliance Processes

Deploying the OPORA Platform goes beyond infrastructure setup - it supports your team in aligning with regulatory requirements, providing the technical documentation and guidance needed to help you fulfil these obligations within your institutional context.

***

### You Will Likely Need to Prepare:

* **Data Management Plans (DMPs).** For grant funders or clinical trials, describing how data is collected, stored, secured, and shared.
* **Institutional Review Board (IRB) Applications & Reports.** Detailing study methodology, privacy safeguards, and patient data use protocols.
* **Ethics Committee Reports.** Especially for longitudinal, AI-based, or cross-border data use.
* **EU AI Act Compliance Reporting.** For projects involving AI systems classified as high-risk (e.g., diagnostic support, behavioural analysis).

***

### We Support You With:

* ✅ Technical system overviews and security architecture diagrams
* ✅ Consent model explanations and data governance flowcharts
* ✅ AI-readiness documentation aligned with GDPR and the EU AI Act
* ✅ Consultation on embedding OPORA into DMPs or IRB submissions

> 🛠️ *We support the infrastructure. You lead the regulatory process—with technical documentation to back every step.*