Published April 25, 2026 | Version v1
Output management plan Open

Clinical Data Governance Checklist (CDGC): For Structured, Unstructured, and AI- Enabled Clinical Systems

  • 1. Holistic Research Canada

Description

The Clinical Data Governance Checklist (CDGC) is a practitioner‑facing governance tool developed for psychotherapy and behavioural health clinics operating in digitally mediated and AI‑enabled care environments. It responds to a growing gap between contemporary clinical data practices and the consent language, governance guidance, and visibility available to frontline practitioners.

Routine outcome monitoring, digital documentation, and AI‑assisted features now generate and transform clinical data across multiple vendors, subprocessors, jurisdictions, and systems. Consent forms and governance processes developed prior to these shifts rarely reflect how client data are collected, derived, retained, shared, or re‑used in practice. This misalignment represents a sector‑wide governance gap rather than an individual clinician failure, with implications for client trust, therapeutic relationships, clinician psychological safety, and ethical and legal accountability.

The CDGC is designed for the realities of clinical practice: resource‑limited settings, relationship‑centred care, and digital platforms not built to support ongoing governance reflection. It is not a compliance audit, legal instrument, regulatory checklist, or performance evaluation, and it does not assess jurisdiction‑specific legal compliance. Instead, it supports structured practitioner reflection by making data practices visible, aligning consent language with actual platform behaviour, and integrating governance awareness into routine clinical work.

The checklist comprises eleven practitioner‑facing sections, analytically grouped into seven governance domains:

  • Consent language and client communication
  • Clinical purpose limitation and integration
  • Data inventory and proportionality
  • Data‑flow mapping and jurisdictional awareness
  • Access controls, confidentiality, and role limitation
  • Lifecycle awareness for derived and AI‑assisted data
  • Vendor governance and ongoing accountability

Completion of the CDGC produces documented awareness and a structured review record rather than a numerical or pass/fail score. It is intended to be revisited iteratively as platforms, features, contracts, and clinical contexts evolve, supporting governance as a continuous clinical practice rather than a static administrative task.

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Digital_Clinical_Data_Governance_Checklist.pdf

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Additional details

Related works

Is supplement to
Preprint: 10.5281/ZENODO.19615183 (DOI)