Shadow AI in Pharma: Clinical Data at Risk

Security and IT

Maintain discovery coverage, investigate technical anomalies and operate access controls. Security should explain what the logs prove and where visibility ends. It also checks whether sanctioned services support identity, logging, retention and configuration standards.

Privacy and legal

Translate observed workflows into data, confidentiality and notification questions. Review terms for training, retention, location and subprocessors. When facts suggest a disclosure, use the established legal and privacy assessment process rather than deciding from a domain count.

Procurement and vendor risk

Prioritize services that employees actually use. Confirm the exact plan, contracting entity and product features because one vendor can offer several materially different data practices. Preserve the assessment date and schedule a review for important services.

Business owners

Explain the task, data and reason for adoption. Decide whether the workflow is valuable enough to sanction, redesign or replace. Owners also nominate local guidance, test approved alternatives and confirm that remediation works in daily practice.

People and communications

Give employees examples they recognize, a simple approved-tool directory and a route to request new uses. Communications should avoid implying that DNS reveals prompts. Training is more credible when it solves the workflow that led users to the tool.

Internal audit and assurance

Test whether scope is documented, findings have owners, exceptions expire and follow-up runs verify change. Assurance can sample the chain from source export to final disposition without needing access to every identity in the operational report.

Scope statement

Identify the log source, dates, included networks and available identity types. List known blind spots such as unmanaged mobile data, direct IP connections or sites that use a different resolver.

This keeps later readers from giving the numbers more certainty than the collection method supports.

Observed-tool register

Keep the service name, matched domains, category, first and last observation, identities and sanctioned status. Store dated vendor-term research beside the observation rather than silently overwriting old decisions.

The result becomes a practical subset of the wider AI system inventory.

Decision record

For each material tool, name an owner, intended use, permitted data, account requirement and disposition. Include the reason for approval, restriction or blocking in language a business user can follow.

A short rationale is more useful than a color with no explanation.

Remediation evidence

Attach tickets, procurement decisions, configuration changes, user guidance and incident references where applicable. Link each artifact back to the finding it addresses.

This traceability shows that discovery led to controlled action rather than a report that was filed and forgotten.

Exception register

Some teams need a restricted tool temporarily. Record the business reason, data limits, accountable owner, compensating controls and expiry date.

Time-bound exceptions prevent urgent workarounds from becoming permanent, invisible policy.

Follow-up comparison

Preserve a comparable later report and explain major changes in scope. Track whether targeted identities moved, whether alternative domains appeared and whether approved services gained adoption.

Trend evidence makes the control testable instead of merely aspirational.