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Imported item 10
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Imported item 11
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Imported item 12
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

S

Imported item 24

Shadow AI is the use of artificial intelligence tools for work without the organisation’s approval or oversight. It can include personal chatbot accounts, browser extensions or unassessed features inside existing software. In life sciences, the concern is what information enters these tools and how outputs influence decisions.

Key Takeaways

  • An approved software subscription does not necessarily mean every new AI feature has been assessed.
  • Patient information and confidential study content should not enter unassessed tools.
  • Clear approved alternatives and practical training are more useful than a policy employees cannot apply.

Where Can Shadow AI Appear?

ElementMeaning
Personal chatbotDrafting a report outside approved systems
Browser extensionProcessing content from an open document
Embedded featureSummarising records through an unassessed service

Australia’s National AI Centre describes unapproved AI use as a governance problem that can arise when workers seek faster or easier ways to complete tasks. Its guidance recommends understanding actual use, setting clear expectations and providing support. Whether a particular tool retains prompts, trains models on them or shares information depends on its configuration and terms. Do not assume that every provider behaves identically, or that deleting a chat removes every copy of the information.

Primary guidance: National AI Centre unapproved AI guidance.

Why It Matters for Data Protection

Consider a hypothetical clinical operations employee pasting a participant narrative into a personal chatbot to improve the wording. We recommend stopping further disclosure, preserving relevant details and escalating through the organisation’s incident process for assessment. For prevention, define permitted tools, permitted data and prohibited uses together. Provide realistic examples, a route to request new capabilities and an approved way to work with sensitive material. Check vendor terms, access controls and retention before authorising a workflow. Assign governance responsibilities explicitly without presenting an “AI officer” job title as a universal legal requirement.

Frequently Asked Questions

Is shadow AI always malicious?

No. It can arise from ordinary attempts to save time or solve a problem.

Is an enterprise account automatically safe?

No. Assess the intended use, configuration, information and contractual terms.

Will banning all AI solve the problem?

A ban alone does not provide approved alternatives or ensure staff understand the boundary.

Related reading: AI literacy; AI officer.

Explore iliomad’s AI officer support for your organisation.

Updated: 27 October 2026