Webinar recording: Governed AI for defensible Regulatory Positions
AI can produce a regulatory answer in seconds. It can summarise a regulation, suggest a classification, create a market-entry pathway or draft a checklist. But a useful answer is not necessarily a defensible one.
Can you explain which product, market, regulatory assumptions and source material the answer was based on? Can a colleague review it? Can the organisation reassess it when the regulation, product or intended market changes?
For Regulatory Affairs, those questions matter as much as the answer itself.
Why general AI answers are not enough for Regulatory Affairs
General AI works from the prompt in front of it. It may produce an excellent response, but it does not inherently know which regulatory requirements your organisation has already assessed, why they were considered applicable, or how that conclusion relates to a specific product in a specific market. That creates a practical limitation.
Every new question risks becoming a new, isolated assessment. The answer may be useful in the moment, but the underlying context, assumptions and regulatory reasoning are not necessarily retained in a controlled, reviewable form.
A regulatory decision should instead begin with an established Regulatory Position: an organisation’s documented and defensible conclusion on how a product is regulated in a defined market.
This connects the product, company, market, applicable requirements and documented rationale. It provides the context needed to assess change, prepare market entry and create further regulatory working material without starting from a blank prompt each time.
What governed AI changes
Governed AI is AI used within defined controls for purpose, data, accountability and human oversight.
In Compliance Studio, the AI works from defined product, company and market context. Its output is identifiable and reviewable, while final regulatory decisions remain with the user.
That changes the nature of the question from:
What regulations apply to this product?
to:
Based on our established Regulatory Position for this product in this market, what does this regulatory development mean and what action is required?
Or, when preparing a new market:
What Regulatory Position do we need to establish for this product in this target market, and what are the next steps?
Watch the webinar recording
In the webinar below, we establish a Regulatory Position for NeuroTrack Home and then use it in two practical scenarios:
Assess a regulatory change: determine whether a new regulatory development affects the established position and document the required action.
Prepare for entry into a new market: create a structured regulatory pathway and identify the next steps.
Establish. Maintain. Act.
A Regulatory Position should not be a one-time assessment stored in a spreadsheet or document.
It should support three connected activities:
Establish by defining product, company and market context, identifying applicable requirements and documenting rationale.
Maintain by assessing regulatory change against the established position and preserving a traceable decision record.
Act by turning the position into practical regulatory pathways, assessments, checklists and other working artefacts.
This is the role of Compliance Studio: to support Regulatory Affairs teams in establishing and continuously maintaining defensible Regulatory Positions across products and markets.
If you would like an independent review of your current applicable-requirements list or Regulations Register, Hoodin offers a complimentary Regulatory Position Review for one product or product category in one target market.
