Regime applicability record
- 0 applicable regimes, 0 evidence items, 0 owners.
- 0 ruled out, with the answer that excluded each.
Global Compliance · Expanded Global Compliance
Regulatory Applicability Intelligence
Work out which obligations may apply to this business from its legal entities, activities, industry, locations, workforce and other verified facts, and show each as appl…
Demonstration: Pellam Diagnostics Ltd (fictional) · Medical devices. Fictional data and a scripted answer.
The situation
- Organisation
- Pellam Diagnostics Ltd (fictional)
- Who is asking
- Head of regulatory affairs
- Industry
- Medical devices
- What happened
- The company is considering a new service line and needs to know which regulatory regimes will apply before it commits.
The question asked
Which regulatory regimes would apply to a remote-monitoring service, given what we plan to do?
What it reads, and who can see the result
- Service definition formAnswers about the planned service.
- Regime library registerSynthetic regimes and their triggers.
- Reads
- The answers entered about the service and the regime library.
- Does not read
- Patient or customer data.
- Permission
- Regulatory affairs' library access.
- Who sees it
- Regulatory affairs, legal and the product owner.
Try it
Answer the questions about the organisation. Each rule becomes applicable, not applicable, or undetermined until the questions it depends on are answered: nothing is assumed.
| Obligation | Where | Status | Evidence and owner |
|---|---|---|---|
| Remote monitoring registration Synthetic Telehealth Code, part 3 | Region A | UndeterminedNeeds: Will the service transmit health readings from a patient's home to the company | None needed |
| Clinical decision support assessment Synthetic Device Act, s. 9 | Region A | UndeterminedNeeds: Will clinicians act on the readings without independent review | None needed |
| Public procurement security schedule Synthetic Procurement Rules, sch. 4 | Region A | UndeterminedNeeds: Will it be sold to public hospitals | None needed |
| Cross-border processing safeguards Synthetic Data Code, art. 21 | Region A | UndeterminedNeeds: Will the service transmit health readings from a patient's home to the company; Will readings be processed by a provider outside the region | None needed |
- Applies
- 0
- Does not apply
- 0
- Undetermined
- 4
- Answered
- 0 of 4
The answer
Simulated answer. Written for this fictional case, not produced by a live model. Only the figures in it are computed, from what you decided above.
0 regimes would apply, 0 would not, and 4 are undecided.
Each regime applies only on facts about the planned service [S1][S2]. Where a fact is not yet given the regime is undetermined, and the table names the question it needs.
The point of the exercise is to know the evidence the new service will need before committing: 0 items across 0 owners if the planned answers are as given.
Relies on: S1 · Regime library extractS2 · Service definition, answered
Review and approval
The head of regulatory affairs decides. Approving records the applicable regimes as the regulatory basis for the business case. It does not register the service anywhere.
Not ready to approve. 4 obligations are undetermined until the questions they depend on are answered. Answer them first; nothing is assumed.
In the product this is a different person with the right permission. Here you play that role to see the rule.
What it produces
Limits of this example
- Synthetic regimes; a real analysis uses the legal text and a lawyer.
- A fact that changes (a new market) changes the answer.
- This is a scripted demonstration on fictional data. No model was called and no real organisation, person or result is shown.
More in Global Compliance
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- Assurance and evidenceWhen an auditor or an inspector arrives, evidence has to be found in a hurry, and gaps appear for the first time.
- Regulatory Change Impact IntelligenceWatch approved authoritative sources, detect changes that matter, identify the entities, processes, systems and controls they affect, and start a governed review and rem…
- Continuous Control MonitoringEvaluate whether each control is operating: evidence present and current, expirations, exceptions and failures, so assurance is ongoing instead of a one-time checklist.
- Contract Compliance IntelligenceRead customer-authorised contracts for obligations, service commitments, deadlines, renewals, restrictions, responsibilities and compliance risks, with citations to the…
- Audit Readiness and Evidence CompletenessConnect each obligation to its controls, evidence, owner and effectiveness, show which artifacts are missing, and produce an evidence-backed preparation and gap report.
The Global Compliance story · This capability in the full register