Time-series sample
Fictional vitals CSV for discussion of drift, gaps, and labeling. Not real patient data.
Scenario brief
You are preparing a 90-day Alberta pilot for a fictional home-monitoring product: wearable sensor, patient mobile app, clinician web dashboard, and advisory-only AI triage support. The product is not approved for sale; this exercise is about planning discipline, not clinical claims.
Assume stakeholders include cardiology, nursing, privacy, IT security, procurement, and finance—as described in the mock requirements pack.
What this page helps you decide
This page helps learners apply the workbook to one integrated scenario. The goal is not to memorize every page; it is to practice connecting workflow, software, hardware, privacy, AI, cybersecurity, operations, risk, and cost into one coherent pilot plan.
Use it after the foundation pages and at least one software, hardware, regulatory, or operations pathway.
Source materials (downloads)
Mock requirements
Numbered stakeholder asks and hard constraints (residency, SBOM, economics).
Risk register starter
Seed rows to complete with severity, probability, and verification IDs.
Facilitator notes
Agenda, breakouts, and common failure modes.
Sample strong / weak patterns
What good and shallow answers look like.
Expected deliverables (teams)
Submit or present the following artifacts. Names are suggestions—match your QMS template IDs if applicable.
- REG-DRAFT-01 — One-page regulatory plan: intended use draft, Canada-first pathway assumption, open questions for RA, and PCCP yes/no with rationale.
- ARCH-DRAFT-01 — Data-flow diagram: wearable → app → API → storage → dashboard; mark Canada regions; show offline / stale-data behavior.
- RISK-DRAFT-01 — Completed CSV (or PDF export) from the risk starter, minimum five rows including cybersecurity and usability.
- PRIV-DRAFT-01 — Half-page PIA outline referencing custodian role, subprocessors, and breach notification handoffs.
- OPS-DRAFT-01 — Table of top five observability metrics with alert owners.
- FIN-DRAFT-01 — TCO sketch showing feasibility vs. $12 CAD/patient constraint at 500 patients.
Supporting templates: templates catalog (traceability matrix, PCCP outline, PIA worksheet, IR runbook, PMS plan).
Scoring rubric (100 points)
| Criterion | Weight | What “meets” looks like |
|---|---|---|
| Safety and risk traceability | 30 | Hazards linked to controls and verification; stale data and alert fatigue addressed. |
| Privacy and Alberta deployment | 25 | HIA / custodian language; residency; PIA triggers; subprocessors. |
| Architecture and operations | 20 | Realistic failover, monitoring, SBOM/CVE response tie-in. |
| AI governance | 15 | PCCP or change policy; monitoring metrics; bias / subgroup discussion. |
| Economics | 10 | Order-of-magnitude TCO coherent with architecture choices. |
Outstanding work explicitly connects mock requirement numbers to design inputs and tests.
Participant pre-read
Practical next step
Before the workshop, pick one deliverable and trace it back to the workbook pages and templates that support it.
- Template or worksheet: mock requirements pack.
- Glossary terms: risk register, PIA, TCO.
- Pathway links: Capstone readiness path, Templates catalog.