Capstone exemplar (worked example)

Last reviewed: 2026-06-29 — see the freshness policy.

Learning objectives

After this chapter you will be able to:

  • Calibrate your own capstone submission against a complete worked example.
  • See how the seven deliverables and five design questions come together in one design.
  • Self-score a submission against the Part 10 rubric before it's reviewed.

What this is (and isn't)

This is one credible answer to the capstone brief — not the answer. It exists so you can calibrate: read it after you've drafted your own, and compare structure and rigor, not the specific technology choices (a different cloud, a different AI feature, or a different dominant quality attribute can all be equally "good" if defended well). Read the Reference architectures overview first — this exemplar follows the same seven-section shape.

1. Requirements summary

Problem. MedBridge Health runs a patient-facing app and a clinician portal, integrates with hospital EHRs, and wants AI features and RWE partnerships. It serves US and Canadian patients today and is opening a pilot in Germany next year.

Scope. In: patient app, clinician portal, EHR ingestion, one AI feature, an RWD/RWE data layer. Out: billing/revenue-cycle systems, the EHR itself.

Stakeholders. Clinicians (chart access, alert fatigue), patients (access, consent), compliance/privacy officer, CISO, CFO (run cost), RWE research partners.

Functional requirements (excerpt). FR-01: clinicians can search a patient's problem list and meds via the portal. FR-02: patients can view their own record and message their care team. FR-03: the platform ingests HL7v2 ADT + FHIR from partner EHRs. FR-04: an AI feature summarizes a patient's chart for the clinician on login.

Non-functional requirements (excerpt — see discovery template):

ID Requirement Source
NFR-01 PHI encrypted at rest (AES-256, CMK) and in transit (TLS 1.2+) HIPAA
NFR-02 US patient data resides in US regions; Canadian in Canadian regions; German (pilot) in EU regions Regional compliance
NFR-03 Clinician portal FHIR read P95 < 500 ms Clinical stakeholders
NFR-04 Audit trail for all PHI access, retained 6 years HIPAA §164.312(b)
NFR-05 AI chart summary must cite source resources and support human override Clinical safety, RAG best practices
NFR-06 Run cost < $15k/month at current volume (50-bed pilot health system) CFO

2. Architecture — C4 context & container

flowchart LR Clinician["Clinician<br/>[Person]"] -->|"portal"| Sys["MedBridge Platform<br/>[Software System]"] Patient["Patient<br/>[Person]"] -->|"app"| Sys EHR["Hospital EHR<br/>[External System]"] -->|"HL7v2/FHIR"| Sys Sys -->|"tokenized extract"| RWEpartner["RWE research partner<br/>[External System]"]
flowchart LR EHR["Hospital EHR"] -->|"HL7v2 MLLP"| Conv["HL7v2→FHIR converter"] Conv --> FHIRstore["Managed FHIR store<br/>(region-pinned per patient population)"] FHIRstore -->|"REST/SMART"| Portal["Clinician portal"] FHIRstore -->|"REST/SMART"| App["Patient app"] FHIRstore -->|"Bulk $export"| Lake["Lakehouse<br/>(OMOP gold)"] Lake -->|"RAG retrieval"| AI["Chart-summary RAG<br/>(self-hosted model)"] AI --> Portal Lake -->|"tokenized"| Share["Secure data share"] --> RWEpartner["RWE partner"]

(This is the L1/L2 pair the C4 chapter calls for — one box for "everyone," one for the engineering/security review.)

3. Key ADRs (three of six)

  • ADR-01: Region-pinned managed FHIR stores per population, not one global store. Rationale: NFR-02 forces residency; a single global FHIR store would violate it for at least one population. Trade-off: three smaller stores to operate instead of one, but each is simpler and residency is structurally enforced, not policy-enforced.
  • ADR-02: Self-hosted RAG model (NIM) for the chart-summary feature, not a managed external API. Rationale: NFR-05 plus HIPAA/GDPRPHI must stay in-boundary; see RAG over clinical corpora. Trade-off: more infrastructure to run than calling a hosted API, in exchange for no new business associate/processor.
  • ADR-03: Tokenized linkage for the RWE partnership, not raw data transfer. Rationale: the partner must never receive identified PHI; tokenization (see RWD/RWE) lets both sides link records without either exposing identities. Trade-off: match-rate tuning overhead vs. a much smaller BAA/DPA surface.

4. Compliance mapping

Control Regime(s) How
Region-pinned storage HIPAA, PIPEDA/PHIPA, GDPR ADR-01: per-population managed FHIR stores
Article 9 lawful basis (Germany) GDPR Care relationship = Art. 9(2)(h); explicit consent for RWE secondary use
Self-hosted AI, no PHI egress HIPAA, GDPR ADR-02
Tokenized RWE sharing HIPAA (min. necessary), GDPR ADR-03
Audit trail 6 years HIPAA §164.312(b) Immutable logs on every FHIR store
Future AI transparency ONCHTI-1(US), EU AI Act (Germany pilot) MLOps pipeline emits source attributes; human-override UI satisfies human-oversight design requirement — see the decision guide triage that surfaced both regimes

Run this system through the compliance decision guide yourself: segment = digital health; jurisdictions = US + Canada + EU; AI = yes. That triage is exactly how this table was derived — it is the "correctness" evidence for the Compliance rubric line.

5. Cost model (back-of-envelope)

Component Monthly (approx.)
3× regional managed FHIR stores (US/CA/EU), low volume $250
Lakehouse storage + compute (OMOP gold, auto-suspend) $600
Self-hosted RAG inference (GPU, right-sized) $2,000
API gateway, audit logging, misc $150
Total ~$3,000/month

Comfortably under NFR-06's $15k ceiling at pilot volume; the GPU inference line is the one to re-model first if volume grows 10× (see TCO).

6. Security review pack (excerpt)

Threat-modeled per the security review checklist: ingress (EHR MLLP feed) authenticated per-partner; egress to the RWE partner is tokenized only, never raw FHIR; the self-hosted model has no outbound network egress rule; audit logs shipped to an immutable, region-matched store (not a US-only SIEM, to respect NFR-02).

7. Stakeholder brief

  • Clinician: "The chart summary appears when you open the portal, cites its sources, and you can always click through to the original record — it doesn't replace your judgment."
  • CISO: "Patient data never crosses a border it isn't supposed to, the AI model runs inside our own network with no external API calls, and every access is logged for six years."
  • CFO: "About $3k/month at pilot scale, scaling roughly linearly with patients; the AI compute is the line to watch if we grow fast."

Self-scoring against the rubric

Dimension Self-assessment
Correctness Data flows end-to-end from EHR to portal/app to lakehouse to RWE partner; nothing hand-waved
Compliance All three jurisdictions mapped via the decision guide; residency structurally enforced, not just documented
Trade-offs Three ADRs each name what was given up, not just what was chosen
Cost Concrete monthly figure with the volume-sensitive line identified
Communication Three distinct one-paragraph framings, each answering that stakeholder's actual question

The dominant quality attribute here is compliance/interoperability, traded against operational simplicity (three regional stores instead of one, a self-hosted model instead of a managed API) — name yours as explicitly as this when you defend your own design.

Check yourself

  1. Where does this exemplar's design most resemble your own, and where does it diverge — and is the divergence a defensible trade-off or a gap?
  2. The exemplar chose a self-hosted RAG model. Under what NFR change would a managed API become the better ADR?
  3. Run this same brief through the compliance decision guide yourself, from scratch, before reading section 4 again — did you get the same regime list?

Further reading

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