Healthcare tech that earns patient trust.
The patient data and the AI decisions both have to be defensible. HIPAA and the AU Privacy Act define the data floor; FDA Software-as-a-Medical-Device and the EU AI Act high-risk obligations define the AI floor. The substrate (identity, audit, evals, lineage) is what makes both checkable rather than aspirational.
The regulatory floor — healthcare
- HIPAA Security Rule · PHI handling, audit logs, access controls (US)
- AU Privacy Act + Notifiable Data Breaches scheme · 30-day breach notification
- FDA Software-as-a-Medical-Device (SaMD) · pre-market submission + post-market surveillance for clinical AI
- EU AI Act · healthcare is largely high-risk (Annex III) · 2 Aug 2026 enforcement
- ISO 13485 + IEC 62304 · medical-device QMS + software lifecycle
- NIST AI RMF + GenAI Profile · the risk vocabulary clinicians + boards will recognise
Run first.
The two diagnostics that surface the most healthcare-specific exposure. Each takes 2–4 minutes; results are shareable via URL hash; nothing is stored.
GenAI Readiness
If you’re shipping a clinical-decision-support or admin-automation use-case, this is the readiness check. EU AI Act high-risk shape baked in.
Open →DiagnosticDevSecOps Maturity
HIPAA audit trail + AU Notifiable Data Breaches both reduce to whether your supply-chain, identity and observability are real.
Open →Reference architectures.
Opinionated paved-paths sized for healthcare constraints — data residency, audit, supply-chain attestation, change-control.
Regulated GenAI Platform
Per-decision audit, prompt registry, signed evidence pack. Sized for clinical-decision-support and high-risk patient-data contexts.
Open →Reference architectureModern Data Platform
Lineage + contracts + access controls. The substrate for de-identification and consent-aware pipelines.
Open →Reference architectureDevSecOps SLSA L3+ Paved Path
Build provenance + signed images for SaMD post-market integrity; SBOM-to-owner alert for vulnerability response SLAs.
Open →Where healthcare teams typically get stuck.
The most-common Tier 2 stuck-points in this sector, with the three substrate moves to the next tier.
GenAI — Piloting
The most common stuck-point in clinical AI pilots. Three moves: prompt registry + eval-gated CI, adversarial-tested guardrails, per-decision audit pipeline.
Open →Stuck tierDevSecOps — Repeatable
Where most healthcare orgs sit. Three moves: workload identity, SBOM owner-loop, policy-as-code admission.
Open →Stuck tierCloud Cost — Aware
Imaging + genomics drives bill into the millions/quarter. Three moves: per-service cost in dev view, quarterly commitment review, named owner per service spend.
Open →Read next.
The essays and reference content that go furthest in healthcare conversations.
The nine controls that make GenAI defensible
The operational distillation — mapped to NIST AI RMF + ISO 42001. Read before the first clinician-facing pilot.
Open →EssayAU AI Safety Standard decoded
The voluntary-today / mandate-trajectory framing matters for healthcare especially — this is where the standard will land first.
Open →Annual reportState of Enterprise Tech in Regulated Industries 2026
Board-ready briefing — healthcare data + GenAI sections.
Open →Common anti-patterns in healthcare.
The named failure modes that show up most across healthcare engagements. The catalogue has all 15; these four are the ones that recur here.
Inline Prompt Pattern
Hard-coded prompts in clinical apps. Cannot be audited; cannot evidence the EU AI Act Article 12 logging obligation.
Open →Anti-patternEval Set That Never Runs
Clinical-safety regressions ship to prod silently.
Open →Anti-patternVault Theatre
PHI-handling apps with static creds. HIPAA audit triggers; AU Privacy Act risk surface.
Open →Anti-patternSBOM Shelfware
FDA SaMD post-market surveillance demands the loop; without it, vulnerability response SLAs slip.
Open →Working on this in Healthcare & Life Sciences?
If you’re building a clinical-decision-support feature, hardening for HIPAA or AU Notifiable Data Breaches, or preparing for EU AI Act high-risk obligations — I work with engineering + clinical-safety + compliance partners to ship audit-ready substrate.
How I work → contact@hellouchit.com →