hmm The Record · ex-5 / 38

01 · The five Necessities → Heal

02 / 05 · Heal

Biomedical Systems

Clinical software, diagnostics, AI-assisted decisions. Cannot ship without regulator clearance.

The need01 / 04

Ageing populations and clinical-labour shortages are pushing more care into clinical software, diagnostics, and AI-assisted decision tools. A scan is misread. A treatable condition is caught late. An AI tool is deployed in a clinic without evidence that it works, and a patient pays the price.

Tier 1: device licensing, clinical software clearance, digital health frameworks. Tier 2: clinical safety reporting, AI risk management for medical devices.

The filter02 / 04

20 regulations mapped. 19 T1, 1 T2.

EX-5 Crystallisation window

In-flight regulations by expected effective year. None yet in force.

None in force Peak · 2027
0 2024 0 2025 0 2026 3 2027 0 2028 0 2029 0 2030
MarketRegulationTierStatus
AUTGA SaMD Regulation Reform T1Expected 2027
JPPMDA AI Medical Device Fast-Track Expansion T1Expected 2027
SGHSA Digital Health Regulatory Framework Expansion T1Expected 2027
Sourcehmm Ventures regulatory dataset. Basis3 dated obligations, 2024 to 2030.
The cohort03 / 04

1,269 companies mapped to the Biomedical Systems Necessities.

EX-6 Necessities-aligned cohort

1,269 companies. Highlighted marks are named outcomes in regulated companies.

Sourcehmm Ventures four-market classified dataset.
The four markets04 / 04
  1. Australia Named acquisition

    Eucalyptus

    Tier 1. Acquired by Hims & Hers Health. 2026.

  2. Japan In-flight regulation

    PMDA AI Medical Device Fast-Track Expansion

    Tier 1. Expected 2027.

  3. New Zealand Monitoring

    Watchlist market

    No dated regulatory trigger in the current dataset.

  4. Singapore In-flight regulation

    HSA Digital Health Regulatory Framework Expansion

    Tier 1. Expected 2027.

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