🇦🇺Australia

ARTG and AMT Non-Compliance Risks

1 verified sources

Definition

The Mechanism: Manual systems fail to support mandatory ARTG identification and AMT terminology for medical supplies. Non-compliance risks regulatory penalties.

Key Findings

  • Financial Impact: AUD 20k-100k penalties for therapeutic goods non-compliance; audit preparation 40+ hours/month manually
  • Frequency: Annual audits, ongoing reporting
  • Root Cause: Lack of standardized item identification in manual tracking

Why This Matters

The Pitch: Outpatient care centers in Australia 🇦🇺 risk AUD 10k+ fines per audit failure. Automation ensures ARTG/AMT compliance reporting.

Affected Stakeholders

Compliance officers, IT managers

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Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Overstocking and Excess Inventory Costs

AUD 600k stockholding reduction post-automation; 20-30% inventory cost savings from optimized levels

Missed Charge Capture for Supplies

100% compliance in patient level costing achieved (pre: significant leakage); improved revenue streams via accurate procedural costing

Expired Medical Supply Waste

AUD 600k reduction in stockholding achieved via automation (equivalent waste pre-automation); typical 5-10% of inventory value lost to expiry in manual systems

Fehlentscheidungen durch unvollständige oder isolierte EHR‑Daten

Logic-based estimate: 1–2 % of outpatient revenue, e.g. AUD 100,000–200,000 per AUD 10m revenue, due to sub‑optimal decisions arising from incomplete or poorly shared EHR data.

Poisons and Controlled Substances Non-Compliance Fines

AUD 5,000-50,000 per offence in fines; 20-40 hours/month manual record-keeping

Schedule 8 Drug Diversion and Theft Losses

AUD 1,000-10,000 per incident in lost inventory; 2-5% annual shrinkage of controlled substances value

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