Cross-Framework Mapping

Australia My Health Records Act 2012vsEU Clinical Trials Regulation (CTR 536/2014)

See exactly how Australia My Health Records Act 2012 controls map to EU Clinical Trials Regulation (CTR 536/2014). Pre-computed mappings, identified gaps, and coverage analysis.

16
Controls Mapped
6
Gaps Found
36%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Australia My Health Records Act 2012 maps to EU Clinical Trials Regulation (CTR 536/2014) with 36% coverage across 8 directly mapped controls. Analysis of 22 Australia My Health Records Act 2012 controls identifies 14 compliance gaps — primarily concentrated in Part 1 — Preliminary.

Source: TheArtOfService Knowledge Graph | 22 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 16 of 16 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Part 7 — Data Governance Board(1 mappings)

MHR-10Establishment and Functions (Division 1)
CTR-II-05Substantial Modification Procedure

Part 4 — Collection, Use and Disclosure(9 mappings)

MHR-5Collection of Health Information3 targets
CTR-II-01Single Application via CTIS
CTR-II-02Part I Assessment (Scientific)
CTR-X-01Data Protection Compliance
MHR-6Use and Disclosure Framework3 targets
CTR-II-01Single Application via CTIS
CTR-II-02Part I Assessment (Scientific)
CTR-X-01Data Protection Compliance
MHR-7Unauthorized Access Prohibition3 targets
CTR-II-01Single Application via CTIS
CTR-II-02Part I Assessment (Scientific)
CTR-X-01Data Protection Compliance

Part 1 — Preliminary(6 mappings)

POFMA-1.1Definitions and Interpretation (Sections 2-3)
CTR-II-05Substantial Modification Procedure
Sec. 2Interpretation2 targets
CTR-II-05Substantial Modification Procedure
CTR-X-01Data Protection Compliance
Sec. 3Scope and Application
CTR-II-05Substantial Modification Procedure
Sec. 6Establishment of the Commission2 targets
CTR-VI-01GMP for Investigational Medicinal Products
CTR-X-01Data Protection Compliance

Related Comparisons

Other Australia My Health Records Act 2012 comparisons

Other EU Clinical Trials Regulation (CTR 536/2014) comparisons

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What are the key differences between Australia My Health Records Act 2012 and EU Clinical Trials Regulation (CTR 536/2014)?

Australia My Health Records Act 2012 has 22 controls across its framework, while EU Clinical Trials Regulation (CTR 536/2014) covers 17 controls. Direct mapping analysis identifies 8 overlapping controls (36% coverage). The frameworks diverge most significantly in Part 1 — Preliminary, where 6 Australia My Health Records Act 2012 controls have no direct EU Clinical Trials Regulation (CTR 536/2014) equivalent.

How many controls map between Australia My Health Records Act 2012 and EU Clinical Trials Regulation (CTR 536/2014)?

Of 22 total Australia My Health Records Act 2012 controls, 8 map directly to EU Clinical Trials Regulation (CTR 536/2014) controls — representing 36% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Australia My Health Records Act 2012 to EU Clinical Trials Regulation (CTR 536/2014)?

14 Australia My Health Records Act 2012 controls have no direct equivalent in EU Clinical Trials Regulation (CTR 536/2014). The highest concentration of gaps is in Part 1 — Preliminary with 6 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between Australia My Health Records Act 2012 and EU Clinical Trials Regulation (CTR 536/2014)?

The domain with the highest gap count is Part 1 — Preliminary (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.