IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs HIPAA Security Rule

What is the difference between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule?

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) is a healthcare framework applying in International, with 21 controls across 6 domains. HIPAA Security Rule is a healthcare framework applying in the United States, with 67 controls across 5 domains. Both govern the same subject, so their requirements overlap; the mapping below shows which controls carry across and which are asked for by only one of them.

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)21 controls

HIPAA Security Rule67 controls

Questions people ask about IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule

What is the difference between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule?

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) has 21 controls while HIPAA Security Rule has 67 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.

Do I need both IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule?

Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule so you can identify shared requirements and avoid duplicate effort.

How do IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule controls map to each other?

Our platform maps controls between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.

Which framework should I implement first, IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) or HIPAA Security Rule?

The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.

Each framework on its own

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

21 controls · Healthcare

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HIPAA Security Rule

67 controls · Healthcare

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Comparisons people read next

Each of these compares one of the two standards above against another it shares controls with.

HIPAA Security Rule vs FedRAMP High57 shared controls HIPAA Security Rule vs FedRAMP Moderate57 shared controls HIPAA Security Rule vs NIST SP 800-53 Rev 5 MODERATE55 shared controls

See all control mappings with interactive gap analysis

Explore the complete mapping between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and HIPAA Security Rule on our compliance platform.

Written and maintained by Gerard Blokdyk, The Art of Service.