HIPAA vs ISO 13485 - Compare Compliance Frameworks | ISMS Directory

HIPAA vs ISO 13485: Which Framework Do You Need?

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Wondering whether to pursue HIPAA or ISO 13485 certification? This comparison covers the key differences between these frameworks, the number of service providers available for each, and guidance on which might be the right choice for your organization.

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HIPAA

HIPAA sets standards for protecting sensitive patient health information in the United States.

Service Providers

Regional Coverage

2 regions

Industry Coverage

4 industries

Browse all HIPAA services →

ISO 13485

ISO 13485 is a compliance framework.

Service Providers

Regional Coverage

1 regions

Industry Coverage

0 industries

Browse all ISO 13485 services →

Dimension	HIPAA	ISO 13485
Service Count	13	1
Regions	Canada Global	Global
Industries	Finance Healthcare Manufacturing Technology

Which Do You Need?

Choose HIPAA if:

- Your clients or partners require HIPAA certification
- You operate in regions where HIPAA is the standard
- You need a HIPAA-specific compliance approach

Choose ISO 13485 if:

- Your clients or partners require ISO 13485 certification
- You operate in regions where ISO 13485 is the standard
- You need a ISO 13485-specific compliance approach

HIPAA vs ISO 13485: Which Framework Do You Need?

HIPAA

ISO 13485

Which Do You Need?

Choose HIPAA if:

Choose ISO 13485 if:

Frequently Asked Questions

What is the difference between HIPAA and ISO 13485?

Can I get both HIPAA and ISO 13485 certified?

Which framework should I pursue first, HIPAA or ISO 13485?