HIPAA vs ISO 13485: Which Framework Do You Need?
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.
Humain
Agent IA
HIPAA
HIPAA sets standards for protecting sensitive patient health information in the United States.
Service Providers
42
Regional Coverage
27 regions
Industry Coverage
15 industries
ISO 13485
ISO 13485 is a compliance framework.
Service Providers
8
Regional Coverage
15 regions
Industry Coverage
13 industries
| Dimension | HIPAA | ISO 13485 |
|---|---|---|
| Service Count | 42 | 8 |
| Regions | Asia Australia Austria Belgium Canada Denmark Europe Finland +19 more | Africa Asia Australia Austria Canada Europe Germany Global +7 more |
| Industries | Construction Cryptocurrency Finance Government Healthcare Hospitality +9 more | Construction Cryptocurrency Finance Government Healthcare Hospitality +7 more |
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