When performing scoping for an r2 assessment, HITRUST requires consideration of risk factors that tailor requirement statements. Four categories are applied: Technical, Organizational, Compliance, and Operational.
Technical Risk Factors consider measurable characteristics such as number of users, systems, or transactions, which directly influence the size and complexity of the control environment.
Organizational Risk Factors address the type of business, industry sector, and whether the entity is a covered entity or business associate.
Compliance Risk Factors incorporate regulatory drivers (e.g., HIPAA, PCI DSS, state laws) that generate additional requirement statements.
Operational Risk Factors consider how data is used, stored, and transmitted, including exposure points like internet-facing systems.
“General” and “Privacy” are not categories formally recognized in the HITRUST methodology. Privacy obligations are accounted for under compliance drivers such as HIPAA, GDPR, or state laws. These categories ensure that control requirements are right-sized to the entity’s unique environment, reducing both over-scoping and under-scoping.
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