When scoping an r2 assessment, selecting regulatory factors is required and may generate additional Requirement...

Regulatory factors are a mandatory part of the scoping process in r2 assessments. These factors represent applicable laws, regulations, or frameworks that impact the organization’s operations. Examples include HIPAA, PCI-DSS, GDPR, state data protection laws, CMS Minimum Security Requirements, and FedRAMP. When a regulatory factor is selected in MyCSF, additional requirement statements are automatically generated within the assessment object. These statements tailor the control environment to match external obligations, ensuring alignment with compliance expectations.

For example, selecting PCI-DSS will add specific controls related to cardholder data protection. Selecting HIPAA will add requirements for safeguarding protected health information. Without selecting these factors, the assessment would not provide complete coverage, and certification would lack credibility. This dynamic tailoring is one of the strengths of HITRUST’s risk-based approach, ensuring each entity’s assessment is relevant to its regulatory landscape.