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Healthcare Compliance – Which Standard Is Right for Your Organization?

Published
Jan 13, 2025
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Meeting data security and privacy compliance requirements is key to growth within the U.S. healthcare market. Unfortunately, many organizations struggle to win business or grow their revenue due to a lack of data security and privacy compliance.  

All healthcare organizations that store or process sensitive data can expect to face compliance challenges, regardless of their size. Healthcare organizations in the initial stages of business should consider which compliance standard works best with their objectives and timelines.  

Comparing Compliance Frameworks  HIPAA  

HIPAA compliance is crucial to any growing healthcare organization, as it must be able to meet its customers’ compliance requirements. Organizations starting their compliance journey can begin with a HIPAA Security Rule Assessment as a stepping stone. The HIPAA Security Rule specifically focuses on safeguarding Protected Health Information (PHI) through appropriate administrative, technical, and physical safeguards. 

A third-party assessor can provide a risk assessment of an organization’s HIPAA compliance through a HIPAA Security Rule Assessment, which indicates to the entity any risks that must be mitigated to comply with the HIPAA Security Rule. The HIPAA Security Rule is relevant to any company that has signed a Business Associate Agreement. 

SOC 2  

SOC 2 is a leading standard for entities within the healthcare industry. Implementing SOC 2 compliance helps organizations stand out in a competitive business landscape due to the enhanced need for audits or certification.  

A SOC 2 examination reports a service organization’s controls relevant to security, availability, processing integrity, confidentiality, and privacy. As a feasible, cost-effective solution, SOC 2 allows businesses to achieve compliance in four to nine months, depending on the scope and existing control environment.  

Moreover, SOC 2 compliance meets the requirements of a broad range of customers who need assurance about the control environment for any organizations that process and store their sensitive data. 

A SOC 2 audit blends well with the HIPAA security compliance requirements mentioned above. Organizations that choose to do one combined audit, SOC 2 plus HIPAA, can demonstrate how their control environment relates to and achieves healthcare requirements. 

HITRUST 

HITRUST is the gold standard for compliance in the healthcare industry. The HITRUST CSF framework allows organizations to take a progressive and proactive approach to risk management and demonstrate compliance. HITRUST covers industry-specific standards, including significant controls from several IT security standards bodies and governance sources. There are three HITRUST assessments - e1, i1, and r2.  

Type of HITRUST assessment 

Approximate number of controls 

Level of management effort, cost, and time to complete 

e1 

44 

Low 

i1 

182 

Moderate 

r2 

280-400 (depending on the size of the organization and scope of the environment) 

High 

HITRUST can be complex depending on the type of assessment organizations choose to complete. To begin your HITRUST compliance journey, consider starting with an e1 assessment. As an entry-level certification limited to foundational cybersecurity controls, e1 assessments minimize audit burden compared to i1 and r2 assessments and are considered the most feasible and cost-effective HITRUST option. 

Whether your organization pursues HIPAA, SOC 2, or HITRUST compliance, you can leverage these compliance frameworks as a growth strategy to act proactively and expand your business in the healthcare industry. 

EisnerAmper helps a wide range of clients navigate their healthcare compliance journey. From creating a detailed road map to identifying gaps and offering tailored solutions, we are ready to help you address your organization’s unique goals and compliance needs. Contact us below with any questions.    

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Pratik Shrestha

Pratik Shrestha is a Senior Manager in the firm’s Assurance and Technology Control Services group.


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