For organizations within and adjacent to healthcare, compliance with regulatory frameworks such as HITRUST helps strengthen the privacy and security of sensitive patient data. However, healthcare compliance has pros and cons, depending on your business environment, security needs, or organizational structure. Read on to learn more about healthcare compliance pros and cons and how to ensure seamless compliance with efficient and powerful cybersecurity.
HealthCare Compliance Pros and Cons of Various Approaches
If your organization operates in healthcare or other, related fields, you are likely subject to the Health Insurance Portability and Accountability Act (HIPAA). Other regulations may apply, as well, such as the Payment Card Industry Data Security Standard (PCI DSS), the California Consumer Privacy Act (CCPA), and more. Complying with all of them can be a challenge.
Luckily, HITRUST enables you to cover all of their requirements in one unified implementation.
Here’s how to evaluate healthcare compliance pros and cons of various approaches to covering for all of your compliance needs, such as opting for HITRUST or addressing them piecemeal:
- First, develop an understanding of the HITRUST CSF certification process.
- Next, identify the pros of achieving and maintaining HITRUST certification.
- Then, assess the cons of addressing compliance needs one-by-one.
Working with a HITRUST CSF compliance partner will help you optimize HITRUST compliance, leveraging healthcare compliance pros while working around the cons.
What is the HITRUST CSF?
The HITRUST CSF is a risk-based security framework that helps organizations within and adjacent to healthcare safeguard their sensitive data from security threats. As one of the most robust and comprehensive security frameworks, the HITRUST CSF encompasses as many as 2,000 controls corresponding to many other regulatory frameworks. It enables broad, strategic risk management and efficient mapping or implementation of other, non-HITRUST requirements.
The HITRUST CSF’s facilitation of streamlined compliance across multiple regulatory frameworks is one of the biggest health compliance pros of HITRUST compliance.
Steps in the HITRUST CSF Certification Process
When it comes to HITRUST certification, organizations within and adjacent to healthcare typically follow five steps to get HITRUST-certified:
- Learning about HITRUST – Considering the breadth of controls within the HITRUST CSF, it is essential to learn as much as you can about the framework before you start the certification process. Investing in HITRUST CSF education will enable the smooth alignment of compliance roles and responsibilities with the intended objectives.
- Scoping out certification requirements – To effectively achieve HITRUST CSF compliance and certification, entities must understand the anticipated resource needs—both time and cost-wise. Requirement scoping will depend on your organization’s IT infrastructure, security needs, and current and future resources.
- Preparation for HITRUST CSF audits – An entity’s preparedness for HITRUST CSF audits will determine the length of the audit process. When preparing for HITRUST CSF audits, it is critical to ensure the documentation of all aspects of compliance, including:
- Current and past security policies
- History of HITRUST CSF risk assessments
- Implemented and proposed configurations
- HITRUST CSF validated assessments – A certified HITRUST CSF assessor conducts a validated assessment, which evaluates an organization’s compliance with the HITRUST CSF. A HITRUST CSF self-assessment will help you better prepare for validated assessments by pointing out any needs for remediating vulnerabilities within your IT infrastructure.
- HITRUST CSF certification – The final step in the HITRUST CSF certification process involves submitting your validated assessment to the HITRUST Alliance for review. If the submitted HITRUST CSF validated assessment passes the HITRUST Alliance audit, you will receive a letter of certification indicating compliance with the HITRUST CSF.
One of the most important considerations at each step of the HITRUST certification process is determining which assessment best fits your organization’s compliance and security needs.
Types of HITRUST CSF Assessments
The HITRUST CSF offers tiered compliance assessments, depending on the total number of controls implemented by an entity. Each level of HITRUST CSF assessment also comes with healthcare compliance pros and cons, depending on the resources required to get certified.
The three types of HITRUST CSF assessments include:
- The low-effort “HITRUST Basic, Current-state (bC) Assessment” is a self-assessment of your security hygiene and provides baseline security assurance to stakeholders.
- The moderate-effort “HITRUST Implemented, 1-year (i1) Assessment” provides a threat-adaptive assessment of the effectiveness of security controls implemented across various security frameworks.
- The high-effort “HITRUST Risk-based, 2-year (r2) Validated Assessment” provides the highest level of security assurance based on a comprehensive, rigorous assessment of security control implementation.
Determining which HITRUST CSF assessment works best for your organization will depend on your desired security assurance, which, in turn, depends on your current and anticipated security goals, stakeholder requirements, and the business environment in which you operate.
Pros of HITRUST CSF Compliance
Once you better understand the HITRUST CSF certification process, it is easier to evaluate the healthcare compliance pros and cons. Any organization within and adjacent to healthcare that invests in HITRUST CSF certification will benefit from several health care compliance pros.
Pro #1 – Robust Security Risk Management
Compliance with the HITRUST CSF provides access to a comprehensive array of controls spanning multiple industries. By bringing all the controls into a single centralized framework, the HITRUST CSF enables organizations to meet the security requirements of multiple frameworks:
- PCI DSS helps organizations secure card payment transactions
- HIPAA helps organizations safeguard protected health information (PHI)
- EU GDPR helps organizations maintain data privacy for European Union citizens
Furthermore, the HITRUST CSF controls are categorized by risk categories, enabling organizations to comprehensively—and more effectively—address industry-specific risk requirements. Control categories in the HITRUST CSF v9.6.0 include:
- Information security management
- Access control management
- Human resource security management
- Risk management
- Security policy management
- Information security organization
- Compliance management
- IT asset management
- Physical security management
- Management of communications and operations
- Information systems management
- Security incident management
- Business continuity management
- Privacy practices management
Based on the anticipated risks to your IT infrastructure, you can choose which controls will best meet your current or future security needs and adjust implementation accordingly. The breadth of controls in the HITRUST CSF situates you to more aptly address a wide range of security risks within and adjacent to healthcare—strengthening your security short- and long-term.
Pro #2 – Flexibility and Scalability
Another of the healthcare compliance pros of HITRUST CSF is that it can be easily adapted to meet the compliance needs of any organization.
The flexibility and scalability of HITRUST CSF come into play, considering an entity’s:
- Compliance experience – HITRUST CSF’s control requirements are prescriptive, meaning that any organization can implement them, regardless of experience with regulatory compliance.
- Resource availability – Similarly, the HITRUST CSF caters to the compliance needs of any organization, regardless of size, structure, or other intrinsic factors. An entity’s choice of HITRUST CSF assessment will determine which controls are implemented and to what degree.
- Desired implementation level – At best, the HITRUST CSF is not a rigid framework that enforces control implementation at a single level. Instead, organizations can implement controls based on their risk profile and desired security posture.
- Adjustable controls – In instances where some controls meet an entity’s needs better than others, the HITRUST CSF allows room for adjustments, provided the desired changes are within the scope of HITRUST CSF.
The HITRUST CSF serves as a highly adaptable framework for organizations with an extended compliance experience and those just starting out on their compliance journey. And the CSF’s one-size-fits-all structure also minimizes the barriers to first-time HITRUST compliance.
Organizations can start out small and scale up eventually as their needs change.
Pro #3 – Streamlined Compliance Assessments
Besides enabling risk management and providing flexibility and scalability, another health care compliance pro of HITRUST CSF is that it offers streamlined compliance assessments.
Most regulatory compliance assessments take up large amounts of time and resources only to meet the requirements of singular frameworks. However, the CSF enables organizations to demonstrate security assurance with single assessments that address controls across multiple frameworks. This is why one of HITRUST’s core slogans is “assess once, report many.”
The HITRUST Basic, Current-state (bC) Assessment might be right for you if you are new to HITRUST CSF compliance and are looking to demonstrate a basic level of security assurance to stakeholders. With the HITRUST bC Assessment, you can lower the costs of audits while also reducing the time spent preparing for them. However, if you are looking for much greater assurance, the HITRUST Implemented, 1-year (i1) Assessment or the HITRUST Risk-based, 2-year (r2) Validated Assessment might be more suitable solutions.
Since both the i1 and r2 are validated assessments, organizations can benefit from:
- Working with a HITRUST-certified Security Assessor to identify gaps in compliance
- Remediating gaps that might pose significant security risks and possible data breaches
- Obtaining a HITRUST certification that demonstrates a high-level security posture
Additionally, the r2 assessment (unlike the r1) provides expanded flexibility when adding factors to a control set that may be specific to state or national regulations.
Cons of Other Healthcare Compliance Solutions
As with any other regulatory framework, compliance with the HITRUST CSF comes with cons. Compared to the health care compliance pros, the cons of HITRUST CSF compliance center around the demands of achieving and maintaining HITRUST CSF certification.
HITRUST CSF Certification is the most efficient way to cover for all your healthcare compliance needs across various applicable frameworks. Choosing to address other compliance needs in an ad hoc or piecemeal manner, on the other hand, may seem more approachable. However, doing so makes organizations subject to two major cons of healthcare compliance—namely, lacking proof of compliance for HIPAA and overlap in controls for various other frameworks.
Con #1 – Uncertainty About Proof of Compliance (HIPAA)
Critically, the healthcare industry’s most directly applicable regulatory framework, HIPAA, does not have an official certification program in place. Covered entities, such as care providers, plan administrators, and clearinghouses, all need to comply with its rules. But, while regular security assessments are required, there is no standardized compliance audit to verify or certify results.
In practice, this means organizations become subject to HIPAA audits randomly, or if a HIPAA violation is suspected or reported to the Department of Health and Human Services (HHS).
Compliance often amounts to ensuring such an audit would be passed, if it were to happen.
That, in turn, means developing assessment procedures for the three prescriptive HIPAA Rules:
- The Privacy Rule – Covered entities must prevent unauthorized uses or disclosures of Protected Health Information (PHI) and ensure data subjects have access, as requested.
- The Security Rule – Covered entities must ensure the seamless confidentiality, integrity, and availability of electronic PHI (e-PHI) by regularly assessing and addressing risks and installing controls in the form of administrative, physical, and technical safeguards.
- The Breach Notification Rule – After a data breach, covered entities must notify all parties impacted by it and the HHS—and a local media outlet, for the largest breaches.
Failure to comply with these rules can trigger penalties laid out in the Enforcement Rule. The lack of an official certification process can leave organizations uncertain about their status.
However, a HITRUST CSF Certification can provide assurance of HIPAA compliance.
Con #2 – Control Overlap and Inefficiencies (PCI DSS, etc.)
As detailed above, HITRUST is infinitely flexible and scalable, including controls and mapping infrastructure to streamline compliance across various frameworks. In contrast, opting to install and assess controls for each applicable regulation one at a time can lead to costly overlap of controls, redundancies, unnecessary bandwidth shortages, and other resource costs.
For example, compare the 14 Control Categories of the HITRUST CSF from above with the 12 Requirements of the PCI DSS v4.0, another framework widely applicable across industries:
- Installing and Maintaining Network Security Controls
- Applying Secure Configuration to all Components
- Protecting all Account Data in Storage
- Encrypting Cardholder Data for Transmission
- Protecting Systems against Malicious Software
- Developing Secure Systems and Software
- Restricting Access to Data by Business Need
- Identifying and Authenticating Users for Access
- Restricting Physical Access to Cardholder Data
- Monitoring and Logging Access to Sensitive Data
- Assessing Security Systems’ Efficacy Regularly
- Supporting Security with Formal Organizational Policies
There is significant overlap between these 12 Requirements and other regulations that may apply to an organization, such as the HIPAA rules detailed above, CCPA requirements, and others. However, the specific language, order, and assessment protocols for each framework differ widely, meaning that organizations may need to install multiple versions of the same control to satisfy the specific needs of different regulations. This inefficiency can be costly!
In contrast, each HITRUST requirement breaks down into multiple Implementation Levels. These include framework-specific Levels (e.g., “Level HIPAA”) that break down the most efficient ways to implement a given control to cover for multiple frameworks’ requirements.
Achieve Healthcare Compliance with HITRUST CSF Certification
Compliance with the HITRUST CSF is critical to protecting your sensitive data, especially if your organization is in or adjacent to healthcare. As a leading HITRUST CSF compliance partner, RSI Security will help you navigate all the stages of HITRUST certification. Our team of experts will help you prepare for audits, optimize controls, and leverage the health care compliance pros, ensuring you meet up-to-date HITRUST CSF compliance standards.
Contact RSI Security today to learn more about HITRUST!