The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and healthcare technology have changed significantly over the past 20 years. Covered entities and their business associates face an ever-evolving risk environment in which they must protect electronic protected health information (ePHI). Although healthcare security budgets may increase this year, the cost of implementing and maintaining adequate security controls to protect an entity’s ePHI far exceeds what is often budgeted. As a result, some ePHI may be under-protected and vulnerable to data breach. A long-term, consistent and cost-conscious approach to HIPAA compliance is needed.
Risk analysis: The foundation of an effective HIPAA compliance plan
Risk analysis is one of four required HIPAA implementation specifications that provide instructions to implement the Security Management Process standard. To further clarify risk analysis, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released guidance on the risk analysis requirement in July 2010. The HIPAA Security Rule states that an organization must conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by the organization.
Janice Ahlstrom, R.N.
Additionally, security risk analysis must be performed in order to comply and attest to Meaningful Use of electronic health records as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.
With the OCR increasing enforcement efforts with a second year of random audits for both covered entities and their business associates related to HIPAA compliance, risk analysis plays a critical role. Organizations need to comply with the HIPAA risk analysis requirement if they are to be fiscally responsible and avoid returning Meaningful Use Medicare and Medicaid payments, avoid OCR fines and avert the cost of breach notification efforts.
Risk analysis – Five steps to getting it right
Today, we find a range of compliance issues and tools used to conduct risk analysis when providing services. Often, HIPAA risk assessment reports do not meet the guidance defined by OCR or support complete review of the security rule controls. Checklists of policies and procedures, penetration test results and IT assessments barely scratch the surface of the data security safeguards. The wide variance in HIPAA risk analysis scope and reporting suggests that many organizations may not truly understand the HIPAA Security Rule and how to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by the organization as defined by the OCR. The five steps below should put you on the right track to be compliant with OCR guidelines.
1. Evaluate your current HIPAA risk assessment
The following components should be included in your current risk assessment efforts:
- Identification of assets that create, store, process or transmit ePHI and the criticality of the data
- Identification of threats and vulnerabilities to ePHI assets, the likelihood of occurrence and the impact to the organization along with a risk rating
- Evaluation and documentation of the administrative, physical and technical safeguards for the organization, by department where applicable, and for each application with ePHI
- Evaluation and documentation of the security measures currently used to safeguard ePHI. Are the controls configured and used properly? What are the vulnerabilities?
- Evaluation of HIPAA policies and procedures – are the documents dated, signed, reviewed periodically and available?
If all of the above items are not included in the scope of your risk assessment, the assessment may not be acceptable with an OCR audit.
2. Select the right HIPAA risk assessment tool
The OCR highlights two tools in its 2010 guidance that provide a framework for risk assessment:
Security Risk Assessment Tool (SRA) - developed by the Office of the National Coordinator for Healthcare Information Technology (ONC). The ONC’s SRA user guide walks users through 156 questions with resources to help understand the context of each question. It also allows users to factor in the likelihood and impact to ePHI in the organization. The tool functions on mobile devices as well. It can be downloaded from HealthIT.gov. The tool is geared towards smaller practices and while a good starting point, it does not take into consideration many of the complexities of larger organizations.
Risk Assessment Toolkit - developed by a team of Health Information Management Systems Society (HIMSS) professionals. The HIMSS Risk Assessment guide and data collection matrix contains a PDF user guide, Excel workbooks with NIST risk analysis references, application and hardware inventory workbooks, HIPAA Security Rule standards, implementation specifications and a defined safeguards workbook. The safeguards are numbered 1-92 and correspond to the Security Scorecard workbook.
The scorecard differentiates numbered safeguard components to be assessed for the organization, by department and within applications that contain ePHI. The HIMSS Risk Assessment toolkit is available at: http://www.himss.org/himss-security-risk-assessment-guidedata-collection-matrix. The tool includes NIST Special Publication 800-30 Revision 1 guidance for completing a risk assessment.
3. Determine the risk analysis frequency
One of the most prevalent challenges in complying with the HIPAA Security Rule’s risk analysis requirement is determining the frequency or triggering conditions for performing a risk analysis.
The HIPAA Security Rule and 2010 OCR risk analysis guidance state that risk analysis should be “ongoing” to document and update security measures as needed. The security rule states that continuous risk analysis should be completed to identify when updates are needed. OCR guidance notes that the frequency of performance will vary among covered entities.
Some covered entities may perform these processes annually or as needed (e.g., bi-annual or every three years) depending on circumstances of their environment. Typically, covered entities that are attesting to Meaningful Use and complying with the spirit of the security rule will conduct an annual HIPAA risk assessment.
4. Perform the risk assessment: insource or outsource
HIPAA does not specify who should perform the risk assessment. Some organizations insource, some outsource and some do both – alternating between insourcing and outsourcing. For example, an organization may hire external resources to conduct the HIPAA risk assessment every other year, and on the off year, the organization may choose to conduct it internally. Where practical, a separation of duties should exist between the HIPAA risk assessment team and the systems implementers and operations staff. Hiring an outside professional to conduct the risk analysis reduces risk by providing an impartial assessment from someone who was not involved in the implementation of your systems or the development of your policies, procedures and security controls.
5. Support cost savings without sacrificing risk assessment quality
How do you contain costs in performing a HIPAA risk analysis? Use an industry standard tool for assessment and stick with it. The industry standard tools also help to define a clear scope of effort. Often organizations can become disconcerted trying to conduct a self-assessment with a previous year’s report provided by an outside professional.
Final analysis: What could be missed, overlooked or found?
Healthcare organizations must implement strong data security safeguards. Doing so supports compliance with the HIPAA Security Rule, reduces risk and helps ensure the confidentiality, integrity and availability of the ePHI the organization creates, receives, maintains or transmits. Conducting internal risk analysis along with annual risk assessments that leverage a professional services provider every other year also reduces risk and maximizes the value of the resources engaged. Finally, leveraging an industry standard toolkit will help your organization be comfortable with conducting self-assessments on alternating years while saving time and money.
Janice Ahlstrom, R.N., director of risk, internal audit and cybersecurity, Baker Tilly email@example.com
Kenneth Zoline, manager of technology risk and cybersecurity, Baker Tilly firstname.lastname@example.org