A security incident can compromise electronic protected health information (ePHI), disrupt operations, affect patient care, and create compliance risks. A thorough HIPAA risk assessment helps healthcare organizations identify and evaluate risks to their ePHI.
The HIPAA Security Rule requires regulated entities to conduct an accurate and thorough assessment of potential risks and vulnerabilities to the confidentiality, integrity, and availability of the ePHI they create, receive, maintain, or transmit. HHS identifies risk analysis as a foundational part of the Security Rule’s security management process.
A risk assessment for organizations managing ePHI does not only mean filling up a list of questions. There is an in-depth analysis of the organizational environment that encompasses potential risks and weaknesses in addition to their effects on the organization.
A HIPAA risk assessment refers to the process of analyzing all the possible threats and weaknesses concerning confidentiality, integrity, and availability of the ePHI.
This should be done based on ePHI created, received, maintained, or transmitted by the covered entity. This involves ePHI that is stored or maintained on systems, applications, devices, networks, and electronic media.
One helpful method for conducting a risk analysis involves:
What do you have? → What could possibly go wrong? → What are the risks involved? → What has to change? → Record and review it.
The HIPAA Security Rule has no set methodology prescribed for doing the risk analysis. However, the chosen method must meet the Rule’s requirements and account for the organization’s size, complexity, capabilities, and environment.
Risk assessment provides an organization with a real image of its surrounding environment in terms of security.
It can help identify issues such as:
Moreover, it will aid in providing information for the organization’s risk management efforts. HHS makes the distinction between the two clear: risk analysis assesses risks, while risk management entails taking the necessary security measures to mitigate such risks to an acceptable level.
Knowing about HIPAA Risk Assessment Requirements is essential prior to conducting the assessment.
An adequate strategy for the assessment would be the one that evaluates the threats and vulnerabilities to the security of the ePHI.
Some important elements to consider according to HHS include:
HIPAA does not prescribe a single template or scoring method. The assessment must reflect the organization’s environment and address the required elements of a thorough risk analysis.
Step 1: Define the Scope
Start by establishing what the assessment covers.
Determine what systems, applications, devices, locations, individuals, and processes create, receive, store, or transmit ePHI.
For example, a healthcare SaaS provider may need to consider:
This helps ensure that the assessment covers all relevant ePHI. According to HHS, the analysis must account for ePHI regardless of where or how it is created, received, maintained, or transmitted.
Step 2: Identify and Map ePHI
Next, determine what ePHI your organization handles and where it goes.
Document:
Use of data flow diagrams will also assist in such cases since these will help in depicting the flow of information in applications and personnel and contractor areas.
Step 3: Identify Threats and Vulnerabilities
Now ask two related questions:
What could cause harm?
That is the threat.
What weakness could allow that threat to cause harm?
That is the vulnerability.
These can include anything from unauthorized access, to viruses and phishing, accidental loss of data, system failure, natural disasters and other forms of dangers. As stated by HHS, the sources of threats are human, natural or environmental.
The vulnerabilities are technical or non-technical and include software that is outdated, improper configuration or absence of security policies.
Step 4: Review Existing Security Measures
Just because you have found a vulnerability does not mean that there are no controls to protect from the vulnerability. Look at the current controls being implemented.
For instance:
Risk: Unauthorized access to the patient database.
Current controls: Authentication, access controls, logging, and monitoring.
Then determine if the above security controls are properly implemented to handle the risk. The HHS has recommended doing the above evaluation of existing security controls.
Step 5: Evaluate Likelihood
Determine how likely each identified threat is to occur or exploit a vulnerability.
Your organization might use categories such as:
Or it may use a numerical scoring model.
The methodology itself may differ depending on the particular organization. The crucial point is to use the chosen methodology and record why a certain methodology is used for this assessment. HHS states that there is no particular methodology which Security Rule prescribes to conduct risk analysis.
Step 6: Evaluate Potential Impact
Next, determine what could happen if the risk occurs.
Consider potential effects on:
For example, a short outage affecting a non-critical internal application may have a different impact from an outage affecting a system required for patient care.
HHS guidance calls for consideration of the potential impact, or criticality, associated with threats affecting ePHI.
Step 7: Determine the Risk Level
Combine your likelihood and impact assessments to determine the overall level of risk.
A simple model might look like:
Risk Level = Likelihood × Impact
For example:
Risk | Likelihood | Impact | Overall Risk |
Phishing leading to account compromise | High | High | High |
Loss of an encrypted backup device | Low | Medium | Medium |
Temporary outage of a non-critical system | Medium | Low | Low |
This was only a simple illustration. Use methodology appropriate to your situation.
HHS recommends that a risk level be defined for every possible combination of threats and vulnerabilities.
Step 8: Create a Risk Management Plan
A risk assessment identifies problems. The next step is deciding how to address them.
For each significant risk, document:
For example:
Risk: Unauthorized access to ePHI
Rating: High
Action: Strengthen privileged access controls and MFA
Owner: IT Security Manager
Target: 60 days
Status: In progress
This turns your HIPAA security risk assessment into an actionable security program.
Step 9: Document Everything
Documentation is an important part of the process.
HHS states that the Security Rule requires the risk analysis to be documented but does not require a particular format.
Your documentation should make it possible to understand:
Step 10: Review and Update the Assessment
A risk assessment for HIPAA compliance should not be done only once.
The organization must conduct updates on the analysis based on any changes in its environment and operations. According to HHS, there might be situations like use of new technology, security incidents, change in business operations, among others, which will make it necessary to redo the risk analysis and security procedures.
For example, reassess risks when you:
Before completing your assessment, confirm that you have:
What is a HIPAA Risk Assessment?
A HIPAA risk assessment evaluates potential risks and vulnerabilities affecting the confidentiality, integrity, and availability of ePHI that a regulated entity creates, receives, maintains, or transmits.
How to conduct a HIPAA risk assessment?
To conduct a HIPAA risk assessment, define the scope, identify ePHI and map its flows, identify threats and vulnerabilities, evaluate existing safeguards, assess likelihood and potential impact, determine risk levels, document findings, and address identified risks through risk management.
How often should a HIPAA risk assessment be performed?
The HIPAA Security Rule does not prescribe one fixed schedule for all organizations. Risk analysis should be ongoing, with reviews and updates as needed based on changes in the organization’s environment, operations, technology, and security risks.
Is a HIPAA risk assessment required?
Yes. Under the Security Rule of HIPAA, a comprehensive risk assessment of threats and vulnerabilities to electronic protected health information must be carried out.
What is the difference between HIPAA risk analysis and risk management?
Risk analysis is concerned with identifying and analyzing risks and vulnerabilities. On the other hand, risk management entails putting in place various security controls to bring down the risks to an acceptable level.
Can a HIPAA risk assessment be automated?
Technology is useful in helping organizations identify their assets, risks, assign corrective actions, gather evidence, and monitor changes. However, technology does not mean that humans are exempt from making decisions.
HIPAA Risk Assessment is a systematic approach for an organization to assess the risks associated with the ePHI environment. It begins with defining the environment and identifying the ePHI, followed by threat identification, vulnerability assessment, likelihood and impact assessment, risk prioritization, documentation, and risk management.
The main thing to remember here is that risk assessment must be done according to your environment and not simply based on a checklist. Your risk assessment must keep up with changes in your systems, vendors, technology, and operations.
If you need a more structured approach for HIPAA Security and Compliance Program Management, Contact Us to learn about your needs and Get Started Today.
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