Disclaimer: This article covers significant areas of software testing for HIPAA compliance and excludes elements such as physical safeguards like non-deployment of software on workstations with open screens. Additionally, please note that the strategies discussed in this article are application-specific and may not be applicable to all applications.
Healthcare organizations are experiencing a high number of data breaches at an alarming rate. The Yuma Regional Medical Center ransomware attack in April 2022, which exposed the data of over 700,000 individuals, is a notable example of this. The graph below also shows that the number of data breaches is increasing year-on-year.
US Healthcare Data Breaches Among Consumers
In response to this, medical organizations are now turning towards software that has unbreachable data protection measures for storing and transmitting medical data. They are adhering to all HIPAA compliance requirements and spending significant time to ensure the security and soundness of the built healthcare software.
This shift in focus makes HIPAA-compliant software testing crucial. Failure to test healthcare software for HIPAA compliance could result in data leaks and illegal usage of the application. It could also lead to severe penalties from the US Department of Health and Human Services.
This is why it is necessary for your healthcare software development team to dedicate sufficient time to building a HIPAA-compliant application and focus on software testing.
At Revinfotech, we have successfully developed, tested, and deployed healthcare apps that cater to multiple stakeholders without a single breach instance.
In this article, we will discuss various ways to test for HIPAA compliance in your application. However, first, let us examine why building HIPAA-compliant software is becoming increasingly challenging.
Is it difficult to build HIPAA-compliant software?
Although healthcare service providers prioritize security to ensure HIPAA compliance, the complexity of the healthcare sector means that certain elements may remain unaddressed. In the absence of a HIPAA compliance software checklist, several challenges can arise. These include the difficulty of protecting a large volume of sensitive data, the lack of resources available for HIPAA compliance, the need to secure multiple data access platforms, the potential rigidity of software built with multiple security requirements, and the need to regularly reassess HIPAA implementation due to changing cybersecurity threats, HIPAA requirements, and IT needs of healthcare organizations. Despite these challenges, there are solutions available that involve HIPAA compliance software testing and regular audits and document updates. In the following sections, we will explore these solutions and the process of HIPAA compliance testing.
Software testing strategies for HIPAA
To ensure that software is HIPAA compliant, it is important to understand the 5 key areas of HIPAA compliance software testing. These areas are:
- User authentication: User authentication can be based on ownership, knowledge, or biometrics. Software testing in this area focuses on more than just ensuring successful login paths for each role. It involves testing for login failures due to issues such as empty user ID and password, invalid user ID and password, expired or blocked accounts, locked-out accounts, login success post-password change, login idle timeout, and data not stored in application memory. Additionally, creating a standard structure of test data such as <PatientFirstName><PatientLastName><TestName><Date><Time> can help in identifying users seamlessly.
- Authorization and access controls: Authorization and access controls involve testing whether the application provides appropriate levels of access to users based on their roles and responsibilities. This includes testing for unauthorized access attempts, role-based access controls, and access control lists.
- Data encryption and transmission security: Data encryption and transmission security involves testing whether the application ensures secure transmission of sensitive data over unsecured networks. This includes testing for proper encryption algorithms, secure protocols, and secure transmission of data between the server and the client.
- Auditing and monitoring: Auditing and monitoring involve testing whether the application logs and monitors activities related to sensitive data. This includes testing for audit log generation, log storage, log review, and event notification.
- Data backup and disaster recovery: Data backup and disaster recovery involve testing whether the application can recover sensitive data in case of disasters or system failures. This includes testing for backup and restore capabilities, disaster recovery plans, and business continuity plans.
By focusing on these 5 key areas during software testing, healthcare organizations can ensure that their software is HIPAA compliant and secure.
Disclosure of information
To facilitate information disclosure testing, two key categories are used – role-based access and patient allocation. Under the role-based access category, users are grouped into logical classes with specific access levels, and under the patient allocation category, the supervisor assigns patients to a healthcare provider for a specific time.
To ensure proper testing, it is essential to design test cases that specify which users can view, modify, add or delete information that they are not authorized to access. Furthermore, it is recommended to establish a practice that all EPHI information is removed and deleted from the system when the app is uninstalled. Proper information disclosure testing should be a critical part of the HIPAA compliance software checklist.
Trails of audits
To ensure HIPAA compliance software testing, audit trails must be carefully evaluated. The following factors should be considered:
- Each audit trail entry must contain the date and time of the action, the user’s ID or name, their access level, the patient record ID on which the action occurred, the action that was performed, the specific event from which it was performed (such as payment or patient charting), and the location or system ID through which the action was taken.
- Audit trail entries must comply with the software’s security requirements and be easily traceable for future investigations.
- Audit trail entries should not be deleted from the audit trail.
- The audit trail should be designed to be viewed by specific user accounts.
- All attempts to breach security must be monitored in the audit trail.
- The audit trail must be encrypted.
Considering these factors will help ensure that the software complies with HIPAA regulations.
Ensuring security during data transfer is a crucial aspect of HIPAA compliance testing. This includes securing data access between physical and mobile devices where the app is installed, transferring data to external devices and locations, and moving data to offline storage locations. During data transfers, it is essential to encrypt the data, which can only be decrypted by authorized users. Here are some best practices for data encryption that should be included in the HIPAA compliance requirements:
- Secure the encryption keys to prevent unauthorized access to system data.
- Encrypt sensitive data, regardless of where it is stored within the system.
- Regularly analyze the performance of the encryption algorithm.
Data usage information
To ensure HIPAA compliance in software testing, it is essential to focus on the five key areas of user authentication, information disclosure, audit trails, data transfer, and data usage. In addition to testing these areas thoroughly, there are specific steps that can be taken to achieve and maintain HIPAA compliance during the healthcare application development process.
- Conduct a risk analysis: The first step is to conduct a risk analysis to identify potential vulnerabilities in the software. This analysis will help to identify areas that require the most attention and resources.
- Create a comprehensive HIPAA compliance policy: It is essential to create a comprehensive policy that outlines the organization’s approach to HIPAA compliance. This policy should cover all areas of the software development process and should be regularly reviewed and updated.
- Train employees: All employees involved in the development process should receive regular training on HIPAA compliance policies and procedures.
- Conduct regular testing: Regular testing of the software should be conducted to ensure that it remains HIPAA compliant. This testing should include both manual and automated testing.
- Document all processes: It is crucial to document all processes related to HIPAA compliance, including testing procedures, risk analysis, and any issues that are identified during testing.
By following these steps, healthcare organizations can ensure that their software is HIPAA compliant and that patient data is protected throughout the software development process.
Testing software in compliance with HIPAA
When developing healthcare apps at Appinventiv, we prioritize the HIPAA software requirements and incorporate them into the end-to-end development cycle, especially in the testing phase. Here are some steps we take to ensure HIPAA compliance:
- Access control: We follow seven modes of access control to ensure that users can only access information necessary for their tasks. This includes a list of access control, distinctive user identification, two-factor authentication, role-driven access, context-driven access, emergency access, and automatic logoff. We also encrypt and decrypt ePHI.
- Sanity testing: We conduct a sanity test to identify defects in the app’s HIPAA compliance standards. This includes verifying high-risk roles, encryption, and audit trail entries.
- Roles matrix: We create a roles matrix based on the client’s risk level for information disclosure, usage frequency, error chances, and impact of errors. This matrix helps us identify risk levels associated with every relationship and fix issues proactively.
- Test cases: We create detailed test cases for each user action in the app, from signing in to managing availability slots, viewing scheduled appointments, joining virtual consultation sessions, and managing profiles.
- Load balancing: We implement failover or load balancing plans to ensure smooth day-to-day operations, resource allocation, and instant recovery during errors. This helps us offer near-complete data protection and minimal data loss.
We follow a process for testing HIPAA compliance
The approach we follow to ensure a health app’s HIPAA compliance testing is distinct from regular app testing approaches. Here is the process we follow:
- Analysis of Documentation Our QA specialists analyze the software documentation containing functional and non-functional requirements to create a checklist of the technical safeguards necessary for your software, followed by a HIPAA compliance testing plan.
- Creation of Roles Matrix We create a chart of roles matrix to identify the current user roles and their associated risk levels linked with performing multiple operations like view, add, delete, and modify ePHI.
- Test Planning and Design The process starts by defining the testing events required for checking software compliance with HIPAA technical safeguards, such as vulnerability assessment, functional testing, and penetration testing. We define the testing team composition, relevant test scenarios and cases, and the share of test automation. We also write scripts around test automation, select and configure the necessary automation tools, and prepare the mandatory test environment and data.
- Test Execution and Reporting We run manual and automated tests based on predefined test scenarios, report any identified HIPAA compliance gaps, and suggest necessary remediation measures.
In conclusion, we have looked at multiple aspects of testing a HIPAA-compliant health app and the process we follow to test the application. Finally, we consider the cost implications of the testing.
HIPAA compliance testing costs
The individual cost of HIPAA compliance testing depends on several factors such as the complexity of the healthcare software, the number of user roles, applicable HIPAA technical testing safeguards, required testing types, the extent of test automation, complexity and number of test cases, software testing sourcing model, and security testing tool costs. By adhering to these HIPAA software testing practices and following our compliance testing process, we ensure that we build a compliance-ready application that is secure against breaches. We achieve this by incorporating the HIPAA compliance software checklist into the design, development, and maintenance efforts. If you need assistance building or testing a HIPAA-ready application, contact us today.
Frequently Asked Questions
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