Healthcare software that handles electronic patient health information (ePHI) must adhere to the Health Insurance Portability and Accountability Act (HIPAA) guidelines of 1996. Federal law lists standards to ensure that sensitive patient health data is not shared without the person’s consent.
If patient data is handled by your organisation’s mobile app, web app, or IoT system, the software must comply with HIPAA requirements. This is why healthcare application testing is so important. Failure to comply with HIPAA can result in severe penalties and patient data theft.
Why Is The HIPAA Compliance Test Important?
The Yuma Regional Medical Center ransomware attack in 2022 is a wake-up call for every software company dealing with sensitive patient data. The attack exposed more than 700,000 patients’ details, proving why HIPAA compliance is necessary. In the US, 1 in 4 customers suffers from stolen healthcare records.
By ensuring HIPAA compliance, software companies dealing with healthcare data can ensure the privacy and security of patient data. It will also help you avoid huge penalties imposed by the Health and Human Services (HHS) of the US government. In severe cases of HIPAA violations, your company may face up to $1.5 million as fines or even 10 years of imprisonment.
The best way to ensure HIPAA compliance is through HIPAA tests for healthcare providers. The compliance testing ensures that the software application meets all standards of HIPAA. By partnering with testing services providers such as ImpactQA, you can rest assured knowing that HIPAA compliance requirements are met.
HIPAA Requirements For Healthcare Software
HIPAA requirements are categorized based on the following five rules:
- HIPAA privacy rule — It guarantees an individual’s right to medical information. No covered entities or business associates are allowed to share information that could breach privacy requirements.
- HIPAA security rule — All software applications must apply safeguards that protect electronic patient records.
- HIPAA enforcement rule — It outlines directives associated with compliance. Failure to enforce HIPAA can result in civil penalties.
- HIPAA breach notification rule — Business associates must notify of any breach of patient health data within 60 days of knowing about the breach.
- HIPAA omnibus rule — Business associates must adhere to the changing HIPAA requirements while ensuring that old HIPAA requirements are also met.
Challenges In Ensuring HIPAA Compliance
The best way to ensure HIPAA compliance is to include compliance requirements from the development stage. The HIPAA test must be conducted exclusively during the testing phase to ensure that HIPAA guidelines are met.
Some of the challenges in ensuring HIPAA compliance are:
- A large volume of data is distributed across electronic health record (EHR) systems.
- Inadequate knowledge and resources to create HIPAA-compliant software solutions.
- Multiple development platforms that don’t have in-built HIPAA compliance systems.
- Stringent cybersecurity requirements.
- Scalability and flexibility requirements of software for data sharing.
- Ongoing security reassessment and implementation.
Understanding HIPAA Test For Healthcare Providers
As part of HIPAA security requirements, a few safeguards are outlined to be followed by business associates dealing with sensitive and private patient data.
- Administrative safeguards — Companies must have clear documents on the security management process. They must analyze ePHI risks and ensure that security mechanisms are in place to mitigate them.
- Physical safeguards — Companies are responsible for physically restricting access to data centers that store ePHI.
- Technical safeguards — Companies must ensure the security of software, hardware, and other technologies that access ePHI.
Testing Strategies For Healthcare Application Testing
To ensure HIPAA compliance, rigorous testing is mandatory. Healthcare application testing ensures that all the guidelines to protect patient health data are followed. It also tests the limits of software safeguards in place to protect against data breaches. The risk management process should also automate breach reporting when a data breach occurs.
Sanity testing and full-feature testing must be conducted at the early stages of the development cycle. The testing strategies chosen for any application depend on the scope and limitations of the application. Testing strategies essential for HIPAA tests are:
1. Access Control
Users with access to patient data should have the minimum access required to complete their tasks. You should test for user-based, role-based, and context-based access to get ePHI. While developing test cases, ensure that the access control list is foolproof. Every user must be uniquely identified throughout the system. Test the security of two-factor authentication for data access.
2. Encrypted Data Transfers
Data about patient health information should always be stored in an encrypted form. The data shared should be decrypted only by authorized users at the time of access. Data should be tested to ensure that secure encryption keys are used. The encryption algorithm should be tested to ensure security. After testing for encryption, risk analysis is also necessary to mitigate data loss risks.
3. Data Sanitization
Testing for data leakage is also essential to ensure HIPAA compliance. The test data used here should act similarly to accurate data. Automated testing tools and data generation techniques help test large data sets to ensure high performance. Different test cases must be drafted for data leakage and breach possibilities.
4. Testing Data Structures
Each patient health record holds different types of data structured in standard formats. The data structure must be tested at various levels using multiple parameters to ensure that the data adheres to the required structure. At any point, the data should be stored in a preformatted structure.
5. Audit Trail
The essential requirement for HIPAA compliance is to ensure that data is auditable—test for audit trail implementation so that any changes to the data are auditable. The trail log should contain all details about the last change made to the data. This will help identify and report data breaches accurately.
6. Load Balancing
HIPAA compliance is critical because mishandled or corrupt data can result in a threat to the life of the patient. Load balancing testing and failover testing must be conducted to ensure that healthcare operations remain undisrupted even when backups are performed. Testing is required to ensure data protection, reduce data loss, and take recovery steps in case of data errors.
Healthcare application testing is inherently complex as it requires domain expertise. The testing team must be aware of how data will be accessed. HIPAA violations can lead to severe repercussions; thus, companies must ensure compliance with rigorous testing. The best way to HIPAA test is to hire a testing partner with experience and expertise in healthcare. The QA team must work with the development team to implement testing and assurance practices throughout the product lifecycle.
Originally published at https://www.impactqa.com on February 20, 2023.
