In 1996, the Health Insurance Portability and Accountability Act (HIPAA) defined standards for safeguarding the sensitive, confidential data of all patients. The act requires health insurance providers to enforce strict privacy and security rules, each designed to protect the patient and all electronically protected health information, known as ePHI.
Since then, these guidelines enforced by the United States Department of Health & Human Services revolutionized how healthcare organizations handle and protect patient information. Healthcare organizations that are successful in following HIPAA requirements administer strict internal protocols as well as spend significant time ensuring the soundness of the healthcare software system.
That puts a lot of pressure on healthcare software testing, especially for a QA team not fully versed on all HIPAA compliance requirements. And when severe consequences across the business can be the result of not thoroughly testing your software teams can become anxious, confused and frustrated from one development cycle to the next.
The best way to combat fear is through education. While HIPAA requirements can be intimidating at first glance, many of these obligated conditions are identical to already-established best practices for protecting information across all kinds of software applications. By knowing what is expected and what must be done to maintain these expectations, your team can implement software testing strategies that guide your testers towards success.
So, what does it mean to be HIPAA compliant? And what software testing strategies can validate the healthcare product’s compliance?
What It Means to be HIPAA Compliant
Am I HIPAA compliant? This is something that every company within the healthcare industry must ask themselves regularly in order to ensure that all internal practices and procedures work in the best interest of the patients.
To be HIPAA compliant means that you protect ePHI throughout your system and through any information exchange by upholding the strictest, strongest privacy and security protocols.
HIPAA requirements centers around these four rules:
- HIPAA Privacy Rule: Protect patient medical records and all ePHI as well as set limits and conditions on the uses and disclosures within the system that may be made without patient authorization.
- HIPAA Security Rule: Appropriate technical, physical and administrative safeguards are in place that ensure the security, confidentiality and integrity of ePHI.
- HIPAA Enforcement Rule: Not following HIPAA compliance requirements leads to Investigations, penalties and/or procedures for hearings.
- HIPAA Breach Notification Rule: Notify patients and the United States Department of Health & Human Services when a breach of unsecured ePHI occurs. Notify the media when a breach impacts more than 500 patients.
How to Comply with HIPAA in Software Testing
If you’re asking, “am I HIPAA compliant?” instead of saying “I am HIPAA compliant,” then chances are your software testing practices need to be reevaluated. When entering the healthcare domain, it is integral that your team understands the specific HIPAA requirements and regulations so that they are included in your testing plan and strategy.
As you gear up for healthcare software testing, incorporate these proven strategies to ensure full compliance:
1. Access Control
In accordance with HIPAA compliance requirements, a user should be allowed to access only the minimum amount of information needed to complete a given task. Strict access control can be achieved with these seven approaches:
- An access control list which allows user access only to specific applications/modules/areas.
- A unique name and/or number to identify and track every user identity within the system.
- User-based access which requires two-factor authentication for entry.
- Role-based access which relies on a user's role to determine access rights. For example, a user with multiple job functions will have multiple roles and thus multiple rights information access.
- Context-based access which restricts access to certain dates/times or devices within a specified information system or network.
- Established procedures for an emergency to obtain essential ePHI.
- Electronic procedures that enforces automatic logoff of an electronic session after a predetermined time of inactivity.
- Encrypt and decrypt ePHI.
2. Encrypted Data Transfers
All data shared among users should be fully encrypted, and only decrypted by authorized users. The same applies to data that is stored elsewhere, such as in the cloud. Following testing, you should perform risk analysis to identify any data loss during transfer or unauthorized access attempts. To uphold HIPAA requirements, follow these best practices for transferring encrypted data:
- Secure encryption keys to prevent unauthorized parties from accessing system data
- Encrypt all types of sensitive data, no matter where it’s stored in the system
- Analyze algorithm performance in encrypting data regularly
3. Data Sanitization
There’s always a possibility when performing application testing for a healthcare organization of a data leakage. To prevent this, make it a standard practice to create test data that acts in the same manner as expected from real data. For example, remove any existing field data (name, address, SSN number, phone number, etc.) and replace it with generic data. The most secure way to approach this is by using automated test data generation tools designed to support high performance for large data sets.
4. Structure All Test Data
Standardize the test data used for verification and validation of modules within the application. For example, if you are testing the generation of reports for a patient, the provided data might be:
Data structuring helps define the testing performed at different levels and across different parameters.
5. Audit Trail
Implement an audit trail to monitor all actions involving patient data in order to abide by HIPAA compliance requirements. This includes modifications, deletions, additions, and just about any other action you can imagine. Along with the action, the audit trail logs the time that it occurred and the user that performed it. Any suspicious activity or data breach can be referenced against the audit trail to determine the origin.
6. Failover/Load Balancing
This is perhaps the most vital reason to uphold HIPAA requirements, as loss of patient data can put a life on the line. Failover plans and load balancing are used to verify the system's ability to continue day-to-day operations while back-ups are performed. It also determines if a system is able to allocate additional resources when needed, and if it can recognize that need once it arises. A strong failover strategy, implemented correctly and tested thoroughly, should provide near-complete data protection, minimal data loss, and immediate recovery in the event of error.
In the healthcare domain, the stakes are very high. Not following HIPAA requirements in protecting patient’s sensitive information within your software system can lead to disastrous consequences, from bad press and loss of patient trust to lawsuits and jeopardizing patient health. And no one on your team wants to be the reason that the business suffers any HIPAA-related repercussions.This is all the more reason to pay close attention to your QA team and your software testing strategy. The end result will be a solid, dependable product, a happy client, and protected patients.
Still asking yourself, “am I HIPAA compliant?” We compiled a full run-down on how to refine your healthcare software testing strategy so that you meet and maintain HIPAA compliance requirements. Download the complete HIPAA requirements guide by clicking below!