How to comply with HIPAA: 5 software testing strategies

Statistics time! A single data breach in the healthcare industry costs an average of USD 10.93M. In addition, over 231M Americans have been affected by healthcare data leaks over the past few years. And with cases such as the 23andMe data breach, we can’t help but admit that the need to comply with data privacy regulations like HIPAA is stronger than ever.

Let’s take a minute to play with imagination. You’re running a healthcare app, handling everything from appointments to prescriptions. But one glitch, one security gap, and you could be facing hefty fines, reputational damage, and a breach of trust with your patients. The stakes are sky-high, and that's where healthcare application testing comes in. Let’s zero in on HIPAA testing in particular since the Health Insurance Portability and Accountability Act is the most reputable document and law in the US.

It's like building defenses to protect against attack. In our case, HIPAA compliance also plays the role of protection and, therefore, authorization to operate.

This introduction is literally a gateway into the topic of HIPAA compliance testing. So, let's delve into the very foundation of the regulatory landscape and why it demands our unwavering attention.

What is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) is a US law that protects sensitive healthcare information. It was enacted in 1996 with the primary purpose of enhancing the efficiency of the healthcare system. In general, this law establishes standards and requirements for the electronic exchange of healthcare information.

Key concerns HIPAA helps with

Essentially, HIPAA sets a comprehensive framework for ensuring the confidentiality, integrity, and availability of patient information. It’s an accepted legal mandate that shapes healthcare data management in the modern digital age.

What it means to be HIPAA-compliant

Primary goal for any healthcare institution, company, or startup is good patient well-being. Any organization should regularly check if their services meet all the HIPAA requirements. However, being HIPAA-compliant, in our case, goes beyond mere adherence to regulations since it involves a commitment to the highest standards of privacy and security in handling patient information.

In general, HIPAA has five sections/levels with different connections to healthcare software.

1/ Patient privacy: HIPAA puts patients' privacy on the top of a “prioritization ladder”. Simply put, healthcare software must be protected against unauthorized access to sensitive patient data so that only authorized personnel can view or handle it.

2/ Data security: The Security Rule within HIPAA necessitates robust safeguards for the mentioned electronic protected health information. Software providers must ensure encryption, access controls, and regular risk assessments, which help to identify and address potential vulnerabilities.

3/ Breach notification: Life happens, no matter how cynical it may sound. And so do troubles. If a data breach has taken place, organizations must follow stringent procedures for timely and transparent notifications to affected individuals, regulatory bodies, and, in special cases, the media.

4/ Comprehensive training: Medical and tech specialists within any healthcare institution must be prepared and well-trained in handling patients' data. And HIPAA mandates such training for these specialists.

5/ Documentation and auditing: Companies must develop a tree of documentation, policies, procedures, and security measures. Make sure you have an internal department that will hold audits and double-check the requirements to ensure ongoing compliance.

The challenge of HIPAA compliance in software

Any healthcare organization or healthcare-related business is between two fires. On the one hand, they must meet stringent demands of patient privacy. On the other hand, they want to deliver as fantastic customer experience as possible through technological advancements.

You must take a proactive and adaptive approach to achieve and maintain HIPAA compliance. As a company, you need to stay abreast of regulatory updates and emerging cybersecurity risks.

And this is not to mention partnership agreements and administrative safeguards. For example, if you outsource any tasks involving ePHI, you must ensure your business associates are also HIPAA-compliant.

So, compliance isn't a one-time event, rather an ongoing chain of actions. Regular audits, updates, and employee training are crucial to maintaining your HIPAA fortress and guaranteeing patient data privacy.

Why is building HIPAA-compliant software difficult?

Let's be honest: when you encounter an intricate maze of HIPAA regulations, it can be enough to make even a seasoned tech specialist break a sweat. HIPAA compliance for software development is akin to making the right medical diagnosis on a whim since the precise diagnosis requires accuracy, foresight, and a deep understanding of all the circumstances involved.

To avoid getting into the on-the-bubble situation, let’s shed light on the most common challenges.

Don’t play with security while scaling

Recall the Security Rule “within” HIPAA. It demands robust safeguards for ePHI. It may be encryption, access controls, and/or secure data storage, but anyway, that all becomes intricate. And think for a while about scaling your business. A little bit challenging to maintain such a massive system, right?

Software development is fluid

Sounds weird, but still. Remember how startupers launch their first project? They test the waters first. In this wordplay, we hid deeper meaning — the nature of software development is akin to water; it is fluid. Because you can’t go with the same software version after years (even months), its agile and iterative nature often clashes with the stability demanded by compliance. Constant updates and changes may introduce vulnerabilities that need meticulous validation.

Data sharing nuances

In the healthcare industry, there are many institutions and many systems of patient data management. Thus, all the data must be carefully gathered and conveniently processed. That’s why healthcare systems are often interconnected, sharing data across various modules and even institutions. Ensuring the secure exchange of information without compromising patient privacy is a significant challenge.

Profile proof

Any system considers every patient as a brunch of data, as an abstract profile. Verifying this profile (read, identity) and granting them appropriate access levels requires sophisticated authentication and authorization mechanisms. Especially when it comes to structures with numerous stakeholders.

No one is immune to mistakes

The machine era is just around the corner… But still it is not here. So we still need people to control complex systems and software in particular. In that sense, no system is foolproof, and human error can be a major vulnerability. And let’s face it, often managers have such errors up to wazoo. Accidental data leaks, improper access controls, and even simple typos can put patient data at risk.

Regulations also evolve

Technologies are evolving at the speed of light. So do HIPAA regulations. They evolve to address emerging threats and technologies. Staying compliant requires constant vigilance and the ability to adapt swiftly to regulatory updates.

Vendor management

In scenarios where healthcare organizations rely on third-party vendors for software solutions, ensuring that these vendors also adhere to HIPAA standards adds an additional layer of complexity.

Five strategies for HIPAA software testing

We want more companies to hire professionals. Firstly, this is how we create reliable conditions for business development. Not always, of course, but predominantly: when professionals work, the job is done much better. At the same time, we create social ties and raise the standard of living of end users through quality products.

However, here are five strategies for a general understanding of healthcare application testing. We will leave out the technical details and give the main things to understand.

1/ Comprehensive security testing

Probably, the most important thing. Security testing identifies vulnerabilities and potential attack vectors, ensuring your software can withstand load or even hacker attacks. Here is how it could be broken down:

Nuances and pitfalls: Regularly update security testing protocols to address emerging threats. Ensure that encryption and access controls are not only implemented but also resilient to potential breaches.

2/ Functional testing

In Ukraine, there was an interesting case when the subway station was built on shaky ground. Consequently, the station was closed due to an emergency situation. The same story with software development. Functional testing ensures your software has robust “ground” — core functions, and they work as intended. While testing, ask yourself something like:

3/ Third-party vendor testing

As we said before, if third-party vendors provide you with software solutions, make sure to test the integration points and data exchange. Thoroughly check if they comply with HIPAA standards. Remember that in the modern world of partnerships, your reputation just can’t depend exclusively on you; it also involves all your partners.

Nuances and pitfalls: Choose a single communication channel with vendors regarding security protocols. If it’s possible, regularly assess and audit third-party systems for continued compliance.

4/ User acceptance testing (UAT)

The main lifehack is involving real users in testing. Yes, it sounds risky, but this also helps to ensure the software works as expected within clinical workflows. User acceptance testing can uncover usability issues that could lead to accidental data breaches or privacy violations.

Nuances and pitfalls: Simulate various scenarios, including attempted unauthorized access, to gauge the system's resilience. Regularly review and update user access permissions.

5/ Regression testing

Software is like a living organism — it evolves and changes. At least, it should. However, each update could introduce new bugs or vulnerabilities. Regression testing helps to nip it in the bud — to avoid and prevent more serious problems.

Key areas to focus on during HIPAA software testing

There is a temptation to turn a HIPAA compliance test into a checkbox exercise. Don’t do that. Dive deep and ensure scrutinizing every nook and cranny within software systems. The effectiveness of testing hinges on the thorough evaluation of critical components that handle patient data.

Data storage and encryption

What to zero in on: Evaluate how patient data is stored, ensuring that it's encrypted both in transit and at rest.

Testing nuances: Assess the robustness of encryption algorithms. You can enhance reliability with the IBE scheme, for example. Try to simulate critical scenarios of data transmission and storage to identify potential vulnerabilities.

User authentication and authorization

What to zero in on: Verify the mechanisms in place to authenticate users and control their access to patient information.

Testing nuances: Conduct penetration testing to assess the resilience of user authentication. The same note — test various access scenarios to ensure compliance with least privilege principles.

Audit trails

What to zero in on: Confirm that audit trails comprehensively log all activities related to patient data, facilitating traceability.

Testing nuances: Validate the accuracy and completeness of audit logs. Test the system's response to unauthorized access attempts, ensuring prompt detection and logging.

Data transmission protocols

What to zero in on: It is not enough to protect data that is stored in one system. It is also important to take care of security when transferring data between systems or networks. Secure communication protocols (i.e., HTTPS, TLS, and SSH) exist exactly for this reason. These protocols ensure that data remains confidential and protected during transmission over the Internet or other networks. Examine the protocols employed for the secure transmission of patient data between different systems.

Testing nuances: Assess the encryption of data during transmission. Simulate network vulnerabilities to gauge the system's resilience to potential breaches. Don’t shy away from backups — create them to prevent data loss and ensure availability in case of system failures.

Third-party integration

What to zero in on: If third-party vendors are part of the software ecosystem, test the integration points for compliance.

Testing nuances: Have a word with vendors before something happens. This helps to understand their security protocols. Validate data exchange processes and assess the impact of third-party systems on overall compliance.

Data lifecycle management

What to zero in on: Evaluate how the software manages patient data throughout its lifecycle, including creation, modification, and disposal.

Testing nuances: Test data disposal mechanisms, ensuring deleted data is irrecoverable. Simulate scenarios of data access requests and assess the system's response. Also, ensure a documented plan is in place to respond to security breaches promptly and effectively, including containment, investigation, notification, and recovery steps.

Access controls

What to zero in on: Ensure that access controls are granular, permitting only authorized personnel to view and handle patient information.

Testing nuances: Conduct role-based testing to validate that each user has appropriate access permissions — test for potential privilege escalation vulnerabilities.

Steps to achieve and maintain HIPAA compliance in software testing

For over 3 years, more than 70% of surveyed people prioritize their health. That means the demand for healthcare services will only grow over the years. This is where HIPAA compliance testing comes into play. Because when it comes to trust, nothing matters more than security, convenience, and delightful user experience.

Below, we outlined the steps any healthcare company should take to set up a robust approach to healthcare application testing.

Step 1: Assessment

Step 2: Testing plan

Step 3: Security measures

Step 4: Test cases and data management

Step 5: Regular compliance audits

Step 6: Train your testers and managers

Step 7: Document policies and procedures

Step 8: Help third-party vendors

Step 9: Address non-compliance

Step 10: Keep up with regulatory updates

These moves will help you not only achieve initial HIPAA compliance but also maintain a proactive and resilient approach to safeguarding patient data throughout the software testing life cycle.

Factors that impact the cost of HIPAA compliance testing

Money talks. When it comes to starting any project, a lot of things are about money. Especially when it is a HIPAA compliance testing. Well, that is fair, but it is uncertain. Because the price often depends on many factors. Here are the main ones.

Scope and complexity of software systems

Testing frequency and intensity

Use of automated testing tools

Training and skill level of testing team

Integration with third-party vendors

Data volume and complexity

Regulatory changes and updates

This is an incomplete list, but it still contains the They can help to make informed decisions about resource allocation, testing strategies, and long-term budget planning for HIPAA compliance testing.

To sum it up

The most important thing is to understand that healthcare organizations have no choice in today's world. Any self-respecting company must realize that it has a responsibility to its customers. And data security is now slowly becoming equal in importance to health security.

HIPAA compliance testing is in the long run. And healthcare companies must recognize it as a vital commitment to safeguarding patient data and upholding the highest standards of privacy and security. Adopting a comprehensive and holistic approach to testing that encompasses security, data management, user access controls, and integration points is like putting your best foot forward; it will positively affect the business, hands down.