Why do you need a HIPAA compliant healthcare app? GlobeNewswire reports the global mHealth apps market size to reach $113 billion by 2026. It correlates to a compound annual growth rate (CAGR) of 25.3%. It means the market will grow at least a quarter annually from its current worth of $45 billion. That also represents the broader rise of healthcare app development trends.
However, even though the mHealth market is rising, it does not mean every software development company can build a mHealth app and get desired profits. To get a piece of the pie, you need, first and foremost, to have a HIPAA compliant healthcare app. Further, we explore the phenomenon of HIPAA, investigate its importance in app development, and provide a checklist for HIPAA compliance along with ten critical steps for building a relevant mHealth application.
Table of Contents
HIPAA in a Nutshell
Health Insurance Portability and Accountability Act (HIPAA) is a piece of legislation developed in 1996. Its fundamental goals are to regulate how organizations handle patient data, decrease healthcare costs, and offer accessible health insurance for vulnerable populations. While HIPAA provides different aspects of functionality, as digitalization was broadly introduced in healthcare, its main objective has shifted toward data security. What is more, the rapid rise in the number of healthcare data breaches propagated such a shift (see Fig. 1).
The evidence above shows that digital transformation comes along with various security challenges. Companies working on app development cannot avoid HIPAA compliant healthcare app and cybersecurity services. In other words, if you intend to develop a video conferencing app that will work with patient data at some point, from the get-go, you need HIPAA compliance and strong cybersecurity measures. Furthermore, Harvard Business Review suggests cybersecurity is much more than a mere tech issue; it is the future of digitization in any given industry.
Basics and Foundations
HIPAA compliant healthcare app works with several key aspects of the principle. To understand what HIPAA is, you need to understand its constituents. In such a case, the starting point of HIPAA is its rules:
These are foundational elements of the HIPAA Act. The rules are regulated and enforced by the Office for Civil Rights (OCR) in the United States Department of Health and Human Services (HHS). If you want to know more about HIPAA or have some compliance concerns in mind, you can always look through HHS’ massive library.
Other foundational aspects that your HIPAA compliant healthcare app include factors like protected health information (PHI), covered entities, and business associates. In short, these terms mean the following:
- PHI is linked to any individually identifiable data. That includes any personal health information. There are 18 key PHI identifiers to consider.
- Covered Entities are people and all associated with the provision of healthcare services. These can consist of healthcare providers and healthcare plans.
- Business Associates are subcontractors for a particular covered entity that includes admitting PHIs. These correspond to Covered Entities with legally binding commitments and work via business associate contracts.
These principles establish the core of the HIPAA compliant healthcare app. Respectively, keeping all the basics in mind, you need to know where to apply the HIPAA Act in software development.
When Should Healthcare App Developers Consider HIPAA-compliance?
The million-dollar question – what software products are subject to HIPAA compliance? Understanding medical app requirements makes a difference between compliance and noncompliance, potentially costing a lot to a software development company. The rule of thumb dictates – that as any aspect of PHI appears within an app, it must be HIPAA compliant healthcare app. For example, you build a healthcare scanning app that will transfer patient scans to providers. In this case, you cannot avoid HIPAA for such an app.
Plunging further, several types of healthcare apps must adhere to the HIPAA rule. Plan your HIPAA compliant healthcare app in any of these categories.
Telehealth
Telemedicine development is on the rise (see Fig. 2). It is one of the categories of HIPAA compliant healthcare apps.
It is safe to say that the development of any telemedicine platform comes hand-in-hand with HIPAA compliance. Why? Namely, the critical purpose of HIPAA compliant healthcare apps is protecting patient privacy and offering top-grade security of patient-vendor communication. There is an entire dedicated section exploring HIPAA compliance in telehealth.
Electronic Health Records (EHRs)
Another category of HIPAA compliant healthcare apps coming toe-to-toe with HIPAA is EHR. If you plan to develop an EHR platform or a mobile EHR app, you must include HIPAA. These tools help healthcare professionals substitute paper-based note-taking with digital ones. Besides, it makes patient data sharing much more straightforward, which improves diagnostics and treatment. EHR backed with HIPAA essentially takes care of patients’ records and makes sure you share and access these securely.
Condition Apps
The final category of HIPAA compliant healthcare app refers to any correlation to the patient’s mental and physical conditions. If a medical app you are developing directly or indirectly relates to a user’s mental or physical health status, you must comply with HIPAA. Moreover, condition apps work with any payment linked to the care provision processes.
For you to have a better grasp of how consideration of HIPAA compliant healthcare app development works, there are several scenarios to examine.
Scenarios to Illustrate
Imagine there is a user with Type 2 diabetes. An individual constantly checks their glucose levels with a personal glucometer. However, this person wants to store glucose data for a particular period to see how it changes. To do that, they download a respective app from the App Store. All the data from the glucometer is then stored within the app. In such a case, HIPAA compliant healthcare app is not required because no PHI was manipulated at any point, and no covered entity or business associate was involved.
Consider another example. A patient has heard about a new AI-based remote patient monitoring app available online. Some clinics provide this app. When this person downloaded the app, it required inserting some patient health data. When the data is inserted, it is automatically synchronized with the clinic’s EHR system. At this point, HIPAA compliance is a must. There are PHIs created and transferred. As well as, there is a covered entity involved – the clinic that introduced the app.
Coursing through different scenarios offers a greater perspective on when HIPAA compliant healthcare app is necessary. First, to understand why there is so much talk about compliance with the HIPAA Act, it is crucial to investigate its significance for patients and healthcare organizations.
Why All the Fuss Around HIPAA Compliant Healthcare App?
Some sources like The Verge argue that, sometimes, HIPAA might be as helpful as it looks. Yet, in most cases, there is a consensus that HIPAA is important. One should investigate how HIPAA compliance aids people and organizations to get a clearer view of the issue.
Importance for Patients
Any regulation is, first and foremost, directed to protect people. It does not matter whether you use innovative technologies like data automation and cloud computing or rely on older methods like EHRs. Users must be sure the information they share will not be breached. Keeping that in mind, HIPAA compliant healthcare app is important because it:
- Ensures secure transfer of patient data
- Protects patients from identity theft
- Makes any type of patient data fraud less likely to occur
- Puts patient interest on the top priority in medical app requirements
In short, HIPAA ensures healthcare app developers do not put profits above patient interests. Besides, on the patient side, the principle takes away the bread and butter of most cybersecurity crimes – sensitive information.
Significance for Hospitals
In turn, apart from patients, healthcare HIPAA software focuses on protecting hospitals and other healthcare organizations. While it may sound a bit pragmatic, the truth is that hospitals constantly look for ways to reduce healthcare expenditures. HIPAA compliant healthcare app allows us to do that by helping healthcare providers avoid hefty fines (see Fig. 3).
Moreover, HIPAA compliant healthcare app is significant for hospitals because it brings the following:
- Prevents any litigation linked to patient data breaches
- It makes it easier to manage and store health data
- Builds trust in a particular healthcare vendor
These aspects are foundational for healthcare organizations. As we mentioned earlier, digitization brings forward new challenges. While many can benefit from tools like predictive analytics, not many know how to handle it in a manner to protect the most valuable thing – patient health data. HIPAA gives you the guidelines you need.
Examples of Healthcare Applications HIPAA Non-Compliance
Nothing speaks louder on HIPAA compliant healthcare app’s importance than some notable non-compliance cases. Besides, it is another chance to stress the importance of data security in healthcare.
Some healthcare organizations thought they could get away from HIPAA compliance. For instance, a large U.S.-based health insurer, Anthem, lost a staggering 78 million patient records due to phishing techniques used by cybercriminals. As a result of the investigation, OCR identified several severe HIPAA violations, the key being an inadequate system of access authorization to PHIs. Due to non-compliance, Anthem was fined a whopping $16 million.
Another example is all about HIPAA non-compliance linked to the usage of unencrypted devices. The OCR investigated a Texas-based cancer research center, MD Anderson, after a breach of 34,000 records. The investigation revealed the center had unreasonable encryption standards, leading to three devices being stolen with thousands of unprotected patient records. This non-compliance led to MD Anderson paying $4.3 million in fines.
These are only a few examples in the long list of healthcare organizations being fined with multimillion-dollar penalties linked to HIPAA non-compliance. After all, all these examples put patient data at risk and made patients susceptible to different identity theft.
How to Ensure Having HIPAA Compliant Healthcare App?
HIPAA compliant healthcare apps stem from following several principles. Are you thinking of starting a telehealth software development project? The insights mentioned further will be of great help.
Physical and Technical Safeguarding for Healthcare Mobile Applications
All aspects of data protection revolve around two aspects – physical and technical safeguards. Healthcare HIPAA software must have a protected backend, secure data transfer networks, and encrypted user devices. These are critical physical safeguards to consider. You can see a complete list of such protective measures here. In turn, technical safeguards entertain unique user identification methods, emergency access procedures, and automatic logoffs. Keeping both physical and technical safeguards establishes a core of HIPAA compliance.
HIPAA Compliant Healthcare App Checklist
When it comes to taking HIPAA compliance further, keep in mind the following checklist of variables:
- Information access. Limit access to PHIs in the app. Only authorized parties should have access to patient data. Use two-factor authentication and bio-authentication for access control.
- Patient data encryption. Encrypt all PHIs using AES 256-bit encryption and S/MIME.
- Auditing. Have an audit mechanism intact. Track down how to access and use the app.
- Data integrity. No unauthorized party should be able to manipulate the PHIs your app works with. To ensure data integrity, consider blockchain technology.
- Safe transferring. Use only secure data transfer connections and protocols. These include SSL/TLS.
- Notifications. Never use PHIs in push notifications and emails. Moreover, remorse all PHIs from outside-the-app messaging.
- Backup. Ensure data protection through backups and removals. When storing data in the cloud, you should always back it up. Besides, users should have an option to remove their PHIs, especially when a person loses their mobile device.
- Privacy policy. HIPAA is all about following particular rules. Have a transparent privacy policy to show users how you follow HIPAA and protect patients’ data.
This checklist grants you a starter pack for healthcare app HIPAA compliance. You can use it for mHealth, telemedicine, and condition-based apps alike.
How Much Does it Cost to Develop a HIPAA mHealth App?
When developing any new app, one of the critical concerns is the budget. The same is true for mHealth apps. While mHealth unlocks the potential of preventive healthcare, you must be ready to spend a hefty sum on building such an app. On average, it costs about $425,000 for the entire mHealth app development cycle (see Fig. 4).
Yet, keep in mind that the number mentioned above is an average one. It is hard to put a specific price tag on mHealth app development because each project is unique.
Besides, when putting the factor of HIPAA into the equation, you should consider additional expenditures. While robust data protection measures are often costly, you also need to pay about $2,000 per month for HIPAA adherence. This number applies to mHealth apps that do not include out-of-box solutions linked to managing PHIs. Moreover, you can always outsource parts of app development to reduce costs.
10 Steps for Developing HIPAA-Compliant mHealth App
With all the bases covered, it is time to proceed to the critical steps needed for developing a HIPAA-compliant mHealth app. You can take the following steps for all mHealth solutions, regardless of the technologies you plan to use.
Step 1. Expert Opinion
Up to now, you might have realized that dealing with HIPAA is not easy. Keeping in mind all the rules, entities, and variables is hard, especially if you only heard about HIPAA while reading this article. The golden rule dictates that attempting HIPAA compliance on your own is challenging.
The best solution is to start with an expert opinion. Hire a third-party expert with tons of experience in meeting HIPAA requirements. This person can audit your system to clarify what you should change to get healthcare HIPAA software compliance. Besides, you can outsource the entire HIPAA-compliant app development process.
Step 2. Categorizing PHIs
The next step is to categorize the data you receive from patients. It is best to double-check whether you need all the data users to provide you. Next, determine which data you can coin as a PHI. Finally, figure out which PHIs you can store and transfer and which ones better stay without access by any third parties. HIPAA compliant healthcare app starts by ensuring the most valuable PHIs are best protected.
Step 3. Separating PHIs
After you detect the PHIs, it is time to separate them from all the rest of the data on the mobile app. When building a HIPAA-compliant mHealth app, always have separate databases for PHIs and non-PHIs. Keeping them apart shows what data you should protect and encrypt first. Besides, keeping all the data together requires a constant encryption-decryption process, which slows down the mHealth app’s performance.
Step 4. Limiting Access to PHIs
In the same manner, most valuable PHIs should be kept away. You need to limit the amount of data to the minimum an app’s functionality requires. Work only with data useful for users, as well as the one that directly impacts the app’s performance. Besides, avoid using caching for patient data. Finally, do not gather users’ geolocation data unless you need it for better performance.
Step 5. Top-grade Encryption
Use the best encryption practices available. If you do not know which ones to choose, apart from the ones we mentioned on the healthcare HIPAA software compliance checklist, you can always look for an expert option. In addition, there are various companies providing cybersecurity services. They ensure all the relevant data coursing through your app has bank-grade encryption for a reasonable price.
Step 6. Testing
Testing is one of the key steps in HIPAA compliant healthcare app development. No wonder application security and the testing market is soaring (see Fig. 5).
Test your mHealth app after every update. Engage in both static and dynamic testing, and check whether all the relevant documentation is up-to-date. If a HIPAA-compliance officer wants to investigate your product for compliance, you will have all the needed information in one place.
Step 7. Third-Party Solutions
Building a HIPAA compliant healthcare app from scratch can be costly. Meeting physical and technical safeguards means integrating various security measures that all dip into your budget. Besides, you will pay for auditing and certification in the development process. As a solution, healthcare HIPAA software uses a pre-made infrastructure with all HIPAA requirements met. Generally, hiring a third-party vendor means signing a business associate agreement with the third party and becoming responsible for storing and managing your app’s PHI data.
Step 8. Integrations
Modern apps are always connected to other apps or platforms. If your app anticipates connecting to cloud services, these should also be HIPAA-compliant. Otherwise, you can find yourself in a position where PHIs are stolen from cloud databases without you even being aware of that. Luckily, there are several reliable cloud-based solutions with HIPAA-compliant backends included. These are the following: Google Compute Engine, AWS, and Datica.
Step 9. Audit, Audit, and Audit
Before, we stressed the importance of testing after every update. Each healthcare HIPAA software development step should be audited from a broader perspective. There are a lot of testing methods involved, including:
- Usability testing
- Functional testing
- Compatibility testing
- Performance testing
- Security testing
- Installation testing
- Manual testing
- Localization testing
These auditing approaches impact HIPAA compliance because you can use PHIs during various aspects of an app’s performance. If you do not want to overbear yourself with all the auditing and testing, you can always outsource it to vendors with expertise and experience. There is always someone to help you with that.
Step 10. Long-Term Thinking
Last but not least, you need to think long-term when working with HIPAA compliance in app development. It entails setting up various procedures to help monitor all the potential HIPAA issues. Keep in mind that your HIPAA compliant healthcare app will constantly be evolving with every new update and iteration. The same should be applied to the app’s security. Think about how you would face potential risks that can compromise PHIs and ePHIs.
Conclusion
All in all, you can tell that HIPAA compliant healthcare app development is multi-staged and complicated. There are many running elements included. It would help to consider the tiniest aspects that can thwart patient data security. Yet, when you meet all the healthcare application HIPAA compliance requirements, you get the product users feel that their data is appropriately protected. Use the steps and the checklist above to build the mHealth app that will improve patient outcomes and make preventive healthcare a new norm.
