The age of the smartphone has made healthcare simpler and more accessible than ever. With their mobile devices in hand, patients can receive medical support from anywhere.

However, for healthcare providers looking to service these patients, this revolutionary ease of access comes with a distinct challenge: HIPAA compliance.

HIPAA (the Health Insurance Portability and Accountability Act of 1996) is the law that governs the handling and protection of every patient’s sensitive health information.

If you work in the healthcare industry, you’re likely familiar with HIPAA. But are you up to speed on the necessary considerations for developing a HIPAA-compliant app? We are—and we’re here to shine a light on them.

Does my mobile app need to be HIPAA-compliant?

If your service accesses, collects, transmits, or stores protected health information (PHI), full HIPAA compliance is generally mandatory. In a nutshell, PHI is any form of “individually identifiable health information” that pertains to a patient’s past, present, or future medical conditions and treatments.

In the context of mobile apps, PHI can include a patient’s:

• Name
• Address
• Phone number
• Email address
• Social Security number (SSN)
• Medical records
• License plate number
• Device identifier or serial number
• IP address
• Full-face photographs
• Specific relevant dates (such as their birth date, admission date, or date of death)
• Biometric identifiers (such as fingerprints and voice data)

As you can imagine, these details are far from uncommon in health apps. Some of the most common app features that require HIPAA compliance are:

• Provider-to-patient email or chat communications
• Storage of other PII (personal identifying information)
• Storage of a healthcare professional’s licensing information

Failure to comply with HIPAA can lead to hefty regulatory fines from the U.S. Department of Health & Human Services and erode user trust, so conforming to all standards when building a healthcare app is essential.

Apps that aren’t covered by HIPAA

Not all health apps fall under HIPAA; plenty of healthcare-adjacent apps land in a gray area. For instance, an app like pliability, which helps monitor physical activity, does not require HIPAA compliance. In fact, most fitness and diet tracking apps don’t have to be HIPAA-compliant, as they’re intended for personal use.

With that said, it’s not always easy to tell if an app should be HIPAA-compliant, especially if you plan to expand functionality down the road.

The best way to determine whether your mobile app needs to be HIPAA-compliant is to consult with an expert. As frequent builders of health and wellness apps, we’re well-versed in the HIPAA requirements and how to implement them.

The three rules of HIPAA compliance

On the surface, HIPAA compliance seems complex (and it certainly can be), but the law essentially boils down to three rules:

• The Privacy Rule – This rule lays out the standards for protecting all PHI. Ultimately, the Privacy Rule makes it easier for patients to access their information while restricting access to unauthorized users.

The Privacy Rule also outlines who HIPAA applies to: covered entities (healthcare providers and health plans) and business associates (people or organizations contracted to execute related responsibilities).

• The Security Rule – This rule is similar to the Privacy Rule but applies specifically to electronic PHI (ePHI). Under the Security Rule, covered entities must implement administrative, physical, and technical safeguards to protect patient data. They must also assess potential risks and develop a risk management plan.

• The Breach Notification Rule – This rule defines what organizations need to do when PHI is compromised. While it doesn’t come up as often as the other rules (especially if privacy and security are well-managed), it’s still crucial to understand.

Once we determine that HIPAA compliance is necessary for your product, the task is to abide by these three rules at every stage of the development process.

How to make a mobile healthcare app HIPAA-compliant

So, what does implementing these rules look like in practice? Guaranteeing HIPAA compliance for mobile apps involves several critical steps that take place throughout development. Here are a few of the major ones.

#1 Consider how and where data is stored

From the beginning, it’s essential to think about the type of data being stored (PHI, doctor information, session data) as well as the way it needs to be stored and accessed. By considering data storage first, all involved teams can ensure HIPAA compliance remains top of mind.

When we developed SirenMD, a HIPAA-compliant app that connects doctors, trainers, and managers with athletes, we had to take inventory of every data source, then choose an appropriate approach to storing that information. Because so many entities were involved, safeguarding patient and provider details was a top priority.

#2 Leverage data encryption

HIPAA requirements state that data should be encrypted at every point of your IT infrastructure, from servers to individual devices. Data encryption allows your app to transmit PHI securely between patients, providers, and storage locations.

Although there are no limitations around how data should be encrypted for storage and transmission, the National Institute of Standards and Technology (NIST) recommends using the following solutions for transmitting data:

• Advanced Encryption Standard (AES) 128, 192, or 256-bit encryption
• OpenPGP
• S/MIME

In many cases, building encryption into a mobile app means working with a third-party expert. For example, we rely on services like SendGrid and SendBird to facilitate secure, encrypted communications.

#3 Follow requirements for mobile app user authentication

As per the HIPAA Privacy Rule, only patients or authorized individuals can view and manage personal information. To give users more control over their data, we’ve implemented various HIPAA-approved methods of user authentication in the past, such as:

• Secure password requirements
• Fingerprint log-in
• Face ID verification

For an additional layer of security, we’ve also utilized a time-out function that logs users out after a period of inactivity. Strategies like these protect users on shared devices or who may be operating in public settings, like a hospital or doctor’s office.

#4 Implement de-identification strategies

Although HIPAA is non-negotiable for healthcare organizations and any of their business associates, there is a way “around” the HIPAA Privacy Rule. Through a process known as de-identification, it’s possible to strip the identifying aspects away so that an individual’s identity can no longer be determined (or re-identified) from the available data.

Data that has been de-identified is no longer considered PHI, making it legal to transmit freely. Because this anonymous information can be used in studies and policy assessments, taking the time to de-identify data can be worthwhile.

De-identification can be achieved through one of two methods: Safe Harbor and Expert Determination. By better understanding your unique needs surrounding PHI, we can help you determine which method best suits your needs—just reach out to start the conversation.

#5 Perform frequent tests and updates

Since one of the foundational aspects of HIPAA is data security, keeping your mobile app up to date is vital. Frequent testing (along with the deployment of any necessary security patches) keeps your users’ ePHI secure.

While developing Counslr (a service that connects students to licensed counselors), we went through a series of tests to ensure user data stays safe. Now that the app has launched, we continue with testing and updates to guarantee it stays HIPAA-compliant.

Performing regular updates also ensures your app remains current with HIPAA regulations. This point is especially pertinent, as changes to HIPAA are expected in 2023.

Frequently asked questions about HIPAA compliance

The particulars around HIPAA can be rather opaque, so questions are natural.

We’ll attempt to address some of the most common inquiries here, but if you have specific questions about HIPAA compliance and mobile app development, feel free to contact us for more information.

What is a HIPAA risk assessment, and why do I need one for my mobile app?

A HIPAA risk assessment is a full organizational review that looks for potential flaws that could put your users’ PHI at risk. Among other things, a risk assessment will help you determine which steps you need to take to bring your app under HIPAA compliance and which you can skip for the time being.

Under HIPAA, covered entities and their business associates must complete a risk assessment. Because your app is a part of your organization’s healthcare infrastructure, an assessment is mandatory.

Do I need a Business Associate Agreement for my mobile healthcare app?

A Business Associate Agreement (BAA) is the legal recognition of a working relationship between a covered entity and a business associate. In the case of mobile app development, the covered entity is typically the healthcare organization funding the app, while the business associate is the company tasked with creating the app.

Business Associate Agreements are often, but not always, necessary when developing a healthcare-related app. However, if the app itself is supposed to be HIPAA-compliant, a BAA is typically required.

Are there any HIPAA-compliant cloud hosting services for mobile healthcare apps?

Many of the most-used hosting services on the market, including Amazon Web Services and Microsoft Azure, offer HIPAA-compliant hosting services.

We use data privacy compliance software like TrueVault to validate third parties and ensure that all vendors we partner with during app production (including cloud hosting services) comply with HIPAA.

Let’s build a HIPAA-compliant mobile app together

Developing a HIPAA-compliant app from the ground up is a tall order. But when you work with an agency that understands HIPAA inside and out, the road to compliance becomes effortlessly smooth.

At Utility, our veteran team can identify if your mobile app needs to be HIPAA-compliant, then help you reach full compliance throughout the design, development, and launch of your product.

And that’s not all we do. From UI and UX design to robust user testing, we don’t stop until we’ve built a digital solution that delights every user. To find out more about our end-to-end approach to app creation for HIPAA-compliant industries, schedule a call with our team.