HIPAA Compliance for Software Development: Best Practices with Checklist

The medical industry uses highly specialized software for everything from hospital management to patient interactions to device integration. However, to deliver these invaluable solutions, companies must achieve HIPAA compliance for software development. Regulations exist for a reason, and adhering to them when creating the moving parts is paramount.

However, HIPAA is a complex set of regulations. Meanwhile, developers aren’t expected to be experts in legal matters. To navigate this and other medical laws, you may need the help of legal counsel. But today, JetBase would like to give you a headstart with a primer on building HIPAA-compliant software.

We will take you through the typical terminology used in HIPAA and similar regulations, talk about what software must do to be compliant, and outline the development process. In addition to that, we’ll provide a simple checklist you can follow to speed things along. This way, you can dive right into development and create excellent and HIPAA-compliant software.

So, without further ado, let’s talk about HIPAA software requirements and how to stick to them.

The Terminology of HIPAA and Medical Software Regulations

While most people generally know what HIPAA is, the details can be pretty murky. That’s not exactly surprising, few people take the time to study up on legislations, especially complex ones. But with almost 12 million people affected by healthcare data breaches in 2023, it’s clear that people need to be aware of HIPAA and its benefits.

So, let’s start off with a simple point - what is the purpose of HIPAA? Well, this regulation and HIPAA-compliant applications are aimed at reducing abuse and fraud in the insurance field. It’s supposed to improve transparency for customers while tightening rules around data storage and processing. Since insurance is directly tied to medical care, HIPAA has become a shockwave rippling through the medical industry.

Pretty much any healthcare service and company is subject to HIPAA nowadays, as it affects all who transfer patient data digitally. Unless a hospital still runs on pen-and-paper protocols, they’re under HIPAA’s watchful eye. And what HIPAA is watching for is PHI-protected health information. This includes:

The interesting point here is the third one. While the first two are quite clear—nobody should be able to find out that Patient A did Procedure B or had Illness C—the third one is highly conditional. If a hospital has data on a person that lists their name and address, that data is, indeed, private. But it’s only subject to HIPAA if it’s directly tied to the first two categories.

Therefore, an app for registering incoming patients might not necessarily need to follow a HIPAA compliance software checklist, right? Well, the reality is that a hospital’s systems are all interconnected and tightly woven together. Thus, the odds of incoming patient data staying within one app’s ecosystem are nearly nonexistent. This means that pretty much any software used in a hospital has to follow HIPAA’s rules.

So, as we’ve established, any information that can be used to connect a patient to a particular case is PHI. Well, according to HIPAA, all of that PHI must be protected at all costs. It’s the job of HIPAA-compliant software to guarantee that info is never misused, exposed, or leaked. Doing so requires developing an app with specific security, accessibility, and transparency points that meet HIPAA’s standards.

In addition, though this is not the topic at hand, it’s important to remember that HIPAA also has requirements for physical conditions in which data is stored. So, if you truly want to meet HIPAA compliance for software development, you’ll need to protect your servers. That’s obviously a bit more straightforward, especially if you operate in cloud environments. In that case, your cloud provider will be responsible for restricting access to the data-hosting servers.

But not everything is so straightforward when it comes to HIPAA, which you’ll see as we talk about HIPAA-compliant software requirements.

HIPAA Compliance Software Requirements in 2025

A curious aspect of building HIPAA-compliant software is that HIPAA is quite severe with its rules but rather vague on how they must be implemented. As a result, developers can work around certain restrictions to make their app HIPAA-friendly without much of a headache. Let’s see what exactly HIPAA requires so you can better understand how to implement it.

Privacy and Control Requirements

HIPAA expects that the flow of patient data is limited to only the essentials, and even those are anonymized in order to protect people’s identities. What this means is all data has to be processed in a specific way that keeps it private while still being usable by doctors. After all, they can’t exactly view a patient’s medical history without knowing who the patient is.

Balancing this set of rules is tricky but doable if you establish permissioned access that gives control of patient data to just two parties—the relevant medical staff and the patients themselves. That’s right, HIPAA-compliant software also requires that you give patients the ability to view their PHI, request a full copy of it, and demand edits to specific information.

Of course, in this scenario, patients can have full view-only access to their data, making another role necessary to build into the apps. Plus, you will have to add the tools for patients to view data and request copies of it, as well as any edits they wish. This means creating some sort of feedback form and establishing an official contact point between the patient and the hospital.

Security Requirements

Another core aspect of HIPAA is protecting PHI from fraud and leaks, which means securing all that information falls on the developers’ shoulders. Security-centric HIPAA compliance software requirements aren’t exactly clear, though. Here’s a quote directly from the US Department of Health and Human Services: “The Security Rule requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.”

No details on what the appropriate safeguards are, of course, but it’s safe to assume that meeting the typical security standards for software is definitely part of it. So, classics like implementing encryption for data at rest and in transit are a must. The same goes for role-based access, which we mentioned above, and containerization to prevent unauthorized data viewing.

There’s also a general rule of thumb that the NIST guide for cybersecurity is quite close to what HIPAA requires. So, if you want to ensure you meet HIPAA software requirements, just stick close to those instructions. While you may want to add some extra security measures, covering the guide points will generally be sufficient.

Notification Requirements

You may build an ultra-secure system, but HIPAA still demands that you have a built-in way to notify patients about any breaches that affect PHI. A mass-report feature must offer the tools to quickly contact those affected with the exact details of the breach, including the type of PHI leaked. In addition, patients must be warned if the data was already viewed and if it’s a high-risk situation.

Plus, for any breaches that affect more than 500 people, the healthcare provider must issue a media notice. So HIPAA-compliant applications should have analytics tools to calculate exactly how many people were affected and in what way.

Data Disposal

HIPAA requires medical providers to offer patients the option to delete their data. This may be easy with physical information, but the process is more challenging for digital data. As you know, a simple deletion doesn’t do the trick, as the data has to be overwritten in order to clear it. Establish necessary protocols within your app that can be triggered upon a patient’s request.

5 Steps for Building Your Healthcare App HIPAA-compliant

A good way to ensure HIPAA compliance for software development is to follow the typical software development cycle while integrating HIPAA-centric thinking into it. So for every step that you would take in a regular project, you consider how legislative restrictions will impact it.

Things like designing your architecture are directly tied to HIPAA, so this method simplifies the workflow while ensuring you end up with a product that meets all the right standards. So, what steps do you need to take to create a HIPAA-compliant medical solution? Here they are.

Step 1. Research and Plan

Studying the market you’re about to enter is pretty standard for a new product, but this time, you’ll also be researching HIPAA compliance software requirements. After all, HIPAA gets updates pretty regularly, and you don’t want to miss some new rule. Doing a deep dive into the legal side of research will pay off down the road when you can run the app with no worries.

Still, don’t forget to actually look at the state of the industry, too, as you need to account for modern trends, patients’ needs, and the availability of solutions on the market. Having an app that’s 100% HIPAA-compliant with no good features is not a great outcome after all.

Step 2. Design Your App

This has less to do with HIPAA compliance software requirements than most other steps, as you simply need to ensure users can navigate the app comfortably. Well, that and having a clear path to request a copy of PHI and/or its deletion. But outside of that, your UI and UX journey should resemble any other software project.

You will iterate to create pleasant, intuitive interfaces and an app with a unique visual identity. This will allow you to market your creation easily and ensure that it is highly usable even by people without technical experience.

Step 3. Developing Versions

Your prototype doesn’t necessarily need full HIPAA compliance for software development, as you’ll be getting a feel for the software’s features and performance. But, as you refine the product, this step becomes integral to HIPAA compliance. For every change you make, consider how it may impact your final product and its legal status.

This will guarantee that your new features won’t come at the expense of disrupting the app’s security or user privacy. We talk a bit about how AI could have the potential for that below, but suffice it to say that any networking or data transfer functionality must be carefully crafted. Do not leave any gaps for attackers to sneak in.

Step 4. QA and Polish

Speaking of careful crafting, extensive testing not only helps make your product better but also allows HIPAA experts to confirm that you’ve implemented everything correctly. At this stage, you’re already presenting a finished product, so they can see all the steps you took to achieve compliance. If something is amiss, they can warn you, and the dev team will patch out any issues.

Step 5. Launch and Support

Last but not least, when everything is double-checked and polished to perfection, you can launch your HIPAA-compliant solution. Your first concern here is marketing, reaching a wide user base, and sourcing their feedback. With these, you’ll be able to push post-launch updates, iron out bugs, and generally keep supporting your software in its lifecycle.

If you follow our HIPAA checklist, which we offer just below, you should have no issues at all. Presenting users with a secure, privacy-friendly medical product isn’t a problem when you’re working with a skilled team like JetBase, so reach out if you need any help.

HIPAA Compliance Checklist for Healthcare Software Development

Using the previous sections, we can outline a HIPAA compliance checklist for software development, covering things you need to include in your work process. Let’s quickly go down the list for some key ones:

Following this HIPAA-compliant software checklist will help you get the essential features that make your app more secure and match the legislation’s requirements. However, as we mentioned earlier, each software project has its own path and can include extra measures.

That’s why we still recommend recruiting an outsource team with experience in medical software and the ability to navigate HIPAA with some intricacy. It’s a good idea to go a bit beyond the standard level when dealing with legislative issues, which can be challenging for a newcomer.

Besides, even if you implement just the basics, it’s vital that you audit them. Just because data is encrypted doesn’t mean that encryption will stand up to scrutiny and possible attacks. A cybersecurity expert can verify the quality of your encryption and other security measures. This will be invaluable down the road when these parts of your ecosystem are tested in practice.

Now that you have a HIPAA compliance software checklist, you can get to the development process. But, before we leave off, there’s one more point we’d like to make.

HIPAA Compliance for AI Healthcare Applications

AI is a pretty major force in the software development industry right now, and with good reason. 65% of polled companies reported using it regularly and it has been proven effective in the medical field, too. But is AI a good fit when it comes to HIPAA compliance for software? Well, it’s a double-edged sword.

On the one hand, using third-party AI models in your app will mean you need to add more security measures to ensure no PHI leaks. After all, good AI trains on the data it processes. So, it’s important to build a closed system where any data the AI works with isn’t sent anywhere else. You don’t want some other company getting a hold of PHI, trust us on that.

On the other hand, though, AI can help with threat detection and data processing, making it much easier to protect PHI and anonymize patient data. This speeds up software development and boosts security all around.

Knowing how to use tools like AI the right way to guarantee HIPAA compliance for software development is our specialty here at JetBase. If you want a healthcare solution done right and fully compliant with local medical legislation–just send us a message.