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How To Make An App HIPAA Compliant: The Ultimate Checklist (2024)

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Since 1996, the U.S. Department of Health and Human Services included a new layer of patient care by incorporating the Health Insurance Portability and Accountability Act (HIPAA) within those regulations that all health organizations should comply with. HIPAA, generally speaking, involves the protection of sensitive patient information, and it is applicable to both physical and digital forms of keeping data.

With the growth of telehealth applications, which include remote communication, digital medical records, and other ways of keeping and sending patient information, HIPAA now includes more indications as to how health organizations should guarantee patient information remains confidential. Technology applied to medicine can be highly beneficial, as with digital phenotyping or telemedicine, but it can also be dangerous if regulations such as HIPAA are not complied with, leading to numerous data security issues in healthcare.

Though these regulations are essential for any health organization, during 2023, nearly 130 billion people were affected by data breaches caused by not complying with HIPAA, either fully or partially. Keep on reading to find out how to make an app HIPAA compliant, what details you should keep in mind during the development process, and how it can benefit both your organization and its users.

At a glance: What is a HIPAA compliant app?

As mentioned above, HIPAA represents a set of regulations created by the HHS to protect sensitive patient information and it includes mobile and desktop applications. This means that, for example, medical records must stay confidential at all times, that only the patient and the medical personnel involved can access them, and that this information must be immediately deleted as soon as it is not necessary. The same applies to patient-doctor communications that could expose medical data. 

What is not allowed under HIPAA?

HIPAA includes guidelines about what features an app should and shouldn’t have. Some examples of what a healthcare app shouldn’t include are:

  • Cloud PHI storage
  • Free-access to the app (without ID verification)
  • Notifications displaying sensitive information

Tips & considerations when building a HIPAA compliant app

Here are some of the features you need to keep in mind and some procedures you can carry out to develop a HIPAA-compliant app: 

Make sure your data is encrypted

One of the main layers of protection that any healthcare app should have is encryption. Encryption guarantees that only those with authorized access (with a password or even 2FA) to the app can see the information stored in it. This way, hackers and interceptors cannot decode the information even if they manage to access it. Additionally, ensure that no PHI is shown on push notifications so that nobody can see this information outside of the app.

Pay attention to third-party solutions

Many mobile apps work in combination with others, e.g. virtual keyboards or storage platforms. These functionalities should be embedded in the app, or work strictly with other apps that are also HIPAA-compliant. For example, with a customized Fleksy medical keyboard for phones, privacy comes first and, even if it is a third-party app, patient information is safe. Unfortunately, most third-party apps or APIs are not HIPAA-compliant, for instance, using Federated Learning or Cloud Learning, leaving an open backdoor to hackers and keyloggers.

Implement effective access controls

Access to the application is the first step where security must excel. Encourage both patients and doctors to use a username and password, or even biometric IDs, for access. You can also add two-factor authentication to take security to the next level. It is highly recommended to implement the request for this information every time the user needs to re-enter in combination with automatic log out after a set time, ensuring unauthorized access is a no-go.

Keep your app updated 

HIPAA and other security regulations are updated regularly, so what worked during the development phase may be outdated a few months later. Maintain a continuous audit program to make sure your protocols are always up and compliant.

Updates should be carried out not just to align with privacy laws but also to minimize the risk of security breaches. Regular audits are essential to ensure every facet of security is up to scratch, safeguarding against unauthorized access to information. Don’t think about HIPAA compliance as a rule you need to follow or just one of the ways to reduce the cost of app development, but as a help to keeping your patients’ information safe.

Foster secure communication practices

Human error is usually the main factor in information breaches and hacks. For this reason, aside from careful security implementations, all users involved should be trained in secure communication practices. For instance, doctors and patients should always communicate through the designated healthcare app, even if it might be a little annoying to use. On this point, it is advisable not to use regular messaging apps, as these are not designed specifically for this purpose and can cause undesired effects. 

Always opt for secure text messaging for healthcare. For example, building a virtual keyboard for healthcare using Fleksy’s SDK will ensure not only privacy and security, but also excellent user experience. Fleksy offers comprehensive customization possibilities as well as powerful autocorrect and text prediction engines that make typing much faster than any other keyboard, even when using medical terms.

Formalize Business Associate Agreements (BAAs)

Many organizations outsource tasks to external providers who could need to access PHI, even if they are not covered by HIPAA. This is common practice in app development, as organizations may need to hire developers, auditors, and other IT specialists to keep the app working. It is wise to cement these partnerships with Bussiness Associate Agreements, which establish each party’s duty and responsibility in safeguarding PHI to guarantee its protection at all times.

Opt for secure data storage solutions

Although cloud storage offers many advantages and has therefore become the most popular form of storage in many industries, it does not fall under HIPAA regulations because it is more prone to breaches and hacks. Hopefully, options specialized in healthcare may arise soon to make sure that cloud storage and data privacy can come together. In the meantime, opt for local storage on each device, and ensure that all information is kept in encrypted folders that no other apps can access.

Emergency access

Both covered entities and business associates must have an emergency protocol ready to be deployed in the case of emergencies to be able to access information immediately. Previously establish who should have the access to all this information and how this procedure has to be carried out.

Limited storage of documentation

Aside from storing information on a local platform instead of cloud servers, healthcare apps should keep as little information as possible Whatever is not necessary for the patient should be promptly deleted to reduce the risk of breaching. For instance, some medical protocols indicate that only studies in the last ten years are valid to understand a patient’s health condition (given that there are no specific syndromes or diseases to track). Therefore, all previous information could be eliminated without any consequences.

Create comprehensive audit trails

Audit trails allow creating a log to track how users access and manipulate information. This can help developers understand where there could be leaks, and, in the case of hacks or breaches, how the information could be retrieved from the app.

Why is HIPAA crucial for healthcare apps?

With technology evolving exponentially, healthcare organizations and patients are relying on digital platforms to keep, save and manipulate sensitive information. At the same time, cybersecurity hazards are an ever-evolving threat that grows at the same pace as new technologies. For this reason, keeping a privacy-first approach is of utmost importance for both ethical and regulatory reasons.

Data breaches and cybersecurity risks

In the last years, the Office for Civl Rights has kept track of the main data breaches within the US territory and analyzed the metrics of how these have grown over the years. For instance, from January 1st, 2018 until September 30th, 2023, there was an increase of 239% in hacking-related attacks, as well as a 278% of ransomware attacks

With these numbers, 2023 was a record year regarding the number of cyberattacks and individuals affected by them. Unfortunately, even the largest companies failed to comply with HIPAA regulations, resulting in billions of patients affected, while only three organizations were breached.

Penalties and consequences of non-compliance

The clearest negative aspect of neglecting compliance is a bad reputation. Patients’ whose information was breached will probably avoid using your services again, or even discard digital platforms for this purpose whatsoever. 

In legal terms, not complying with HIPAA regulations can lead to heavy fines, which depend on whether your organization was aware of being non-compliant, tried to fix the error and notified patients about the breach.

The perfect solution for 100% HIPAA compliance

The best to comply with HIPAA is working with subject matter specialists who are experienced in the matter, updated on new regulations, and ready to adapt your app to make it HIPAA compliant. 

With Fleksy, you will be able to create a virtual keyboard for healthcare that works hand in hand with your app, ensuring that it meets all your user needs while staying compliant with regulatory requirements. Download our keyboard SDK to develop your own standalone or in-app keyboard for your healthcare app.

With Fleksy, you will be able to create a virtual health care keyboard that works in parallel with your app, ensuring that it meets all user needs and complies with regulatory requirements. Download our keyboard SDK to develop your own standalone or in-app keyboard for your healthcare app.


How much does it cost to make an app HIPAA compliant?

It is true that making an app compliant can be costly both in terms of monetary expenses and development efforts. However, the impact of having a bad reputation or having to pay fines because of neglecting compliance is much worse than that. If you want to make the process more cost-effective by all means, we highly suggest contacting experts who are experienced in development with a security-first approach, like Fleksy. According to Biz4Solutions, the cost for developing a medium to large-scale HIPAA-compliant app is around $50,000.

How much does it cost to be HIPAA-certified?

According to the HHS, there is not exactly a certificate you can get to verify you’re complying with HIPAA. However, you can undergo a regular assessment to make sure you are in line with their regulations. Because this can be done through internal audits or by external entities, the costs may vary. For example, Sprinto offers assessments from 10,000 to 150,000 depending on entity size and complexity, while Schellman charges between 20,000 and 80,000 for the same service.

How do you know if something violates HIPAA?

To ensure you are not violating HIPAA guidelines, you can carry out audit trails internally, or hire external auditors who specialize in the matter. Research your auditor to see if they are updated with HIPAA changes, as these happen often, and you can fall behind easily.

Does HIPAA apply to mobile apps?

Yes. HIPAA applies to all forms of PHI manipulation, either physical or digital. Nowadays, with technological advances growing bigger in the healthcare industry, organizations must be especially careful about making their patients’ information private and safe at all times.

How do you check if an app is HIPAA compliant? 

From the point of view of patients, some factors that indicate HIPAA compliance are user authentication (either through passwords, 2FA or biometric ID), time-limited access and encryption notices. Though these factors are not enough to say an app is HIPAA-compliant, they hint towards a commitment with safety from the organization.

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