A Guide to Building HIPAA-compliant Software

In 2019, 10 fines for a total of $12,274,000 were issued for violations of HIPAA process regulations. The average financial penalty of $1,227,400 per case means that even the slightest neglect can lead healthcare providers to catastrophic losses. In the digital age, the value of privacy protection is higher than ever because interconnected information systems are often exposed to the threat of data leaks. It does not mean that healthcare providers should abandon the benefits of digitalization. Instead, they should consider the existing data privacy regulations and ensure top-notch security of their software. In this material, we will discuss the main HIPAA IT regulations, along with the act’s main provisions, and explain how healthcare providers can make their software HIPAA-compliant.

HIPAA compliant app

(Source: HIPAAjournall)

What compliance do medical HIPAA rules actually require?

HIPAA (Health Insurance Portability and Accountability Act) is the most valuable privacy regulation in the U.S. domain of healthcare. The Office for Civil Rights (OCR) has introduced it to establish national standards for the protection of certain health information. The act applies to various aspects of healthcare and includes HIPAA IT requirements primarily applied to PHR apps.

Main provisions of HIPAA healthcare regulations

HIPAA includes the following rules: Privacy rule. Establishes privacy disclosure standards. Security rule. Establishes standards to safeguard private data. Breach notification rule. States that providers have 60 days to notify the U.S. Department of Health and Human Services about a data breach. Enforcement rule. Establishes standards for data breach investigations. Omnibus rule. Modifies other HIPAA healthcare rules by integrating HITECH regulations.

HIPAA compliant app


HIPAA Security Rule

HIPAA compliant

(Source: HIPAAacademy)

Depending on the severity of responsibility, an entity that has violated medical HIPAA regulations may be punished from $100 per incident up to $1.5 million. 

Entities and data covered by HIPAA

There are two categories of entities who must comply with HIPAA. 

  1. Covered entity. A healthcare provider, a health plan, or a health clearinghouse that are medical compliant. Those entities can use medical information apps and patient management software in their working processes. In turn, such software is exposed to data leaks and, consequently, violations of healthcare HIPAA privacy and security rules. It is important to note that provided by covered entities applications that do not involve such entities will not lead the latter to any legal issues. 

  2. Business associates. These are partners of covered entities provided with access to patients’ private data and medical records. This category includes software providers, cloud storage providers, financial organizations, and lawyers cooperating with a covered entity. If a software provider required to develop a HIPAA app fails in securing a patient’s private data, it may lead both them and covered entities to financial punishments according to HIPAA EHR requirements. A company that provides software for general use in a healthcare setting cannot be regarded as a HIPAA-compliant business associate. 

HIPAA rules apply to protected health information (PHI), which can be distinguished into:

  • patients’ medical data;
  • other personally identifiable data related to a patient. 


If a medical app is not personalized to a specific patient (it does not contain a user’s personal identifiable information), all data stored in it will not be considered as PHI. Information leaks from such a medical information app are not covered by HIPAA requirements on privacy because the leaked data cannot be regarded as private. 

How to create HIPAA-compliant software

You cannot become a HIPAA-certified company, but the focus on HIPAA software security requirements is still essential if you want to avoid the fines. We provide HIPAA compliance guidelines to secure you from unpleasant surprises. 

Mind the safeguards

There are numerous safeguards you should consider while working on a HIPAA-compliant app. The basic point is understanding whether an application is covered by the regulation or not. HIPAA software compliance is required if:

  • an app collects, stores, and transmits personally identifiable patient data;
  • an app has the capabilities to collect, store, and transmit personally identifiable patient data. 

If your medical app is covered under HIPAA, you should mind the points that will help you determine whether it is compliant with the regulations. HIPAA compliance software checklist includes:

  • storage encryption;
  • data transport encryption;
  • user authorization;
  • authorization monitoring;
  • access control;
  • data backup;
  • secure cloud or on-premise servers;
  • automatic log off;
  • emergency mode of your HIPAA application. 

The rapid development of cloud technologies makes more and more businesses rely on cloud-based software. Most cloud platforms are developed with the help of GCP, AWS, and Microsoft Azure. Google, Amazon, and Microsoft establish the top-notch security standards, such as NIST 800-53, to ensure HIPAA-compliance software development with the help of their cloud platforms. However, all cloud providers indicate that the responsibility of a covered by HIPAA medical entity and its business associates remain the essential aspects in terms of establishing data security. 

Ensure a step-by-step approach to HIPAA app development

A comprehensive plan aimed at meeting HIPAA requirements has to include three essential steps.

  1. Preliminary risk analysis. This stage includes the analysis of PHI storages, documentation of potential risks, evaluation of potential data leaks’ outcomes, the development of a HIPAA compliance checklist for information technology, and the establishment of a strategy focused on improving security. 
  2. Elimination of all determined risks. At this stage, a HIPAA-compliant entity should eliminate all the identified data security threats. Everything depends on the nature of the detected problems. Typically, this phase includes both staff training promoting security awareness and the establishment of additional information protection protocols, such as two-step authentication. 
  3. Security maintenance. After improving the security of one’s software for healthcare, a covered entity or its business associate should ensure long-term risk management. This step includes login monitoring, audit trails, vulnerability scans, and continuous event monitoring arranged according to HIPAA compliance requirements. 

Successful implementation of such stages requires a proficient approach and significant technical capacities. Outsourcing the development of HIPAA-compliant healthcare applications or its security optimization to dependable software providers is a popular solution among healthcare providers.

Choose reliable partners to fulfill HIPAA compliance requirements 

Binariks is a reputable partner with solid experience in developing HIPAA-compliant applications. We facilitate our partners on various stages of a project, namely: 

  • platform development;
  • mobile development;
  • cloud solution;
  • UX/UI design;
  • Internet of Things;
  • quality assurance;
  • BigData analytics. 

Our portfolio includes multiple cases of providing clients from the healthcare sphere with top-notch HIPAA apps. In particular, Binariks optimized a personalized patient monitoring system. Our dedicated team of cloud specialists used native AWS services to enhance the flow of information and increase the analytical capacities of the client’s software. We also paid much attention to the security of patients’ identifiable data stored on a platform to deliver a HIPAA-compliant product meeting all client’s expectations. 

Binariks helped an American provider of healthcare technologies in the maintenance of two applications dealing with healthcare plans. Our developers also used Swift and React Native to create two new HIPAA-compliant mobile apps for the client. The products deal with patients’ identifiable data, which has made our developers focus on delivering secure products that meet all HIPAA requirements.

Make sure to check our portfolio to get more information on our expertise in developing HIPAA-compliant apps.

In conclusion

Violation of healthcare HIPAA regulations can lead healthcare providers and their associates to significant fines. Entities covered under HIPAA regulations should establish multiple technical safeguards, utilize a comprehensive strategic approach to software development, and rely on reputable partners. As a company with solid experience in developing HIPAA-compliant applications, Binariks offers its service to businesses from the healthcare domain. Contact us to discuss your medical software plans and our potential role in them. When the cost of any mistake is overwhelming, it is important to choose credible digital security experts as partners.