How to Get Your App (Software) HIPAA Certified

What is HIPAA in essence and how to make your software solution correspond with its regulations? Find out in the article.

Our world continues to be gradually consumed whole by digital technologies, with the mobile app development industry staying at its peak of demand. To achieve good client reach and more operational flexibility, every other company or business now gets a dedicated mobile application. And healthcare organizations aren’t an exception here. In order to operate with medical patient data, however, a set of requirements and legal regulations must be followed. 

What is HIPAA?

HIPAA or Health Insurance Portability and Accountability Act is a regulatory document that defines the rules of exchanging and processing private data of medical nature. Its main purpose is to set the standards of patient medical data protection and govern the non-disclosure of privileged medical information as a whole. It was first introduced in 1996, in the USA with the goal of increasing the quality of portability and reporting in medical insurance. 

HIPAA regulations guarantee patients that all their personal info is treated in a proper manner. Types of such info include:

  • Data on a person’s state of health (both physical & mental);
  • History of visits to healthcare organizations & medical attendance as a whole;
  • Financial history related to medical affairs;
  • Patient’s personal data (documents, contact info, photos, any patient identifying info).

Ultimate HIPAA compliance allows providing crucial social norms – personal privacy and confidentiality. As such, the medical staff should be able to store private patient data in such a way that nobody can access it directly without the patient’s consent. The only exceptions in this case are an emergency situation, in which such data is required to save a human life, or a legal claim.    

What does HIPAA compliance mean for developers?

The field of medicine, like any other acting industry, calls for a thorough implementation of digital technologies. According to expert forecasts, the medical mobile app market’s total volume is expected to reach $11,2 million by 2025. Healthcare-oriented software development, however, has its nuances. The underlying aspect here is PHI or Protected Health Information. I.e., a special approach is required to protect any confidential info. 

There is a common conception that PHI governs strictly medical information, such as diagnosis, examination results, meds prescriptions, state of health readings, etc. The standard goes beyond that, however, requiring to protect patient photos, full name, email address, phone and insurance numbers, medical card number, and other similar data as well. Any app that collects and stores info of such kind falls under legal regulations. 

Data protection laws in the US

As it turned out, secret medical information may have a high demand among scammers. Thus, it may be used to acquire illegal meds or blackmail people. Based on the high risks of malicious use of private healthcare data, the US government introduced yet another protecting regulation – HITECH Act.  

Health Information Technology for Economic and Clinical Health (HITECH) Act came into effect in 2003 with the intention of enhancing the HIPAA law’s efficiency. Gradually, these legal standards covered partner companies that get access to PHI on behalf of medical establishments as well (e.g., insurance companies need personal patient data when providing claim analysis services).  

The rapid development of IT technologies, however, set the stage for new HIPAA compliant software. It allowed many organizations to start collecting data with the help of online services and keep databases on cloud-based platforms. Thus, the Omnibus Rules appeared in January 2013. This is a special HIPAA appendix that slightly coined the basic meaning of the ‘business partner’ notion. Now, subcontractors of regular business partners are also considered full-fledged partners working on behalf of a med establishment.   

PHI & software development

With the introduction of the Omnibus Rules, the legal responsibility addressed medicine app developers, cloud service providers, and outsourcing companies. Any partner company that has even highly-restricted access to any confidential data falls under the HIPAA regulations. Such companies are obliged to keep the data utterly secure.  

In order to properly settle contradictions between business partners and subcontractors, Business Associate Agreements or BAA are made. BAA is a standard HIPAA-based document (essentially, an agreement) that governs sufficient PHI protection. American organizations have high security policy demands. According to the statistics for 2018 alone, 158 healthcare data hacking incidents took place. That’s why HIPAA requirements must be strictly met by development companies. 

How to Become HIPAA Compliant

Not all companies that provide software solutions for med organizations are obliged to go through special certification. Only those whose products imply the processing of personal data must comply with the HIPAA regulations. However, there is no governmental structure that would grant respective certificates. There are only companies that conduct audits, coaching sessions, and practical courses.  

They help service providers to study all the regulations and approve HIPAA software compliance off the books. Such companies give all the necessary theoretical documentation according to their client’s status and specialization. A certificate is only granted after the completion of a complex yet structured test. This is quite a beneficial approach to things.  

Even after passing the test, though, only a particular service provider and nobody else is responsible for their in-house compliance management system. As we already mentioned, most US establishments require to sign Business Associates deals, so any improper handling of patient data might result in significant losses. As the statistics indicate, 70% of companies experience at least one incident of incorrect PHI handling a year. Make sure you make your app HIPAA certified if you are working on one for a healthcare client. 

HIPAA Compliant Features

Companies striving to become HIPAA compliant will have to introduce several new procedures in their regular workflow. Data recording becomes crucial. All the documentation must be registered and managed with utter precision and accuracy. 

The whole set of HIPAA regulations is subdivided into three major sections:

  1. Privacy Rule
  2. Security Rule
  3. Breach Notification Rule

The Privacy Rule delineates the regulations of personal privacy. This standard grants free access to personal medical records for patients. In such a manner, patients get to manage all the processes involving their data via a specialized care app with HIPAA compliance. 

The Security Rule defines a number of private digital data security and protection regulations. This section is further subdivided into: Technical, Physical, and Administrative Safeguards. These are very important points to adhere to when one’s work should involve HIPAA compliant cloud storage.

Technical Safeguards include:

  • Access management;
  • Management audit;
  • Organization authentication;
  • Data transfer security;
  • Wholesomeness of data.

Physical Safeguards include:

  • Facility Access management;
  • Workstation Use;
  • Workstation Security;
  • Device & Media management.

Administrative Safeguards include:

  • Security Management processes;
  • Security Officer assignment;
  • Staff Security (including HIPAA compliant emails for staff workers);
  • Data Access management;
  • Security Education;
  • Incident Prevention procedures;
  • Emergency case plan of actions;
  • Administrative Assessment;
  • Business Partner Deals & other agreements (including HIPAA compliant texting).

The Breach Notification Rule collects regulations on data leaks. This section obliges companies that fall under the Privacy and Security Rule to timely notify the government about any personal med data leaks. Companies must follow a set order and form of notification. An HIPAA breach may result in a huge fine. 

Implementing procedures that limit the numbers of staff that have direct access to patient info is a complex but necessary task for any company that wishes to go along with the HIPAA regulations. 

HIPAA compliant app development cost

Organizations that seek partners for the development of HIPAA compliant mobile applications are looking at quite a wide range of candidates. Currently, many development companies note that proper handling of personal documents and data has its strong sides and costs of acquiring HIPAA compliance are reasonable. 

Talking about the financial side of the question, the development of HIPAA compliant apps with a humble functionality intended for small-scale medical establishments may ultimately cost $4,000 – $12.000. Larger projects must take care of the full spectrum of requirements, implementing risk analysis and management, security education, policy development, flaws’ scanning, etc. Such HIPAA compliant apps may start at $50,000.


Private data protection implies a whole complex of actions directed at granting client security. Companies that are well-established in this aspect have always been at least one step ahead of their competitors. If a mobile app development company operates in the US market, it is simply obliged to become HIPAA compliant. This is a legal foundation that is beneficial both to med organizations and their clients.