How HIPAA compliance software is developed.

An Introduction to HIPAA:

 HIPAA is an acronym that stands for Health Insurance Portability and Accountability Act. The policy, which was passed in 1996, lays out a set of norms and regulations for the protection of all forms of patient health data. The policy, which is solely applicable to US territory, safeguards patients and their data security. If a company does not follow these rules, it will face significant financial penalties.

Who Is Required to Follow HIPAA?

HIPAA requirements apply to any organization or entity that holds, processes, or transmits protected health information (PHI). There are 18 HIPAA Identifiers that define PHI. PHI is defined as data that has any of these identifiers and is subject to HIPAA requirements. HIPAA laws must be followed by healthcare providers, health plans, and healthcare clearinghouses.

Business associates (BAs) are healthcare vendors and corporations that handle providers’ PHI and must agree to HIPAA regulations. This means anyone handling PHI, such as digital health companies, as well as organizations that supply productivity tools like CRM or ERP systems, must comply with HIPAA.

HIPAA-compliant software is required for certain applications:

The type of data that an application generates, sends, or stores

The type of thing with which the software connects or is designed


The domain of healthcare software interacts with two sorts of data:

Consumer health information (CHI).

This category contains data that apps can collect even from a fitness tracker, such as heart rate readings, steps taken, calories burned, and so on.

Protected health information (PHI).

PHI is made up of health information and personal identifiers. The first sort of information refers to a patient’s physical or mental health or condition, as well as healthcare costs. This includes doctor bills, emails, lab test results, MRI scans, and other information generated, used, or disclosed in the course of providing healthcare services. Health data also includes information about a patient’s healthcare insurance coverage, as well as geolocation facts that identify a person’s location within a smaller area than a state.

HIPAA software compliance is required if an application collects, processes, stores, or transfers any PHI, according to the rule of thumb.


Two types of enterprises should seek HIPAA compliance, according to the Privacy Rule:

Covered entities

Covered entities include:

Health and Human Services (HHS) have created a standard for financial and administrative transactions between hospitals, clinics, nursing homes, pharmacies, private practices, dentists, psychotherapists, chiropractors, and other healthcare providers.

Health insurance companies, health maintenance organizations, corporate health plans, government programs like Medicare and Medicaid, and military and veterans’ health care program are all examples of health plans.

Clearinghouses serve as a link between healthcare providers and insurers, processing non-standard health data received from both.

The law will almost certainly apply to an application designed for use by a covered entity, such as communication between doctors and patients. Even apps that deal with hospital staff records and educational records for medical institutions may be subject to HIPAA software standards.

Business associates

As part of a service to, or on behalf of, a covered entity, these individuals or organizations collect, retain, process, or transfer individually identifiable health information. Attorneys, accountants, billing businesses, software suppliers, hosting/data storage, email and encrypted email providers, healthcare app developers, and other third parties that may inadvertently handle patients’ data are included in this category.

Anyone who qualifies as a covered entity or business associate must comply with the following requirements:

To guarantee the confidentiality, integrity, and security of electronically transmitted PHI, implement the appropriate administrative, physical, and technical safeguards following the HIPAA Security Rule (ePHI).

Limit the use and sharing of PHI to what is necessary to complete the task at hand.

Reduce the number of businesses and individuals that have access to patient information, and provide employee training on how to protect it.

To guarantee that PHI is properly safeguarded, sign a business associate agreement (BAA) with any party who has access to it.

Software Development Rules That Comply With HIPAA

Electronic PHI storage options have mostly overtaken paper-based techniques in recent years. The same electronic modes, on the other hand, increase the possibility of a data breach.

Regardless of the number of documents stolen, most PHI data breaches end in financial loss. Hackers steal personal information to sell it for profit. However, illegal data disclosure is only one of the concerns.

Modifications to classified information are a typical occurrence. Changes to a patient’s medical records, as well as certain diagnoses, might lead to treatment errors. Patients are more likely to suffer personal injury in such scenarios, which can even be fatal.

The HIPAA defines five fundamental guidelines that all healthcare software programs must follow to avoid all of the above threats and disasters:

The HIPAA Privacy Rule

According to the most recent version, the HIPAA Privacy Rule defines the standards for protecting PHI. As a result, clinical history, payments for healthcare treatment, and any other medical information must be kept safe and out of the hands of third parties.

In addition, the rule outlines the circumstances in which certain people can gain access to PHI without the patient’s permission. It also establishes the patients’ limitations and rights.

Patients can examine and obtain copies of their medical records under this law. Patients can also seek corrections if there is a mismatch or an error.

The HIPAA Security Rule

The HIPAA Security Rule establishes security requirements for PHI. It contains special security advice and restrictions for health information. This rule essentially assists in the detection, correction, and prevention of future security threats.

To ensure effective PHI protection, covered companies must conduct a periodic data breach risk analysis, according to the rule.

The HIPAA Enforcement Rule

In the event of a data breach, the HIPAA Enforcement Rule defines the investigation requirements and financial penalties. The penalty amount, on the other hand, is determined by the number of medical records disclosed and the frequency with which a company’s data is breached.

A first-time breach can cost a business anything between $100 and $50,000, but future breaches can cost up to $1.5 million.

The Breach Notification Rule

If the data breach affects fewer than 500 people, the firm must notify them all within 60 days of the breach being discovered, according to this guideline. The employer must also notify the US Department of Health and Human Services’ Office for Civil Rights within 60 days after the start of a new calendar year.

If a data breach affects more than 500 people, the organization is required to notify the media as well.

The Omnibus Rule

The Omnibus Rule was added to the above-mentioned rules in January 2013. This rule often extends business associates’ responsibility to comply with HIPAA rules when dealing with PHI.

How to Develop HIPAA-Compliant Software

The Omnibus Rule, a collection of statutory changes to HIPAA that modifies the original Act to allow for new technology, must be met by healthcare software. The following components must be included in healthcare software to be fully HIPAA compliant:

Encryption and decryption of data in a secure manner:

To prevent attackers from detecting data leaks, every data must be encrypted before transmission. HTTPS and certificates are commonly used to encrypt transmission channels. To safeguard the database from hacking, the data is encrypted at the storage location.

Safe and secure backup:

Software should be developed to recover and restore lost data to prevent data loss due to system failure. Encryption is also used for backup data.

Restricted access:

Patient records should only be accessed and viewed by authorized personnel. User permission and identification tracking via unique user identities should be included in healthcare applications.

Automatic logout:

To prevent unauthorized users from getting access, after an authorized user has received the relevant records, the system should automatically log them out.

Emergency mode:

Software should incorporate protective emergency mechanisms in case of power failures or other interference.

Data storage:

Healthcare systems must be able to safely store ePHI.


Healthcare software should be designed in such a way that it cannot be tampered with by unauthorized individuals.


When ePHI is no longer required, the system should be able to permanently erase it, making it unrecoverable.


The HIPAA Confidentiality and Privacy Rules safeguard the security of protected health information (PHI) and limit its disclosure of information to those connected to treatment, payment, and healthcare services.

HIPAA compliance ensures security and credibility, which contributes to the growth of a healthcare organization. Choosing a trustworthy software partner who understands what security and privacy safeguards should be in place is important.

The next objective is to work with a team that has extensive experience and knowledge of healthcare applications. Building the proper software solution for healthcare businesses necessitates years of technological experience.

Werq Labs ( creates software solutions that comply with all international security standards. We’ve put together the finest development, design, and testing teams in the business to deliver top-notch solutions to our clients.

One of our healthcare clients is Werq. Inc. For more information about our work, go to

If you have a healthcare app idea, our expert developers can convert it into a market-ready and profitable web or mobile application using the best development standards and time-tested processes.


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