HIPAA-Compliant Software Development Checklist

Jun 13 2022

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Building A Powerful Software Solution that Adheres to HIPAA Compliance

Healthcare is one of the most transformative and challenging industries regarding complexity and importance. Not only that, but the industry has also become increasingly vulnerable to potential digital risks around privacy, security, and accessibility. Since many organizations invest in innovative technologies to address patient care, they should be aware of the continuously changing rules and regulations that software must abide by. Therefore, HIPAA is one of the essential requirements to meet when developing a healthcare software or app.

This blog will explore what it takes to achieve HIPAA compliance for software and its violations cost. Let's learn more about the basics and the considerations while initiating HIPAA-compliant software development in life sciences.

What is HIPAA Compliance?

HIPAA, or Health Insurance Portability and Accountability Act, is a US federal statute presented in 1996 to regulate the healthcare data industry. This act focuses on how the healthcare industry processes personal information to ensure its safety and privacy.

Introduced by the 104th US Congress and signed in 1996 by President Bill Clinton, HIPAA focuses on simplified administration, the safety of the electronic record and health information. HIPAA empowers users to maximize healthcare IT solutions sincerely, satisfactorily, and seamlessly without compromising privacy. In a nutshell, HIPAA protects the privacy of a user's crucial health information.

For any healthcare software to receive HIPAA compliance, a framework is required to guide the concerned. This will ensure that the compliance process has been conducted per the HIPAA rules. The initial part of HIPAA compliance understanding, and execution is to get aware of the healthcare software industry data.

The initial part of HIPAA compliance understanding, and execution is to get aware of the healthcare software industry data.

  • PHI (Protected Health Information) — includes doctor bills, emails, MRI scans, medical information, geolocation details, and test results.
  • CHI (Consumer Health Information) — This set comprises data that can be collected from any fitness tracker, such as the number of steps, number of calories burnt, or heart rate readings.

Why Is HIPAA Important?

HIPAA is important because it prevents healthcare fraud and ensures all health information is secured appropriately. It has introduced several significant benefits for organizations and patients to help transition from paper-based records to digital copies of health information. However, in today's highly connected and personalized healthcare industry, access and use of this information cause concern for marketers within the healthcare ecosystem.

Last year, there were 712 data breaches within the healthcare industry, resulting in a 10.9% increase over a year, according to the HIPAA Journal's Healthcare Data Breach Report.

With the growing number of cyberattacks, it is now more than necessary for healthcare providers to have secure patient information.

What are the Benefits of Complying with HIPAA?

HIPAA helps regulate the flow of healthcare data and ensures that it is protected from any data fraud, theft, and breach. There are plenty of benefits for healthcare firms.

Risks, Penalties, and Justice

The penalties for HIPAA violations can be costly. In addition, the penalty will increase with the number of patients and the amount of neglect.  HIPAA rules violations often result in terminations, criminal charges like imprisonment and fines, and sanctions from boards. The directions to carry out justice depend on these five factors listed below:

  • Number of individuals that participated in the violation of rules
  • The violation was made unintentionally or with malicious intent
  • Harm and effects caused by the violations
  • Whether any step was taken to correct the mistakes or not
  • The nature and type of violations

There are four categories for the penalty structure, as mentioned below -

Tier 1: A violation that the covered entity was unaware of and could not have realistically avoided had a reasonable amount of care had been taken to abide by HIPAA Rules

Tier 2: A violation that the covered entity should have been aware of but could not have avoided even with reasonable care. (But falling short of willful neglect of HIPAA Rules)

Tier 3: A violation suffered as a direct result of "willful neglect" of HIPAA Rules in cases where an attempt has been made to correct the violation

Tier 4: A violation of HIPAA Rules constituting willful neglect, where no attempt has been made to correct the violation

With that being said, let's dig deeper into the critical considerations for developing healthcare software compliant with HIPAA regulations.

Developing a HIPAA Compliant Healthcare Software

At Icreon, we always strive to focus on building safety- and privacy-first custom software solutions. When we develop HIPAA-compliant custom software, we follow many requirements as a custom software development company.

Let's take a look at them.

Evaluate IT Infrastructure and Policies

The first step is to conduct a detailed assessment of the healthcare facility to recognize the security and administrative policy gaps.

Conduct Cybersecurity Measures

Data breaches are a significant threat to any healthcare facility, so technical safeguards should be robust. This would minimize the risk of any unauthorized access.

Ensure Transport Encryption

When developing HIPAA-compliant software, it is mandated to ensure that health data is encrypted in transmissions. This is achieved by using HTTP protocols and SSL.

Ensure Backup and Storage Encryption

There's always a primary focus on offering robust recovery and backup services, ensuring the data isn't lost in any emergency.

Assure Integrity

While building the HIPAA-compliant software, it is essential to have an infrastructure set up to ensure the transfer of information is well-protected.

Make Measures for Disposal

Archived and backup data that is expired should be disposed of. All the unused data is being removed in a safe, non-retrievable manner.

Which Healthcare Software and App Should Comply with HIPAA rules?

When we measure software against the requirement of complying with the HIPAA privacy rule, there are three essential criteria to be defined:

  • Entity - When the application is used by hospitals, doctors, or insurance providers like a covered entity, they will comply with the HIPAA-compliant software requirements. For instance, you're planning to create an application that enables patient-doctor interaction. Your app must comply with HIPAA rules, as hospitals and doctors are covered entities. Besides, an application that helps users follow medication instructions won't need to follow the HIPAA privacy rules as there's no covered entity included. While discussing commodities, it is also essential to look into the privacy rules. Because it focuses on protected health information while also describing who should be responsible for safeguarding that PI details are not disclosed
  • Data - Any mobile app-related HIPAA compliance mainly focuses on safeguarded health information, such as medical information, that can be utilized to recognize an individual with that data disclosed while availing services like treatment or diagnosis. PHI (Protected Health Information) has two sections - personally identifiable information and medical data. A crucial point to note is that the data is called PHI only when any personally identifiable information is connected to the medical data. For instance, an app that helps doctors diagnose skin elements by observing anonymous photos does not come under any PHI. But when it comes to the patient's name or address, it is a PHI. In a nutshell, any information stored or shared in any app is identifiable individually, so it must comply with the HIPAA compliances.
  • Software Security - This is one of the last factors that help identify whether or not healthcare application development comes under the HIPAA rules and is related to the particular technology while also having several standards available for the protection of ePHI.

HIPAA Compliance Checklist for Software Development

Regarding healthcare software development, there are several requirements and critical limits set by medical organizations. Let's take a quick look into those important HIPAA compliance checklist insights while developing HIPAA-compliant software –

  • Do you have a privacy policy available between all the essential roles and stakeholders?
  • Have you ensured if your healthcare solution requires HIPAA compliance for software or not?
  • Depending on standards, do you have stable cloud-based storage and devices for your healthcare software?
  • Have you engrained all the crucial security features and encryption logic in your healthcare software, compliant with HIPAA standards?
  • Have you collected all key metrics to measure HIPAA compliance for the software process?
  • Have you partnered with a trusted IT service provider with better software development and healthcare industry expertise?
  • Is your budget for accomplishing the standards set? Is it aligned with the company's cost lines?

Are You Ready to Develop HIPAA-Compliant Software?

The demand is getting higher for developing HIPAA-compliant software – as hospitals, clinics, and medical procedures are upgrading with technology. However, designing HIPAA-compliant systems isn't as easy as creating generic software; you need professionals with a successful track record of building first-class healthcare software. At Icreon, we have extensive years of experience working with healthcare companies who trust us to deliver HIPAA-compliant software.

Gain a competitive edge while ensuring your software is HIPAA compliant. Explore our custom software development services.