HIPAA Compliance Checklist for Software Development

Quick Summary: Security is the most important criterion in software development, and in the healthcare industry, it’s paramount. Hence, we’ve compiled this comprehensive checklist of HIPAA compliance rules and steps to ensure your software aligns with healthcare data privacy standards. Keep reading this blog for the full picture!

If you are looking forward to building a healthcare application that will interact with electronically protected healthcare information (ePHI), like healthcare startups or hospitals. You must realize that HIPAA will be on your radar in that situation! Do you want to know why HIPAA is so important?

It is a significant piece of legislation, to be sure. HIPAA as a concept first appeared in 1996. It was integrated to address a specific issue, i.e., the issue of insurance coverage, especially for people between jobs.

Notice that these employees would have lost their insurance coverage if HIPAA had not been in place. It is one aspect we are looking into, and HIPAA is not just confined to it; there is more! Want to know what?

The following objective of HIPAA was to prevent fraud in the healthcare niche and ensure that all the protected health information was secured appropriately. Also, it intends to limit and restrict authorized users' access to healthcare data.

"Everyone should have health insurance? I say everyone should have healthcare. I'm not selling insurance quotes, Dennis Kucinich".

In one way or the other, it is justified that HIPAA has several benefits for the healthcare industry. Not only does it help to streamline the administrative functions of healthcare, but also it enhances the efficiency in the healthcare industry. And the cherry on top, it ensures that protected health information is shared securely. Fascinating facts about HIPAA, right?

Now let us dive into the concept of HIPAA, why it is important, and which health applications should comply with HIPAA rules. Let us also look into its audit checklist, security rule, privacy rule, steps to make software HIPAA-compliant, and most importantly, FDA regulations and medical devices. Without further delay, let's get started!!

What is HIPAA?

We shall attempt to comprehend the meaning of HIPAA and its significance in this part. Let's first understand what HIPAA is to understand its significance better.

"HIPAA stands for Health Insurance Portability and Accountability Act."

The current version of HIPAA was released in 1996. Its main goal is to provide patients with a practical solution to the issue of healthcare and insurance. The main objective of HIPAA was hence accomplished. It is important to note that HIPAA doesn't apply to all players in the healthcare industry. Still, it mainly applies to those covered by the health insurance laws of 1996, i.e., employers and their workforce.

Well, now a few of you must be wondering what is meant by "healthcare." It includes medical care in hospitals and medical labs and complementary services like X-rays and lab tests. The term "healthcare" means any healthcare procedure related to medical treatment or diagnosis of diseases or injuries where protected health information (PHI) is involved. "So, what is PHI HIPAA?"

If we look at HIPAA, the definition of "PHI" by HIPAA is as follows: Tracking medical care that happens between different healthcare providers with a common identity, including any financial transactions related to such care.

The term applies to information related to that care and the communication thereof, such as clinical reports, bills, claims forms, communications between providers, and claims forms sent to health plans. Other examples include reports on diagnosis codes, hospital discharge summaries or discharge instructions, lab results, and other communications between providers regarding care.

Do you want insight into health insurance software? Refer to our guide and get a complete comprehension of the same.

Now that we have clarity on what HIPAA is and what protected health information is, let us unleash the aspect of its importance, are you also wondering why it is essential? Read on to find its answer!!

Innovate Your Medical Offerings with Futuristic Healthcare Software Development Services

Give it a Shot!

Why is HIPAA Important?

The importance of HIPAA will be unleashed when you learn about what HIPAA protects. Let's look into it!!

"HIPAA is important because it helps to protect an individual's privacy and security and also is a means by which employers can set uniform standards of healthcare treatment across.

HIPAA also offers a framework for preventing PHI from being accessed or used without authorization. At the same time, this framework helps in the proper use, storage, sharing, and handling of PHI for healthcare purposes."

In simple words, HIPAA was introduced to ensure that patient's private health information was secure.

Are you curious about EHR and how to build it from scratch? Read our blog and enlighten your knowledge!

Health Applications That Need to Integrate with HIPAA Rules

Looking at, understanding, and analyzing the applicable rules and considering HIPAA standards is a crucial part of custom software development. Yet again, what is it that exactly falls under HIPAA's domain?

Well, the criteria that define whether HIPAA will regulate an application are one: the types of entity that uses the software, and two: the kind of data that the software generates, stores, and shares. To comprehend it better, let's take a closer look.

1. Type of Entity That Uses the Software

It is to be noted that HIPAA rules and regulations apply to the covered entities and the business associates. The list includes individuals that create, access, and store protected health information (PHI). Are you still wondering who has to be HIPAA-compliant? The list is as follows:

• Healthcare Providers
• Healthcare Plans
• Healthcare Clearinghouses
• Healthcare Business Associates

Suppose you want hands-on, detailed information about the entities regulated by HIPAA. In that case, you can simply look into the guidance the US Department of Health and Human Services provides.

2. Data Covered by the Software

The data discussed here typically refers to the health records and any medical information used to identify the patients. It includes sensitive data on prescriptions and diagnoses. As previously mentioned, this data is also known as protected health information or PHI.

To be precise, compliance with HIPAA is essential, especially for health applications that contain individually identified data stored locally or on a third-party server. Plus, if you are looking forward to creating healthcare software like this, ensure that it can meet all the requirements from the HIPAA compliance checklist.

Read more: All-in-one guide for successful healthcare software development.

HIPAA Compliance Checklist for Software Development

Before we look into the checklist, we need to understand who is subject to regular HIPAA audits. Well, the covered entities and the business associates are subject to regular HIPAA audits, and there are two vital goals of HIPAA audit; wondering what those are.

Number 1 is to ensure that all the vulnerabilities are mitigated.

Number 2 is to verify that the product meets HIPAA requirements.

Not to overlook that the checklist can differ depending on the type of covered entity or business associates. Developing applications for healthcare providers is a serious business. Naturally, if the app violates any HIPAA compliance requirements, there will be consequences. Thus, it's critical to learn how to create a HIPAA-compliant healthcare software application.

Now without any further ado, let us look at the checklist of procedures, policies, documents, and software that falls under the category of HIPAA audit.

Pace Up Your Productivity and Growth at 2X with Healthcare CRM Software Development

Leverage Our Services

1. User Authorization

The US government divides the level of identity assurance in software applications into four categories. Only a single element of authentication is used at the lowest levels. The security level is at its lowest when a user has unrestricted access to the system with only a password. Multi-factor authentication is used at higher levels, requiring users to confirm their email addresses, cell phones, etc.

You must incorporate at least two of the following elements into your software for it to be HIPAA-compliant:

• Knowledge - A visitor must enter a unique piece of information that only authorized users are aware of.
• Possession - The platform gives consumers more information, such as a security code. The visitor must provide the information to prove that they are the rightful owner of it.
• Location - Giving access only if the user is present in a specific area when the request is made.
• Inherence - A biometric scan to confirm a user's unique trait that cannot be replicated or altered.

Healthcare software solutions that comply with HIPAA must keep track of its users. Also, clinicians should be able to get patient data without needing to adhere to a convoluted routine each time they require crucial data.

2. Remediation Plan

The US government requires that the company create a plan to remediate any breaches in data. It goes beyond simply getting notifications from the authorities about a breach. The goal is critical because it will ensure that all sensitive records are protected and properly contained and that the necessary steps have been taken to repair any damage caused by the breach.

As a result, it lists the following best practices for safety:

• A schedule outlining all the actions to be taken to ensure data security.
• A clear description of how to recover from any data breach that has already happened.
• A description of how to protect data from future attacks.
• A description of the procedures that all personnel must adhere to to ensure their safety.
• A list of all entities responsible for carrying out the plan, like a team or department, who will be directly in charge of monitoring the process.
• A section listing all insurance policies and procedures that will allow you to deal with data leaks.

As HIPAA requires safe software development methods, the remediation plan is essential. Analyzing the precise task your firm must complete satisfying security compliance is the key issue here, as it always is. Therefore, integrating medical and software expertise is essential for composing the best remediation plan for HIPAA-compliant software.

3. Emergency Mode

In relation to HIPAA compliance, a team must be in place to troubleshoot any breaches. And it also needs to have a written plan for dealing with an emergency, such as a network failure or data attack.

The importance of this document is that it will allow your staff to address a problem and prevent further damage from happening quickly. It's critical because it outlines all the steps in case of a breach or attack. Thus, include the following details in your HIPAA-compliant healthcare app's emergency plan:

• A comprehensive list of every team member, including every employee's title, phone number, and email address.
• A thorough examination of the data that users can access.
• A description of what transpires in the absence of a team member.
• A record outlining all communication channels with security teams, insurance companies, and 3rd party providers that need to be in contact during emergencies.
• The contact details of your insurance provider.

Business partners must define the emergencies where the plan can be used effectively and assure any potential dangers in the strategy.

Want an understanding of how custom software development is transforming the future of the healthcare industry? Read our blog and get an insight!

4. Authorization Monitoring

The company should maintain and monitor a log of every user that has access to any part of the system. Thus, by searching the register, security officers might be able to detect if a hacker is accessing a patient's data or if a user has broken into their account.

It goes without saying that this is crucial to comply with HIPAA because it will ensure complete and accurate information about your company's IT structure. HIPAA compliance checklist for authority monitoring:

• Activity logs and audit controls - The system must log all user activities. You should include details of every page visited, every file accessed, and every application launched.
• Classification – Record every action taken by an individual accurately. In addition to storing details of user accounts or passwords, you must ensure that you follow the classification standard.
• Data Integrity – Keep a record of all changes made to patient data or documents. When the paper is accessed or changed, the system must detect the change, when it was made, and by whom.
• User IDs and passwords - Every user must have a unique account. The system must enforce a password policy that requires users to change their passwords or reset them every so often. All user accounts and passwords should also be kept in a secure location.

Embark Towards Your Goals by Modernizing the Medical Infrastructure with Healthcare IT Services

Get Started!

5. Data Backup

HIPAA compliance for medical apps requires that you have an automatic backup of data. In the event of a system failure, every record, file, and application must have a backup as soon as possible, which will help to recover data lost by any bug or hardware failure.

To make their software HIPAA compliant, organizations must consider the following factors:

• Redundancy – Ensure your system's data is mirrored at least three times. Note that you store it at a minimum of two different storage locations.
• Encryption – Data encryption is a simpler and quicker technique for protecting data. For the highest level of data security, the application should use the best protocol and two-factor authentication.
• Monitoring – If there is any unfortunate event, the system should be able to back up immediately and alert the organization's team.

Rules of HIPAA Compliance

To comply with HIPAA, software or application development must adhere to all relevant laws, regulations, and revisions. HIPAA should ideally be strict (with many rules and harsh penalties) and generous (giving liberty to apply the many governments in the best way possible).

Well, HIPAA defines 4 rules that each healthcare software app should follow:

Rule 1 – HIPAA Privacy Rule

The rule protects the disclosure and the use of healthcare records and other PHI. It enhances the health data flow to eliminate theft and fraud. With this rule, patients get a few rights to their healthcare data. Wondering what all does it includes? Well, it establishes the right to obtain a copy of their health data, inspect them, and ask for amendments and alterations.

Rule 2 – HIPAA Security Rule

Designing of the rule is to protect the security of a patient's health information by implementing a few measures. It is important to note that the Security Rule applies only to "covered entities" and business associates. Covered entities are mainly healthcare providers, health plans, and healthcare clearinghouses, while business associates are mainly subcontractors of covered entities.

Rule 3 – HIPAA Enforcement Rule

The regulation outlines how the HHS (Department of Health and Human Services) would enforce the HIPAA law. The regulators determine accountability and compute penalties if a non-HIPAA-compliant app is created. Investigations typically start with a data breach or a complaint. The HHS, nevertheless, has the option to investigate even in the absence of a trigger.

Rule 4 – HIPAA Notification Rule

This HIPAA regulation alerts all business partners and entities if there is a PHI breach. The HHS determines what constitutes a breach based on the volume and kind of the PHI implicated, the type of disclosure, whether the data was viewed, and the risk of exposure.

Within 60 days of the breach's detection, notifications must be delivered to everyone affected. The organizations must adequately notify the media if the breach affects more than 500 people.

These are a few rules for HIPAA compliance. Do you want to learn about healthcare SaaS startups and look into its guide for budding entrepreneurs? Refer to our blog and get a clear picture of the same.

Steps to Make Software HIPAA-Compliant

Ensuring compliance with HIPAA requirements for healthcare software development is crucial. One can achieve this by following three steps mentioned as follows:

Step 1 – Conduct a risk management

Step 2 – Abolish the risks and adjust processes

Step 3 – Ensure long-term risk management

Enhance Efficiency and Get Better Data Management with Medical Software Development

Let's Begin

FDA Regulations and Medical Devices

One of the foremost reasons for privacy concerns is the use of medical devices and the data shared by them. Additional to the HIPAA rules for healthcare apps, the developers must follow another set of rules by Food and Drug Administration (FDA).

FDA is a US federal agency responsible for protecting public health through the regulations and supervision of food safety, medications, and medical devices.

Note: It is essential to have compliance with FDA regulations. Plus, it is as vital as following HIPAA rules.

Furthermore, it is essential for all MedTech and medical software providers that work in the US market. According to FDA regulations, the mHealth app can be classified as a medical app if it can satisfy any of the following conditions:

• It is used as an accessory to a regulated medical device.
• It transforms a medical healthcare software platform into a controlled medical device.

With this, it is clear that FDA regulations and guidelines for medical devices will also apply to mobile health applications. You may also connect with the right healthcare software development partner to understand the technicalities of these compliances and get better guidance based on your organization’s needs.

ConclusionRegarding HIPAA compliance, healthcare app developers must follow all rules, regulations, and guidelines to ensure the utmost security for patient data. The best way to create these apps is by following well-defined design, development, testing, and deployment methodologies.Radixweb, a leading custom healthcare software development company, can help with all your HIPAA compliance needs. We specialize in applying medical software development and management across the healthcare industry. With 25+ years of experience in this niche, we help our clients implement HIPAA-compliant software in the best way possible. If you have any questions, do not hesitate to reach out to us.