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The Ultimate Software HIPAA Compliance Checklist According to Experts

Vadim Peskov
Vadim Peskov
The Ultimate Software HIPAA Compliance Checklist According to Experts

The Ultimate Software HIPAA Compliance Checklist

Before any development, you’ll want to review this software HIPAA compliance checklist.

According to current United States laws, all software must comply with ongoing privacy regulations.

If you work in the health care field and plan to use (or build your own) HIPAA compliance software, it’s your responsibility to ensure that you remain HIPAA compliant at all times. Anything less could lead to disastrous consequences for you and your organization.

Before you take your next steps or many any decisions regarding software, you will want a working understanding of what HIPAA actually is, what is required of you to stay compliant, why compliance matters, and possible issues that may arise in the event that you are not.

Fortunately, you don’t have to handle these HIPAA IT compliance questions alone.

Diffco is here to help.

Our developers are not only well-versed in HIPAA compliance, but we have what it takes to help you build software that gets the job done while keeping you out of the violation danger zones.

What Is HIPAA Compliance?

HIPAA compliance refers to adhering to the Privacy Rule standards first established by the 1996 Health Insurance Portability and Accountability Act (HIPAA) regarding protected health information.

Privacy Rule standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals’ privacy rights to understand and control how their health information is used. Within HHS, the Office for Civil Rights (“OCR”) has responsibility for implementing and enforcing the Privacy Rule with respect to voluntary compliance activities and civil money penalties. (HHS.gov)

Basically, this rule assures that a patient’s privacy must be respected. It also provides standards by which health information may be shared (or not shared).

When it comes to HIPAA compliance, protected information includes:

  • All medical records
  • An individual’s past, present or future physical or mental health or conditions
  • Individually identifiable health information used
  • Individually identifiable health information disclosed during the course of treatment
  • The provision of health care for an individual
  • The past, present, or future payment for the provision of health care to an individual

Broken down more specifically, protected patient information could include

  • Name
  • Contact Information
  • Date of Birth (DOB)
  • Date of Admission and Discharge
  • Social Security Number (SSN)
  • Account and Medical Record Numbers
  • Vehicle Identification Details
  • ID Information (including full-face photos)
  • IP Address
  • Web URLs
  • Diagnoses
  • Treatments
  • Recommendations

HIPAA regulations affect everyone involved in health care and treatment, including

  1. Health plans and providers
  2. Health care clearinghouses
  3. Any health care provider who transmits health information electronically
  4. Business associations (including partners and employers)

HIPAA protects private individuals and allows them to control the flow of their own health information. In these days, when data is more valuable than ever, such protections have become

increasingly important.

Perhaps most importantly, HIPAA protections can help private individuals mitigate the risks involved in seeking treatment.

With their protections secured, they no longer have to worry that their personal health information will be stolen, used against them, or leveraged by others who may want to commit fraud.

When patients feel safe and know that their health information is protected, they are more willing to be honest about their conditions and symptoms. This gives nurses, doctors, and other healthcare professionals the information they need to make the best and most effective decisions for each patient.

With HIPAA compliance in place, everyone wins.

Does Your Software Need to Be HIPAA Compliant?

Whether your healthcare software application needs to be HIPAA compliant will depend on several variables.

Begin by asking these two questions:

  1. Who will be using your software?
  2. What kind of data is being stored, used, or shared?

The answers will help you determine whether HIPAA compliance software requirements are needed.

Consideration 1: Who will be using your software?

According to current regulations, the burden of ensuring HIPAA compliance falls either on a “covered entity” (such as healthcare organizations and others listed in the section above) or a business associate who has access to any private healthcare information.

If any individuals or entities your software falls into these categories, then it must be fully HIPAA compliant.

Consideration 2: What kind of data is being stored, used, or shared?

Will your software store, use, or share institutional health data?

If so, it must be designed to ensure full HIPAA compliance.

The 5 Basic HIPAA Rules and Requirements

Overall HIPAA compliance can be broken down into five basic rules that all software applications must follow.

Before you make any decisions about software applications, make sure you understand all five basic rules and how they could impact development.

Rule 1: The HIPAA Privacy Rule

The HIPAA Privacy Rule puts the right of discretion in the patient’s hands rather than in the hands of the businesses that hold their data.

This rule affirms that individuals have the right to privacy, and they alone have the right to share that information at their own discretion. Healthcare institutions and providers do not share that right.

The HIPAA privacy rule also grants patients the right to request and inspect their medical records and request corrections if they see mistakes or errors.

The burden of protecting and maintaining those records, however, falls on the institutions—an aspect that certainly has implications for software development.

Rule 2: The HIPAA Security Rule

While the Privacy Rule oversees the sharing of private data and information, the HIPAA Security Rule regulates how that data is protected.

Certain safeguards are required to be put in place and maintained to prevent breaches of security.

Without the HIPAA Security Rule informs how you approach building your software, what IT solutions you can or cannot use, and how your data should be encrypted.

Rule 3: The HIPAA Enforcement Rule

The HIPAA Enforcement Rule, which was added in 2015, provides additional layers of privacy and security.

The Enforcement Rule

  • Institutes procedures for investigating misconduct
  • Sets both civil and financial penalties that can be levied if an individual or institution violates HIPAA standards

Knowing that real penalties await impresses on software developers the seriousness of the task at hand.

Rule 4: The HIPAA Breach Notification Rule

The HIPAA Breach Notification Rule requires that notifications of a breach must be issued within 60 days of the discovery of the incident or fewer.

If it is found that notification of the breach was unnecessarily delayed for some reason, further financial penalties will be imposed.

Rule 5: The HIPAA Omnibus Rule

Effective in 2013, the Omnibus Rule further strengthens the original HIPAA protections—particularly electronic protected health information (ePHI).

The Omnibus Rule expanded the rights of individuals to protect and access their ePHI.

While this is good for individuals, it does create an added layer of considerations for software developers.

Possible Additional Rules to Consider

If you have already determined that your software should be HIPAA compliant, know that there are still some additional rules you will want to consider.

First of all, while there are federal guidelines in place that will affect everyone, there are also certain rules, procedures, and principles that can vary by state, county, or even industry.

When it comes to HIPAA compliance, you can’t be too careful, and sometimes you just don’t know what you don’t know.

It’s important to conduct careful research and perhaps even consult a professional who can alert you of potential pitfalls, saving you untold grief down the road.

HIPAA Compliant Checklist

Especially during the software development phase, it’s important to keep these compliance guidelines in mind—and for good reason.

HIPAA compliance is not a matter to be taken lightly. Violations can result in fines ranging anywhere between $100 and $50,000 per violation.

So it’s best to know what you’re getting into.

Risk Assessment

Strive for a big-picture view of your organization, its current IT policies, what sort of data you’re dealing with, and where there may be gaps in your procedures and policies that make HIPAA compliance challenging.

Make sure your software solutions take all areas of concern into consideration.

Access Control

Access control helps you define roles, grant authorization in accordance with those roles, and set parameters around the use of data.

Session Time 

Determine whether you’re going to set limits on sessions, whether sessions will “time out,” and under what conditions the application will end a session automatically.  

Data Protection and Encryption

Encryption ensures strong security for your data by making it inaccessible and unreadable outside your application.

Data Backup and Recovery

To stay HIPAA compliant, you must make a patient’s medical information not only secure but also available. That means you have to take measures to prevent information from being lost or corrupted.

That’s why a system and location for data backup is an essential step in every HIPAA compliance plan.

Protected Information

 If your application communicates data, that communication must be accomplished via end-to-end encryption that keeps information protected at all times. 


There are various methods by which you can ensure that your application has the strongest levels of authentication.

Strong authentication methods may include

  • Requiring strong passwords
  • Enabling two-factor authentication or multi-factor authentication
  • Relying on certificate-based authentication (CBA)
  • Establishing a biometric system (facial, voice, or fingerprint keys)

Proper Storage

Per HIPAA guidelines, data security best practices require that any private healthcare information is stored only on servers that have secured a signed Business Associate Agreement (BAA).

Security and Ongoing Monitoring

No matter how foolproof you try to make your software system, there will always be a potential for error. That’s because even the best systems are used by people, and people are known to make mistakes.

A robust system of ongoing evaluation and monitoring must be established to prevent present and future data breaches.

Emergency and Remediation Plan

Data breaches are serious matters. Whether the breach is the result of factors you could reasonably have foreseen or not is something an investigation will determine.

In the meantime, to prevent further violations, you’ll need a system by which your software can assess who has been affected and notify them immediately.

Diffco Can Help

Between this complete HIPAA compliance checklist and our team’s expertise, your healthcare organization can have the HIPAA compliant software needed to improve current efforts or scale.Given the high stakes involved, not to mention the regulatory fees and penalties you might face if you are found out of compliance, it’s important to take all steps necessary to ensure your software is built to keep you HIPAA compliant at all times.

The good news is that you don’t have to handle this matter alone.

Diffco can help.

The teams involved in our premium development services all understand current HIPAA guidelines and how to build software that keeps compliance in mind.

Our world-class developers can help you create software that does everything you need it to do while still staying compliant and protecting individual healthcare information along the way.

We specialize in

  • Mobile development
  • Back-end development
  • Front-end development
  • AI development
  • Computer vision development
  • Team augmentation

To hear more about what we have to offer, or if you have further questions about our software HIPAA compliance checklist, please feel free to contact us today.