How and Why to Make Your Software Application HIPAA-Compliant?

How and Why to Make Your Software Application HIPAA-Compliant?
HIPAA (Health Insurance Portability and Accountability Act)  is known well across every area of the healthcare sector. Originally, it was put into place in 1996. And in 2013, it was greatly expanded and explained by the Final Omnibus Rule Update.

As we know, while creating software for the healthcare industry, one must follow limits and strict requirements set by both state regulators and medical organizations. Hence, our custom healthcare software development services ensure that your applications are robust and HIPAA-Compliant. This ensures improved patient care, cost-effectiveness, and enhanced diagnostics.

However, before knowing how & why to make your software HIPAA-Compliant, one must know what HIPAA compliance is. So, let’s begin with its brief introduction.

What is HIPAA Compliance?

As we mentioned earlier, HIPAA is an abbreviation of the Health Insurance Portability and Accountability Act (HIPAA). It represents numerous rules and standards created to protect patient health data in any form. It contains the following major provisions:

1. Portability
2. Medicaid Integrity Program/Fraud and Abuse
3. Administrative Simplification

The first of all provisions, “Portability” provides available and renewable health coverage and also removes the pre-existing condition clause for individuals changing employers and health plans under defined guidelines.

Second Provision, the Medicaid Integrity Program (MIP), assures that the Centers for Medicare & Medicaid Services (CMS) has a funding source for integrity activities. Moreover, it expands its authority to hire anti-fraud contractors.

The third and last "Administrative Simplification" provision, implements standard transaction and code sets, identifiers, security, and privacy rules throughout the healthcare industry.

Administrative and Simplification Requirements of HIPAA

So, the major requirements of administrative simplification effect:

1. Transactions and code set: Forms standards for electronic transactions and external medical data code sets.
2. Identifiers: Forms a standard for National Provider Identifiers (NPIs) and a standard for a unique employer identifier.
3. Security: Orders the administrative, technical, and physical requirements for covered entities to use in safeguarding protected health information.
4. Privacy: Forms a set of national standards for the security of certain health information.

Below are the entities affected by the HIPAA administration simplification requirements:

All health plans (Medicare, Medicaid, and commercial plans)
Providers which electronically transmit or store health information 
Clearinghouses of Healthcare

Basic HIPAA Rules

There are four basic HIPAA rules:

1. HIPAA Privacy Rule

This rule delineates when PHI can be used or shared.

2. Security Rule

It controls how to protect electronic health information. Security Rule is very technical and also specifies best practices.

3. Enforcement Rule

This rule explains how the HIPAA law is enforced and when corrective actions will be taken.

4. Breach Notification Rule

It controls when a covered entity must notify certain individuals and organizations of PHI breaches.

HIPAA Safeguards

HIPAA Safeguards are security standards to protect secure and maintain (electronic-protected health information) e-PHI. It is of three types:

1. Administrative Safeguards

  • Security Management Process
A covered entity must analyze and identify potential risks to e-PHI. And, one must implement security measures which decrease vulnerabilities and risks to a reasonable and appropriate level. 

  • Security Personnel
It is very important that a covered entity designates a security official, especially one who is responsible for developing and implementing its security policies and procedures.

  • Workforce Training and Management 
One must make sure about the appropriate supervision and authorization of workforce members who work with e-PHI. Also, one must train all workforce members regarding its procedures and security policies. And, if someone from workforce members violates its policies and procedures, they must have and apply appropriate sanctions against him.

  • Evaluation
It is also a very important step that a covered entity performs a periodic assessment. This will help to evaluate how well its security policies and procedures meet the requirements of the Security Rule.

2. Physical Safeguards

  • Facility Access and Control
Moreover, while ensuring that authorized access is allowed, a covered entity must limit physical access to its facilities.

  • Workstation and Device Security
To specify the proper use of and access to workstations and electronic media, a covered entity must implement policies and procedures. 

Also, to ensure appropriate protection of electronic-protected health information (e-PHI), one must have in place policies and procedures regarding the removal, disposal, transfer, and re-use of electronic media.

3. Technical Safeguards

  • Access Control
Furthermore, one must implement technical procedures and policies which permit only authorized persons to access electronic-protected health information (e-PHI).

  • Audit Controls
And, to record and examine access and other activity in information systems that contain or use e-PHI, one must implement software, hardware, and/or procedural mechanisms.

  • Integrity Controls
Moreover, to ensure that e-PHI is not improperly altered or destroyed, it is a must to implement policies and procedures.

  • Transmission Security
One must implement technical security measures to guard against unauthorized access to e-PHI that is being transmitted over an electronic network.

What Happens If You Do Not Follow These HIPAA Rules?

When one does not follow each of these rules, and particularly, the security rules, it can cost hefty fines. For instance, Cignet Health was fined $4.3 million for breaking the privacy rule in 2010. Recently, one more big name 'Memorial Healthcare Systems' that did not audit the systems correctly was fined $5.5 million.

However, based on the violation type, like not knowing of the violation or willful neglect, fines can run from $100 to $50,000 for a single incident.

HIPAA-Compliant for Health Applications: What Does it Mean for Developers?

Not all health applications in the market are HIPAA compliant. So, how to check if your apps are HIPAA compliant or not. So, the criteria to check are:

  • The app user: Entity type
  • The app information type: The information which is stored is generated or shared
  • The app software type: Encryption type
Hence, you’ll have to comply with HIPAA, if your app is intended for use by a Covered Entity.

Additionally, this act covers the transactions of PHI, i.e., protected or personal health information. Personal health information includes a patient’s medical record or information that is used for health care services such as treatment, operations, or payment.

However, the US Department of Health and Human Services describes 18 classes of personal information which comprise the PHI in combination with health data. Its full list is as follows:

  • Patient’s name
  • Geographical subdivisions smaller than a state
  • Phone numbers
  • Dates related to the patient (birth date, admission date, discharge date, date of death)
  • Any Social Security Numbers
  • Health Plan Numbers Beneficiary
  • Medical record numbers
  • Account details
  • Certificate/license numbers
  • Fax numbers
  • Serial numbers and Vehicle identifiers
  • Emails, Web URLs
  • Device identifiers and serial numbers
  • IP addresses
  • Photographic images
  • Biometric identifiers
  • Passwords, Unique ID, and Codes
So you must develop a HIPAA compliant medical app, if you collect, store, or transmit any of this data.

Another criteria for this act is the technology which we use to protect electronic PHI and control access to it under certain standards like access controls, audit controls, and integrity: 

  • The Audit Controls standard needs a medical app developer to have the software, hardware, and/or procedural mechanisms in place that record, track, and examine activities in systems which contain or use electronic PHI. 
  • The Integrity standard needs procedures and policies to protect electronic PHI from improper alteration or destruction to be used by a covered entity.
  • Generally, the Access Controls standard needs unique user identification system automatic logoff, emergency access procedures, and data encryption & decryption at all stages.
So, most likely, you have to develop HIPAA compliant apps if your prospective app will exchange PHI with doctors and medical facilities in electronic form.

How to Become HIPAA-Compliant?

For ensuring HIPAA Compliance, some elements must be implemented in software for medical organizations. Based on the following recommendations, our developers adopt the features which they need to adhere to all requirements.

1. Audits

To identify possible risks for privacy violation or data breaches, Healthcare providers must perform regular audits. These audits analyze the compliance level of a particular medical organization.

Also, it provides detailed information concerning risks and current errors, including recommendations. However, these audits may include a form of quizzes, which makes them easier for medical staff.

2. Recovery Plan

These audits help in forecast risks or detect errors which are related to HIPAA compliance. In spite of this, a remediation plan permits healthcare providers to clear mistakes and also prevent their reappearance. This is why such plans have to be included in medical software.

Furthermore, every medical institution must develop its recovery plan. And, the software must be able to initiate a particular plan for a particular situation.

3. Documentation

To work with documents is the main task of any medical software. Though the software helps facilitate documentation processing, therefore, many healthcare providers execute resembling systems in their organizations.

Here are some required principles that software development organizations use in their projects, especially for medical software in document processing.

  • Comprehensibility
  • Simplicity
  • Strict structure
  • Secure data storage
Moreover, reliable data storage allows organizations to save money and ensure electronic-protected health information (ePHI) security.

4. Managing Relationships with Business Associates

The software must also control the company’s relationships with its business associates, like contractors who are responsible for managing ePHI. The system must monitor the execution of specific agreements. It will help healthcare providers by ensuring the security of PHI when entrusting it to business associates.

5. Security

No one can fully exclude the risk of data breaches in any medical organization. So, it is very important that Software detects those breaches then create a corresponding report and further apply preliminary measures to avoid further data “sharing."

Also, it has to prevent data breaches by blocking the use of portable data storage devices.

HIPAA Compliance Checklist for Software Development

Here we are listing the important factors for HIPAA-compliant software based on safeguards listed in the HIPAA Security Rule. These factors allow your software to ensure both ePHI security as well as privacy.

Important features for HIPAA-compliant software are:
  • Authorization of the user
  • Access control
  • Authorization monitoring
  • Data backup
  • Remediation plan
  • Emergency mode
  • Automatic log-off 
  • Data encryption and decryption

Some Key Points to Keep in Mind about Making the Software HIPAA-Compliant

As a fact, HIPAA governs all m-health (mobile health) apps. And, rules for both startups and well-established companies are the same. Similarly, for both mobile apps (Android and iOS) and web apps, security is a top priority.

So, here are some more key points, one must keep in mind while making the Software HIPAA-Compliant:

1. Clear + comprehensive role and responsibility

An expert must explain the security requirements for your healthcare app. Also, they must review the app architecture.

2. Minimum risk and exposure

Limit the use and sharing of PHI. For that, don’t access, display, or store data that is not necessary. Avoid storing cache PHI whenever possible.

Also, provide secure PHI data transmission and storage when using cloud storage. That means, the cloud storage also must be HIPAA compliant.

3. Secured data transmission and storage

Encryption of data helps to stay HIPAA compliant. It is essential to use available tools and protocols to encrypt and verify data while stored as well as transmitted. Also, make sure that one does not transmit PHI using SMS & MMS because both are not encrypted.

4. The app must be secure, and its security must validate constantly

The app must attain an authentication feature after a certain period of inactivity. Make sure never to use push notifications containing PHI.

Also, avoid storing PHI in backups and highly vulnerable log files, especially while using SD cards in Android devices.

Final Thoughts

HIPAA is an ultimate authority in all things “healthcare,” and that includes the intrinsic, delicate realm of healthcare app development. Though there are many ways to develop such an app, not all of which end up in compliance or are ready for long-term market success.

Keep in mind that in this very time-consuming endeavor, one or all of these points will be crucial. And, all will help you to make your software HIPAA-Compliant.

Our team at Covetus has broad experience in creating HIPAA-Compliant healthcare software and apps. Do reach out to us for any further details or queries!
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