A Guide To HIPAA Compliant Healthcare Software Development

HIPAA compliant software development is in trend, especially since the enactment of HIPAA, which stands for the Health Insurance Portability and Accountability Act. This legislation focuses on the safeguarding of users' data while also suggesting methods to achieve the highest security. Additionally, it imposes heavy fines and penalties for violations. 

If you have a health tech solution then HIPAA is a mandatory requirement. Contrary to popular opinion, the HIPAA-compliant software development process or making your existing solution HIPAA compliant differs somewhat from traditional software development. For instance, you have to first sign a Business Associate Agreement (BAA) with the part access to Patient Health Information (PHI).

Don’t let these terminologies confuse you, as you have come to the right place. We are going to cover this and all. And by the end of this blog, you will know

• What is HIPAA?
• Why is HIPAA compliance important?
• What is a HIPAA-compliant software checklist?
• HIPAA-compliant software development process
• How to ensure it in healthcare IT solutions?

Let’s first define HIPAA compliance software and why you need it.

What Is HIPAA Compliance Software?

HIPAA-compliant software means the software that is adjusted to make you, your company, and your colleagues HIPPA compliant. It incorporates all the HIPAA guidelines for the secure handling of patient’s PHI (Protected Health Information). 

Indeed, HIPAA is a strict law so to save you from the fines and penalties we have prepared a HIPAA compliance checklist with the help of our team.

HIPAA Compliance Checklist For Software Development

HIPAA-compliant software has certain security controls to safeguard sensitive health information. So below is the HIPAA compliant software checklist that offers an overview of the controls that must be in place whilst the HIPAA-compliant software development such as

• Access Controls
• User Authentication
• Audit Controls
• Encryption
• Transmission Security
• Data Backup
• Business Associate Agreements

Sr no	HIPAA Checklist	Details
1.	Access Controls	Establish technical policies and procedures for electronic information systems to safeguard electronic protected health information. Software users should only have access to data that is required to perform their jobs.
2.	User Authentication	Implementation of procedures to authenticate that a person or an entity seeking access to data is the one who claimed. Administers should provide unique login credentials for each employee.
3.	Audit Controls	Deployment of software, hardware, or procedural mechanisms that can examine and record activity in information systems that contain electronically protected health information.
4.	Encryption	Employ mechanisms to encrypt the electronic protected health information whenever it is deemed appropriate. Especially to maintain the confidentiality of PHI
5.	Transmission Security	Healthcare providers must deploy technical security measures that protect against unauthorized access to PHI, especially being transferred via an electronic network. Products should implement SSL and TLS certificates when possible to prevent unauthorized access.
6.	Data Backup	It is necessary to establish and implement the procedures to maintain and create mechanisms that support data backup. Such as retrievable exact copies of protected health information.
7.	Business Associate Agreements	With any other business associate, healthcare software developers should sign a Business Associate Agreement (BAA) to work with healthcare clients to safeguard PHI. BAA also says that each signatory party should be responsible for maintaining their compliance.

Recently, InvoZone developed a HIPAA compliant app Stitch Health. Read how we developed this seamless app that helped in fulfilling our client’s dream of seamless communication.

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Why Do You Need HIPAA Compliant Software Development In 2023?

Well, the answer lies in the  HIPAA-compliant software development benefits 

• Simplification plus streamlining of processes to achieve potential clinical goals. 
• Mitigate risks of legal consequences due to safety failures.
• Full-fledged testing of custom solutions specific to healthcare needs.
• Helps in ensuring high security of Patient Health Information (PHI)
• Provides easy compliance opportunity
• A periodic review of conformity efforts (helps update all actionable measures).

HIPAA Compliant Software Development Process

The process of HIPAA compliant software development depends upon the type of medical software and its functional scope. The series of steps followed are given below:

1. Compliance & Engineering Of Software

The first step is signing a Business Associate Agreement (BAA) with the development partner who has access to PHI to fulfill the legal obligation. Specifically related to security, encryption methods, and security documentation, etc.

2. Market And Competitors Research 

In the second step, our team does research into market trends and gathers compliance requirements for HIPAA regulation. Including other applicable federal and local legal acts, and guidelines of appropriate agencies (FDA, FCC SAMHSA, etc.). Also, in this step, the software requirements and specifications are decided. In addition to usage risks description and mitigation plan.

3. HIPAA Software Project Planning

The third step is a little comprehensive and the following things are planned and determined before the software development process starts

• Identification of Project Scope.
• Selecting a development approach for HIPAA-compliant software.
• Analyzing software development risks. 
• Budget, KPI, and sprint planning.
• Appointment of project manager.

4. MVP Development

In this stage, the company develops user scenarios and plans convenient journeys for medical software users (medical practitioners and patients). The user flow is planned to keep in view the HIPAA compliance security measures. 

For instance emergency access to patients' data, software access control, etc. This stage also involves UI prototyping, UI design, and User interface design documentation (all screens and assets). 

5. Medical Software Development & Testing

In the software development stage, the back-end such as the server side of the application and APIs are developed with a focus on PHI security. As well as the UI design elements related to the front end. Once the software is developed the testing is done to kill any bugs and detect any medical defects, check the software for functional requirements, security, HIPAA compliance, and usability for the target audience.

6. Launch And Maintenance

After the proper testing, the medical software is deployed and revisions to healthcare software documentation are done. Once all the requirements of the launch are met, the maintenance phase is initiated to fix revealed defects, employ security patches, and resolve incidents to ensure the uninterrupted functioning of the medical software. 

Also, regular security audits are done to check PHI security and HIPAA compliance, and keeping in view user feedback new features are included.

The tools and technologies we have used for the development of the solutions are below.

How Much Does It Cost To Develop HIPAA-Compliant Software?

The ​​HIPAA-compliant software development cost depends upon the complexity of the project. The average cost can range from $50 to $250 or more per hour. Let’s see what the price can be depending on the duration of the projects.

 

How can InvoZone Healthcare Software Development Services help you? 

InvoZone with the experience of dealing with 300+ projects and  97% success rate has provided flawless healthcare apps to its partners. Our healthcare software development services set us apart in the market because of the following things

• Time Zone alignment
• 300+ project experience
• Expertise in the latest tech stacks
• 500+ professionals 
• Flexible pricing models
• Meticulous planning

We plan to focus on some of the vital things in the HIPAA-compliant platform. 

If you have an idea for a healthcare app, make sure that you contact a software development company that ensures HIPAA compliance like us. You can book a free consultation with just one click below.

Frequently Asked Questions

1. What is HIPAA compliance in software development?

HIPAA compliance in software development indicates adhering to the Health Insurance Portability and Accountability Act (HIPAA) regulations when developing healthcare-related software. It encompasses implementing strict security and privacy measures to secure Patient Health information (PHI) and ensure the confidentiality as well as availability of healthcare data within the software system.

2. How to build HIPAA-compliant software?

To develop a HIPAA compliant software you have to follow these steps:

• Complete comprehension of HIPAA regulations.
• Deployment of strict access controls.
• Encrypt data at rest and in transit.
• Regular security audits.
• Risk assessments.
• Development of a robust data backup & recovery plan.
• Regular monitoring and updating of security measures.

3. What is required for software to be HIPAA compliant?

The software should have the following requirements to be HIPAA compliant as: 

• Implementation of Access controls
• Encryption of patient data
• Secure user authentication