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A Comprehensive Guide to HIPAA-Compliant Software Development in 2023

While building healthcare software development, you have to ensure that your healthcare software development complies with the HIPAA business associate agreement to protect personal health information (PHI). Healthcare Software development simplifies numerous hospital management and patient care functions to ensure efficiency and effectiveness in diagnoses, treatments, administration, hospital networking, information flows, etc. 

Companies who indulge in healthcare software development ensure that they build software with US-based HIPAA compliance to avoid penalties, legal claims, and fines. Let’s get in-depth research about HIPAA compliance to implement it better while in software development. 

What is HIPAA compliance?

The 1996 Federal law known as the Health Insurance Portability and Accountability Act (HIPAA) mandates that covered entities and business associates take responsibility for regulating their security practices to meet specified standards.

HIPAA business associate agreement implies the established guidelines and standard of security and protection rules for individual personal health information from illegal authorities and vulnerable threats. To achieve HIPAA compliance, healthcare providers, health plans, healthcare clearinghouses, as well as business associates must implement specific measures and safeguards. These measures include:

HIPPA Compliance

Ensure Privacy

Ensuring that individuals’ protected health information (PHI) is kept confidential. Moreover, it can only be disclosed for legitimate healthcare purposes or as permitted by the patient.

Strong Security

Implementing safeguards to protect electronic PHI (ePHI) from unauthorized access, breaches, and cyber threats. However, this includes measures like access controls, encryption, and risk assessments.

Threat Alert Notification

Reporting any breaches of unsecured PHI to affected individuals, the U.S. Department of Health and Human Services (HHS), and, in some cases, the media.

Easy Transactions and Code Sets

Standardizing electronic healthcare transactions to facilitate the exchange of health information between different entities.

Unique Identifiers

Assigning unique identifiers to healthcare providers, health plans, and employers to simplify electronic transactions.

Enforcement Rule

Outlining the penalties and procedures for enforcement of HIPAA regulations, including fines for non-compliance.

Achieving and maintaining HIPAA compliance is crucial for healthcare organizations and their partners to protect patient privacy, maintain data security, and avoid legal consequences. In fact, non-compliance can result in significant fines and damage to an organization’s reputation. Therefore, organizations subject to HIPAA regulations must establish and maintain policies, procedures, and security measures to ensure compliance with the law.

Reasons Why Your Healthcare App Should Be HIPAA-Compliant

  • Not implementing HIPAA-compliant regulations may cause heavy penalties and harm your brand reputation.
  • HIPAA claims the protection of personal health information (PHI) from unusual data synchronization, unwanted data accessibility, and disclosures.
  • Moreover, you gain patients’ trust by informing them of the secure personal health information (PHI) backed by HIPAA compliance. 
  • Most healthcare providers prefer HIPAA-compliant software development companies to build healthcare software development. By implementing HIPAA-compliant, you can increase the potential of your business and generate more revenue streams by getting piles of projects.
  • HIPAA compliance implementation can save you illegal claims, penalties, and fines, plus certainty of data security. 
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What Are The Imperative Requirements Of HIPAA Compliance?

HIPAA (Health Insurance Portability and Accountability Act) encompasses five significant rules that healthcare software applications must adhere to ensure compliance with the HIPAA business associate agreement law. These rules are:

Privacy Rule

The HIPAA Privacy Rule establishes standards for safeguarding patients’ protected health information (PHI). Healthcare software applications must ensure that PHI is kept confidential and that only authorized individuals can access it. Privacy rule also outlines patients’ rights regarding their health information, including the right to access and request amendments to their records.

Security Rule

The HIPAA Security Rule focuses on protecting electronic protected health information (ePHI). Healthcare software applications must implement technical, administrative, and physical safeguards to secure ePHI from unauthorized access, breaches, and cyber threats.  Additionally, it includes security rules like access controls, encryption, audit trails, and risk assessments.

Breach Notification Rule

In the event of a breach of unsecured PHI, healthcare software applications are required to notify affected individuals promptly. Moreover, the Breach Notification Rule sets specific requirements for reporting violations and mitigating their impact.

Transactions and Code Sets Rule

This rule standardizes electronic healthcare transactions to facilitate health information exchange between healthcare providers, health plans, and other covered entities. Healthcare software applications must adhere to these standardized transaction formats as well as code sets to ensure consistency and interoperability in healthcare data exchange.

Unique Identifiers Rule

The Unique Identifiers Rule assigns unique identifiers to healthcare providers, health plans, and employers. In fact, these unique identifiers help streamline electronic transactions and reduce the risk of errors in patient records.

Costs of HIPAA-Compliant Software Development

The costs of HIPAA-compliant software development vary depending on some factors, including:

  • The complexity and scope of the software: A simple mobile app for patients may cost around $30,000 to develop, while a complex telemedicine system could cost upwards of $250,000.
  • Experience and location of the development team: Developers in more expensive regions, such as the United States and Western Europe, will typically charge higher rates than those in Eastern Europe or Asia.
  • The type of software: Web-based software is generally less expensive to develop than mobile or desktop software.
  • The number of features: The more features a software program has, the more expensive it will be to develop.
  • The need for integrations: If the software needs to be integrated with other systems, such as an EHR, this will also add to the cost.

On average, a fully functional, HIPAA-compliant software development project costs around $50,000. However, the cost can range from as low as $10,000 for a very simple project to as high as $1 million or more for a complex enterprise system.

In addition to the development costs, ongoing costs are associated with maintaining HIPAA compliance. This includes the cost of regular security audits, employee training, and software updates.

How MMC Global Can Help In Building HIPAA-Compliant Software

However, software development companies like MMC Global practice HIPAA-compliant regulations to ensure software security and life span. With the help of step-by-step HIPAA-compliant software development, you can build high-performing, secure software solutions for the healthcare industry. 

At MMC Global, we follow stringent steps with diverse project methodologies, which include:

Gathering software requirements: by brainstorming, competitive analysis, and market research, we collect imperative requirements and build our version of product ideation.

HIPAA Compliant Standards: We keep HIPAA compliant in mind; we gather HIPAA regulations, local legal acts, standards, and guidelines of appropriate governmental agencies (FDA, FCC, SAMHSA, etc.).

Sort Out Features: We understand the unique requirement of features to build custom software development solutions. Our expert developers make a list of every possible feature to create software that is scalable and adaptable. 

UI UX Design: our dedicated team of UI UX designers converts ideation into a creative design to give an appearance to your software. From low-fidelity design to high-fidelity design and prototyping, our UI UX engineers cover every essential step to make the user interface more optimized and intuitive.

Development: We assign projects to dedicated developers who specialize in decided tech stack to ensure the quality of codebase development. 

Testing & Deployment: We perform all necessary testing, from unit to regression testing, to ensure the software quality. After settling bugs and errors, we deploy software and provide support and maintenance whenever needed.

Let’s take a step forward with us and create healthcare software with HIPAA compliance standards and protection. Our team is capable enough to implement HIPAA regulations to make your software secure.

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