How To Develop Custom HealthTech Software For Secure HIPAA Compliance?

How To Develop Custom HealthTech Software For Secure HIPAA Compliance?

Healthcare professionals’ work is more important than ever because many hospitals are understaffed. However, healthcare providers must handle patient records with the same level of confidentiality they would expect for their own. This additional duty of secrecy must be carried out meticulously to prevent the leak of Privacy. 

Client safety necessitates this effort, but it is not without its difficulties. Health Insurance Portability and Accountability Act or HIPAA rules management makes it easy for already overburdened staff to comply. About 75% of businesses in the healthcare industry spend 6% or less of their total budget on IT security.

There is a clear advantage to using digital software in healthcare, leading to its widespread adoption. Hospitals may improve their workflow and employees’ lives by using computer programs that increase productivity and efficiency. This article will discuss the benefits of HIPAA compliance software, from its definition and applications to the changes it may bring to an organization.

Why You Need HIPAA Compliance Software

Healthcare providers have benefited from HIPAA compliance programs developed over the years. Even if a hospital uses industry-standard video conferencing software, there is no assurance that it is HIPAA-compliant. As a consequence of this, putting in place software for managing HIPAA compliance will assist in ensuring that an organization is adhering to the appropriate procedures.

Unauthorized access to protected health information (PHI) or exposure to PHI is the cause of about 34% of all data breaches in the healthcare industry. Hence, the main goal of HIPAA compliance software is to aid in protecting and securing patient personally identifiable information (PHI). 

Because of the wide spread of the Coronavirus, the utilization of telemedicine has been more widespread in recent years. As a result, maintaining the confidentiality of sensitive patient information has become increasingly difficult. If you need to provide personal information, it’s best to do it face-to-face rather than over insecure channels like email or text.

Healthcare providers may safely provide telemedicine services to distant patients thanks to HIPAA compliance software. Using HIPAA-compliant software, patients can confidently share medical records and have secure conversations with their doctors. Therefore, the patient and the healthcare provider are protected from penalties for breaking HIPAA rules.

Requirements for HIPAA-compliant Software Development 

The need for HIPAA compliant software development is at an all-time high as hospitals, clinics, and small medical practices are now compelled to keep their systems up to speed with modern technology. This has increased the number of businesses that need software development. 

When one considers all of these factors, one concludes that there is a significant need for software engineers specializing in the healthcare industry. But developing software specifically for healthcare is a far more difficult challenge than developing general software solutions.

The stringent compliance standards of HIPAA necessitate specialized software development for the healthcare industry. The stringent requirements of the HIPAA for privacy and security are not satisfied by generic software. Electronically protected health information (ePHI) requires healthcare software developed with security to send, receive, and store this data without compromising patient privacy.

In addition, to comply with the HIPAA requirements and safeguard patient information, the following conditions must be met:

HIPAA mandates that healthcare providers conduct regular audits to identify possible data security breaches or patient privacy infractions. 

HIPAA-compliant software should be able to analyze audits to determine the degree of compliance of a medical organization while offering information and suggestions for reducing risk.

Healthcare practitioners can repair mistakes and stop them from happening again with the use of a remediation plan. The medical software has to have a remediation strategy incorporated. In addition, medical professionals need to develop their rehabilitation programs and use medical software to implement those plans.

  • Processing of Documents 

Because healthcare software interacts with papers, it should adhere to certain guidelines for processing documentation, such as maintaining a standard formatting scheme. And keep things as simple as possible, ensuring that information is securely stored, and so on.

  • Business Relationship Management

Any person or organization that assists a covered entity in managing electronically protected health information (ePHRs) is considered a business associate (BA) under HIPAA. 

This comprises a variety of third parties associated with healthcare providers, such as certified public accountants, consultants, software developers, and others. The government scrutinizes these organizations, and if there is a data breach, they might be held accountable and subject to penalties.

Software systems must be able to identify risks, vulnerabilities, and security breaches to comply with HIPAA security requirements. These standards mandate that software systems have built-in protections. 

They have to determine which data has to be backed up, when encryption must be employed, and which data needs to be authenticated. Also, they must regulate access through both traditional desktops and digital storage devices.

Steps to Develop Custom Software for HIPAA Compliance

HIPAA compliance in developing custom HealthTech software may seem daunting at first but may be readily implemented with a systematic approach. 

Let’s have a look at some of the crucial stages involved in the creation of custom software:

Step 1: Specify the Project Scope

The scope of a project must be defined before it can go into development. The project’s scope includes determining what features and functions the software must have to be HIPAA compliant. It must examine the nature of the data the program will process and the means through which it will be acquired, stored, and communicated. 

The project charter should also study the software’s target audience. The project scope allows for the technical specifications of the program and the provision of aid in creating a risk management strategy. 

Step 2: Analyzing the Risks Involved

HIPAA compliance is not possible without doing a thorough risk analysis. Possible loopholes and threats to the software and the business are considered. You need to begin the project by doing a comprehensive risk assessment and updating it regularly as the project is developed. 

Physical security, data storage, data transfer, and access restrictions should all be evaluated as part of this process. In addition, it must consider any vulnerabilities that could result from using the program. 

Step 3: Setting Up the Necessary Protections

Earlier, it was established that the HIPAA security regulation mandates using administrative, physical, and technical protections to secure sensitive patient data. To effectively apply these measures, software developers and organizations must work closely together.

Step 4: Create a Safe Software Design

The risk assessment’s recommended protections and the HIPAA regulations must inform the software’s design. Safeguarding information both at rest and in transit is the responsibility of the designers, who should use safe design patterns and encryption techniques. 

Security measures must be included in the software’s architecture to deter hackers from accessing sensitive information. An audit trail with recording features must be included to monitor who makes what modifications to data.

Step 5: Protection of Stored and Transmitted Information

Securing data storage is crucial for guarding sensitive digital data. Data encryption at rest and in motion is required for HIPAA compliance. Databases, hard discs, and backups must be encrypted for this to work. Access to sensitive data stored electronically must be monitored and reported, and encryption keys should be kept safely. 

Step 6: Safely Authenticating and Authorising Users

For purposes of HIPAA compliance, sensitive information must be accessible only to approved parties. Multi-factor authentication (MFA) and other secure user authentication methods should be implemented.

Strong passwords and regular password changes are essential for creating and managing user accounts. In addition, role-based access control (RBAC) must be implemented to limit user access to information to that which is strictly necessary for their roles.

Step 7: Testing Software

To ensure the software performs as expected and complies with HIPAA regulations, thorough testing is essential. Testing for functionality, performance, and vulnerabilities is all necessary. Using real-world situations in testing can help you find bugs and flaws in the program.

Step 8: User Education and System Implementation

Software development and testing are followed by user security training. HIPAA compliance standards and the organization’s policies and procedures for dealing with electronically protected health information (ePHI) should be included in the training. The program may be released when the users have been instructed on how to utilize it.

Benefits of Automating Healthcare Compliance

Although American healthcare organizations must comply with the Health Insurance Portability and Accessibility Act, there are several additional advantages to using HIPAA compliance software. Some of the benefits that businesses have seen as a result of HIPAA regulatory management software include the following:

  • Facilitate Better Experience for Patients

The time saved by automating HIPAA compliance may be better spent elsewhere. Regulatory tasks, like HIPAA compliance, might be automated using the software. With this task in the automation tool’s “safe hands,” healthcare providers’ human capital may be better allocated toward making strategic judgments, ultimately leading to greater financial success. Healthcare compliance automation may improve the quality of care by freeing up doctors and nurses to focus on patients rather than on repetitive, error-prone tasks.

  • Lower the Possibility of Violation Penalties

Because of HIPAA’s status as a federal law, the consequences of breaking its privacy provisions or failing to comply with its requirements are serious. By automating compliance, decreasing the possibility of human mistakes, and constantly following compliance policy, the healthcare industry can ensure it is doing its part. If a data breach does occur, expenses may be mitigated by demonstrating compliance and implementing the process for disclosure.

  • Conduct Efficient Internal Audits

No independent government audit guarantees conformity with HIPAA, HITECH, or PHIPA. In cases where allegations of noncompliance are made, the OCR will launch formal audits and investigations. By instituting a thorough and reliable self-assessment mechanism to monitor policy and procedure compliance, healthcare organizations may avoid being audited by the OCR. Between 2009 and 2021, the OCR received 4,419 healthcare data breaches involving 500 or more records.

  • Put Together Data and Operations

Automation technologies aid healthcare organizations in self-assessment preparations by centralizing all their compliance data in one location. This allows healthcare providers to efficiently and rapidly evaluate their current level of compliance and risks. Concrete measures may be taken to guarantee compliance in healthcare, such as automating the collection of evidence, monitoring controls around the clock, teaching staff about security awareness, and creating a policy center.

  • Follow Regulatory Updates

Organizations get updates and amendments to HIPAA from the Health and Human Services (HHS), while the Office for Civil Rights (OCR) guides implementation. HIPAA’s legal language, standards, and exclusions demand a full grasp of the legislation and its flaws. Automated compliance software may greatly mitigate the dangers associated with the most current HIPAA rules and regulations.


Developing software that complies with HIPAA regulations is essential to ensuring the privacy and safety of patients. If a healthcare provider or business partner does not comply with regulations, they might suffer considerable financial and reputational losses. 

Creating software of this kind is a difficult process that must be meticulously planned, implemented, and continuously monitored. Organizations can design compliant custom software for the healthcare industry by following the methods indicated in this article. This enables the organizations to offer patients the level of privacy and protection that is appropriate for them.


  • How can HIPAA compliance software prevent the loss of PHI?

Employees must know how to protect patient privacy since they often handle sensitive health information. Thanks to compliance programs, each worker may quickly and readily discover the procedures to protect customer data.

  • What benefits do digital compliance software offer?

Since HIPAA compliance software exists only in the digital realm, healthcare workers may take advantage of time-saving efficiencies and improved lines of communication that are not available when dealing with compliance in person using paper forms. When important data can be maintained digitally securely, it reduces the quantity of paperwork that employees would have to deal with.

  • Explain the Right to Access Initiative and its Connection to HIPAA.

The goal of this program is to have healthcare providers be more careful when handling requests for patients’ medical records. HIPAA mandates steep penalties for organizations that fail to comply with the Right to Access Initiative since doing so would violate patient privacy seriously.

  • How HIPAA affects a patient’s Right to Access their records?

Patients will pay less to access their records thanks to HIPAA’s establishment of a time limit within which requests should be completed and its authorization to develop processes for filing such requests by covered entities. These regulations were enacted to ensure that businesses would not be allowed to restrict patients from gaining access to their records or overcharge them.

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