Ultimate Guide to HIPAA Compliant Software Development

In 2019, the Department of Health and Human Services’ Office fined 10 for violations of HIPAA process regulations for a total of $12 274 000. The average financial penalty of $1 227 400 per case means that even the slightest neglect can lead healthcare providers to considerable financial losses.

In the digital age, the value of privacy protection is higher than ever because interconnected information systems are often exposed to the threat of data leakage. It does not mean that healthcare providers should abandon their digitalization plans. Instead, they should consider the existing data privacy regulations and ensure the top-notch security of their software. In this material, we will discuss the main HIPAA IT regulations and explain how healthcare providers can make their software HIPAA compliant .

What does HIPAA compliance mean for software companies?

Those physicians, dentists, clinics, pharmacies, nursing homes, and other healthcare service providers that have access to electronic medical data are called “covered entities.”

‘If a software company interacts with a solution that gathers and processes personal identifiers of patients, HIPAA standard applies to the software provider.’

Under HIPAA, every organization that is a covered entity or a business associate must be compliant. Business associates are defined under HIPAA as any person or company who offers a service to a covered entity that involves the disclosure of PHI. According to this definition,

“all software firms in the healthcare industry that keep, share, or simply have access to identifiable health information of patients must be HIPAA compliant.”

Three major elements determine whether or not your application will be subject to HIPAA regulations:

HIPAA (Health Insurance Portability and Accountability Act) is the most valuable privacy regulation in the US healthcare domain. The Office for Civil Rights (OCR) has introduced it to establish national standards for the protection of certain health information.

Compliance with HIPAA entails fulfilling the requirements of HIPAA, its regulations, and revisions. HIPAA HIPAA compliant app development establishes five fundamental requirements that all healthcare software applications must adhere to

• Privacy Rule

The rule is intended to improve the flow of health data while reducing fraud and theft and grants patients some rights about their health information such as the ability to examine, receive a copy, and request adjustments to their data.

• Security Rule

The Security Rule establishes criteria for the protection of ePHI generated, received, used, or maintained by a covered organization. According to the rule, covered entities must implement "adequate administrative, physical, and technological protection to maintain the confidentiality, integrity, and security" of ePHI.

• Compliance Rule

The Enforcement Rule specifies how the Department of Health and Human Services (HHS) will enforce HIPAA, with regulators evaluating culpability and imposing fines for noncompliance.

• Notification regulations

The Rule requires HIPAA-covered organizations and their business partners to notify HIPAA-covered entities and their business associates about a breach of unsecured PHI, including paper-based and electronic PHI.

• General Rule

It establishes the rules concerning interoperability in healthcare solutions and alters numerous HIPAA Privacy, Security, and Enforcement rules, making it more difficult to dodge breach reporting, expanding non-compliance responsibility to business partners, and imposing additional privacy limits for the use of PHI.

“Medical software used to collect, amass, store, transmit, and/or operate PHI must comply with HIPAA and adhere to its laws and regulations. However, if an application does not handle protected health information, it is excused from HIPAA compliance.”

Want to become HIPAA-compliant?

Learn about best practices of FHIR implementation.

Download whitepaper

There will be consequences if the software violates any HIPAA compliance restrictions. Thus, it’s critical to understand how to make a healthcare software program HIPAA-compliant.

The HIPAA compliance checklist for software development to assist you in developing safe solutions:

1. Users authorization

The US government organizes the identity assurance in software applications into four tiers. At the most basic levels, only a single authentication element is used.

• Knowledge: requires entering a unique data set as a PIN or password, which only the legitimate user can access.
• Inherence: predict the use of a biometric scan to confirm a user's intrinsic trait that cannot be replicated or modified.
• Place: grants access only if the user is at a certain location at the moment of access.
• Possession: provides extra data to users, such as a security code. As a result, to secure legal custody of the information, the visitor must put in such data.

A HIPAA-compliant software solution must remind its users to obtain patient data without a complicated routine every time.

2. Emergency mode

It outlines the procedures, duties, and practices for keeping patient records safe during an emergency. What has to be included in your HIPAA-compliant software emergency plan?

• A comprehensive list of all team members, including their jobs, contact information, and duties.
• A step-by-step approach for carrying out the strategy (how, when, by whom)

Business colleagues must clearly identify the potential hazards and characterize the crises in which the plan may be employed effectively in this strategy.

3. Remediation plan

The plan is a security strategy that specifies the steps done by business associates to secure patient data. As a result, it details best practices in safety, covering the following aspects:

• Each team member's duty for the same is identified.
• An action plan for overcoming future issues
• A list of all the actions that will be completed to maintain data security.

As a result, the remediation plan is the most important document for HIPAA compliance in software in terms of safe development techniques. The key problem is determining the precise duties that your business needs to meet security compliance.

4. Data backup

All electronically protected health information (ePHI) must be copied on another reliable data storage system, according to this HIPAA regulation. To make HIPAA-compliant EHR software, the firm must focus on the following aspects:

• Encryption is a simpler and faster data security technique. For best data protection, the apps should employ a 256-bit AES protocol and two-factor authentication.
• Monitoring: if the backup system fails, the system must be able to notify the organization's staff instantly.

One significant benefit of regularly backing up data is that even if the original file copy is compromised, the information will remain safe..

5. Monitoring

App developers and owners should frequently test the effectiveness and security of access algorithms. As a result, the preventative steps are an essential aspect of the comprehensive HIPAA compliance checklist for software development:

• Audit controls and activity logs: Use an automated risk detection system to identify any questionable attempts to enter the system easily.
• Logging out automatically: Any healthcare software should be developed such that a user automatically logs out of the system after their shift is finished.

How to make your software HIPAA compliant?

As an experienced healthcare software development partner, we accumulated profound expertise in protecting PHI, improving patient experience, and cultivating patient safety culture with high-quality healthcare solutions. Our experienced developers implement the functionality required to fulfill your needs. See more of our case studies to prove our expertise.

Conduct audits regularly

It detects potential risks of data breaches or privacy violations. It is used by HIPAA-compliant software to review the compliance level of a medical organization and offer information about risks and present problems. We shape quizzes to make it more simple for medical workers to use.

Establish HIPAA-compliant business relationships with associates

HIPAA-compliant software also manages the company's connections with its business associates. A system must monitor the execution of specified agreements governed by the HIPAA Omnibus Rule to help healthcare professionals ensure PHI security.

Secure your data from cyber attacks

Medical Software has to identify such breaches, provide a report, and take preliminary steps to prevent further data "sharing." and protect data by prohibiting the use of portable data storage devices.

Employ recovery strategy

Strategy will enable healthcare practitioners to fix all errors and prevent them from recurring. Furthermore, each medic must create a recovery strategy, considering their specialty and protocols. The program should be able to begin a specified strategy in response to a given scenario.

Order documentation

Primary function of every organization is to work with papers. Many healthcare providers employ such systems in their businesses since the software aids in the processing of documents.

Make your data storage secure

HIPAA violation costs are unreasonable. A regulation violation might cost up to a million dollars. Reliable data storage safeguards against hacker assaults to save money while ensuring the security of electronically protected health information (ePHI).

What are the rules for becoming HIPPA-compliant?

There are numerous safeguards you should consider while working on a HIPAA-compliant app. The basic point is understanding whether the regulation covers an application or not. HIPAA software compliance is required if an app collects, stores, and transmits personally identifiable patient data;

HIPAA-compliant development methods are established by a set of laws and regulations that outline the basic recommendations for HIPAA-compliant software development.

1. HIPAA's Privacy Rule

HIPAA establishes full patient control over personal health records by outlining patient rights concerning medical records, the ability to seek and get a copy of protected records, and the ability to alter and update as needed.

Healthcare solutions should be enabled by a variety of data management capabilities that are accessible to approved patients.

2. HIPAA Security Regulation

It specifies that protection must be in place to protect patient health data from unauthorized access. High safety standards apply to all software systems used in healthcare-related companies.

Healthcare companies should implement administrative, physical, and technical processes and policies to ensure security and confidentiality. Technical protections include everything necessary for secure access to electronic health records, such as personal authorization, secure data storage, and transfer.

3. HITECH Act

The rule has to encourage healthcare providers to use electronic health records (EHR) and increase privacy safeguards for healthcare and medical data. It provided financial incentives for deploying EHR software and set much harsher fines for HIPAA Privacy/Security Rules breaches.

Today, the percentage of healthcare institutions that use EHRs is about 100%. This means improved patient medical data centralization, portability, and quality across numerous healthcare systems.

How to build HIPAA-compliant software?

Ensure a step-by-step approach to HIPAA app development. A comprehensive plan meeting HIPAA requirements has to include these steps.

Step 1: Gather medical software requirements

Would you start building a project without knowing the user’s intentions? Suppose no, the requirements gathering phase includes collecting a list of requirements, and users’ pain, eliminating language ambiguity, identifying corner cases, establishing project goals and objectives, and prioritizing the requirements.

Step 2: Project planning by HIPAA

To have the booming HIPPA software development define the responsibilities of each team member, and set measurable objectives. identify deliverables, timeframe, stages, and designated resources. We consider and define policies, procedures, and guidelines for maintaining privacy and security, outlining numerous healthcare offenses.

Step 3: UX and UI design for medical software

The next step is to provide a pleasant user experience that will lead to increased user engagement and attention. As more adults use mobile devices to manage their healthcare, major roles at home and in the care facilities, as providers apply from scheduling software to diagnostics.

Step 4: Healthcare software development

After an overview of how the UX design should be, developers focus on creating, deploying, and supporting software to build custom solutions for medical and pharmaceutical organs, software products, and devices. You may want to think about hiring programmers who have prior experience working with FHIR integration or any other HIPAA-compliant standard.

Step 5: Preparing and launching medical software

This stage includes the analysis of PHI storage, documentation of potential risks, and evaluating potential data leaks' outcomes. A HIPAA-compliant entity should eliminate all the identified data security threats at this stage. Everything depends on the nature of the detected problems. Typically, this phase includes staff training, promoting security awareness, and establishing additional information protection protocols, such as two-step authentication.

Step 6: Maintain, audit, and develop healthcare software

After improving the security of one's software for healthcare, a covered entity or its business associate should ensure long-term risk management. This step includes login monitoring, audit trails, vulnerability scans, and continuous event monitoring according to HIPAA compliance requirements.

Successful implementation of such stages requires a scrupulous approach and significant technical capacity. Outsourcing the development of HIPAA-compliant healthcare applications or their security optimization to dependable software providers is a popular solution among healthcare providers.

Developing high-quality healthcare software that fulfills HIPAA's stringent requirements is no easy undertaking. It needs knowledge and competence, which the top development teams can only provide.

Choose your HIPAA-compliant software development team

Our HIPPA-compliant software developers team consists of experienced and skilled professionals; let’s look at their responsibilities.

• Back- and front-end developers build healthcare software's business logic and server side, highlighting security and HIPAA compliance, and create the user interface for healthcare applications.
• QA engineers run test cases, set a test strategy, and report medical software problems and vulnerabilities.
• DevOps engineer builds and maintains medical software development infrastructure, creates CI/CD pipelines for automatic software deployment, and chooses and configures tools for daily monitoring of HIPAA-compliant software performance.
• Project manager develops a healthcare software development project, assigns duties to a project team, manages project delivery (including time and budget), analyses project risks, proposes mitigation strategies, and promotes team communication and collaboration.
• Business analyst collects medical software needs and discovers technical limits; develops the software idea and specification; assesses healthcare software usage hazards; designs software features; and specifies required app integrations with other software (e.g., EHR).
• Solution architect selects a HIPAA-compliant technology stack and develops a healthcare software architecture while keeping HIPAA and other requirements in mind.
• Consultant for HIPAA compliance provides guidance on healthcare software architectural components, technology stack, development process, and project documentation management to guarantee HIPAA and other related laws and regulations are met.
• UX/UI designer performs UX research, designs user experiences and interactions with software emphasizing usability and accessibility, develops UX prototypes, and creates an interface for healthcare software.

Technologies & tools for HIPAA-compliant software development

Our software development team and solution architects are constantly expanding our toolset to deliver HIPAA-compliant applications. As of now, we have the expertise and hands-on experience of working with the top HIPAA-compliant technologies. And while more and more tools are adjusting to the HIPAA regulations, the general toolset looks like this:

How much does it cost to build HIPAA-compliant software?

A full-featured HIPAA-compliant software costs around $50,000 on average. For example, the cost of developing HIPAA-compliant software for a mobile patient app without EHR integration costs $30,000, and telemedicine software costs $150,000 - $250,000.

HIPAA compliance professionals in Eastern Europe charge between $25 and $49 per hour for this service, whereas specialists in India and several Asian nations may charge less than $25 per hour. Thus, a HIPAA compliance software audit costs around $6,500 in the United States and Western Europe and approximately $2,450 in Eastern Europe.

It may appear that being HIPAA compliant is both costly and difficult. However, protecting the security of health information and winning the trust of your patients is valuable.

As a rule, the more complicated a healthcare application, the more steps there will be. The average time to develop an app is four months. In short, these aspects affect the cost of building HIPPA-compliant software:

• Performance requirements for medical software
• Type of healthcare software as web, mobile
• Mobile platforms that are supported (iOS, Android)
• Count of user roles (e.g., patients, doctors, administrators).
• The quantity and complexity of characteristics (e.g., IoT integrations will increase the cost)

• Data storage capacity is required or not
• License costs for cloud services or ready-made HIPAA-compliant software components
• Integration of software with remote patient monitoring devices or tracking tags.
• The number and complexity of medical IT system interconnections (EHR, practice management system, procurement software, etc.)

Binariks experience in HIPAA compliant software development

Binariks can be your partner with solid experience in developing HIPAA-compliant applications.

Our portfolio includes multiple cases of providing clients from the healthcare sphere with top-notch HIPAA apps. In particular, Binariks optimized a personalized patient monitoring system . Our dedicated team of cloud specialists used native AWS services to enhance the flow of information and increase the analytical capacities of the client's software. We also paid attention to the security of patients' identifiable data stored on a platform to deliver a HIPAA-compliant product meeting all client's expectations.

Binariks helped an American provider of healthcare technologies in the maintenance of two applications dealing with healthcare plans. Our developers also used Swift and React Native to create two new HIPAA-compliant mobile apps for the client. The products deal with patients' identifiable data, which has made our developers focus on delivering secure products that meet all HIPAA requirements.

We understand how to fulfill HIPAA software standards and design medical solutions with secured patient portals to manage their electronic health information to patients and other authorized stakeholders.

Check our portfolio to get more information on how to develop HIPAA-compliant apps.

Conclusion

Violation of healthcare HIPAA regulations can lead healthcare providers and their associates to significant fines. Entities covered under HIPAA regulations should establish multiple technical safeguards, utilize a comprehensive strategic approach to software development, and rely on reputable partners. As a company with solid experience in developing HIPAA-compliant applications,

Binariks offers its service to businesses in the healthcare domain. Contact us to discuss your medical software plans and our potential role in them. When the cost of any mistake is overwhelming, it is important to choose credible digital security experts as partners.