HIPAA-Compliant Software Development: A Comprehensive Guide

The Essence of HIPAA-Compliant Software Development

HIPAA compliance is compulsory for software that stores, processes, or transfers personal health information (PHI) and operates in the US market. The development of medical software according to HIPAA guidelines minimizes the risks of patient data loss, theft, alteration, and potential legal claims and financial reparations.

Based on its practical expetise, ScienceSoft knows how to set up a cost-effective and reliable process of HIPAA-compliant software development.

HIPAA-Compliant Software Development Process

Specifics of a HIPAA-compliant development plan depend on the type of medical software and its functional scope. ScienceSoft designed the following generalized plan of HIPAA-compliant medical software development based on our 18 years of hands-on experience in the domain.

Step 1: Medical software requirements gathering, compliance requirements engineering and software planning

Duration: from 4 weeks.

• (When you outsource any project activities) Signing of a Business Associate Agreement with a consulting or development partner having access to PHI to ensure their legal obligation to follow HIPAA compliance guidelines on data security, encryption methods, security practices documentation, etc.
• (For product companies) Market and competitors research in the respective medical software niche, identification of target customers, software idea productization.
• (For healthcare organizations) Business needs analysis and elicitation of medical software requirements.
• Gathering compliance requirements for the HIPAA regulation and other applicable federal and local legal acts, standards, and guidelines of appropriate governmental agencies (FDA, FCC, SAMHSA, etc.).
• Listing and prioritization of medical software features, outlining main user scenarios (e.g., for patients, doctors), splitting features into subscription plans (for medical software products).
• Designing the architecture and integrations of HIPAA-compliant software and selecting a fitting tech stack. Note: Cloud services in use should comply with HIPAA.
• (For medical software products) Planning configuration capabilities that allow users to modify certain software modules.
• Assessment of usage risks (e.g., potential software misuse) for HIPAA-compliant software and risk mitigation plan design.

Phase deliverables:

• Signed Business Associate Agreement.
• Medical software feature list with traceability between user/business needs and the features.
• Software compliance specification with references to appropriate clauses of standards and regulations (HIPAA, CCPA, etc.).
• Software requirements specification.
• A high-level design of medical software architecture.
• Medical software usage risks description and a mitigation plan.

Step 2: HIPAA-compliant software project planning

Duration: from 2 weeks (may run simultaneously with step 1).

At ScienceSoft, this step includes:

• Project scope identification.
• Choosing a development approach for HIPAA-compliant software.
• Assessment of software development risks (e.g., delays in the development).
• Budget planning.
• Project scheduling (planned development iterations, key milestones, etc.) and KPI planning.

Phase deliverables:

• Budget plan.
• Project schedule and KPI plan.
• Mitigation plan for medical software development risks.

Step 3: Design of UX and UI for healthcare software

Duration: from 2 weeks.

• UX design – to visualize key software functionality in the identified user scenarios and plan convenient journeys for medical software users (patients, medical specialists, admins). The user journeys are planned taking into consideration HIPAA compliance and security measures like user session timeout, emergency access to patients’ data, software access control, etc.
• UI prototyping – to visualize software look for different user groups.
• UI design – to create graphic interface elements of healthcare software according to the defined visual accessibility requirements.

Phase deliverables:

• UX wireframes.
• User interface design documentation (all screens, assets, and source files).

Step 4: Medical software development

Duration: from 2-6 months for an MVP.

During this stage, ScienceSoft conducts:

• Back-end software development – to develop the server side of the application and APIs with a focus on PHI security.
• Front-end development of healthcare software – to transform UI design elements into a functioning user side.
• Testing – to detect and fix medical software defects, check software against its functional requirements, verify software stability, security, and HIPAA compliance, validate usability and accessibility for target users.

Phase deliverables:

• Developed software.
• Detailed architecture design.
• Application’s source code.
• Test documentation.

Step 5: Pre-launch activities and medical software launch

Duration: from 1 week.

• Revision of HIPAA-compliant software usage risks – to identify new usage risks, address them, and update the risk mitigation plan.

• Revision of HIPAA-compliant software documentation – to check if any medical software requirements changed during the development process and update software documentation to ensure documentation cohesiveness for future HIPAA compliance audits.
• Software compliance check according to relevant medical standards (e.g., IEC 82304-1:2016 for software integrated with smart medical devices or sensors).
• Pilot rollout of medical software for a focus group – to present the fully developed app to the focus group (e.g., a group of patients in a hospital), evaluate their satisfaction with the app, get their feedback, and adjust software accordingly.
• Launch of HIPAA-compliant software.

Phase deliverables:

• Deployed medical software.
• Revised healthcare software documentation.
• App setup guide, admin guide, support guide, user guide (for all user groups).

Step 6: Healthcare software maintenance, audit, and evolution

Duration: continuously.

ScienceSoft offers to our healthcare customers the following after-launch services:

• Medical software support and maintenance – to fix revealed defects, implement security patches, resolve incidents, and ensure uninterrupted work of medical software.
• HIPAA compliance and security audits – to regularly verify medical software and its infrastructure for HIPAA compliance, check PHI security, etc.
• Evolution of medical software – to implement new medical software features according to user feedback.

Consider Professional Services for HIPAA-Compliant Software Development

With over 18 years of hands-on experience in medical IT, ScienceSoft offers end-to-end HIPAA-compliant software consulting and development services.

Why ScienceSoft

• 18 years in healthcare IT and 20 years in cybersecurity.
• Mature quality management system confirmed by ISO 13485 and ISO 9001 certifications.
• ISO 27001 certification to guarantee customers’ data security.
• Working experience with healthcare standards (e.g., HL7, FHIR, DICOM, ICD-10, CPT, XDS/XDS-I).
• A top HIPAA consulting provider in 2022, according to Atlantic.net.
• For the second straight year, ScienceSoft USA Corporation is listed among The Americas’ Fastest-Growing Companies by the Financial Times.

Typical Roles for HIPAA-Compliant Software Development

In most cases, ScienceSoft's HIPAA-compliant software development teams consist of:

Sourcing Models of HIPAA-Compliant Software Development

Benefits of HIPAA-Compliant Software Development Outsourcing with ScienceSoft

Technologies ScienceSoft Uses for HIPAA-Compliant Software Development

ScienceSoft's healthcare IT team usually chooses the following tools and technologies during our HIPAA-compliant medical software projects:

Costs of HIPAA-Compliant Software Development

Cost factors

From ScienceSoft’s experience, each medical software project has specific tech requirements and limitations, so the cost factors vary from customer to customer. Here, we outline general cost factors for HIPAA-compliant software.