HIPAA-Compliant Software Development

• (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 software 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.

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.

Best practice: ScienceSoft’s project managers plan Agile development (Scrum, Kanban, etc.) for complex medical software development projects to easily accommodate potential project scope changes in later project stages.

• 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).

Best practice: If a client needs to cut the healthcare software development time, ScienceSoft launches the UX and UI design stage simultaneously with the software project planning stage.

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.

Best practice: ScienceSoft usually starts with creating an MVP for HIPAA-compliant software to quickly present core software functionality with a simple UI design. It allows getting early stakeholder or market feedback on software and adding new features to it based on the feedback analysis.

• 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).

ScienceSoft offers our healthcare clients 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.