How to Build an EHR System

For software product companies

• Analyzing the market of EHR products, identifying the competitors, and defining target customers and their needs.
• Shaping an EHR concept, including competitive features like CDS modules, medical specialty features, AI capabilities, and more.
• Creating a marketing strategy to promote the EHR product to hospitals, health networks, private practices, etc.
• Planning the monetization approach and service options (e.g., subscription plans with access to basic or advanced EHR feature packs).
• Identifying applicable EHR compliance requirements (e.g., HIPAA, GDPR, ONC, FDA).
• Developing a business case with TCO and ROI calculations.

For healthcare providers

• Analyzing the current care and billing operations to determine the business needs to be addressed with a new EHR.
• Collecting user feedback on the current health records system.
• Creating an EHR concept reflecting the needs of medical and administrative staff.
• Developing the EHR adoption strategy.
• Planning data migration from the former health records system.
• Identifying applicable EHR compliance requirements (e.g., HIPAA, GDPR, ONC, FDA).
• Developing a business case with TCO and ROI calculations.

• Defining functional and non-functional EHR requirements to create a software requirements specification.
• Designing a secure-by-design and flexible EHR architecture (e.g., microservices-based).
• Designing APIs to smoothly integrate EHR with popular healthcare software products or internal systems (clearinghouse software, laboratory information system, medical imaging software, and more).
• Selecting a suitable tech stack (e.g., HIPAA-compliant hosting, cost-efficient and secure cloud components for scalable data storage).
• Mapping the EHR usage risks and developing a risk mitigation plan.

• Selecting an approach to project management (Scrum, Kanban, etc.).
• Planning the project team, timeframes, key milestones, KPIs, and budget.
• Planning the ONC certification process (US only) or certification according to the requirements of other local authorities.
• Creating a risk assessment and mitigation plan for EHR development (e.g., certification delays, scope creep).

• Conducting UX research to define user scenarios for all user roles (e.g., physicians, nurses, administrative staff).
• Designing UX wireframes and testing the UX.
• Creating UI prototypes for the EHR using the wireframes.

• Developing back end and front end in 2–4-week iterations.
• Creating APIs for EHR integration with medical software or smart medical devices.
• Implementing security features for PHI protection (e.g., role-based access, data encryption, MFA).
• Testing the EHR (including functional, integration, performance, security, compliance, compatibility, and accessibility testing).

• Updating the EHR usage risks matrix and project documentation to make sure all changes are reflected for future certification, support, and updates.
• Conducting a HIPAA compliance pre-audit or GDPR compliance audit.
• Submitting the EHR to the ONC-Authorized Testing Laboratory (for the US) or other local EHR certification bodies.
• If the EHR features SaMD capabilities: submitting the software for premarket approval according to the FDA 501k program (US) or MDR requirements (EU).
• Creating and publishing quick start guides for physicians, nurses, and other user groups.
• For healthcare organizations: migrating healthcare data from the legacy systems.

• EHR software deployment to the chosen environment and EHR launch.

• For product companies: executing the marketing strategy to gain customers (e.g., utilizing online channels and industry conferences to promote the software, establishing interoperability with other popular medical software products).
• For healthcare organizations: executing the EHR rollout and adoption strategy; training medical staff on the software use.

• Launching a help desk to handle questions and issues reported by the EHR users.
• Monitoring user satisfaction and maintaining the EHR by fixing defects, resolving incidents, adding security patches to ensure compliance, and more.
• Upgrading EHR functionality based on the user feedback.