Healthcare Software Development

HIPAA-compliant software development creates applications that meet Health Insurance Portability and Accountability Act requirements for protecting patient health information (PHI). This includes administrative safeguards (policies, training, risk assessments), physical safeguards (facility access controls, workstation security), and technical safeguards (encryption, access controls, audit logs, transmission security). HIPAA compliance is legally required for covered entities (healthcare providers, health plans, clearinghouses) and business associates handling PHI. We build HIPAA compliance support into software architecture from day one with encrypted data storage and transmission, role-based access controls, comprehensive audit trails, automated breach detection, and Business Associate Agreement (BAA) support. Your organization remains responsible for overall HIPAA compliance including policies, training, and risk management.

Custom healthcare software development costs typically range from $75,000 to $500,000+ depending on system complexity, integration requirements, compliance needs, and feature scope. A basic patient portal with EHR integration costs $75K-$150K. Comprehensive practice management or LIMS systems range from $200K-$400K. Enterprise hospital integration platforms can exceed $500K. However, total cost of ownership over 5 years is typically 40-60% lower than off-the-shelf solutions when factoring in per-user licensing fees, integration costs, and customization expenses. We provide detailed project estimates after requirements analysis and can structure development in phases to spread investment over time while delivering incremental value.

Yes, we specialize in Epic and Cerner EHR integration using HL7 v2.x, HL7 FHIR, and proprietary APIs. Our team includes Epic and Cerner certified developers with experience integrating with Epic MyChart, Haiku, Canto, Cupid, Resolute, and Beaker modules as well as Cerner Millennium, PowerChart, and RevWorks. We build bidirectional interfaces for patient demographics, lab orders and results, medication orders, clinical documentation, scheduling, and billing. Integration approaches include HL7 message interfaces, FHIR API connections, Epic Interconnect, Cerner Open Engine, and custom web service integration. We handle Epic and Cerner version differences, customize integration for your specific environment, and provide ongoing support for EHR upgrades and changes.

FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures in FDA-regulated industries including pharmaceuticals, biotechnology, medical devices, and clinical research. Compliance is required when replacing paper-based processes for clinical trials, manufacturing records, quality systems, laboratory testing, or regulatory submissions with electronic systems. Requirements include system validation (IQ/OQ/PQ), comprehensive audit trails documenting who did what and when, electronic signature controls with unique user authentication, data integrity measures preventing unauthorized changes, and change control documentation. We develop 21 CFR Part 11 compliant systems with validated electronic signatures, complete audit trail generation, system validation protocols and documentation, secure authentication mechanisms, and change control processes. All deliverables include validation documentation to support FDA inspections.

Healthcare software development timelines range from 3-9 months depending on project scope, integration complexity, and compliance requirements. A patient portal or basic workflow automation system takes 3-4 months. Comprehensive practice management or LIMS systems require 5-7 months. Enterprise-scale hospital integration platforms or clinical trial management systems need 7-9+ months. We follow agile development methodology with 2-week sprints, delivering working software incrementally. You see progress every two weeks and can begin using core features before full project completion. Timeline factors include: number of system integrations (Epic, Cerner, lab systems), regulatory compliance requirements (HIPAA, FDA 21 CFR Part 11), custom workflow complexity, and validation documentation needs. We provide detailed project timelines during requirements analysis and maintain transparent progress tracking throughout development.

HIPAA certification does not officially exist - there is no formal HIPAA certification for software vendors or developers issued by HHS or any government agency. What does exist is HIPAA compliance, which means software meets HIPAA Privacy Rule, Security Rule, and Breach Notification Rule requirements. We provide HIPAA compliance support by building software with required technical safeguards (encryption, access controls, audit logs), developing security risk assessment documentation, implementing privacy controls, creating Business Associate Agreement frameworks, and providing compliance documentation to support your overall HIPAA compliance program. We do not claim to 'certify' you as HIPAA compliant because compliance is an ongoing organizational responsibility, not a one-time certification. Instead, we ensure the software we build meets or exceeds HIPAA technical requirements and provides tools to maintain continuous compliance. Your organization remains responsible for overall HIPAA compliance including administrative and physical safeguards, policies and procedures, training, and risk management.

Yes, we support Australian healthcare organizations with TGA (Therapeutic Goods Administration) compliance, Privacy Act 1988 compliance, My Health Records Act requirements, and state health information regulations. For TGA compliance, we provide software validation documentation (IQ/OQ/PQ), ARTG submission support for Software as a Medical Device (SaMD), ISO 13485 quality system integration, and GxP-compliant systems for pharmaceutical manufacturing. For Privacy Act compliance, we implement the 13 Australian Privacy Principles (APPs) including consent management, privacy impact assessments, data breach notification to OAIC, and cross-border data transfer safeguards. We integrate with My Health Record system using secure APIs, NASH certificates, and consent management. Our team understands differences between US HIPAA and Australian privacy regulations and can build systems serving both markets with jurisdiction-aware compliance controls.

You own 100% of the software, source code, documentation, and intellectual property we create for your project. After deployment, we provide ongoing support and maintenance including bug fixes, security patches, regulatory updates, infrastructure monitoring, and technical support. Support options include: managed services (we handle all hosting, monitoring, updates, and support), dedicated support retainer (priority support with guaranteed response times), and time and materials support (pay only for support as needed). We also offer enhancement and feature development services to expand your system over time. You're never locked in - you own the code and can maintain it internally, hire another vendor, or continue working with us. We provide comprehensive technical documentation, system architecture diagrams, deployment procedures, and knowledge transfer to ensure your team can understand and maintain the system. Most clients choose ongoing partnership with us for peace of mind and continuous optimization.

We build custom HL7 v2.x and HL7 FHIR integration platforms that connect your healthcare systems with EHRs, laboratory systems, billing platforms, and other clinical systems. HL7 v2.x integration includes message parsing and generation (ADT, ORM, ORU, DFT, SIU messages), interface engine development, message routing and transformation, error handling and monitoring, and HL7 acknowledgment processing. FHIR integration includes RESTful API development, FHIR resource mapping (Patient, Encounter, Observation, MedicationRequest, etc.), OAuth 2.0 authentication for SMART on FHIR, and FHIR search and subscription implementation. Our integration platform provides centralized message monitoring, transformation rules for data mapping, error alerting and recovery, message replay capabilities, and comprehensive audit logging. We handle both real-time and batch interfaces, support multiple HL7 versions and FHIR releases, and provide ongoing monitoring and support for interface maintenance.

We implement defense-in-depth security architecture with multiple layers of protection for patient health information (PHI). Technical safeguards include: encryption at rest using AES-256 for all PHI storage, encryption in transit using TLS 1.2+ for all data transmission, multi-factor authentication (MFA) for user access, role-based access controls (RBAC) with principle of least privilege, comprehensive audit logging of all PHI access and changes, automated backup with encryption and tested restoration, intrusion detection and prevention systems (IDS/IPS), web application firewall (WAF) protection, automated vulnerability scanning and patching, and security information and event management (SIEM) for threat monitoring. Infrastructure security includes: isolated network segments for PHI systems, private cloud or dedicated server hosting, database encryption and access controls, secure API authentication using OAuth 2.0 or API keys, regular penetration testing and security audits, and incident response procedures. All security controls are documented and mapped to HIPAA Security Rule requirements to support your compliance program.

Yes, we provide comprehensive data migration services from legacy healthcare systems to modern platforms. Our data migration process includes: legacy system analysis and data mapping, data extraction from legacy databases and file systems, data transformation and cleaning to target format, validation rules to ensure data integrity and completeness, incremental migration with rollback capabilities, data reconciliation comparing source and target, and parallel operation support during transition. We handle migration from legacy practice management systems, outdated EHRs, paper-based records requiring digitization, custom Access or Excel databases, mainframe and AS/400 systems, and discontinued vendor platforms. Migration includes patient demographics, clinical history, lab results, medication lists, billing and claims history, and scanned documents. We ensure HIPAA compliance throughout migration with encrypted data transfer, audit trails of all migration activities, and validation that no PHI is lost or corrupted. Most migrations are completed with zero data loss and minimal operational disruption through careful planning and phased cutover approach.

We have extensive experience serving Australian healthcare organizations with compliance for Privacy Act 1988, Australian Privacy Principles (APPs), My Health Records Act, TGA regulations, and state/territory health information acts. Our Australian healthcare projects include: My Health Record system integration using NASH certificates and secure APIs, Privacy Act compliance with consent management and OAIC breach notification, TGA software validation for Software as a Medical Device (SaMD) including ARTG submissions, state health information act compliance for NSW, VIC, QLD, and other jurisdictions, and ACSC Essential Eight cybersecurity framework implementation. We understand critical differences between US HIPAA and Australian privacy regulations including stricter consent requirements under APPs, mandatory NDB (Notifiable Data Breaches) scheme reporting to OAIC, and TGA validation requirements for medical device software. Our team can build systems serving both US and Australian markets with jurisdiction-aware compliance controls, ensuring your software meets regulatory requirements in both countries without compromise.

We implement proactive compliance monitoring and provide ongoing regulatory update services to ensure your healthcare software remains compliant as HIPAA, FDA, TGA, and other regulations evolve. Our compliance maintenance approach includes: continuous monitoring of regulatory changes from HHS, FDA, TGA, OAIC, and other healthcare agencies; automated compliance dashboards tracking adherence to current requirements; quarterly compliance reviews assessing new regulatory requirements against your system; priority regulatory updates deployed within 30-60 days of requirement changes; compliance documentation updates reflecting new requirements; and annual security risk assessments identifying emerging threats and compliance gaps. When regulations change (like HIPAA Omnibus Rule updates, FDA draft guidance on Software as a Medical Device, or TGA consultation papers), we proactively notify you, assess impact on your system, recommend necessary changes, and implement updates on your timeline. Most clients choose our managed services with ongoing compliance support rather than one-time development, ensuring continuous regulatory adherence and peace of mind. Compliance is not one-time - it requires continuous monitoring and adaptation to regulatory evolution.

Yes, our healthcare software supports value-based care initiatives, quality measure reporting, and alternative payment models including Medicare MIPS (Merit-based Incentive Payment System), MACRA, ACO (Accountable Care Organization) programs, and bundled payment arrangements. We build population health management platforms with: clinical quality measure (CQM) tracking for CMS quality programs, eCQM (electronic clinical quality measures) automated calculation and reporting, HEDIS measure tracking for health plan quality, care gap identification and patient outreach automation, risk stratification algorithms identifying high-risk patients, care coordination workflows for care teams, social determinants of health (SDOH) data integration, and value-based care analytics dashboards showing quality performance, cost metrics, and financial outcomes. Our systems integrate with EHRs to extract clinical data, calculate quality measures automatically, generate CMS quality reporting files (QRDA Category I and III), and provide real-time dashboards showing progress toward quality goals. We help healthcare organizations maximize MIPS scores, achieve ACO shared savings, and demonstrate quality performance required for value-based contracts with payers.

We prioritize clinical workflow optimization and user adoption from day one through human-centered design, clinician involvement, and change management support. Our approach includes: clinical workflow analysis sessions with physicians, nurses, and staff to understand current processes, pain points, and efficiency opportunities; user experience (UX) design focused on minimizing clicks, reducing cognitive load, and streamlining common tasks; clinician advisory boards providing feedback on prototypes and design decisions; iterative design with working prototypes every 2 weeks for early feedback; usability testing with actual clinical users before final deployment; training program development including role-based training materials, video tutorials, and quick reference guides; super-user identification and training to support peers during rollout; phased rollout strategies starting with pilot departments before organization-wide deployment; go-live support with our team onsite or available remotely during initial days; and post-deployment optimization addressing user feedback and workflow refinement. We understand that poorly designed healthcare software increases clinician burnout and gets abandoned. Our goal is software that clinicians actually want to use because it makes their work easier, not harder. Most implementations achieve 85-95% user adoption within 30 days through this clinician-centered approach.