Healthcare IT Solutions USA | Medical Software Development & EHR Integration
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Healthcare IT Solutions in USA | HIPAA-Compliant Medical Software
Big0 delivers enterprise-grade healthcare IT solutions for the United States medical industry, serving hospitals, physician practices, payers, pharmaceutical companies, and health technology innovators. Our expertise spans HIPAA-compliant software development, HL7 FHIR interoperability mandated by the 21st Century Cures Act, FDA-regulated medical device software, and integration with major US EHR systems including Epic, Cerner Oracle Health, and Meditech.
We serve healthcare organizations across major medical hubs including Silicon Valley health tech, Boston's medical innovation corridor, Cleveland Clinic, Mayo Clinic, Johns Hopkins, and Nashville's healthcare IT concentration. Our solutions improve patient outcomes, reduce costs, and ensure compliance with evolving US healthcare regulations.
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HIPAA Security Rule Implementation Comprehensive HIPAA compliance for protected health information (PHI) across administrative, physical, and technical safeguards. Implementation of required security measures: access controls with unique user identification, encryption of PHI at rest and in transit (AES-256), audit logging capturing all PHI access, automatic logoff, and emergency access procedures. Risk analysis and management per HIPAA Security Rule requirements.
HIPAA Privacy Rule Compliance Privacy controls for patient rights: access to medical records (within 30 days), amendment requests, accounting of disclosures, and restriction requests. Minimum necessary standard limiting PHI access to what's required for job function. Business Associate Agreements (BAAs) with all vendors handling PHI including cloud providers (AWS, Azure, GCP with HIPAA BAAs).
HITECH Act & Breach Notification Health Information Technology for Economic and Clinical Health (HITECH) Act compliance including breach notification requirements. Notification to HHS within 60 days for breaches affecting 500+ individuals (posted publicly on HHS "Wall of Shame"), individual notification, and media notification for breaches affecting 500+ individuals in state/jurisdiction. Breach risk assessment following NIST SP 800-66 guidance.
HIPAA Audit & Compliance Monitoring Ongoing HIPAA compliance monitoring including quarterly risk assessments, annual security reviews, workforce training documentation, and policy updates. Preparation for OCR (Office for Civil Rights) HIPAA audits which resumed in 2020. Sanctions policy for workforce violations and incident response procedures.
HL7 FHIR Interoperability
21st Century Cures Act Compliance Implementation of 21st Century Cures Act Final Rule requiring health IT developers to support data exchange without information blocking. FHIR APIs providing patient access to electronic health information including clinical notes (OpenNotes). United States Core Data for Interoperability (USCDI) v1, v2, and v3 data elements support.
HL7 FHIR API Development Build standards-compliant FHIR APIs using HL7 FHIR R4 (current version) supporting USCDI data classes: Patient Demographics, Procedures, Medications, Immunizations, Laboratory Results, Clinical Notes, Provenance, and more. SMART on FHIR implementation for third-party app authorization using OAuth 2.0.
EHR Integration via FHIR Integration with major US EHR systems using FHIR APIs: Epic's FHIR APIs (App Orchard marketplace), Cerner (now Oracle Health) FHIR APIs, athenahealth, eClinicalWorks, and Allscripts. Patient data access, appointment scheduling, clinical documentation, and results retrieval via standardized interfaces.
Health Information Exchange (HIE) Integration Connection to regional and national health information exchanges including CommonWell Health Alliance, Carequality framework, and state HIEs. Longitudinal patient records aggregating data across providers. Query-based document exchange and subscription-based notifications for care coordination.
Electronic Health Records (EHR/EMR)
Epic Integration & Custom Development Deep expertise with Epic Systems—the dominant EHR in US hospitals (covering 250+ million patient records). Epic Interconnect for system-to-system integration, MyChart patient portal customization, Epic App Orchard third-party applications, and Chronicles database reporting. Epic training and certification for development teams.
Cerner (Oracle Health) Solutions Cerner Millennium integration and development supporting PowerChart, Discern, and CCL (Cerner Command Language) reporting. Transition to Oracle Health following Oracle acquisition—cloud migration and integration with Oracle Cloud Infrastructure. HL7 interface development and Cerner APIs.
Specialty EHR Systems Integration with specialty-specific EHRs: Modernizing Medicine (ophthalmology, dermatology), Dentrix (dental), AdvancedMD (independent practices), NextGen (ambulatory practices), and eClinicalWorks (community health centers). Workflow customization for specialty-specific documentation and billing.
EHR Implementation & Optimization End-to-end EHR implementations for hospitals and practices including system selection, data migration from legacy systems, workflow design, provider/staff training, go-live support, and post-implementation optimization. Meaningful Use attestation support and MACRA/MIPS reporting.
Telehealth & Remote Patient Monitoring
Telehealth Platform Development HIPAA-compliant telehealth platforms supporting video consultations, secure messaging, e-prescribing, and digital intake forms. Integration with Epic MyChart Video Visits, Cerner telemedicine, or standalone platforms. State licensure compliance—providers must be licensed in patient's state. DEA requirements for controlled substance prescribing via telemedicine.
Remote Patient Monitoring (RPM) Solutions Connected device integration for chronic disease management: blood pressure monitors, glucometers, pulse oximeters, weight scales, and continuous glucose monitors (CGMs). Real-time data transmission to provider dashboards with automated alerts for out-of-range values. CPT codes 99453, 99454, 99457, 99458 for Medicare reimbursement.
Telepharmacy & Medication Management Telepharmacy solutions connecting patients with pharmacists for medication therapy management (MTM), medication reconciliation, and adherence monitoring. Integration with e-prescribing networks (Surescripts), pharmacy benefit managers (PBMs), and retail pharmacy chains (CVS, Walgreens, Walmart).
Mental Health & Behavioral Telehealth Specialized telehealth for psychiatry, psychology, and counseling. Integration with mental health screening tools (PHQ-9, GAD-7), outcome measurement, and crisis intervention protocols. Compliance with 42 CFR Part 2 for substance abuse treatment records requiring stricter privacy than HIPAA.
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Get Started TodayFDA Medical Device Software
Software as a Medical Device (SaMD) Development Development of FDA-regulated medical device software following 21 CFR Part 820 (Quality System Regulation) and FDA guidance on Software as a Medical Device. Risk classification (Class I, II, or III) and regulatory pathway determination (510(k) premarket notification, de novo classification, or PMA).
IEC 62304 Software Lifecycle Implementation of IEC 62304 medical device software lifecycle processes. Software development planning, requirements analysis, architectural design, detailed design, unit testing, integration testing, system testing, and release procedures. Software safety classification (Class A, B, or C) determining rigor of development processes.
Software Verification & Validation Comprehensive V&V activities ensuring software meets user needs and specifications. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Traceability matrix linking requirements to design, code, and tests. Design History File (DHF) maintenance for FDA inspections.
Cybersecurity for Medical Devices Medical device cybersecurity following FDA premarket guidance (2014) and postmarket guidance (2016). Threat modeling, security risk assessment, software bill of materials (SBOM), vulnerability management, and coordinated disclosure programs. Compliance with upcoming FDA cybersecurity requirements in FDORA (Food and Drug Omnibus Reform Act).
Patient Engagement & Portals
Patient Portal Development HIPAA-compliant patient portals providing secure access to medical records, test results, visit summaries, and provider messaging. Integration with Epic MyChart, Cerner Patient Portal, or custom portal development. Meaningful Use Stage 2/3 requirements for patient engagement (5% patient portal use, secure messaging).
Mobile Health Applications Consumer health apps for medication reminders, symptom tracking, appointment scheduling, and health education. Apple HealthKit and Google Fit integration aggregating data from wearables. FDA considerations for medical device classification (wellness vs. medical device determination).
Patient-Reported Outcomes (PROs) Digital PRO collection for clinical research, quality improvement, and value-based care programs. Integration with clinical trials, registry participation, and quality reporting programs (MIPS, Bundled Payments). Validated instruments (PROMIS, EQ-5D, disease-specific measures).
Health & Wellness Coaching Platforms Digital health coaching for chronic disease management, lifestyle modification, and preventive care. Diabetes prevention programs (CDC-recognized), cardiac rehabilitation, weight management, and tobacco cessation. Integration with health plan wellness programs and employer health benefits.
Revenue Cycle Management
Medical Billing & Claims Processing Integration with claims clearinghouses (Change Healthcare, Availity, Waystar) submitting electronic claims to Medicare, Medicaid, and commercial payers. Real-time eligibility verification, claim scrubbing, and denial management. Support for professional claims (CMS-1500), institutional claims (UB-04), and dental claims (ADA).
Practice Management Systems Scheduling, registration, eligibility verification, charge capture, billing, and payment posting. Integration with EHRs for clinical-financial data flow. Patient payment processing (credit cards, payment plans) and patient billing statements.
Value-Based Care & Alternative Payment Models Analytics and reporting for Accountable Care Organizations (ACOs), bundled payment programs, and MACRA/MIPS quality reporting. Medicare Shared Savings Program (MSSP), comprehensive primary care initiatives, and commercial value-based contracts. Quality measure calculation (HEDIS, MIPS) and risk adjustment.
Prior Authorization Automation Electronic prior authorization (ePA) using industry standards (NCPDP SCRIPT for pharmacy, X12 278 for medical). Integration with payer prior authorization portals and automated clinical criteria checking reducing administrative burden on providers.
Clinical Decision Support & Analytics
Clinical Decision Support Systems (CDSS) Evidence-based clinical alerts, order sets, and treatment protocols integrated into EHR workflows. Drug-drug interaction checking, allergy alerts, duplicate therapy detection, and guideline-based recommendations. SMART on FHIR CDS Hooks for standards-based integration.
Population Health Management Risk stratification, care gap identification, and patient outreach for chronic disease management and preventive care. Integration with health plan data, claims data, and social determinants of health (SDOH). Predictive analytics for hospital readmission risk, ED utilization, and chronic disease progression.
Healthcare Analytics & Business Intelligence Operational analytics (throughput, capacity, staff productivity), financial analytics (revenue cycle, cost accounting), and clinical analytics (quality measures, outcomes, utilization). Integration with Epic Cogito, Cerner HealtheAnalytics, or custom data warehouses.
AI/ML for Healthcare Machine learning models for diagnosis support, medical imaging analysis, sepsis prediction, and readmission prevention. Natural language processing (NLP) for clinical documentation, coding assistance, and adverse event detection. Compliance with FDA AI/ML guidance for continuous learning algorithms.
Pharmaceutical & Life Sciences IT
Clinical Trial Management Systems (CTMS) Software supporting clinical research including protocol management, site selection, patient recruitment, visit tracking, and regulatory compliance (21 CFR Part 11 for electronic records). Integration with Electronic Data Capture (EDC) systems, safety databases, and investigator portals.
Pharmacovigilance & Drug Safety Adverse event reporting systems meeting FDA MedWatch requirements and global pharmacovigilance regulations. Integration with FDA FAERS (Adverse Event Reporting System), signal detection analytics, and case management workflows.
Real-World Evidence (RWE) Platforms Integration of claims data, EHR data, patient registries, and patient-generated data for post-market surveillance, comparative effectiveness research, and regulatory submissions. Support for FDA's Real-World Evidence framework for regulatory decision-making.
Pharmaceutical Sales & Marketing Sales force automation, healthcare provider (HCP) data management, sample inventory, and compliance with Sunshine Act (Open Payments) requirements. Integration with IQVIA and other healthcare provider data sources. PhRMA Code compliance for interactions with healthcare professionals.
USA Regional Healthcare Expertise
Silicon Valley & San Francisco: Health Tech Innovation Epicenter of digital health innovation with concentration of venture-backed health tech startups, Apple Health ecosystem, Google Health initiatives, and consumer health applications. Expertise with FDA de novo pathways for novel technologies, direct-to-consumer health apps, and wearable device integration.
Boston: Medical Device & Academic Medical Centers World-class academic medical centers (Mass General Brigham, Beth Israel Lahey) and medical device innovation. FDA regulatory expertise with proximity to FDA New England regional office. Biotech and pharmaceutical IT for industry concentration in Cambridge/Boston corridor.
Nashville: Healthcare IT & HCA Hub "Healthcare capital of America" with HCA Healthcare (largest US hospital system), Community Health Systems, and Envision Healthcare headquarters. Healthcare revenue cycle, hospital IT systems, and value-based care analytics expertise.
Cleveland: Cleveland Clinic & Health Systems Cleveland Clinic (ranked #2 US hospital) and major health systems. Expertise with complex academic medical center requirements, clinical research IT, and specialty care applications (cardiac care, oncology, transplant).
Research Triangle, NC: Healthcare Research & Analytics Concentration of clinical research organizations (CROs), pharmaceutical companies, and Duke Health/UNC Health systems. Clinical trials IT, health services research, and healthcare analytics.
USA Healthcare Regulations & Standards
Federal Regulations - HIPAA Privacy Rule & Security Rule (45 CFR Parts 160, 164) - 21st Century Cures Act Final Rule (information blocking) - FDA regulations: 21 CFR Part 11, Part 820, SaMD guidance - Medicare Conditions of Participation (CoPs) - Stark Law and Anti-Kickback Statute (AKS) compliance
Quality & Accreditation Standards - The Joint Commission standards - NCQA (National Committee for Quality Assurance) HEDIS measures - CMS Quality Payment Program (MIPS, APMs) - State licensing requirements for telehealth - DEA requirements for e-prescribing controlled substances
Interoperability Standards - HL7 FHIR R4 (Fast Healthcare Interoperability Resources) - HL7 v2 messaging (ADT, ORM, ORU) - USCDI (United States Core Data for Interoperability) - DICOM for medical imaging - IHE (Integrating the Healthcare Enterprise) profiles
Healthcare Technology Stack
EHR/EMR Systems - Epic Systems (dominant in US hospitals, 31% market share) - Cerner/Oracle Health (second largest, 25% market share) - Meditech (community hospitals) - athenahealth (cloud-based, ambulatory) - eClinicalWorks, NextGen, AdvancedMD
Interoperability & Integration - HL7 FHIR R4 APIs - Mirth Connect (interface engine) - Rhapsody Integration Engine - Redox (healthcare API platform)
Telehealth Platforms - Zoom for Healthcare (HIPAA-compliant) - Doxy.me (simple telehealth) - Teladoc Health (enterprise) - Epic MyChart Video Visits - Amwell, MDLive (consumer platforms)
Healthcare Cloud Platforms - AWS for Healthcare (HIPAA-eligible services) - Microsoft Azure Health (FHIR service, health data services) - Google Cloud Healthcare API - Oracle Cloud Infrastructure for Healthcare
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Get Started TodayFrequently Asked Questions
HIPAA compliance requires comprehensive security and privacy controls for protected health information (PHI). Technical safeguards include: (1) Access Controls: Unique user IDs, automatic logoff, encryption/decryption mechanisms, and emergency access procedures; (2) Audit Controls: Comprehensive logging of PHI access, modifications, and disclosures with tamper-proof audit trails; (3) Integrity Controls: Ensuring PHI isn't improperly altered or destroyed; (4) Transmission Security: Encryption of PHI in transit (TLS 1.2+, AES-256). Administrative safeguards: Security Officer designation, workforce training, risk analysis, and incident response procedures. Physical safeguards: facility access controls and workstation security. All vendors handling PHI require Business Associate Agreements (BAAs)—ensure cloud providers (AWS, Azure, GCP) sign HIPAA BAAs. Annual security risk assessments required. OCR (Office for Civil Rights) violations result in $100-1.5M fines per violation category.
Epic Integration: (1) Epic App Orchard: Submit third-party applications for Epic marketplace requiring Epic review and approval; (2) Epic APIs: Use FHIR APIs for patient data access following SMART on FHIR standards, or Epic Interconnect APIs for system-to-system integration; (3) HL7 Interfaces: Traditional HL7 v2 messaging (ADT, ORM, ORU) for patient demographics, orders, and results; (4) Epic Training: Developers typically need Epic proficiency training ($5,000-15,000 per person). Cerner Integration: (1) Cerner FHIR APIs: OAuth 2.0 secured APIs for patient data; (2) CCL (Cerner Command Language): Direct database queries for reporting; (3) HL7 Interfaces: Standard messaging integration. Both require coordination with health system IT departments, security reviews, and BAAs. Timeline: 3-9 months from initial discussions to production depending on complexity. Costs: $50,000-500,000+ for comprehensive integration depending on scope.
FDA Software as a Medical Device (SaMD) requirements depend on risk classification. Class I (low risk): General controls, usually exempt from premarket review. Class II (moderate risk): 510(k) premarket notification demonstrating substantial equivalence to predicate device ($5,000 FDA fee, $100,000-300,000 total cost, 3-12 months). Class III (high risk): Premarket Approval (PMA) with clinical trials ($300,000+ FDA fee, millions total, years timeline). Development must follow: (1) 21 CFR Part 820 Quality System Regulation with design controls; (2) IEC 62304 software lifecycle; (3) Risk management per ISO 14971; (4) Software V&V with Installation/Operational/Performance Qualification; (5) Cybersecurity per FDA guidance including threat modeling and SBOM; (6) Design History File documenting entire development. Maintain Quality Management System (QMS) and prepare for FDA inspections.
21st Century Cures Act Final Rule (effective 2020-2022 phased implementation) prohibits information blocking and mandates patient data access. Requirements: (1) No Information Blocking: Healthcare providers and IT developers cannot interfere with access, exchange, or use of electronic health information—exceptions exist for privacy, security, preventing harm, but burden of proof is high. Violations result in significant penalties; (2) FHIR APIs Required: Health IT developers must publish APIs using HL7 FHIR R4 standard with USCDI data elements for patient access without special effort; (3) USCDI Support: Support for United States Core Data for Interoperability (currently v3) including demographics, medications, problems, procedures, immunizations, lab results, clinical notes, provenance; (4) SMART on FHIR: Enable third-party app authorization using SMART on FHIR protocols. Impact: Patients can access complete medical records via apps, enables innovation in patient-facing health apps, requires ongoing API maintenance as USCDI expands annually.
HIPAA-compliant telehealth requires: (1) Video Conferencing: HIPAA-compliant platforms with signed BAAs (Zoom for Healthcare, Doxy.me, VSee)—consumer platforms like standard Zoom, Skype, FaceTime not HIPAA-compliant without BAA; (2) Encryption: End-to-end encryption for video, audio, and chat; (3) Access Controls: Password protection, waiting rooms, meeting locks preventing unauthorized access; (4) PHI Minimization: Don't display PHI in meeting names, use unique meeting IDs not personal IDs; (5) Recording Compliance: If recording sessions, obtain patient authorization and store recordings securely with encryption. State licensure critical—providers must be licensed in patient's physical location state during telemedicine visit. DEA requirements for prescribing controlled substances—Ryan Haight Act generally requires in-person visit before prescribing controlled substances via telemedicine (COVID-19 exceptions expired). Medicare telehealth reimbursement follows specific requirements (patient location, originating site, eligible services). Costs: HIPAA-compliant platforms $20-50 per provider/month.
Medicare reimbursement for digital health services: (1) Telehealth: Medicare pays for telehealth services (95+ CPT codes) including E/M visits, therapy, consultations. Geographic restrictions (patient in rural area) lifted during COVID public health emergency but some restrictions returning; (2) Remote Patient Monitoring (RPM): CPT 99453 (device setup), 99454 (device supply), 99457 (first 20 minutes monitoring), 99458 (additional 20 minutes). Requires 16 days of data per month. Typical reimbursement $50-100 per patient per month; (3) Chronic Care Management (CCM): CPT 99490 (first 20 minutes), 99439 (additional 20 minutes) for comprehensive care management. Requires certified EHR, 24/7 access, care plan. Reimbursement ~$42-84 per patient per month; (4) Principal Care Management (PCM): Similar to CCM but for single chronic condition. Medicaid varies by state—some states offer robust telehealth coverage, others minimal. Prior authorization often required for Medicaid. Health IT must support proper documentation, billing codes, and integration with claims systems for reimbursement.
Premier healthcare IT talent markets: Boston leads with academic medical centers (Mass General Brigham, Beth Israel), biotech/pharma concentration, and universities (MIT, Harvard) providing talent pipeline ($130,000-220,000 for senior health IT developers). Silicon Valley/San Francisco dominates digital health innovation with venture capital, Apple/Google health initiatives, and consumer health tech ($150,000-250,000, highest costs). Nashville offers healthcare IT concentration with HCA, CHS, and health IT companies at lower costs than coasts ($100,000-170,000). Cleveland provides academic medical center expertise (Cleveland Clinic) with Midwest costs. Research Triangle NC combines Duke/UNC health systems, clinical research, and cost-effectiveness ($95,000-160,000). Seattle offers Fred Hutchinson, UW Medicine, and Microsoft health initiatives. For HIPAA-compliant development, consider whether offshore development is acceptable (requires BAAs with offshore vendors, data residency concerns)—many healthcare organizations restrict development to US-based teams. Epic/Cerner expertise concentrated near large health systems using these platforms.
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