Digital Health, IoT & Security Engineering
Digital Health Platform Development, Medical Device Software & HIPAA Security Engineering
Consumer-grade digital health apps and wearable health platforms. FDA 21 CFR Part 11 and ISO 13485 compliant medical device software. HIPAA-compliant PHI masking and security architecture, built for regulated clinical and consumer health environments.
Apps that work as software but fail as healthcare tools, because clinical workflow alignment, patient literacy, accessibility requirements, and regulatory context were not included in the product design requirements.
Wearables generating continuous physiological data streams with no HIPAA-compliant ingestion layer, no EHR integration, and no clinical alerting logic, the device exists, but the clinical value does not.
SaMD shipped without IEC 62304 documentation, ISO 14971 risk files, or a regulatory pathway strategy, creating 510(k) submission failure and product liability exposure at commercialization.
Production healthcare databases copied into dev and test environments without PHI masking, because the masking was never implemented or does not preserve referential integrity.
Digital Health, IoT & Security Engineering, What We Build
Five capability areas from consumer digital health apps and FDA-regulated medical device software through healthcare IoT platforms and HIPAA security architecture.
Digital Health Platform Development
Patient engagement, remote monitoring, telehealth, and drug pricing platforms built for clinical workflow integration and real-world patient use.
- Patient engagement: condition management apps, medication adherence tools, and chronic disease coaching, WCAG 2.1 AA accessible
- Remote patient monitoring platform: PRO collection, device data ingestion, symptom tracking, and clinical alert generation on threshold breach
- Telehealth: video consultation infrastructure, asynchronous messaging, e-prescribing, and EHR chart documentation integration
- Drug pricing transparency: real-time formulary lookup, patient cost estimation, and therapeutic alternative comparison
Medical Device Software Development, FDA & ISO 13485
SaMD development with regulatory compliance built into the process, not assembled retrospectively before submission.
- SaMD classification and regulatory strategy: intended use definition, IEC 62304 safety classification, 510(k)/De Novo pathway selection
- IEC 62304 software lifecycle: development plan, requirements, architecture, unit/integration/system testing, and release documentation
- ISO 14971 risk management: hazard identification, risk estimation, control measures, and residual risk evaluation
- Design controls: design input, output, review, verification, validation, and transfer per FDA QSR 21 CFR 820.30
Wearable Health App Development & Device Integration
Wearable connectivity engineered for clinical data quality, not just consumer dashboards.
- HealthKit (iOS) and Health Connect (Android): continuous background collection, Garmin, Fitbit, Dexcom, Omron, and Masimo SDK integration
- Device-to-cloud pipelines: FHIR Observation from device streams, HIPAA-compliant ingestion via AWS IoT Greengrass or Azure IoT Hub
- Clinical alerting: threshold-based alerts (SpO2, heart rate, glucose) with configurable escalation paths to care managers
- EHR integration: FHIR R4 Observation resources written to Epic, Cerner, or Athenahealth, visible in the clinical chart
Healthcare IoT Platform Development
Connected device ecosystems integrated into secure, governed clinical data infrastructure.
- FDA-regulated device integration: infusion pumps, patient monitors, glucometers, via HL7 FHIR Device resource and IHE DEV profiles
- Secure device-to-cloud: X.509 certificates, TLS 1.3, MQTT/AMQP protocol support, AWS IoT Greengrass edge computing
- Real-time stream processing: Apache Kafka or AWS Kinesis for high-velocity ingestion, Flink for streaming analytics
- Remote patient monitoring: structured home device capture, adherence tracking, care manager dashboard, and clinical escalation
Data Masking, PHI De-Identification & HIPAA Security
PHI security implemented at the architecture level, across production, development, testing, and analytics environments.
- PHI masking: Datavant, Delphix, DataSunrise, referentially intact masking for dev/test that preserves data relationships
- De-identification: HIPAA Safe Harbor and Expert Determination for research datasets and third-party data sharing
- HIPAA architecture: VPC isolation, AES-256 encryption, TLS 1.2+, IAM least-privilege, PHI audit logging, BAA-aligned cloud config
- SOC 2 Type II readiness: security, availability, confidentiality criteria implementation with evidence collection and audit preparation
Built for the Teams Shipping Regulated Health Products
Building regulated digital health products, HIPAA from Day 1, FDA compliance, and EHR connectivity for enterprise sales.
- HIPAA-compliant architecture
- FDA SaMD regulatory strategy
- ISO 13485 QMS implementation
- Epic App Orchard integration
Remote patient monitoring platforms, patient engagement tools, and HIPAA security architecture for health system digital programmes.
- Remote patient monitoring
- Patient engagement apps
- HIPAA architecture review
- IoT device integration
Connected device clinical trials, ISO 13485 medical software, and HIPAA-compliant data environments for pharma R&D.
- ISO 13485 medical device software
- Digital therapeutics
- Clinical trial device data
- PHI masking for research
Frequently Asked Questions
What is ISO 13485 and when does digital health software require it?
How do you maintain HIPAA compliance throughout the software development lifecycle?
What is the difference between PHI data masking and PHI de-identification?
How do you integrate wearable device data into a clinical platform without compromising data quality?
Explore the Systems Around Your Digital Health Platform
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