Special-category data
Health data needs explicit Article 9 basis, tighter retention and clinical access controls. We design for it from the schema up.
GDPR MDR AI-native
Healthtech Software Development for US and EU Digital-Health Teams
We engineer healthtech products for clinics, payers, and digital-health vendors that need senior delivery without compliance gaps. YuSMP Group ships HIPAA-capable telehealth platforms, remote-patient-monitoring backends, and SaMD-aware applications — with FHIR-native data layers, audit-ready logging, and EU data residency on request. Yerevan teams overlap the US East Coast daily, so PHI questions get answered the same business day.
Our healthtech practice covers four product lanes: telehealth and virtual-care platforms, remote patient monitoring (wearables, device ingestion, alerting), EHR and EMR integration with Epic, Cerner/Oracle Health, Athenahealth and Meditech, and SaMD-aware clinical applications. We deliver under a dual-jurisdiction posture — HIPAA Security and Privacy Rules for US covered entities and business associates, plus GDPR, EU MDR awareness, and EU data residency for European patient cohorts. Engineering follows IEC 62304-aware lifecycle practices, ISO 13485 aware QMS habits, and FHIR R4 / HL7 v2 interoperability from day one.
Challenges
Industry challenges we solve
MDR classification drift
Adding a single ML inference can reclassify your software as a medical device. We flag and document changes across the SDLC.
Interop complexity
FHIR, HL7 v2, DICOM, IHE profiles and national variants pile up fast. We standardize on FHIR R4 and bridge legacy carefully.
Clinician UX debt
Every extra click steals minutes from patient care. We co-design with clinicians and instrument task-time relentlessly.
Validation cost
Regulatory validation can crush velocity if bolted on. We separate GxP-relevant flows and keep the rest agile.
Cross-border care
Multi-country deployments meet conflicting consent and prescription rules. We build country-aware policy layers.
Solutions
Solutions we build
Telemedicine platforms
Video consultations, e-prescriptions, scheduling and patient messaging with end-to-end encryption.
EHR and EMR
Modular electronic health records with FHIR APIs, role-based clinical access and audit trail.
MedTech SaaS
Companion software for medical devices, including data ingestion, dashboards and remote monitoring.
Patient apps
Onboarding, symptom tracking, adherence and care plans with accessibility WCAG 2.2 AA built in.
Clinical AI
Decision support, triage and imaging assist with model risk controls and traceable training data.
Payer and admin
Claims, prior authorization and provider directories integrated with existing payer cores.
Stack
Technology stack
TypeScript, React, Node.js, Python, FastAPI, Java, Spring, PostgreSQL, HAPI FHIR, DICOMweb, Kafka, Kubernetes, Azure Health Data Services, AWS HealthLake, Terraform, OpenSearch.
Compliance
Compliance & regulations
GDPR-aligned · ISO 27001 ready · SOC 2 Type II in progress · HIPAA-capable · CCPA-acknowledged
EU
- GDPR (Art. 9) — special-category health data, DPIAs, lawful basis.
- EU MDR 2017/745 — software as a medical device, technical files.
- IVDR 2017/746 — in-vitro diagnostic software.
- eIDAS — EU Digital Identity Wallet, qualified electronic signatures.
US
- HIPAA + HITECH — PHI safeguards, BAAs, breach notification.
- FDA 21 CFR Part 820 — Quality System Regulation for SaMD.
- FDA 21 CFR Part 11 — electronic records and signatures.
- NIST SP 800-63 — identity assurance for patient portals.
Shared: ISO 13485 quality management · IEC 62304 software lifecycle classes A, B, C · ISO 14971 risk management.
Cases
Selected HealthTech case studies
HealthTech · Clinics
Service for Medical Clinics
A patient app plus a role-based staff suite that unifies multiple clinics — appointments, records, and dashboards, HIPAA-capable for the US & EU.
HealthTech · Diagnostics
Unilab
Patient app for a 40-city lab network — appointment booking, digital results, 2,500+ tests, scheduling and accounting integrations.
HealthTech · Endoscopy
ArgoView
Tablet-first endoscopy recording, patient records, and DICOM/HL7 export — built on Laravel + React with browser-tier WebRTC capture for US & EU clinics.
Why YuSMP
Why healthtech teams choose YuSMP
Clinical fluency
Engineers and BAs who speak SNOMED, FHIR and clinician workflow — not just JIRA.
MDR + FDA-aware SDLC
Lifecycle artifacts ready for both EU notified body review and FDA 21 CFR Part 820 design controls without slowing down product work.
Dual-region residency
EU data residency by default · US options on request. SCCs and BAAs only when there's a clinical reason to cross.
FAQ
HealthTech FAQ
Are you familiar with EU MDR for software as a medical device?
Yes. We work with manufacturers on Class I-IIa SaMD, supporting technical documentation, risk management per ISO 14971 and software lifecycle per IEC 62304.
Do you cover US FDA 21 CFR Part 820 and HIPAA-compliant device software?
Yes. We deliver SaMD under FDA 21 CFR Part 820 Quality System Regulation, design controls and 21 CFR Part 11 electronic records/signatures, with HIPAA technical safeguards baked into the device software.
How do you handle special-category health data under GDPR?
We map Article 9 lawful basis, encrypt data at rest and in transit, minimize fields to the clinical minimum and implement DPIAs for any new processing.
How do you handle HIPAA PHI and HITECH breach notification in US deployments?
We apply HIPAA Privacy, Security and Breach Notification rules to PHI handling, execute BAAs with downstream subprocessors, and run HITECH-compliant breach detection and 60-day notification workflows.
Do you integrate with HL7 FHIR and DICOM?
We build FHIR R4 APIs, ingest DICOM imaging, and bridge HL7 v2 from legacy hospital systems. Profiles validated against national IGs where applicable.
Can you support ISO 13485 quality management?
We align our SDLC artifacts to ISO 13485 quality records and 62304 software classes A-C, working alongside your QMS team or notified body auditor.
Do you support eIDAS identity flows for EU patient portals?
Yes. We integrate eIDAS-compliant identity providers, the EU Digital Identity Wallet and national eID schemes for patient authentication and consent.
Do you use NIST SP 800-63 identity assurance for US patient portals?
Yes. We design US patient portals against NIST SP 800-63-3 IAL2/AAL2 identity assurance, with ID.me, Login.gov or Okta CIAM patterns for verified patient access.
Do you build US-bound HIPAA-aligned products?
Yes. For cross-Atlantic products we layer HIPAA technical safeguards on top of GDPR controls and execute BAAs with downstream subprocessors.
Ship safer, faster healthtech with senior US & EU engineers
Response within 1 business day. NDA on request.