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. Explore how we deliver this through our HIPAA-compliant software development service.
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.
This page frames these obligations as healthtech delivery challenges. For the controls, evidence and audit path in depth, see our dedicated HIPAA-compliant software development, GDPR compliance consulting and EU AI Act compliance services — the vertical challenge here, the compliance how-to there.
Interoperability
The healthcare interoperability landscape we build against
Health software is only as useful as the systems it talks to. We engineer directly against the EHR, standards, device and payer ecosystems US and EU care depends on — FHIR-native by default, with PHI kept to the clinical minimum so each integration stays inside the HIPAA and GDPR boundary.
EHR & EMR systems
Epic, Oracle Health (Cerner), Athenahealth, Meditech, Allscripts/Veradigm, eClinicalWorks and NextGen — through vendor APIs, SMART on FHIR apps and HL7 v2 bridges from legacy hospital systems.
Standards & profiles
HL7 FHIR R4, HL7 v2, C-CDA and IHE profiles, DICOMweb imaging, and terminologies (SNOMED CT, LOINC, ICD-10, CPT) validated against national implementation guides.
Devices & wearables
Remote-monitoring ingestion over Bluetooth LE and Continua, plus Apple HealthKit and Google Health Connect, streamed into custom-built alerting and dashboards.
Identity & consent
NIST SP 800-63 IAL2/AAL2 patient verification (ID.me, Login.gov, Okta CIAM) in the US; eIDAS providers and the EU Digital Identity Wallet for European portals.
Pharmacy & labs
e-Prescribing via Surescripts-class networks, lab orders and results over HL7/LOINC, and diagnostic-imaging exchange for connected care pathways.
Payer & claims
X12 EDI 837/835 claims and eligibility, prior-authorization workflows and provider-directory feeds wired into existing payer cores.
How we deliver
Our healthtech engineering process
Compliance is designed into delivery, not audited in at the end. Every healthtech engagement moves through five stages, with HIPAA, GDPR and medical-device obligations treated as first-class engineering concerns from day one.
1 · Discovery & regulatory classification
We map the applicable regime up front — HIPAA/HITECH in the US, GDPR Article 9, MDR and IVDR in the EU — and decide early whether the software is a medical device, fixing its IEC 62304 class and opening an ISO 14971 risk file.
2 · Architecture & data residency
A FHIR-native data layer, PHI minimized to the clinical minimum, audit-ready logging, and residency (EU by default, US on request) are fixed in the architecture — with BAAs and SCCs scoped only where care genuinely crosses borders.
3 · Compliance-enforced build
Senior engineers build with HIPAA technical safeguards, encryption at rest and in transit, role-based clinical access and 21 CFR Part 11 electronic records as defaults — not retrofits — across our cloud & DevOps pipeline.
4 · Interoperability & validation
We connect EHR, HL7/FHIR and DICOM interfaces, validate against national IGs, and run design controls and GxP-relevant validation, coordinating with your QMS team or notified body where SaMD applies.
5 · Launch & clinical vigilance
HITECH breach-detection and 60-day notification workflows, post-market surveillance and traceable change records go live with the product, and every release ships with SBOMs and threat-model deltas.
Ongoing partnership
Post-launch we run regulatory-change tracking, resilience testing and iterative delivery as the product and its clinical obligations evolve.
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.
What clients say
Clinical workflow software that hospitals actually adopt is rare. YuSMP built an iPad-first endoscopy platform with HD video capture, DICOM export, and HL7 integration. Medical staff needed almost no training because the UX is genuinely intuitive.
Medical staff adoption depends entirely on UX simplicity. YuSMP built a patient-facing app and a staff suite that share a single data model, meaning zero reconciliation lag between what the patient sees and what the clinician acts on. Onboarding a new clinic now takes one day.
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.
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From the blog
In-depth guides on building healthcare software — EHR integration, HIPAA and data compliance.
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