How Nomius helped to build a compliant healthtech product

Across multiple markets

From healthtech solution idea to global release

We made patient data usable without compliance risk

Software development with compliance-ready design

ZenBit Tech had an idea to help patients understand their lab results through AI analysis. The technology extracs biomarkers, AI interprets results and a user-friendly interface delivers clarity.
But medical data is in the most regulated categories of information and any product using it must be compliant before it ever reaches users.

Before go to market, ZenBit Tech needed to prove compliance with:
🇪🇺 GDPR (European Union) for patient consent, lawful basis for processing, data minimization, retention policies
🇬🇧 UK GDPR + Data Protection Act 2018 (United Kingdom) for UK-specific data protection rules, DPIAs, ICO oversight, cross-border transfer safeguards
🇨🇭 FADP / nFADP (Switzerland) for enhanced transparency, stricter consent requirements, data subject rights, cross-border data transfer controls
🇺🇸 HIPAA (United States) for protected health information handling, audit trails, breach notification, Business Agreements
It means you hire experts in every market, wait for slow approvals and build compliance by hand. Yet you still worry you missed something.

So the biggest risk wasn’t AI accuracy, it was data responsibility. Storing patient lab results would immediately make ZenBit Tech a medical data controller. It’d increase legal exposure, audit scope and operational complexity. So, without compliance ready solution, even the best technology product can’t enter the market

And we created architectural background with compliance ready decision in mind — the white label platform for patients without storing the data and API for existing solution with storing through third party partners

Dmitry Broshkov

Software developer
Founder ZenBit Tech

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Nomius guided ZenBit Tech to build two compliant delivery models

Nomius didn't just tell ZenBit Tech what regulations existed, it recommended the exact architecture that minimizes legal liability to maintain full auditability. By integrating Nomius from day one, compliance became a product feature, not a blocker.

White-label platform for patients (no data storage)

For patient use cases, it’s built a white-label platform where patient data is never stored.
Patients upload their lab reports (PDF or image). The system processes the file ephemerally. Biomarkers are extracted, normalized and explained in simple language. Results are returned to the patient as a clear, human-readable report. After processing, the data is removed according to strict retention rules.
ZenBit Tech is used only to:

record proof of consent
log processing events and timestamps
fingerprint transformations for traceability
generate compliance evidence

It allows to offer a patient solution without becoming long-term custodians of medical data.

API for existing digital health solutions (with third-party stores data)

For healthtech, medtech and wellness platforms, the requirements are different. Such systems are expected to store patient records within their own certified or regulated infrastructure (such as EHRs or compliant cloud environments).
To support it, it’s built an API integration model:

patient data is stored and controlled by third-party partners.
Lab Results Analyzer processes data via secure APIs without retaining PHI.
ZenBit Tech manages pseudonymized compliance metadata, audit trails and evidence without storing medical data.

Partners receive harmonized lab results together with:

signed compliance receipts and processing confirmations
immutable transformation and normalization logs
consent and DPIA-supporting evidence
regulator-ready audit packages generated on demand

This model keeps data custody and controller responsibility with platforms already equipped to store medical data. With Nomius integrated from day one, compliance becomes automatic.

How It Works:
From Idea to Global Market with Nomius

All you need in a one platform

Discovery and Validation

Nomius partnered with ZenBit Tech to map regulations across 3 markets (USA, UK, EU, Switzerland).
Medical data regulation blocked an MVP that stored patient records, so we turned to a compliance-ready design. As the result, we avoid becoming a data controller.

Technical Implementation

ZenBit Tech engineered a system where compliance were implemented from day one. The solution for MVP was a zero-storage architecture that processes data ephemerally and records only metadata to deliver a product that is both usable and auditable without retaining patient records.

Nomius Compliance and Market Entry

With compliance-ready infrastructure for the Lab Results Analyzer, it applies market-specific requirements. So, compliance doesn’t have to be documented for every country, the company profile needs to be filled in only once. Regulatory changes are monitored continuously. Documents and checks are updated automatically. Auditable Market-Ready certificates are issued for each jurisdiction. Finally, enter globally with minimal legal issues.

Technical & Compliance Wins

Enter Global Market

Building a compliant healthtech product requires months of consultation and infrastructure development. With Nomius implemented from day one, the solution ready with compliance built-in

Reduce Legal Risk

Technical solution reduces exposure to data breaches, regulatory audits and potential fines. Nomius provides the proof of compliance without the liability of data custody

Lower Operational Cost

No need for expensive medical data storage, backups or dedicated compliance teams. Compliance-ready design works for multi jurisdiction

Want to implement compliance-ready design?

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