Healthcare & Life Sciences
Digital health platforms built for GDPR, MDR and NIS2. Telemedicine, EHR systems, and clinical data management tools.
About this industry
Healthcare software for Poland and the EU starts with data protection. Health data is a special category of personal data under GDPR, so encryption, access accountability and data minimisation are the starting point, not something bolted on before launch. We design systems with full audit logging, role-based permissions and EU hosting from day one.
The second pillar is interoperability. Clinics and hospitals run HIS, LIS and PACS systems, and in Poland they also exchange data with the P1 platform operated by the e-Health Centre - e-prescriptions, e-referrals and electronic medical records. We build HL7 and FHIR-based integrations so that an EHR system or a telemedicine platform does not become yet another data silo.
The third area is sector regulation. If software supports diagnosis or treatment decisions, it may qualify as a medical device under the MDR, which changes how it is built and documented. Many healthcare providers also fall under NIS2. Products aimed at the US market additionally need HIPAA compliance - we assess all of this during discovery, before any code is written.
How we deliver
Audit & Analysis
In-depth analysis of clinical processes and regulatory requirements.
UX Design
Intuitive interfaces for patients and medical staff.
Development & Integration
Secure APIs, hospital system integrations, and HL7/FHIR.
Compliance & Deployment
Security certification, testing, and production deployment.
Key challenges
Data Security
End-to-end encryption and patient data access control.
Interoperability
Integration with existing HIS, LIS, and PACS systems.
Scalability
Architecture supporting thousands of concurrent telemedicine sessions.
Regulations
GDPR, MDR requirements for medical software and NIS2, plus HIPAA for projects aimed at the US market.
Accessibility
Platforms accessible to patients of all ages and needs.
Patient Portal
Self-service - test results, prescriptions, appointment booking online.
Compliance and security
GDPR
Health data needs a legal basis under Article 9 GDPR, a record of processing activities and usually a data protection impact assessment. We implement encryption at rest and in transit, access logs, retention rules and EU hosting and prepare details for your data processing agreement.
MDR (Medical Device Regulation)
Software intended to diagnose, monitor or support treatment may qualify as a medical device. Together with your regulatory adviser we help pin down the intended purpose, then run software lifecycle documentation in line with IEC 62304 and risk management that make the conformity assessment easier.
NIS2
The directive covers healthcare entities, among others, and requires cybersecurity risk management and incident reporting, including across the supply chain. We deliver monitoring, backups, incident response procedures and the documentation an auditor expects from a software supplier.
HL7 FHIR and Poland's P1 platform
HL7 and FHIR make data exchange between medical systems predictable, and in Poland integration with the P1 platform (e-prescriptions, e-referrals, electronic records) follows e-Health Centre specifications. We design the integration layer, terminology mapping and testing against external systems.
Frequently asked questions
How much does custom healthcare software cost?
It depends on scope: a patient portal with online booking needs a very different budget from an EHR integrated with P1 and laboratories. Mid-size healthcare projects usually fall within EUR 14,000 - 47,000. We give a precise quote after a discovery workshop, and our guide to custom software cost explains the main cost drivers.
Can we use AI to handle patient communication?
Yes, within clear limits. AI works well for appointment booking, visit reminders and answering practical questions about opening hours or preparation. It does not diagnose or replace medical staff. We process conversations on GDPR-compliant infrastructure, patients are told they are talking to an AI assistant, and anything unusual is passed to reception.
How long does it take to launch a telemedicine platform?
A first version with video visits, doctor calendars and payments usually takes a few months. Integrations with an existing HIS, data exchange with P1 and a possible MDR pathway extend that timeline. That is why we start with a short analysis that separates what must be in the first release from what can wait for later stages.
Will our software count as a medical device?
That depends on the intended purpose defined by the manufacturer. Administrative tools, booking and billing systems usually are not medical devices. Features that support diagnosis, therapy selection or patient monitoring may fall under the MDR. It is worth assessing this with a regulatory adviser before the project starts, and we adapt our development process and documentation accordingly.
Have a project in mind?
Let's discuss your needs. Book a free consultation and learn how we can help bring your vision to life.
