IT Solutions for Healthcare

GDPR-compliant software for hospitals, medical device manufacturers and telemedicine providers – reliable, secure and certification-ready.

Healthcare software with the highest security and compliance requirements

Healthcare places unique demands on software: GDPR-compliant handling of sensitive patient data, certification requirements for medical devices (IEC 62304, MDR) and zero-error tolerance in critical systems. BitPointer GmbH develops healthcare software that meets these requirements – from hospital IT through to telemedicine platforms.

Medical device software according to IEC 62304 (Class A, B, C)
GDPR-compliant patient data management & pseudonymisation
Hospital information systems (HIS) & clinical workflows
Telemedicine platforms & digital patient communication
HL7 FHIR / DICOM integration for interoperability
MDR-compliant software documentation & risk analysis (ISO 14971)

Why BitPointer for healthcare IT?

GDPR & data security

Patient data deserves special protection. We implement encryption, access controls and audit trails according to GDPR requirements and BSI IT-Grundschutz – so your system remains auditable and legally sound.

Regulatory compliance

From IEC 62304 (software life cycle) via ISO 14971 (risk management) to the EU MDR: we know the regulatory requirements and integrate them into the development process from day one – not as afterthoughts.

Interoperability & standards

Healthcare IT thrives on connectivity. We integrate your systems via HL7 FHIR, DICOM and standardised APIs – for seamless communication between hospital, laboratory, practice and telemedicine.

FAQ

Frequently asked questions about IT solutions in healthcare

IEC 62304 is the international standard for the software life cycle of medical devices. It defines processes for development, maintenance and risk management of software in medical devices. Manufacturers who want to place products on the EU market must meet EU MDR (Medical Device Regulation) requirements, which recognise IEC 62304 as a harmonised standard. We support you with compliant development and documentation.

We follow a privacy-by-design approach: data minimisation, end-to-end encryption, role-based access controls (RBAC), complete audit trails and pseudonymisation wherever possible. All systems run on German or EU servers. In addition we prepare the required records of processing activities and support Data Protection Impact Assessments (DPIA).

Yes. We have experience with common HIS/RIS/PACS systems and integrate via HL7 v2, HL7 FHIR R4 and DICOM. Older proprietary systems can also be connected via middleware adapters. A careful interface analysis before project start ensures that all integrations are stable and maintainable.

Telemedicine platforms must offer video communication (GDPR-compliant, no US cloud), secure prescription and findings transmission, and an accessible user interface for patients of all ages. Requirements of the DiGA regulation also apply if the platform is to be approved as a digital health application. We cover all technical and regulatory layers.

We support you with IQSM (Integrated Quality and Safety Management)-compliant development processes and prepare the necessary technical documentation: software risk analysis (ISO 14971), verification and validation reports, and change management evidence. Final certification is performed by a notified body – we prepare you optimally for that.

Ready to start a healthcare IT project?

Talk to our experts about GDPR-compliant software solutions for healthcare – free of charge and without obligation.

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