Compliance

GDPR-Compliant Healthcare Software Development

Build healthcare products that meet GDPR data protection requirements from the architecture level. Data residency, encryption, consent management, and patient rights built into your product for European and cross-border markets.

Key features

Built for healthcare developers who need it to just work

Secure, compliant, and aligned with industry standards

Our development practices follow HIPAA, ISO 13485, and HL7 FHIR standards. Every project includes security architecture review, compliance documentation, and audit-ready infrastructure.

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HIPAA, ISO and HL7FHIR logos showing Momentum's expertise and recognition.

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Jan Kaminski
Board Member & Co-Founder
Jan Kaminski
Board Member & Co-Founder

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FAQ

How does GDPR apply to healthcare software?

GDPR applies to any software that processes personal data of individuals in the European Economic Area. Health data is classified as a "special category" under GDPR, requiring explicit consent and additional safeguards. This includes patient records, health monitoring data, wearable device data, and any information that reveals a person's physical or mental health condition. If your healthcare product serves European users, GDPR compliance is mandatory.

What is the difference between HIPAA and GDPR?

HIPAA applies to Protected Health Information (PHI) in the US healthcare system and governs covered entities and business associates. GDPR applies to all personal data of EU residents, with health data as a special category requiring higher protection. Key differences: GDPR requires explicit consent for health data processing, grants broader individual rights (data portability, right to be forgotten), and applies regardless of the processor's location. HIPAA focuses on technical safeguards and business associate agreements. Products serving both markets need to satisfy both frameworks.

How do you handle GDPR data residency requirements?

We design infrastructure with data residency controls that keep personal data within required geographic boundaries. For European healthcare products, this typically means EU-based cloud regions (AWS eu-central, eu-west, Google Cloud europe-west, Azure West Europe). Data processing agreements, sub-processor documentation, and cross-border transfer mechanisms (Standard Contractual Clauses) are built into the architecture and vendor agreements.

Can you build software that is both HIPAA and GDPR compliant?

Yes. We build unified compliance architecture that satisfies both HIPAA and GDPR requirements. The technical controls largely overlap: encryption, access controls, audit logging, and breach notification. The key additions for dual compliance are GDPR-specific consent management, individual rights implementation (deletion, portability), data residency controls, and documentation that maps to both regulatory frameworks.

What GDPR patient rights do you implement in healthcare software?

We implement the full set of GDPR individual rights as application features: right of access (patients can export their data), right to erasure (secure deletion workflows), right to data portability (structured, machine-readable data export), right to restrict processing, and right to withdraw consent. Each right has an audited workflow with logging that satisfies GDPR accountability requirements.

How do you handle healthcare data security under GDPR?

GDPR requires "appropriate technical and organisational measures" for healthcare data security. We implement: AES-256 encryption at rest, TLS 1.2+ in transit, role-based access controls, comprehensive audit logging, data pseudonymization where applicable, regular security assessments, and breach detection with the 72-hour notification requirement built into monitoring. Our GDPR compliance services include security architecture review, penetration testing coordination, and ongoing vulnerability management.

Do you use automated tools for GDPR compliance?

Yes. Through our partnership with Vanta, a compliance automation platform, we provide continuous GDPR compliance monitoring for our clients. Vanta integrates with cloud providers, identity systems, and development tools to verify data protection controls automatically: encryption status, access policies, data residency configuration, and audit logging. Evidence is collected continuously rather than assembled before audits. This covers GDPR alongside approximately 50 other frameworks, so clients operating across HIPAA, GDPR, and SOC 2 can manage compliance from a single platform.