GDPR Compliance for HealthTech
— Audit-Ready in 2–4 Months

Yes. Under Article 3, GDPR applies extraterritorially to any HealthTech company that offers services to people in the EU or monitors their behaviour, even with no EU office. EU customers also flow these obligations down through Article 28 DPAs, so GDPR compliance is effectively required to win and keep EU business.

ISpectra delivers GDPR readiness for HealthTech in 2–4 months — data mapping and Article 30 RoPA, Article 35 DPIA, policy implementation, DSAR workflows and breach response. Running GDPR with ISO 27701 or SOC 2 in parallel takes a little longer.

Data mapping and Article 30 RoPA, an Article 35 DPIA, lawful-basis and consent records, a 40+ policy library, Article 32 technical and organisational measures, DSAR workflows, an Article 28 DPA and sub-processor programme, EU-US transfer mechanisms, Article 27 EU-representative guidance, a 72-hour breach plan, training and a free Network VAPT.

Most HealthTech firms are controllers for their own user data and processors for customer data handled on instructions. We map both roles across your contracts and data flows and build the obligations into your policies and DPAs.

A DPO is mandatory where core activities involve large-scale or systematic monitoring or special-category data. Where you lack the role, ISpectra supplies a virtual DPO (vDPO).

Transfers need a valid Chapter V mechanism. We help you self-certify to the EU-US Data Privacy Framework, or implement EU Standard Contractual Clauses plus a Transfer Impact Assessment, then fold the mechanism into your DPA programme.

Fines reach up to €20 million or 4% of global annual turnover, whichever is higher. For HealthTech, the bigger cost is usually lost EU enterprise deals and damaged trust after a complaint or breach.

Yes. GDPR shares up to 70–85% of its controls with ISO 27701, ISO 27001 and SOC 2. We build the control set once and reuse it across frameworks, so running them together is far cheaper than doing each alone.