Cybersecurity for Healthcare & Innovation
Cybersecurity risks extend across every domain of life sciences, from R&D through clinical trials, manufacturing, healthcare delivery, and AI deployment. The consequences of cybersecurity failures can be severe: compromised patient safety, corrupted research data, stolen intellectual property, regulatory sanctions, and lasting reputational damage. iliomad Health Data provides domain-specific cybersecurity frameworks aligned with each operational context and regulatory requirement.
Cybersecurity Domain Coverage
We deliver cybersecurity services focused on regulatory compliance and assurance for healthcare, clinical research, and health data environments. Our work supports conformity, documentation, and risk governance across clinical systems, medical devices, AI applications, and vendor ecosystems, aligned with HDS, HIPAA, MDR/IVDR, ISO 27001, and the EU AI Act.
Clinical trials rely on digital platforms, remote monitoring, and cloud EDCs each presenting cybersecurity challenges.Security must protect patient data and research integrity while meeting regulatory requirements for HDS, HIPAA, and FADP compliance.
In healthcare settings, cybersecurity failures can directly affect patient safety. Medical device security, penetration testing, access management, and audit logging must meet MDR/IVDR and healthcare-specific requirements.
Large-scale health data processing requires robust security architecture encryption, access control, API security, and zero-trust approaches protecting sensitive information in data warehouses and analytics platforms.
AI systems require specific security measures model integrity validation, training environment isolation, and post-market cybersecurity monitoring meeting AI Act and ISO 27005 requirements.
Third-party and supply chain security is increasingly critical vendor due diligence, secure data exchange, and contractual compliance addressing the risks inherent in complex vendor ecosystems.
Effective incident response is essential detection capabilities, response protocols, regulatory notification procedures, and recovery processes minimising impact when security incidents occur.
How iliomad Health Data Can Help You
iliomad Health Data provides domain-specific cybersecurity frameworks that align with each operational context and regulatory requirement helping you implement controls proportionate to your risks, demonstrate compliance to regulators and partners, and build cybersecurity capabilities protecting your most critical assets. Our approach integrates cybersecurity with data protection, quality management, and regulatory compliance.
FAQs
Our frequently questions
Healthcare and life sciences organizations face strict regulatory requirements for protecting patient data and research integrity under GDPR, HIPAA, MDR/IVDR, ISO 27001, NIS2 Directive, and the EU AI Act making cybersecurity a compliance obligation, not just an IT concern. Inadequate security creates regulatory exposure, blocks clinical trial approvals, triggers authority investigations, compromises patient safety, and derails due diligence during fundraising or M&A transactions.
We deliver regulatory-focused cybersecurity covering clinical research security (trial data protection, EDC systems, investigator site controls), healthcare and MedTech security (medical device cybersecurity, hospital system integration, patient data protection), data platform security (cloud infrastructure, data warehouses, analytics environments), AI system security (algorithm protection, model integrity, adversarial robustness), supply chain security (vendor risk management, processor assessments, third-party controls), and incident response capabilities (breach containment, notification procedures, remediation planning). Our approach prioritizes regulatory compliance and risk governance, not generic IT security.
Key cybersecurity regulations include GDPR Article 32 (security of processing), HIPAA Security Rule (US health data), MDR/IVDR Annex I (medical device cybersecurity), ISO 27001 (information security management), ISO 13485 Section 4.1.6 (QMS risk management), NIS2 Directive (critical infrastructure), EU AI Act Article 15 (AI system robustness), and FDA guidance on medical device cybersecurity. With compliance experience across 66 countries, we navigate overlapping requirements and implement harmonized security controls that satisfy multiple regulatory regimes efficiently.
We focus on regulatory compliance, risk governance, and security documentation that satisfies auditors and authorities we are not a penetration testing firm or security operations center. However, we work closely with your technical security teams or recommend specialized technical partners to ensure security controls are properly implemented, documented, and aligned with regulatory requirements like MDR/IVDR cybersecurity obligations or ISO 27001 certification.
Contact us through our website form or email directly. We'll schedule an initial consultation to understand your regulatory landscape, identify immediate priorities, and propose a tailored engagement that fits your timeline and budget.
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