AI Healthcare
AI enables transformative improvements indiagnostics, clinical decision support, precision medicine, and healthcareoperations but deployment requires careful attention to patient safety, dataprotection, and regulatory compliance.
Healthcare AI Domains
We guide healthcare providers and HealthTech companies through the regulatory complexity of AI-powered care. From diagnostic imaging to robotic surgery, our expertise covers the full spectrum of healthcare AI navigating the AI Act, MDR/IVDR, GDPR, and sector-specific standards like ISO 13485.
Whether your AI supports clinical decisions, enables precision medicine, powers telehealth, or streamlines operations, we ensure appropriate risk classification, documentation, human oversight, and data governance are built in from the start.
AI-powered diagnostics such as imaging analysis, pathology interpretation, predictive risk models offer tremendous potential but require rigorous compliance with AI Act, MDR/IVDR, and bias prevention requirements.
AI-powered CDS integrated into EHRs and clinical workflows requires appropriate risk classification, human oversight, technical documentation, and data governance ensuring safe, compliant operation.
AI in genomics and personalided medicine requires deep attention to data governance, cross-border flows, and genetic data protection alongside AI Act compliance.
AI in telehealth, chatbots, and remote monitoring must meet transparency, consent, and safety requirements ensuring patient-facing AI operates within appropriate boundaries.
AI in robotic surgery demands strict safety attention post-market surveillance, human oversight protocols, and documentation meeting both AI Act and ISO 13485 requirements.
AI in billing, scheduling, and resource optimisation must remain transparent, fair, and accountable even when not directly involved in clinical decisions.
How Iliomad Health Data Can Help You
iliomad Health Data ensures your healthcare AI systems operate under full compliance with all applicable frameworks helpingy ou balance innovation with accountability, leverage AI's potential while protecting patient safety, and build applications earning trust from regulators, clinicians, and patients.
FAQs
Our frequently questions
AI applications in diagnostic imaging, clinical decision support, precision medicine, virtual health, robotic surgery, and administrative operations must comply with EU AI Act, MDR/IVDR, GDPR, and sector-specific standards like ISO 13485. We provide integrated AI regulatory, data protection, and cybersecurity compliance across all healthcare AI applications, with experience in 66 countries.
Critical risks include diagnostic AI lacking EU AI Act conformity assessment and clinical validation, clinical decision support systems without proper human oversight frameworks, precision medicine AI processing genetic data without adequate GDPR safeguards, telehealth AI lacking transparency documentation, robotic surgery AI without proper risk management, and administrative AI making decisions affecting patient care without explainability. These trigger regulatory rejections, patient safety issues, and authority investigations.
We provide AI regulatory compliance (EU AI Act conformity assessment, MDR/IVDR integration, algorithm validation), data protection compliance (patient data governance, consent frameworks, privacy integration), and cybersecurity compliance (AI system security, adversarial robustness, model integrity). Our services cover diagnostic AI, clinical decision support, precision medicine, virtual health, robotic surgery, and administrative AI applications.
No - it depends on the AI's purpose and risk: diagnostic AI and clinical decision support are typically high-risk (requiring conformity assessment), precision medicine AI analyzing genetic data is often high-risk, virtual health chatbots are usually limited-risk (transparency only), administrative AI for scheduling is minimal-risk (no specific requirements), and robotic surgery AI is high-risk. We assess your AI systems and implement compliance based on actual regulatory classification.
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.
Any Questions ?
