Why AI Governance Matters in Healthcare
Artificial Intelligence is revolutionizing how healthcare companies engage with patients, professionals, and data. But without guardrails, AI can introduce:
- Regulatory risk and legal exposure
- Bias, misinformation, and patient safety concerns
- Data privacy violations (e.g., GDPR, HIPAA)
- Unintended promotional compliance breaches
At Eunomia, we help life sciences companies implement responsible, compliant, and defensible AI governance frameworks—from policy to practice.
Our AI Governance & Enablement Services
AI Risk & Use Case Assessment
- Map and classify AI/ML use across the business (e.g., medical content generation, HCP targeting, automation)
- Score use cases under EU AI Act, GDPR, and ICH frameworks
- Identify high-risk, regulated, or human-in-the-loop models
Governance Framework & SOP Design
- Build AI governance operating models with defined roles, decision rights, and escalation paths
- Develop audit-ready SOPs for AI deployment, validation, monitoring, and incident handling
- Integrate AI governance with your existing risk and compliance controls
Policy & Ethical Guardrails
- Create AI/algorithm governance policies addressing transparency, bias, explainability, and data ethics
- Embed controls to prevent off-label use, promotional risk, or patient safety violations
- Tailor policies to internal use or third-party AI tool acquisition
Compliance Chatbots & AI Agents
- Design and deploy custom compliance chatbots to assist employees with SOPs, FMV, data privacy, and HCP engagement queries
- Build bots using rules-based and natural language models, tailored to your own documents and jurisdictional codes
- Ensure conversational agents are efficient, context-aware, and strictly compliant—reducing bottlenecks and increasing field confidence
Training & Change Management
- Deliver modular training programs to legal, compliance, and cross-functional teams on AI risk and responsible usage
- Build awareness campaigns on red flags and regulatory watchpoints (e.g., hallucinations, automated decisions)
AI Vendor Due Diligence & Oversight
- Review and assess third-party AI tools for data handling, explainability, IP ownership, and bias
- Support vendor onboarding, contracts, and ongoing monitoring
Monitoring, Reporting & Audit Support
- Create AI lifecycle trackers for updates, retraining, and validation logs
- Support audits and regulatory inspections on AI-related governance topics
Why Clients Choose Eunomia
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Cross-functional Expertise
We blend compliance, legal, medical, and tech know-how to govern AI across silos. -
Practical Implementation
From chatbot deployment to policy drafting—we operationalise AI governance. -
Regulatory Alignment
We build AI compliance that anticipates EU AI Act, FDA guidance, GDPR, and IFPMA/EFPIA codes. -
Tools That Work
Our chatbots and AI governance tools are intuitive, easy to implement, and tailored to your existing content.
FAQs
At Eunomia Pharma Services, our team of Compliance experts provides strategic guidance and operational support at both Europe and local country level.
Our mission is to design innovative
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