5 Aug | CHICC Expert Workshop: Trust in Healthtech – Security, Compliance & AI

In an environment where digital and AI‑enabled health technologies are rapidly reshaping care, trust is increasingly won or lost on the strength of a company’s security, evidence and governance measures. Robust protection of data is a non-negotiable, clear accountability for AI‑driven solutions is a must, and demonstrable compliance is essential.

This workshop will provide healthtech professionals with a practical, end‑to‑end view of how to build secure, compliant products that are safe, trusted and primed for adoption and scale across complex health environments.

By attending, you will gain an actionable playbook for embedding security and compliance into product design and organisational strategy, sharpening your path to cyber‑readiness, regulatory approval and market access.

Our experts will examine:

• Current and emerging cybersecurity threats in health technology
• Core principles of cyber governance, board-level responsibilities and security ROI
• AI and security – an existential threat or potential ‘vaccine'?
• Protecting health data, incident preparedness and penetration testing
• The role of ISO certification in compliance, regulation, market access and stakeholder trust
• ISO 27001: Data and cyber security, privacy and information security management systems (ISMS)
• ISO 42001: Information technology and AI management systems (AIMS)
• ISO 13485: Medical devices, quality management systems (QMS) and regulatory requirements
• AI regulatory requirements and reality – considerations for compliant product development
• Leveraging AI in a QMS – opportunities, limitations and the boundaries of regulatory compliance
• The role of the human – traceability, accountability and record-keeping
• Practical case studies and lessons learnt.

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MEET OUR EXPERTS

Lyal Collins, Senior Security Consultant, Aura Information Security

Lyal Collins is a Senior Advisory Consultant based in Melbourne, working closely with organisations to transform their security posture. With more than three decades of experience in information management and cybersecurity, Lyal has held senior roles in both government and private sectors, including Chief Information Security Officer for a leading security consultancy. He specialises in PCI DSS, ISO 27001, NIST CSF, AU ISM, NZ ISM, privacy, and governance, and holds several security qualifications.

Lyal’s expertise lies in understanding business drivers and risks, then developing pragmatic, prioritised, and deliverable actions to improve security. He has extensive experience supporting startups and established businesses in the digital health sector, helping them meet compliance requirements, manage risk, and build resilient, scalable security programs.

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Seetal Erramilli, Business Development Manager – ANZ, Regulatory Services | Medical Devices, BSI Group

Seetal Erramilli is a Business Development Manager at BSI (British Standards Institution), where he works with medtech and digital health companies across Australia and New Zealand to navigate regulatory requirements, quality management systems, AI governance, and market access.

With over 15 years of experience spanning medical device product development, commercialisation, regulatory strategy, and business development, Seetal has worked closely with startups through to multinational organisations to help bring innovative technologies to market safely and effectively.

Drawing on experience from both industry and conformity assessment, Seetal is passionate about demystifying complex regulatory and compliance requirements and helping innovators view them as strategic enablers rather than barriers. He regularly collaborates with medtech entrepreneurs, accelerators, and industry organisations to build regulatory capability across the ecosystem.

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Neroli Anderson, Quality Assurance and Regulatory Affairs Consultant, Luminoma Diagnostics | Head of Regulatory Affairs, TeleMedC | Advisor for medical device, SaMD and SiMD companies

Medical device quality and regulatory affairs specialist with 10 years' experience turning complex, multi-country compliance requirements into successful product approvals.

I've implemented certified ISO13485 quality management systems and led regulatory submissions across the EU, UK, Australia, US, and Asia-Pacific markets. My focus areas: ISO13485/MDSAP compliance, quality system audits, regulatory affairs and clinical research management, from pre-market studies through to post-market evaluations, working closely with notified bodies and regulators.

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