Cybersecurity Resource Guide for Healthcare Startups

AUTHOR(S)

FERDINAN TUAZON

ABSTRACT

— The healthcare sector is no different to any industry in being a target of cyber attacks. Increasing interconnected modern healthcare devices and networks carrying sensitive and private patient data make them prime targets. Healthcare start-ups often with limited resources and cybersecurity expertise are particularly vulnerable in securing their devices. This article takes the key cybersecurity requirements from the US Food and Drug Administration (FDA), the European Union (EU) regulations, and International Medical Device Regulators Forum (IMDRF) documents to create a resource guide for healthcare organizations responsible for designing and developing medical devices at risk of cybersecurity threats. It emphasizes the importance of integrating cybersecurity in the whole product life cycle of a medical device from premarket development until post-market surveillance. Keywords — Cybersecurity, Healthcare, Start ups, Medical Device, Regulatory