Collaborative Security for Medical Devices – Best Practices for Device Manufacturers and Healthcare Delivery Organizations

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By
Protiviti

Ensuring the Safety of Patient Data Security and Privacy

This article underscores the critical need for collaboration between medical device manufacturers (MDMs) and healthcare delivery organizations (HDOs) to mitigate cybersecurity risks posed by connected medical devices. It advocates prioritizing security throughout the medical device lifecycle, from design and implementation to maintenance and disposal. It also recommends adhering to guidance from regulatory bodies like the FDA and industry standards such as NIST and HIPAA to establish robust defenses against cyber threats. Key collaborative strategies include documenting and sharing roles and responsibilities, utilizing Manufacturer Disclosure Statement for Medical Device Security (MDS2) forms and Software Bill of Materials (SBOMs), and disseminating user manuals that detail security configurations and preventive maintenance cycles.  

Additionally, developing device whitepapers and custom implementation guidance can enhance understanding and provide a competitive edge. Participation in information-sharing consortiums and working groups, such as MedISAO, H-ISAC and HIMSS, fosters transparency and collective knowledge. Conducting joint cybersecurity risk assessments using frameworks like NIST's Cybersecurity Framework helps identify vulnerabilities in integrated environments. Coordinating incident response plans with MDM partners ensures comprehensive planning and resilience. This article emphasizes that medical device security is a shared responsibility, requiring MDMs to incorporate security features and guidance while HDOs implement and maintain these measures. By working together, MDMs and HDOs can create a secure healthcare delivery system that protects patient well-being and data privacy.