Medical Device Supply Chain Cybersecurity
Medical Device Manufacturers (MDM's) have a Responsibility to Mitigate Cyber Risk
According to the Food & Drug Administration (FDA) Medical device manufacturers (MDMs) and health care delivery organizations (HDOs) should take steps to ensure appropriate safeguards are in place for mitigating cyber risk.
Background
The FDA has published general guidance for supply chain organizations in the medical device market. There are responsibilities for vigilance in identifying risks and hazards associated with the medical devices including risks related to cybersecurity. In addition, Medical Device Manufacturers (MDM's) are responsible for putting appropriate mitigations in place to address patient risks and ensure proper device performance.
The list of guidance includes several white, papers, publications and regulatory guidelines for the MDM's to develop their device and cyber programs. These include, Playbook for threat modeling, Best practices for communicating Cybersecurity Vulnerabilities, NIST guidance on pre and post management of cyber security incidents, and strengthening Cybersecurity Practices. In addition to the FDA, the Healthcare Supply Chain Association (HSCA) published additional guidance and contract language for Manufacturers and Healthcare Delivery Organizations (HDO's).
Challenge
A MDM should develop a comprehensive Cybersecurity Program for their organization that enables cybersecurity best practices throughout the corporate function and development of products. The topics below as described in the HSCA publication are very standard practices that any manufacturing company should follow.
- Compliance with FDA guidance relative to Cybersecurity Risks
- Products should be free of known malware or other vulnerabilities
- MDM's should comply with all reasonable security practices for network and device security guidelines and best practices: FISMA, ISO, SANS, NIST
- MDM's should be able to resolve cybersecurity threats and vulnerabilities in a timely manner
- MDM's should follow Cybersecurity best practices such as ISO 27001, SOC II or NIST.
- Follow Vulnerability scoring standards and process to address both vulnerabilities and threats
- Apply security processes for access control, encryption and cybersecurity monitoring
Solution
Cytellix® has developed the only solution in the industry that can assess, identify and detect "known" and “unknown” threats in any environment, while providing complete threat, vulnerability and regulatory compliance visibility in real-time.
The Cytellix® Cyber Watch Portal (C-CWP™) was specifically designed to support supply chain organizations who have both regulatory obligations for cybersecurity and overall cyber threat, vulnerability and reporting obligations. Our multi-frameworks support for all standards based Cybersecurity including ISO, NIST, PCI, SOC II prepares MDM's to meet the obligations in cost effective and low friction process.
In case where a supply chain needs to be managed from a cybersecurity, compliance and vulnerability perspective, the C-CWP™ option to add our patented Cytellix® Executive Cyber Watch Portal (E-CWP) that enables complete visibility of the supply chain in a single pane of glass is a solution that is invaluable.
Advantages
By combining proactive compliance and risk management, situational awareness, threat detection, vulnerability management and incident response Cytellix® safeguards the entire organization.
Other key advantages include:
- Compliance with FDA guidance relative to Cybersecurity Risks (C-GRC™)
- Turnkey endpoint detection and response solution (C-EDR™)
- Security framework-based assessments, monitoring and reporting capabilities (NIST, ISO, PCI, GDPR, PCI, SEC, FDA)
- Real-time vulnerability management, industry standard scoring, reporting and Workflow
- 24x7x365 monitoring of threats and response solutions
- Guidance and best practices for security solution implementations - MFA, Encryption, Access Control
Every client also benefits from Cytellix®'s industry-leading range of standard
cybersecurity services and solutions, including:
Cytellix® Platform
Action
Medical Technology Manufacturers of all sizes are at exceptional risk if they fail to implement effective, comprehensive cybersecurity at a core level. To explore how we can assist your organization, and to schedule an assessment of your current cybersecurity posture, contact us.
Cytellix® Cyber Watch Platform (C-CWP™)
C-CWP™ provides value by baselining the truth about the true cyber posture of our customers. We then move towards a cybersecurity mesh architecture of integrated continuous improvement that aligns with business objectives. C-CWP™ is an interoperable and open platform designed for change in posture and threat landscape. C-CWP™ is delivered as a complete “turnkey” outsourced service or in combination with internal teams and previously purchased security capabilities
Cytellix® Endpoint Detection Response (C-EDR™)
Cytellix® Endpoint Detection & Response (C-EDR™) is a flexible solution that can be used standalone, enables bring-your-own-license or can be provided turnkey as a complete managed solution with our C-GRC™, C-MDR™, XDR, SOC 24x7x365 managed Turnkey Solutions. The Cytellix turnkey C-EDR™ is a Enterprise grade solution that is complete and has full integration with the Cytellix platform.
Cytellix® Governance Risk & Compliance (C-GRC™) & IT Risk Management (IRM)
Risk Management requirements are evolving to align to the changes arising from compliance risk shifting towards regulatory impact on business process. The demand on organizations to understand their cybersecurity posture, report status and meet regulatory obligations is driving demand across the enterprise (small>large) for a non-technical, turnkey all-inclusive platform.
Cytellix® Managed Detection Response (C-MDR™)
Patented technology compiles information from the vulnerability's, governance, risk, compliance assessments, event data, and analytics. Delivers real-time analysis, including continuous improvement visualization and scorecard.
Extended Detection Response (C-XDR™)
The Cytellix® Extended Detection Response (C-XDR™) solution leverages our flagship Cytellix Cyber Watch Portal (C-CWP™) as turnkey compliance, awareness and response platform. Our C-XDR™ includes, vulnerability management, devices profiling, network segmentation, asset discover, threat intelligence, leak detection, EDR, pre-defined use cases for log ingestion and correlation of threats and our USA based 24x7x365 Security Operations Center (SOC). The Cytellix platform leverages our in-house AI/ML models for real-time telemetry, threat discovery/hunting and ticket reduction. This is a complete turn-key, affordable XDR solution.
Cybersecurity for Small and Medium Business
Cytellix® has designed its platform to enable the small and medium business to adopt quickly, with low friction at an affordable price. We have found that the tasks of both regulatory compliance with cybersecurity frameworks and building a high quality cybersecurity monitoring and infrastructure is a significant time, resource and expense issue for SMB's.
How We're Different
Cytellix® is a first-of-its kind patented SaaS platform that brings together cybersecurity, compliance, and risk management under one fully integrated umbrella. We know your "real security posture" and can provide a new way to manage and deploy cybersecurity capabilities, risk awareness, and compliance with a plan tailored to your specific situation and needs.
Contact Us
The Cytellix® team of experts have been delivering cybersecurity for the past 15-years to some of the largest networks in the world. This expertise is delivered to our SMB customers as an affordable, precise, and comprehensive solution designed for organizations who need to comply with Cybersecurity regulatory requirements. There is no other fully integrated GRC, MDR, XDR, EDR single pane of glass solution that is as rich in capabilities, as easy to use and available in production today.