Managing Cybersecurity Vulnerabilities
Throughout the Product Lifecycle
Certified ISO 27001
We help Medtech manufacturers address cybersecurity throughout the product lifecycle, including during the design, development, deployment, and maintenance of the device.
In an era where technology and healthcare converge, the advancement of medical devices has transformed patient care, offering unprecedented opportunities for monitoring, diagnosis, and treatment. However, this connectivity brings with it a significant challenge – cybersecurity threats, which pose a real risk not only to the integrity of medical devices but also to patient safety and data privacy.
CYBERSECURITY FOR MEDICAL DEVICES
RECENT DEVELOPMENT PROJECTS
CLIENT CASE STUDY:
Managing Cybersecurity Risk for a Cloud-based Patient Management Platform
Our client is a medical technology company that develops products to improve the quality of life for patients with neurohealth disorders. They rely on Syncro Medical to design and implement cybersecurity measures for their cloud-based patient data management platform including:
- Monitoring of and mitigations for the OWASP top ten security risks
- Generation/monitoring of software dependencies in the Software Bill of Materials (SBOM)
- Implementation of HIPAA password guidelines
- Protecting and isolating user credentials
- Protecting and isolating Personal Identifiable Information (PII)
CLIENT CASE STUDY:
Mitigating Cybersecurity Vulnerabilities in Legacy Medical Devices
A global medical technology company engaged Syncro Medical to accelerate software fixes of known security vulnerabilities for a legacy market-leading product in their diagnostics portfolio.
Our client faced a pivotal challenge when results of a software vulnerabilities assessment identified five priority categories and they did not have sufficient internal software development resources available to address the problem.
Syncro Medical quickly mobilized by creating and then executing a plan to mitigate the complex array of security vulnerabilities. As a result, this client was able to address the problem while keeping their internal resources focused on other critical projects and priorities.
Don't let cybersecurity vulnerabilities threaten the safety and marketability of your medical devices.
Contact us today to learn how we can assist your team in assessing product risk and in developing and executing a mitigation plan.
Why Is Cybersecurity for Medical Devices Important?
As medical devices become more interconnected and reliant on the internet, they become more vulnerable to cyber threats. These risks range from unauthorized access and control of medical devices to the theft of sensitive patient data. The implications are profound, affecting not just the functionality of the devices but also potentially leading to critical health risks for patients.
Understanding the Risks:
•Data Breach: Unauthorized access to confidential patient data can lead to privacy violations and identity theft.
•Device Tampering: Cyberattacks can alter the functioning of a device, risking patient health.
•Service Disruption: Cyber threats can cause system failures, interrupting essential medical care.
Mitigating the Risks: What Can Manufacturers Do?
The FDA urges manufacturers to monitor and assess cybersecurity vulnerability risks, and to be proactive about disclosing vulnerabilities and solutions to address them.
•Conduct a Vulnerability Assessment: The assessment evaluates if the system is susceptible to any known vulnerabilities, assigns severity levels to those vulnerabilities, and recommends remediation or mitigation.
•Implement Robust Encryption: Ensuring data transmitted to and from the device is encrypted can protect against interception and misuse.
•Regular Software Updates and Patches: Keeping software up to date is crucial to protect against known vulnerabilities.
•Secure Device Authentication: Employing strong authentication mechanisms can prevent unauthorized device access.
•Develop a Rapid Response Plan:A clear, swift response strategy for potential breaches is essential for minimizing risks.