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MAKE BETTER DECISIONS WITH CYBRMD
Our medical device cyber experts will help you overcome the burgeoning risk management, regulatory, and market demands of the digital health arena.
Cyber Regulatory Support
At CYBRMD, we consult with device manufacturers and users to help mitigate cybersecurity, data privacy and interoperability risks and meet the abundant regulatory requirements.
Medical Device Security Risk Assessment
We help provide management with a precise picture of cyber risk, along with recommendations on how to improve overall risk, and compliance of regulatory obligations.
Compliance Advisory Services
We provide advisory and coordination support with key cybersecurity breach assessment, notification, and reporting requirements for each jurisdiction in which your organization operates. This specialized service helps you successfully navigate healthcare’s complex federal and state regulatory requirements.
We work with your team to evaluate the existing compliance protocols while providing meaningful feedback on the various elements and identified shortfalls. The assessment also offers insight into industry best-in-class practices that can improve the device.
CHALLENGING QUESTIONS FOR COMPLICATED ISSUES
Cybersecurity in Healthcare
Recent article in Wired Magazine stated that Medical Devices are the Next Security Nightmare
MEDICAL DEVICE SECURITY IS MISSION #1
The experts at CBYRMD have extensive experience in medical devices, cybersecurity, interoperability and patient care systems. We understand IoMT and the rigorous requirements of bringing a medical device to market. We are available to help address your concerns and challenges., and well as help you identify new opportunities and potential revenue streams.
SHUTTER SECURITY HOLES
CYBRMD consultants provide a full array of medical device services, including technical testing, device/protocol assessment, security program development and endpoint security services. We only focus on the healthcare industry and are considered the leading authorities on medical device cyber security issues and regulations.
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DOWNLOADS & LINKS
Trust CYBRMD to keep you up to date on important issues and guidelines affecting medical device cybersecurity and ever changing government regulations and guidelines.
>DOWNLOAD FDA CYBERSECURITYFACT SHEET
>DOWNLOAD FDA DRAFT GUIDANCE FOR MANAGEMENT OF CYBERSECURITY OF MEDICAL DEVICES
>VISIT MEDICAL DEVICE AND HEALTH IT JOINT SECURITY PLAN from the HPHSCC
SECURING HEALTHCARE ECOSYSTEMS
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To address medical device cyber security requirements; the FDA, Health Canada and EU have determined that vulnerability scan and penetration tests should be considered during the development lifecycle of all connected medical devices. Following are 5 frequently asked questions relating to the cyber security of medical devices:
No, just because you do not find anything does it indicate that the device is secure. You would be wise to understand that cyber security must be based on a well-structured, ongoing development process plus frequent tests.
No, there are no laws that require you to execute a test, however, most compliance documents and industry standard guidelines HIGHLY RECOMMEND that such a scan be considered.
You must consider security related tests to show that ANY change did not have a negative effect on the cyber security of your device. In most cases tests should be executed after any and all changes.
In theory, yes, you can however, you need to have the appropriate expertise within your organizational structure In our opinion, you should have an external resourcetest your devices.
The answer is simple — IMPARTIALITY. The strongest argument for having a 3rd party assessment is the impartiality of that provider.
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