Safety researchers have found safety deficiencies in many medical devices, and in response to this unfavorable situation, the US Food and Drug Administration (FDA) has issued regulations on the safety of medical devices . This announcement is intended to reiterate that in addition to the use of security, information security should also be a key consideration in the development of medical devices.
In the development of medical devices, a lot of energy is bet on the consideration of ensuring safety and reducing patient risk. Despite this, as the networking performance of different instruments continues to increase, security researchers have found security deficiencies in many medical devices. One example is the 1,400 security vulnerabilities found in a common infusion pump.
In response to this unfavorable situation, the US Food and Drug Administration (FDA) issued specifications for managing the safety of medical devices. This announcement is intended to reiterate that in addition to the use of security, information security should also be a key consideration in the development of medical devices.
FDA guidelines for network security and static analysis
After realizing that medical devices should comply with more stringent safety objectives, the FDA issued guidelines for cybersecurity management in 2014; with the further spread and application of wireless communications, networks and the Internet in medical devices, medical devices Security is also facing unprecedented challenges.
Further, unlike other instruments, medical devices are directly related to patient safety and privacy. Risk management (including security enhancement and vulnerability management) is the most important part of medical device software development - and static analysis is the most important part of the process.
The number of home care and "wearable" medical devices has grown exponentially, and they are only one branch of medical devices. Similarly, for other business and Internet of Things (IoT) business opportunities, these developments are faced with security, data security and privacy considerations.
The FDA's guidelines cover a wide range of topics and are intended to establish advanced security management practices; this guideline lists a number of reasons for the need to enable automated tools, including the following:
“Manufacturers should be cyber-safe when designing and developing medical devicesâ€; this is a topic that GrammaTech has been focusing on – taking security into account at the very beginning of R&D, rather than as an add-on after development. It is very crucial. The following is a detailed description.
“The definition of assets, threats, and security vulnerabilities should be properly discussed when designing and developing.†Static analysis integrates seamlessly with good software development processes with a special focus on detecting and identifying program code and binaries. Security vulnerabilities.
“Assessing the impact of security threats and vulnerabilities in device capabilities on end users/patients, and the likelihood that these threats and vulnerabilities will be exploitedâ€; for example, by analyzing contaminated data, GrammaTech's CodeSonar tool can Track data sources across the software and identify potential security vulnerabilities from outside.
“Manufacturers should provide documentation related to their medical device cybersecurity before submitting a product launch review; static analysis tools provide reporting tools to assist with file processing, test completion, and software readiness.
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Shandong Shengli Bioengineering Co., Ltd , https://www.shenglipharm.com