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FDA presents best practices for medical device vulnerabilities

The agency has noted that the communication about cyber risks must be easy to understand and available online.

The US Food and Drug Administration has released a new best practice document this week. It will help the healthcare and the government agency to design a communication approach for cyber security vulnerabilities. It will further help the agency to deal properly with the medical device vulnerabilities. They will be able to deal better with such issues.

The Center of Devices and the Radiological Health of the agency have noted that the document is not guidance. It does not create any regulatory expectations. Rather the authors are hoping that this document might act as a useful resource for the industry stakeholder and the federal partners.

The document noted that the increased use of connected medical devices in the country led to an increase in cyber security vulnerabilities. During a past meeting, the patient advisor has raised the importance of clear and actionable communication about such vulnerability to promote public health. Also, it had the potential to mitigate the potential harm.

Thus while developing a cybersecurity communication strategy, the FDA advises the stakeholders and the federal partners to consider some elements. Interpretability is highly necessary as it makes things easy for people to read and understand by keeping things simple, timely, and readable. The Risks and benefits must have better attention if the device is life-saving. The availability and the findability of information are also important. The structure of the communication materials, outreach, and distribution of vehicles, etc., are also very important factors.

This week Medtronic has issued an urgent device recall for the MiniMed remote controller for optional use of insulin pumps. It can offer better protection against cyber security risks. FDA will take collective action to address the medical device vulnerability. The framework created will help the clinical provider to understand the kind of language they need to communicate with a patient.

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