Many patients and healthcare practices are, and so is the U.S. Food and Drug Administration (FDA).
That is why the FDA issued draft guidelines to medical device makers to protect patient information.
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Cybersecurity continues to be a growing threat in the healthcare industry, and this threat has now expanded to medical devices.
The cybersecurity threats facing medical devices could risk both the safety and the effectiveness of the devices.
So what does the FDA’s guidance say?
It recommends that companies involved with the manufacturing of medical devices:
- Monitor and assess cybersecurity risks,
- Coordinate with other companies, the government, and other groups to disclose vulnerabilities, and
- Take measures to address potential risks early.
The guidelines are not legally binding.
The FDA also advised as to how to monitor devices after the medical devices have been cleared for marketing.
We help our clients perform thorough risk assessments for all of their medical devices and medical technology. This step is essential to protect your patients and to make them feel comfortable about the security of their health information.
The guidelines are currently open for public comment. After the 90 day comment period has expired, the FDA will issue its final guidance.
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