As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers.

Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort of cyber threat could have consequences for the integrity of the data and the privacy of the patient.

In fact, when building a connected device, it’s recommended to always assume your device will be the subject of some kind of cyber threat in order to mitigate such events from ever taking place. Regulatory bodies across the world have developed standards and requirements to guide medical device manufacturers with creating safe and secure connected devices.

In this article, we’re going to look at some key regulatory guidelines for medical device cybersecurity found in IEC 62304—“Medical device software—Software life cycle processes,” ISO 14971—“Medical devices—Application of risk management to medical devices,” and FDA guidance documents, which represent industry best practices and current manufacturing standards.

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