“We are aware of hundreds of medical devices that have been infected by malware or dangerous computer software”, said Bill Maisel of the US FDA.

Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly “connected” to the Internet, hospital networks, and to other medical devices.

Some examples of recently highlighted vulnerabilities:

• Malware at one point slowed down fetal monitors used on women with high-risk pregnancies being treated in intensive-care wards.
• A virus caused a device to potentially expose sensitive patient information by sending it to outside servers.
• A catheterization laboratory was temporarily closed because malware had infected computer equipment needed for procedures to open blocked arteries.
• Drug infusion pumps remotely manipulated to change the dosage delivered to patients;
• Wireless implanted cardioverter-defibrillators maliciously programmed to deliver unnecessary and potentially fatal shocks or to prevent a shock from occurring when it was needed;
• Temperature settings on blood storage refrigerators reset; and
• Electronic health records altered in such a way as to cause doctors to misdiagnose conditions and prescribe the wrong treatments.

Some of these examples have occurred in clinical use and others in “ethical hacking” studies. In the United States, the FDA expects “medical device manufacturers to take appropriate steps to limit the opportunities for unauthorized access to medical devices. Specifically, we recommend that manufacturers review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise of the security of the hospital network that may be connected to the device”. Worldwide, medical device regulators are expecting the industry to address the various cybersecurity threats in all their forms.

Cybersecurity in Medical Devices – An advanced one day training programme

By attending this one day event you will gain specialised knowledge about the nature of cybersecurity threats, the array of tools and technologies available to hackers and the risk to patients and your business. We will equip you with state-of-the-art knowledge on how to effectively deal with the threat throughout the development lifecycle through both effective preventive measures and detection techniques.

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