Internet use in the medical industry has tremendously grown over the past years. The continual propagation of mobile medical devices and the amount of data in hospitals are trends medical device manufacturers should keep in mind. Also, tracking cyber-security trends should be the main aim of device manufacturers due to an increased number of cyber-attacks on medical devices. Since lives are at stake, the FDA has stepped in to guide manufacturers to ensure the safety of medical devices in the global internet world. It has called for the protection of these devices as hackers may hack them for malicious purposes.
How Hackers can Hack and Use Medical Devices
Most of the systems in the hospitals have high levels of security. However, medical devices may be an area of vulnerability and these medical devices are the point where the hackers may find entry into hospital systems. The main aim of hacking the systems is not to harm the patients but to have access to research data and patients’ records. In turn, the information is used by hackers to gain access to the hospital’s financial system or steal valuable patient information.
The stolen data may be used in manipulating the administrators for redemption. Hackers can also use the information to trigger malfunctions in the systems, thus indirectly harming patients. Besides, the information can also be used in creating undetectable malware that may take control of a drug pump. The malware can then cause the drug pump to inject dangerous doses of medication to patients, leading to their death.
FDA’s Opinion on Medical Devices and Cyber-Security
According to the FDA, addressing medical device cyber-security threats should be a shared responsibility. When these duties are shared, they will reduce the menace of injury, patients’ illness, and death. Besides, device manufacturers, healthcare facilities, providers, and patients must come together to curb security threats. Some of the medical device cyber-security concerns device manufacturers need to consider include:
- Every cyber-security blackmail is unique, and no single approach can address each scenario.
- Connecting medical devices through wireless or wired devices may not operate as intended, which leaves them exposed to hackers.
- The time taken to approve medical devices by the FDA is lengthy, while cyber threats are emerging daily.
The FDA has offered directives to the device manufacturers to develop cyber-security controls to ensure the devices are safe from hackers. Also, the cyber-security controls will ensure security and proper functionality of the medical devices. Some of those proposed security controls include; strong passwords, restriction of firmware, software updates, and user authentication.
Additionally, the FDA also proposes a collaboration between experts in cyber-security and medical device manufacturers to come up with strongly protected devices. It is also adding that security safeguards be implemented in the early stages of device design. To evade all these threats, cyber-security safeguards must be understood from the point of design to the risk management viewpoint.
Entities like Predictive Oncology (NASDAQ: POAI) that offer personalized medical remedies certainly take cyber threats seriously, and all sector players would do well to go above and beyond to prevent cyber-attacks from compromising their products or systems.
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