Medical devices are becoming more advanced as technology evolves, providing patients with better care and connectivity with medical professionals.
From insulin pumps to pacemakers, many people enjoy a better quality of life, and fewer doctor visits thanks to connected medical devices. However, these devices have one considerable drawback: the potential for cyber-attacks.
Any time a medical device depends on a wireless or wired connection or uses software, it can be exploited by cyber-attackers who wish to gain control or information about users or cause disruptions. Therefore, robust security is needed to ensure these devices help users instead of harming them.
Here is a look at some effective strategies for ensuring maximum protection from cyber threats throughout the medical device product lifecycle.
Cyber Threats To Medical Devices
Any malicious action or attempt to exploit the vulnerabilities of a connected medical device or its software is considered a cyber threat. Many potential cyber-attack sources exist, from criminals and hackers to terrorists and insiders.
Here is a look at some of the top cyber threats facing medical devices:
- Theft of data
- Manipulation of the device
- Unauthorized access to the device or its data
- Denial of service
- Ransomware
- Malware
- Interference with the device’s communication system or network
- Unauthorized control of the device
Any of these threats can cause significant harm to the health and safety of the patient using the device, in addition to infringing on their privacy. Some hackers may target entire product groups when vulnerabilities are identified, compromising multiple users simultaneously.
For healthcare providers and medical device manufacturers, cyber-attacks can result in legal liability, regulatory action, damage to their reputation, and financial losses. Therefore, protecting these devices from cyber threats throughout their life cycle is essential. Below are strategies that can be used at each stage to ensure proper protection.
Design & Development
Cybersecurity best practices must be incorporated into the design and development of medical devices. This requires performing threat modeling to identify potential risks and mitigate them.
Authentication, encryption, firewalls, and anti-tampering technology should be implemented at this stage. Manufacturers must also follow cybersecurity guidance issued by regulators.
Pre-Market
Before these devices are offered to the public, device manufacturers should take measures to demonstrate that they are secure. This entails conducting cybersecurity risk assessments and validations and documenting the devices’ cybersecurity specifications.
It is also important for manufacturers to draft clear instructions on how the device can be used and maintained safely. If there are any known limitations or vulnerabilities, they must be disclosed at this stage.
Post-Market
Security efforts should not cease once the products have entered the market; cybersecurity is an ongoing process that requires regular monitoring and adjustments. A cybersecurity incident response plan should be set up to address any issues or events that arise, and an appropriate team should be put in place to handle these issues.
Cybersecurity professionals should provide timely updates and patches to minimize fallout when threats or vulnerabilities are identified. Any cybersecurity-related issues or actions should be communicated clearly to customers, healthcare providers, and regulators.
User Guidelines
The healthcare providers and patients who use these devices must be informed about proper cybersecurity protocols. This includes instructions on configuring the device settings to suit its usage and environment. Information should also be provided on using strong passwords and encryption to protect the device and its data.
All users should be informed of best practices to ensure the device remains under their physical control and avoid any unauthorized connections and modifications. Manufacturers should provide clear and specific instructions for reporting any questionable or unusual behavior or activity. In addition, they should explain how the device can be securely disposed of when it is no longer required.
Users should also be warned to connect their devices to software and other devices only if they have been specifically instructed by their healthcare provider or the device manufacturer.
The FDA recommends updating these devices and regularly checking for patches or fixes. However, patients should avoid applying fixes to the device on their own, particularly those they find on the internet.
All alerts emitted by the device should be investigated promptly. Family members and caregivers should also be educated on the proper use of the device, particularly if the patient is not tech-savvy.
Learn More About Medical Device Security From The Cybersecurity Professionals
Modern medical devices can improve countless lives, but it is important to remember that cyber-attacks constantly threaten their safety and functionality.
The cybersecurity professionals at Advantage Tech can help device manufacturers, patients, and healthcare providers ensure they use these devices safely and develop tailored strategies that protect them around the clock. Contact us today to learn more about our services.
