Cybersecurity is one of the biggest concerns for manufactures in 2023, especially for medical device, equipment and supplies manufacturers. Particularly since the pandemic, hospital and other medical-related entities have been targeted by hackers with an estimated 35 million healthcare records “compromised, exposed, or impermissibly disclosed” in 2019 alone. With so much sensitive information under threat, medical manufacturers need to actively incorporate cybersecurity into every aspect of their business to prevent security breaches.
The cybersecurity risks for medical devices are high. Hackers can go after medical records through devices to conduct identity theft or take over wireless medical devices with ransomware and force victims to pay for their devices to be released. These ransomware incidents have the potential to be deadly, as items like pacemakers and insulin pumps are susceptible. Medical devices are often targeted by hackers because they are considered easier access points into otherwise secured networks. To fortify the safety of devices, medical manufacturers must incorporate security protocols into their product designs from the beginning.
What Regulators Expect
Regulators expect medical manufacturers to take cybersecurity seriously. While the FDA is probably the main government entity medical manufacturers will engage with, it is important to remember that the FDA partners with several federal agencies, including the U.S. Department of Homeland Security (DHS), to oversee cybersecurity in medical devices. The Omnibus spending bill expanded the FDA’s authority to enforce cybersecurity for medical devices so that the Agency can verify that new technologies contain cybersecurity protections and that devices will be managed throughout their product life cycles (MedTech Dive). The FDA requires that medical device manufacturers meet quality system regulations (QSR) by addressing cybersecurity risks. In 21 CFR Part 820, the FDA recommends that manufacturers consider:
- Cybersecurity as an integral part of device safety and the QSR
- Security by design
- Security risk management
- Security architecture
- Testing/objective evidence
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How to Meet the Secure Product Development Framework
The FDA also advocates that manufacturers follow a Secure Product Development Framework (SPDF) during all aspects of a product’s life cycle, including development, release, support, and decommission. The SPDF is a set of foundational software development practices meant to reduce software vulnerabilities. To comply with SPDF expectations, the FDA likely had these practices in mind for manufacturers:
- Define security requirements for product development
- Implement roles and responsibilities
- Implement supporting toolchains with automation
- Define and use criteria for product security checks
- Implement and maintain secure environments for product development
- Protect all forms of code from unauthorized access and tampering
- Provide a mechanism for verifying product release integrity
- Archive and protect each product release
- Design product to meet security requirements and mitigate security risks
- Review the product design to verify compliance with security requirements and risk information
- Reuse existing, well-secured software when feasible instead of duplicating functionality
- Create source code by adhering to secure coding practices
- Configure the compilation, interpreter, and build processes to improve executable security
- Review and/or analyze human-readable code to identify vulnerabilities and verify compliance with security requirements
- Test executable code to identify vulnerabilities and verify compliance with security requirements
- Configure product to have secure settings by default
- Identify and confirm vulnerabilities on an ongoing basis
- Assess, prioritize, and remediate vulnerabilities
- Analyze vulnerabilities to identify their root causes
While this list is extensive, manufacturers should see these objectives as just the start of a comprehensive cybersecurity strategy, as specific strategies like encrypting medical device data are still necessary. If you need a plan for managing cybersecurity and your products throughout their product life cycle, Datix can help. With 25 years’ experience in software solutions, we understand how difficult it is to utilize technology at optimum levels securely. Our team of experts will work with you to understand your unique business needs and maximize your systems.
Cybersecurity will continue to be a pressing issue for medical manufacturers as digital tools become even more engrained into medical care and management. By incorporating cybersecurity into every aspect of your business, it is possible to stay ahead of hackers and keep patient’s personal information safe.
Learn how Cybersecurity Impacts HIPAA Compliance
With 25 years of experience, we understand what it takes to maximize software. Datix will work with you to understand your unique business needs to support your goals. Our team of experts promises to be by your side throughout your implementation and beyond.