Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

4 Ways the FDA is Improving Medical Device Security

FDA Commissioner Scott Gottlieb described the agency’s plan to improve cybersecurity to combat attacks on medical devices.

Medical Device Security
Medical Device Security

Although there haven’t been any cases of hackers exploiting medical devices, the risk is real. On October 1st, FDA Commissioner Scott Gottlieb laid out the agency’s four-step plan to strengthen its cybersecurity program for medical devices. Here’s what you need to know:

1. Cybersecurity "playbook."The FDA teamed up with Mitre Corp., a nonprofit that operates federally funded research and development centers, toroll outa playbook to help hospitals and health systems with cybersecurity readiness for medical devices. The playbook outlines how to develop medical device inventories, conduct training exercises among staff and take steps to reduce patient safety concerns.

2. Information sharing.The FDA will establish information sharing analysis organizations to gather and disseminate information about cybersecurity risks. One ISAO will bring together device makers to share information about potential vulnerabilities and emerging threats, while another project will encourage government agencies, such as Homeland Security, to develop collaborative responses to cyber-threats.

3. Updated premarket guidance.The FDA's current premarket guidance was finalized in 2014. In October, the agency plans to publish an update with new cybersecurity guidance — such as asking manufacturers to provide a "cybersecurity bill of materials," or a list of commercial and off-the-shelf software and hardware components in a device that could be susceptible to vulnerabilities.

4. Dedicated resources.The FDA Center of Excellence for Digital Health, which the agencyproposedin its budget for fiscal year 2019, will support a cybersecurity unit focused on medical devices, including those that are software-based or fall under the category of digital health.

List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging