Medical Device Cybersecurity: Understand the Latest Developments – Webinar Recording/Transcript
A hacker gains access to a care provider’s computer network through an email phishing attack and turns off all ICU heart monitors, putting multiple patients in peril. This was the realistic scenario put out in a report from the U.S. Department of Health and Human Services, which listed medical devices as one of the top five cybersecurity threats.
Likewise, the FDA is pushing manufacturers on cybersecurity — an estimated 70 percent of devices are running outdated, no-longer-supported Windows operating systems. A surprising number have critical vulnerabilities for which a patch was long-ago available.
If your medical devices are connected to networks, other devices or the internet, they’re vulnerable to attacks that can impact their safety and effectiveness.
This presentation will show you how to incorporate cybersecurity into your quality system and defend it to interested third parties. You’ll stay compliant, bolster your device defenses and protect patients — not to mention stay out of security breach-related headlines.
Eric Henry, a senior quality systems and compliance advisor in the FDA and Life Sciences practice of the law firm King & Spalding, will explain how to bolster your medical device cybersecurity. In particular, he’ll address the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory activities.
- How cybersecurity relates to design controls and the quality system more generally
- Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts
- How addressing cybersecurity risk relates to product risk management
- What regulatory literature currently exists globally and some of the ways they compare to each other (e.g., FDA premarket and postmarket cybersecurity guidances, AAMI TIR-57 and TIR-97, IMDRF cybersecurity guidance, MDCG cybersecurity guidance, and various national guidance documents)
- Common cybersecurity issues identified during inspections and submission reviews
Ensure your devices can withstand attack, keep patients safe … and make sure your business isn’t part of the next hack-related headline.
Meet Your Presenter
Eric Henry is a senior quality systems and compliance advisor in the FDA and Life Sciences practice of the law firm King & Spalding. He has 30 years of global leadership and practitioner experience in a variety of quality, compliance and product development roles, with a specialization in large organizational change and remediation programs, software quality (including cybersecurity), medical device design controls, risk management, audit management and management controls. Prior to joining King & Spalding in late 2018, Mr. Henry led global technical and quality organizations at Philips, Medtronic, GE Healthcare, Boston Scientific and Hologic. Prior to entering the medical device industry, he led a software quality management and program management consulting firm and held software design and development leadership roles in a variety of companies.
Who Will Benefit
- Software engineers
- Quality assurance personnel/engineers
- Regulatory affairs personnel
- Legal personnel
- Functional and business leaders
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Aug. 2, 2022