Secured Health: Cyber Guidelines on Medical Devices Explained

Today, healthcare is one of the most targeted industries by cyber threat actors, with the highest average cost of a data breach, a staggering $10.10 million per breach. The wealth and breadth of sensitive patient information collected and stored, as well as the life-saving care provided by medical professionals that increasingly rely on digital technologies, makes it an enticing target. Medical devices, in particular, low doctors to administer advanced and ongoing care by monitoring or regulating patients’ health. These qualities, of being worn by or implanted in a patient, digitally or remotely accessible, and gathering patient data, make them particularly vulnerable to cyber threats. In response, the federal government has shared new guidelines for cybersecurity in medical devices and, in December 2022, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include a cybersecurity provision for application submissions of medical devices to the FDA. As medical device manufacturers submit applications for new devices or updates that require premarket review by the agency, medical device businesses, especially the C-suite, board, and counsel, will want to understand the new cybersecurity requirements to incorporate them into product designs, rather than lengthen the approval process. As threats against the healthcare industry evolve, staying current on the regulatory response enables leadership and attorneys to ensure compliance, reduce liability, and protect their organization’s assets. 

In this online seminar, our expert panelists begin by introducing the role of cybersecurity in the healthcare industry, including the uses of technology in medicine and the factors that make healthcare the most targeted industry by threat actors. Our speakers review the distinct types of medical devices and their specific cyber vulnerabilities. They discuss the recent addition of regulations and guidelines, including what they entail. Lastly, our experts give advice on how manufacturers should incorporate cybersecurity measures and the importance of monitoring of these medical devices. 

Topics covered in this webinar:    

1. Introduction to Cybersecurity and Medical Devices  

2. FD&C Amendment Section 524B  

3. FDA Guidance: “Cybersecurity in Medical Devices”  

4. Cybersecurity Recommendations for Manufacturers 

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