Thursday, September 26 • 9:00 AM - 9:45 AM Eastern Time (US & Canada)
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Location: Conference Room 52B
Title: Cost of Connectivity: Managing the Evolving Landscape of Cybersecurity Regulations
Event Type: Master Class Conference
In recent years, the MedTech industry has seen a steep incline in the popularity of connected medical devices, spurred by the need for remote monitoring solutions during the pandemic, the recent rise in AI utilization, and the continued popularity of these devices for the increased convenience and capabilities they provide both providers and their patients. Unfortunately, with the increased presence of these devices also came the increased risk of cybersecurity attacks and healthcare data breaches. Since 2018, the healthcare industry has seen a 239% increase in hacking-related data breaches and a 278% increase in ransomware attacks1. These risks have led the FDA to increase oversight of products with these features and potential vulnerabilities, issuing the final guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, in September of 2023.
In this presentation, Accorto Regulatory Solutions will give a brief overview of the FDA’s evolving cyber security regulations, discuss which types of devices these regulations apply, and dive into how MedTech innovators can prepare for these regulatory hurdles in the early stages of product development, giving them a competitive advantage when it comes to planning and budgeting for the development of their application for pre-market authorization. This will include understanding the additional cost elements associated with ongoing cyber security risk assessments, collecting additional information, and building cyber security measures into the product development process.
[1] https://www.hipaajournal.com/healthcare-data-breach-statistics/
