Webinars >>FDA Regulations
Cybersecurity and FDA: Rules for Software and Software Containing Devices
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Healthcare and FDA regulated industry is increasingly exposed to cybersecurity challenges with the rapid progress into paperless and electronic systems. In terms of cybersecurity practices, many aspects of this industry are no different from say the banking systems, but there also exist several concerns unique to the FDA-regulated devices particularly due to the risks to safety of patients and security of personal health information. Over the last few years, FDA has been slowly building rules and guidance documents to help the industry address common concerns prior to approval and ongoing monitoring post-approval. There is lack of easily available information for developers leading to many guessing FDA’s expectations or worst dealing with negative feedback from FDA during review of applications. This seminar will discuss the current status and future projections for cybersecurity measures expected by FDA in regulated products.
Why should you attend:
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This webinar is a must for anyone using cloud storage, electronic communications, networked devices, smartphones, remote monitoring, electronic health records, electronic data capture, PCs, and any device connected to internet by wires or wirelessly. FDA rules for cybersecurity measures in devices used to generate, analyze, store or deliver data during development phases and approved for use will be discussed. The webinar is intended to provide regulatory perspectives on cybersecurity aspects of FDA-regulated products and practices. Instructions will be provided and checklists discussed using examples to highlight the common concerns and FDA-acceptable solutions.
Areas Covered in the Session:
  • What products are covered under cybersecurity measures
  • FDA’s current rules for cybersecurity measures in regulated devices and delivery systems
  • How FDA monitors cybersecurity concerns
  • FDA rules for CDS, IoT, MDDS, software, apps, and other related products
  • FDA and DHS’s ICS-CERT
  • FDA internal cybersecurity measures to protect industry information
  • Best practices to assure your computer systems, both online and physical are protected and compliant
Who will benefit:
  • Information technology personnel
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: December 16, 2019
​Duration: ​60 Minutes
​Time: 3 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com