Cybersecurity and FDA: Navigating FDA Rules for Cybersecurity in Regulated Products

Date: June 10, 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
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
Clinical Professionals
Vice presidents, Directors and Managers
People working in the FDA-regulated industry
People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.