Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Companies Nervous About 'Sharing' Organizations Touted In FDA Cyber Guidance

This article was originally published in The Gray Sheet

Executive Summary

Industry groups have questions and concerns about the Information Sharing and Analysis Organizations highlighted in FDA's recent postmarket cybersecurity draft guidance. The agency's use of the term "essential clinical performance" in the document has also raised concerns, comments submitted to FDA show.

You may also be interested in...



Device-Makers Have Amped Up Defenses Against Hackers

As reports of potential cybersecurity vulnerabilities and ransomware attacks on health-care institutions have increased in recent years, manufacturers are stepping up efforts to protect their products and reputation. To defend against such attacks companies are developing strategies and hiring hackers who are able to understand potential adversaries.

J&J, Hacker Work Together To Fix Insulin Pump Vulnerability

US FDA says the collaborative approach taken by an independent security researcher and Johnson & Johnson/Animas in responding to a potentially fatal cybersecurity vulnerability with the firm's Animas OneTouch Ping insulin pump should be a model for the industry that aligns with the agency's recent draft guidance.

St. Jude Hacking-Risk Allegations: US FDA Continues Assessment, As Firm Files Lawsuit

While conflicting reports have surfaced regarding the veracity of allegations from a short-seller that a significant number of St. Jude cardiac rhythm management devices have serious cybersecurity flaws, FDA says plans to complete an initial assessment of the allegations soon. The Minnesota device-maker, meanwhile, says it is suing the short-seller for disseminating false information.

Topics

UsernamePublicRestriction

Register

MT034733

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel