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The Overlooked Cyber Threat to Diagnostic Devices: Lessons from Synnovis Cyberattack and Beyond
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The Overlooked Cyber Threat to Diagnostic Devices: Lessons from Synnovis Cyberattack and Beyond

Tools & processes
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Vulnerability management
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Medcrypt

December 13, 2024

Navigating the Evolving Landscape of Medical Device Cybersecurity
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Navigating the Evolving Landscape of Medical Device Cybersecurity

Thought leadership
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Medcrypt

December 4, 2024

Top 5 Things People Get Wrong About SBOM Generation
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Top 5 Things People Get Wrong About SBOM Generation

Vulnerability management
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Tools & processes
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Thought leadership
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Jobe NaffJobe Naff
Jobe Naff
Medcrypt

October 30, 2024

Cybersecurity in FDA CDRH’s Proposed Guidance List for Fiscal Year 2025
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Cybersecurity in FDA CDRH’s Proposed Guidance List for Fiscal Year 2025

FDA readiness
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Regulatory
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Thought leadership
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 28, 2024

Meeting FDA Cybersecurity Requirements with Medcrypt Guardian & RTI Connext
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Meeting FDA Cybersecurity Requirements with Medcrypt Guardian & RTI Connext

Company
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Cryptography
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Tools & processes
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All authorsAll authors
All authors
Medcrypt

October 22, 2024

One Year Later: The Impact of the PATCH Act and Final Premarket Guidance on Medical Device Cybersecurity
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One Year Later: The Impact of the PATCH Act and Final Premarket Guidance on Medical Device Cybersecurity

FDA readiness
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Regulatory
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Thought leadership
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

October 2, 2024

Leading the Charge in Vulnerability Management with Helm
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Leading the Charge in Vulnerability Management with Helm

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Medcrypt

September 24, 2024

Penetration Testing for Medical Devices: Understanding the Basics and Unique Challenges
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Penetration Testing for Medical Devices: Understanding the Basics and Unique Challenges

Tools & processes
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Thought leadership
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Medcrypt

September 12, 2024

Why Secure DICOM is Poorly Accepted: Understanding the Challenges
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Why Secure DICOM is Poorly Accepted: Understanding the Challenges

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All authorsAll authors
All authors
Medcrypt

September 3, 2024

Top Myths and Deficiencies of Software as a Medical Device (SaMD) Cybersecurity
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Top Myths and Deficiencies of Software as a Medical Device (SaMD) Cybersecurity

Tools & processes
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Thought leadership
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Vulnerability management
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Medcrypt

August 27, 2024

Cybersecurity Risk Exposure of Radiology Practices and Imaging Centers
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Cybersecurity Risk Exposure of Radiology Practices and Imaging Centers

Thought leadership
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Tools & processes
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Regulatory
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Medcrypt

August 8, 2024

The Current State of DIY Artificial Pancreas Activities
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The Current State of DIY Artificial Pancreas Activities

Thought leadership
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Vulnerability management
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 2, 2024

The Critical Importance of Secure Communication in Medical Imaging
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The Critical Importance of Secure Communication in Medical Imaging

Thought leadership
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Regulatory
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Medcrypt

July 22, 2024

FAQ on Operating Systems (OS) for Medical Devices
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FAQ on Operating Systems (OS) for Medical Devices

Vulnerability management
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Thought leadership
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Tools & processes
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Medcrypt

July 12, 2024

Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices
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Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices

Thought leadership
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Company
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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

July 3, 2024

The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?
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The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?

Thought leadership
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Regulatory
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Sara FarnsworthSara Farnsworth
Sara Farnsworth
Medcrypt

July 3, 2024

Software as a Medical Device: Understanding, Regulations, and Security Priorities
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Software as a Medical Device: Understanding, Regulations, and Security Priorities

FDA readiness
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Tools & processes
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Vulnerability management
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All authorsAll authors
All authors
Medcrypt

July 2, 2024

Case Study: Optimizing Vulnerability Management: Helm Outperforms Competitors
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Case Study: Optimizing Vulnerability Management: Helm Outperforms Competitors

Tools & processes
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Vulnerability management
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Thought leadership
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All authorsAll authors
All authors
Medcrypt

July 1, 2024

What are you missing? Understanding cybersecurity reasons for FDA approval delays
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What are you missing? Understanding cybersecurity reasons for FDA approval delays

Thought leadership
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Regulatory
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FDA readiness
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Vulnerability management
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All authorsAll authors
All authors
Medcrypt

June 5, 2024

Decoding SBOM and Vulnerability Management: A Comprehensive Q&A Guide
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Decoding SBOM and Vulnerability Management: A Comprehensive Q&A Guide

Tools & processes
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Thought leadership
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Om MahidaOm Mahida
Om Mahida
Medcrypt

May 16, 2024

Decoding FDA Guidance: A Deep Dive into the Premarket Cybersecurity Update
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Decoding FDA Guidance: A Deep Dive into the Premarket Cybersecurity Update

FDA readiness
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Regulatory
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Thought leadership
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

May 1, 2024

Case Study: Enhancing Vulnerability Management Efficiency: A Comparative Analysis of Helm and Alternative Tools
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Case Study: Enhancing Vulnerability Management Efficiency: A Comparative Analysis of Helm and Alternative Tools

Tools & processes
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All authorsAll authors
All authors
Medcrypt

April 24, 2024

Case Study: Elevating Post-Market Vigilance Through Enhanced Vulnerability Detection
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Case Study: Elevating Post-Market Vigilance Through Enhanced Vulnerability Detection

Tools & processes
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Thought leadership
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Om MahidaOm Mahida
Om Mahida
Medcrypt

April 17, 2024

Are all SBOM tools created equal?
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Are all SBOM tools created equal?

Tools & processes
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Vulnerability management
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Om MahidaOm Mahida
Om Mahida
Medcrypt

April 11, 2024

Are SBOMs moving the needle for improving medical device cybersecurity?
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Are SBOMs moving the needle for improving medical device cybersecurity?

Tools & processes
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Vulnerability management
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Om MahidaOm Mahida
Om Mahida
Medcrypt

March 28, 2024

Directors, VPs, and C-Suite Executives’ Approach to FDA Stock Deficiency Letters (Part 4/4)
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Directors, VPs, and C-Suite Executives’ Approach to FDA Stock Deficiency Letters (Part 4/4)

FDA readiness
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Regulatory
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 19, 2024

Regulatory Affairs’ Approach to FDA Stock Deficiency Letters (Part 3/4)
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Regulatory Affairs’ Approach to FDA Stock Deficiency Letters (Part 3/4)

FDA readiness
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Regulatory
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Thought leadership
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Medcrypt

March 18, 2024

Proposed updates to align FDA Premarket Cybersecurity Guidance with Section 524B of the FD&C Act
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Proposed updates to align FDA Premarket Cybersecurity Guidance with Section 524B of the FD&C Act

FDA readiness
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Thought leadership
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Regulatory
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Medcrypt

March 14, 2024

Product Engineers’ Approach to FDA Stock Deficiency Letters (Part 2/4)
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Product Engineers’ Approach to FDA Stock Deficiency Letters (Part 2/4)

FDA readiness
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Regulatory
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Thought leadership
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Medcrypt

March 13, 2024

FDA is issuing deficiency letters- why you should care (Part 1/4)
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FDA is issuing deficiency letters- why you should care (Part 1/4)

FDA readiness
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Regulatory
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 11, 2024

Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment
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Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment

Thought leadership
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Vulnerability management
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

March 1, 2024

HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)
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HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)

Regulatory
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Thought leadership
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Vulnerability management
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Tools & processes
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

February 26, 2024

Meet the Experts: Naomi Schwartz
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Meet the Experts: Naomi Schwartz

Company
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Medcrypt

January 29, 2024

Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations
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Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations

All topics
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 18, 2023

Building Trust in a Connected World: Digital Certificates in Healthcare
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Building Trust in a Connected World: Digital Certificates in Healthcare

Cryptography
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All authorsAll authors
All authors
Medcrypt

November 15, 2023

Medcrypt helps you navigate RTA
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Medcrypt helps you navigate RTA

FDA readiness
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Thought leadership
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All authorsAll authors
All authors
Medcrypt

November 9, 2023

Medcrypt Wins University of California San Francisco Digital Health Award for Best in Class in Patient Safety
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Medcrypt Wins University of California San Francisco Digital Health Award for Best in Class in Patient Safety

Company
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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

November 3, 2023

Those Crafty Lil’ Buggers
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Those Crafty Lil’ Buggers

Vulnerability management
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Thought leadership
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

November 2, 2023

Happy Final FDA Cybersecurity Premarket Guidance Day to those who celebrate!
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Happy Final FDA Cybersecurity Premarket Guidance Day to those who celebrate!

Vulnerability management
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Company
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

September 27, 2023

What is eSTAR?
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What is eSTAR?

Tools & processes
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Cryptography
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FDA readiness
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

September 13, 2023

Prepare for RTA: What is the FDA Medical Device Review Process?
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Prepare for RTA: What is the FDA Medical Device Review Process?

FDA readiness
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 29, 2023

White House’s National Cybersecurity Strategy Implementation Plan (NCSIP)
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White House’s National Cybersecurity Strategy Implementation Plan (NCSIP)

Cryptography
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Tools & processes
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

July 26, 2023

A Tool to Accelerate Meeting FDA Cybersecurity Expectations: Introducing Helm by MedCrypt
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A Tool to Accelerate Meeting FDA Cybersecurity Expectations: Introducing Helm by MedCrypt

FDA readiness
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Medcrypt

June 21, 2023

FDA Cyber Device Guidance — Generate and maintain requisite documentation proving you’ve done so as part of your FDA regulatory submission
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FDA Cyber Device Guidance — Generate and maintain requisite documentation proving you’ve done so as part of your FDA regulatory submission

No items found.
All authorsAll authors
All authors
Medcrypt

April 10, 2023

FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)
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FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)

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All authorsAll authors
All authors
Medcrypt

April 7, 2023

FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device
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FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device

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All authorsAll authors
All authors
Medcrypt

April 6, 2023

FDA Cyber Device Guidance — The more you know…
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FDA Cyber Device Guidance — The more you know…

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All authorsAll authors
All authors
Medcrypt

April 5, 2023

Forbes Technology Council Post: How Does Healthcare Cybersecurity Compare To Other Industries?
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Forbes Technology Council Post: How Does Healthcare Cybersecurity Compare To Other Industries?

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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 1, 2022

The Need for Scientifically-Sound Cyber Risk Assessment
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The Need for Scientifically-Sound Cyber Risk Assessment

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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

September 14, 2022

I have an SBOM, now what?
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I have an SBOM, now what?

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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

August 2, 2022

FDA’s Cybersecurity Authority in 2023
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FDA’s Cybersecurity Authority in 2023

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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

March 29, 2022

Healthcare Is A Cyber Criminal’s Dream, But It Doesn’t Have To Be This Way
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Healthcare Is A Cyber Criminal’s Dream, But It Doesn’t Have To Be This Way

Cryptography
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

February 24, 2022

Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity
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Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity

Vulnerability management
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

January 22, 2022

Omnibus Act Impact on Medical Device Cybersecurity
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Omnibus Act Impact on Medical Device Cybersecurity

Tools & processes
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Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

January 11, 2022

The Benefits of Software Transparency
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The Benefits of Software Transparency

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Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

December 14, 2021

Medical Device Manufacturer Secure Development Lifecycle
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Medical Device Manufacturer Secure Development Lifecycle

Company
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FDA readiness
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 18, 2021

4 Key Constraints Preventing Healthcare from Proper Cybersecurity Medcrypt
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4 Key Constraints Preventing Healthcare from Proper Cybersecurity Medcrypt

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Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

August 2, 2021

What Medical Device Manufacturers Should Learn in 2021
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What Medical Device Manufacturers Should Learn in 2021

Cryptography
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Tools & processes
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All authorsAll authors
All authors
Medcrypt

April 21, 2021

2024 H-ISAC Fall Summit: Cybersecurity in Healthcare with Medcrypt
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2024 H-ISAC Fall Summit: Cybersecurity in Healthcare with Medcrypt

Thought leadership
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Company
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All authorsAll authors
All authors
Medcrypt

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