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MDISS RESOURCES

Studies, research, standards and templates from MDISS, our Members and Partners.
https://cdn2.hubspot.net/hubfs/3415072/MDISS%20Fall%20Congress%202017%20Ungated%20Slides.zip
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https://cdn2.hubspot.net/hubfs/3415072/Kurt%20-%20How%20to%20Join%20MDISS%20Nov2'17.pdf
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https://cdn2.hubspot.net/hubfs/3415072/Axel%20MDISS%202017%2011%2001.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Doug%20CSD%20-%20MDISS%20-%201Nov2017%20-%20Maughan%20-%20FINAL.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Boris%20Public%20Health%20MDISS%2031OCT2017.Lushniak.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Boris%20MDISS%20FALL%20CONGRESS%202017%20-%20UMD%20SPH.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Joe%20AAMI%20STANDARDS%20PRESENTATION%20FOR%20MDISS%2011-1-2017.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Michael%20WHISTL%20basics%20MWL.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Anne%20MESH%20MDISS%2011.01.17.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Rita%20MDISS%20George%20Mason%20Univ%20%2010312017.pptx
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https://cdn2.hubspot.net/hubfs/3415072/Resources/Guidance%20for%20Industry%20Cybersecurity%20(OTS).pdf

FDA Guidance: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

Medical device cyber vulnerabilities represent a risk to their 'safe and effective' operation, and typically require an ongoing maintenance effort to mitigate.  This is the FDA's guidance on how existing regulations apply to those cyber maintenance activities.

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https://www.mdiss.org/hubfs/Resources/NIST%20cybersecurity-framework-v1.11.pdf

HIMSS/NEMA Standard HN 1-2013: Manufacturer Disclosure Statement for Medical Device Security

The MDS2 form and instructions how to complete it. The intent of the MDS2 is to supply healthcare providers with information to assist them in assessing the risks and vulnerabilities of medical devices, as they pertain to disclosure of PII.

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https://www.mdiss.org/hubfs/Resources/NIST%20cybersecurity-framework-v1.11.pdf

NIST Cyber Security Framework (CSF) Jan 2017

This resource lays out a national, voluntary risk-based Cybersecurity Framework (a set of industry standards and best practices) in partial fulfillment of executive order 13636. 

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http://novasano-3415072.hs-sites.com/join-mdiss

JOINING MDISS

What do you get as an MDISS member? Read all about it here. 

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http://novasano-3415072.hs-sites.com/membership-deck

MDISS MEMBERSHIP DECK

Let this presentation help you make a case for MDISS (converted into a PDF for your font-preserving sanity). DRIVE CHANGE. JOIN MDISS.

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http://novasano-3415072.hs-sites.com/web-standards-list

Web Standards

Click for additional FDA-recognized international device security standards.
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https://cdn2.hubspot.net/hubfs/3415072/Resources/UL%202900%20STANDARD%20(Volume%2082).pdf

UL 2900 Standard (Vol 82)

This resource aids US medical device market registrants in the demonstration that their products' cybersecurity requirements comply to FDA guidance.

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https://cdn2.hubspot.net/hubfs/3415072/Resources/The%2062443%20Series%20of%20Standards.pdf

The 62443 series of standards

The 62443 series of standards have been developed to address the need to design cybersecurity robustness and resilience into industrial automation control systems. 

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https://cdn2.hubspot.net/hubfs/3415072/Resources/Standards%20FDA%20Myths_Facts.pdf

FDA Fact Sheet

Check out the FDA Fact Sheet.
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https://cdn2.hubspot.net/hubfs/3415072/Resources/OWASP%20SecureMedicalDeviceDeployment.pdf

OWASP

OWASP Secure Medical Device Deployment Standard. Intended to serve as comprehensive guide to the secure deployment of medical devices within a healthcare facility.

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https://cdn2.hubspot.net/hubfs/3415072/Resources/FDA%20Postmarket%20Guidance%20for%20Cybersecurity%201400044.pdf

Postmarket Management of Cybersecurity in Medical Devices

Guidance for Industry and Food and Drug Administration Staff.
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https://cdn2.hubspot.net/hubfs/3415072/Resources/FDA%202014%20HealthITreport_FINAL.pdf

FDASIA Health IT Report

Check out the proposed strategy and recommendations for a risk-based framework in the FDASIA Health IT Report now!
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http://novasano-3415072.hs-sites.com/faq

MDISS FAQ

Learn more about MDISS with our Frequently Asked Questions!

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https://cdn2.hubspot.net/hubfs/3415072/Resources/MDISS%20logos%20for%20sharing.zip

MDISS Logo Files (Vector & Raster)

Go ahead. Use our logo. You know you want to.
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https://cdn2.hubspot.net/hubfs/3415072/Resources/MDISS%20Brand%20Guide.pdf

MDISS Brand Guide

Want to market MDISS? Give your designers a copy of this brand guide and we’ll both look good.

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https://cdn2.hubspot.net/hubfs/3415072/Resources/MDRAP%20OVERVIEW%20FOR%20POSTER-SESSIONS.pdf

MDRAP overview for poster sessions

The MDRAP creates cyber risk assessments that are dynamic, contextual, and actionable.  

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Denise Anderson,
President, NH-ISAC

"MDISS's deep device expertise & assessment platforms help NH-ISAC advance the security of the health sector overall. That means our shared membership can better prepare for -- and respond to -- cyber threats."