Studies, research, standards and templates from MDISS, our Members and Partners.

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.


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.


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. 


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.


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. 


FDA Fact Sheet

Check out the FDA Fact Sheet.


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


Postmarket Management of Cybersecurity in Medical Devices

Guidance for Industry and Food and Drug Administration Staff.

FDASIA Health IT Report

Check out the proposed strategy and recommendations for a risk-based framework in the FDASIA Health IT Report now!
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."