MDISS

F.A.Q.'s

Question: How many man-hours does it take to complete an MDRAP Assessment for a given device?

Answer: About 1 to 1.5 hours depending on the expertise and skill of the Biomed running the assessments. Assessments will get quicker as your team gets more familiar with the platform.

Question: What does the Medical Device Risk Assessment cover?

Answer: The MDRAP questionnaire consists of about 135 questions that start with the MDS2 (Medical Device Security Manufacturers Disclosure Statement) and go somewhat deeper.  Follow up questions gather details relative to potential risks, vulnerabilities, organizational impact, and level of effort required to remediate the risk.

Question: What’s the difference between MDRAP and MDS2?

Answer: MDRAP was commissioned by the US Department of Homeland Security to provide a platform that would go beyond MDS2, and allow healthcare and security professionals to make rational comparisons between and tradeoffs among the myriad security project choices they face.  MDRAP was developed with input from over 20 different technology and healthcare organizations, along with leading medical device cybersecurity experts unaffiliated with MDISS.

Question: I have a bunch of MDS2s already. Do I throw them out?

Answer: Absolutely not! MDRAP contains a built-in MDS2 “ingestor” that enables fast and easy uploads of the security information that you DO have on hand for your device inventory. Having an MDS2 just makes finishing your MDRAP assessment a lot faster, and then MDRAP makes it possible to compare all of the security projects on your plate rationally.

Question: How do I get MDRAP?

Answer:

  1. Join MDISS online at join.mdiss.org.  It’s free to healthcare organizations, HDOs and GPOs.  Other types of companies and individuals can purchase memberships from the INDIVIDUAL to the LEADERSHIP level.  And because MDISS is a 501(c)3 non-profit, your donations and fees are tax-deductible.
  2. We’ll ask you to confirm your email address and automatically sign you up for an onboarding session.
  3. Here’s where you’ll want to start thinking about how much you want to share your assessments with the rest of the MDRAP community.  The benefits to sharing are huge (often, someone else has already assessed the device you’re looking for, and you might be able to skip your assessment completely).  But sharing isn’t required.  It’s just encouraged.

That’s it, you’re up and running!  At this point you’ll probably want to upload information about a bunch of devices you already have in your inventory.  During the onboarding, we’ll tell you how to send that file to us, and our engineers will load all that up for you, FREE, and we’ll do the matching to devices already in our database, too!

Finally, if you want, we can schedule a FREE hands-on training for the rest of your biomed team to show them how to fill out MDRAP assessments quickly and efficiently.  But this is often unnecessary – the platform is very easy to use.  And as a MDISS member, we are here to support you or your team anytime you get stuck.

Question: How much will MDRAP cost my institution?

Answer: As a project funded largely by the Department of Homeland Security, MDRAP is free to use, but you must join MDISS in order to get access to the platform and enjoy the benefits of our onboarding, continuous support and sharing functions.

Question: Do you have any list of medical devices on the market?

Answer: Yes, MDISS and MDRAP hosts a massive digital catalog of electronic medical devices that is cross-indexed to the US FDA’s own database. You can search our catalog to find devices to quick-add them to your inventory or you can provide a spreadsheet to MDISS and we’ll do the initial upload of your inventory to MDRAP for you – no charge.

Question: Do we need individuals across several departments to be involved for these assessments?

Answer: A trained biomed with access to device documentation and MDS2 files should be totally capable of completing an MDRAP assessments with minimal assistance. Sometimes it helps if the biomed works side by side with someone from IT to complete assessments together. 

Question: When I’m BULK IMPORTING my catalog of devices into MDRAP, what are the fields I need to include in my spreadsheet?

Answer:

  1. Device Name   
  2. Manufacturer
  3. Location
  4. Department/Care Area
  5. Serial # (Optional)
  6. Asset Tag (Optional)
  7. In Service On (Optional)

Question: What kind of analysis and recommendations will I receive from MDRAP Analytics?

Answer: The MDRAP Analytics Scoring Framework includes the ability for sets of risk assessment questionnaires to be computed and visualized. This visualization of results includes multiple quantifiable analytical dimensions such as computed risk, computed likelihood of an event and level of effort to remediate this event. MDRAP visualization tools plot “Level of Effort to Remediate” against “Impact to Organization” and “Likelihood of Occurring” so that your teams can more rationally decide what to work on first.  MDRAP provides additional hints and notes relevant to HDOs to help them select specific vulnerabilities for mitigation based on the assessment results.

Question: I know MDRAP allows me to plot out assessments of dozens of different devices together on the same screen…. But does MDRAP allow me to compare multiple different assessments of the same device?

Answer: Not yet.  But soon!

Question: Is there an option to view other institutions’ assessments for the devices in my inventory?

Answer: YES, you can view “shared” assessments from the larger MDISS/MDRAP community via the ASSESSMENTS tab.  Not all organizations share.  But if you’re sucking down lots of assessments that other people did, karma would dictate that you might want to share your work with the community, in turn. 

Question: What does sharing entail?

Answer:

We know sharing is hard, especially in medical contexts.  But crowdsourcing is key to making device assessments work for everyone.  If every hospital has to do their own assessments of every device they own, then positive network-effects never come into play, and you might as well quit MDISS, NH-ISAC, HIMSS and ICS-CERT and enjoy your private island of duplicated effort.

That being said, every hospital network uses devices slightly differently, so an assessment sourced from outside your organization will always need to be “asterisked”, so you can make sure to “handicap” those scores against your internal reality. By creating standardized “risk management portfolios” MDISS and MDRAP hope to help you leverage standardized risk mitigation strategies and best-practices vulnerability aggregation… saving you lots of time, lots of money and helping you avoid re-inventing the wheel again and again.

Question: What are the benefits that come with using MDRAP?

Answer: MDRAP is particularly useful for:

  • Quick evaluations of current risk and security control effectiveness for each medical device in an HDO. Creation of initial (baseline) risk assessment for medical devices in the context of a Common Security Framework profile.
  • MDRAP assessments can be used as the basis for a desired or “target” CSF profile, giving you insight into the chances for success and the subsequent impact of new risk controls on your operations. Dozens, hundreds and then thousands of MDRAP assessments are crunched by the MDRAP analytics engine to find both “quick wins” and “hidden killers” that you can take to management.
  • Over time, as MDRAP assessments are updated based on changes to the device or its environment, MDRAP can provide early warnings about risk-creep and highlight systems and individual devices that probably need to be re-examined in detail. MDRAP’s ability to track changes over time and plot those against risk-reduction effectiveness make MDRAP one of those tools that becomes more valuable the more you use it.

STILL HAVE QUESTIONS?

Drop us a line at info@mdiss.org

As a grass-roots) organization, MDISS is really about YOU. We'd love to hear from you.


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MDRAP AND MDISS
TERMS OF SERVICE

This website, domain and the products and services delivered through it are operated by the Foundation for Innovation, Translation and Safety Science, Inc. doing business as the Medical Device Innovation, Safety and Security Consortium (“MDISS”). Throughout the site, the terms “we”, “us” and “our” refer to MDISS. “You”, “Member”, “Your” “User” refers to you, the customer. “The parties” refers to both MDISS and you, the customer. MDISS offers this website, including all information, tools and software delivered as a service (e.g. MDRAP) available from this site to you, the user, conditioned upon your acceptance of all terms, conditions, policies and notices stated here. The MDISS store and e-commerce platform is hosted by Shopify, Inc.; they provide us with the online e-commerce platform that allows us to sell our products and services to you. By visiting our site and/or downloading or purchasing something from us, you engage in our “Service” and agree to be bound by the following terms and conditions (“Terms of Service”, “Terms”), including those additional terms, conditions and policies referenced herein and/or made available via hyperlink. Inclusively, these Terms of Service apply to all users of the site, including without limitation to users who are browsers, shoppers, vendors, customers, merchants, and/ or contributors of content. Please read these Terms of Service carefully before logging in, using our website or participating in any MDISS organized event. By accessing or using any part of the site, you agree to be bound by these Terms of Service. If you do not agree to all the terms and conditions of this agreement, then you may not access the website nor use any MDISS software or services. If these Terms of Service are considered an “offer”, then “acceptance” is expressly limited to these Terms of Service.

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Occasionally there may be information on our site or in the Service that contains typographical errors, or inaccuracies or omissions that may relate to any number of product characteristics. We reserve the right to correct any errors, inaccuracies or omissions without prior notice, and to change or update information or even cancel orders if any information in the Service or on any related website is inaccurate at any time of order, at any time, even after you’ve placed your order.

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You expressly agree that your use of, or inability to use, the service is at your sole risk. The service and all products and services delivered to you through the service are (except as expressly stated by us) provided 'as is' and 'as available' for your use, without any representation, warranties or conditions of any kind, either express or implied, including all implied warranties or conditions of merchantability, merchantable quality, fitness for a particular purpose, durability, title, and non-infringement.

In no case shall join MDISS, our directors, officers, employees, affiliates, agents, contractors, interns, suppliers, service providers or licensors be liable for any injury, loss, claim, or any direct, indirect, incidental, punitive, special, or consequential damages of any kind, including, without limitation lost profits, lost revenue, lost savings, loss of data, replacement costs, or any similar damages, whether based in contract, tort (including negligence), strict liability or otherwise, arising from your use of any of the service or any products procured using the service, or for any other claim related in any way to your use of the service or any product, including, but not limited to, any errors or omissions in any content, or any loss or damage of any kind incurred as a result of the use of the service or any content (or product) posted, transmitted, or otherwise made available via the service, even if advised of their possibility. Because some states or jurisdictions do not allow the exclusion or the limitation of liability for consequential or incidental damages, in such states or jurisdictions, our liability shall be limited to the maximum extent permitted by law.

SECTION 13 – INDEMNIFICATION
Subject to Exhibit B and any other agreement entered into between the parties that separately addresses indemnification, each party is solely responsible for his/her actions and omissions, and Member is solely responsible for the actions and omissions of its Member Representative(s). Member shall indemnify, defend, and hold harmless MDISS, its directors, officers, employees and agents from any third-party claims, liabilities, losses, fines, penalties, charges, judgments, damages or expenses (including reasonable attorneys’ fees) (each, a “Claim”) resulting or arising from Member’s participating in the activities of MDISS including, but not limited to, accessing, using, or distributing information provided by MDISS, Member’s employees or agents or resulting or arising from other information provided by Member hereunder. The indemnification obligations under this section shall survive the termination or expiration of this Agreement with regard to any Claim resulting or arising from actions or omissions that occur prior to the termination or expiration of this Agreement. In the event of any such Claim, MDISS shall promptly provide notice of such Claim to Member. Member shall then have the sole right to control the conduct of the claim or suit and MDISS shall reasonably cooperate in the conduct of such Claim at the expense of Member. In no event, however, may there be a settlement of any such Claim without the written consent of MDISS which consent shall not be unreasonably conditioned, delayed or withheld

SECTION 14 – SEVERABILITY
In the event that any provision of these Terms of Service is determined to be unlawful, void or unenforceable, such provision shall nonetheless be enforceable to the fullest extent permitted by applicable law, and the unenforceable portion shall be deemed to be severed from these Terms of Service, such determination shall not affect the validity and enforceability of any other remaining provisions. The indemnification obligations under this section shall survive the termination or expiration of this Agreement with regard to any Claim resulting or arising from actions or omissions that occur prior to the termination or expiration of this Agreement. In the event of any such Claim, MDISS shall promptly provide notice of such Claim to Member. Member shall then have the sole right to control the conduct of the claim or suit and MDISS shall reasonably cooperate in the conduct of such Claim at the expense of Member. In no event, however, may there be a settlement of any such Claim without the written consent of MDISS which consent shall not be unreasonably conditioned, delayed or withheld.

SECTION 15 – TERMINATION
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SECTION 16 - ENTIRE AGREEMENT
The failure of us to exercise or enforce any right or provision of these Terms of Service shall NOT constitute a waiver of such right or provision. These Terms of Service and any policies or operating rules posted by us on this site or in respect to The Service constitutes the entire agreement and understanding between you and us and govern your use of the Service, superseding any prior or contemporaneous agreements, communications and proposals, whether oral or written, between you and us (including, but not limited to, any prior versions of the Terms of Service). Any ambiguities in the interpretation of these Terms of Service shall not be construed against the drafting party.
SECTION 16 - GOVERNING LAW These Terms of Service and any separate agreements whereby we provide you services shall be governed by and construed in accordance with the laws of New York.

SECTION 17 – MDISS MEMBERSHIP
WHEREAS, MDISS’ mission is to protect public health and well-being by advancing computer risk management practices to ensure wide availability of innovative and safe medical devices through collaborative innovation activities with providers, payers, manufacturers, universities, government agencies, technology companies, individuals, patients, patient advocates and associations; and WHEREAS, Member is interested in being a user of MDISS services and software, and an MDISS member so it can participate in MDISS’ activities; NOW, THEREFORE, for and in consideration of the premises and the mutual covenants contained herein and other good and valuable consideration, the receipt, adequacy and sufficiency of which are hereby acknowledged, the parties hereto covenant and agree as follows:

Membership. Upon payment of the dues set forth in Section 2, Member shall become a member of MDISS and shall be able to send representatives who are employed by Member (“Member Representative(s)”) to participate in MDISS’ activities. Member Benefits. Each Member shall have the benefits listed on Exhibit A in addition to access to the Medical Device Risk Assessment Platform (“MDRAP”) in accordance with the terms and conditions attached hereto as Exhibit B. Dues. Membership dues are described in Exhibit C. Membership dues are subject to change. Member will be given a minimum 30 days written notice ahead of any change in dues or fees. Except as provided in Section 12, dues for the initial term of this agreement are non-refundable in the event of early termination.
Term. This Agreement shall have an initial term of twelve (12) months which is effective from the Initiation Date specified in Exhibit C, and shall continue (if renewed) for successive twelve (12) month periods on the Renewal date, also specified in Exhibit C. Either party must give notice of its intent not to renew at least thirty (30) days prior to the expiration of the then current membership term.
Termination. Notwithstanding anything to the contrary contained herein, Member may terminate its participation in MDISS at any time upon MDISS’s receipt of notice thereof. In addition, this Agreement shall terminate automatically, if: (a) Member is no longer a member in good standing of the MDISS (including via material breach of this Agreement); (b) Member no longer satisfies all of the eligibility criteria for MDISS membership; (c) Member is dissolved or liquidated; or (d) MDISS is dissolved. Termination of membership shall not relieve the Member of any obligations that arose prior to such termination (including, without limitation, the payment of any dues that accrued prior to such termination), or limit any liability that Member may otherwise have to MDISS. Use and Disclosure of Information. General discussions and information exchanged by Members at meetings of MDISS are non‐confidential. Member grants MDISS the right to use any and all data entered into MDISS systems by the Member in furtherance of MDISS’ public health mission provided such data and its use in any papers or reports in support of MDISS’ public health mission is de-identified, de-tagged and aggregated such that none of the data is attributable to the Member unless the Member provides written consent. MDISS Work Product. All intellectual property of the Member contributed to MDISS by the Member shall remain the intellectual property of the Member. However, MDISS owns the compilation of collective work of all participants in MDISS’ activities (“MDISS Work Product”) and has the non-exclusive, irrevocable, royalty-free, worldwide rights (i.e., a license) to use the contribution in connection with the development of the Work Product for which the contribution was made. Members are solely responsible for determining whether disclosure of any contributions that they submit to MDISS requires prior consent of other parties, and if so, to obtain it. Member agrees to execute any document or instrument MDISS deems reasonably necessary to enable MDISS to apply for, prosecute, and obtain copyrights, patents, or other proprietary rights in order to transfer to MDISS all rights, title, and interest in said Work Product. Co-Marketing Allowed. MDISS may identify Member publicly in marketing materials as a member of MDISS on the MDISS website or otherwise. Each party may use the other’s name and logo (collectively, “Marks”) of the other on a non-exclusive basis during the Term, in connection with (a) MDISS membership drives, events or work product, and Member’s status as a Member, and (b) identifying joint projects and/or information shared according to the terms of this Agreement. No other use of either party’s Marks is permitted except with such party’s prior written permission.
Limitations. A Member’s participation in MDISS and a Member’s use/submittal of intellectual property from/to MDISS is on an “as is” basis, without warranties or conditions of any kind, either express or implied including, without limitation, any warranties or conditions of title, non‐infringement, merchantability or fitness for a particular purpose. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO EACH OTHER OR TO ANY MEMBER FOR INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS) ARISING FROM ACTS UNDER THIS AGREEMENT EVEN IF SUCH PARTY OR MEMBER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NO LIMITATION OF EITHER PARTY’S OR ANY MEMBER’S LIABILITY SHALL APPLY WITH RESPECT TO ANY CLAIMS BASED ON SUCH PARTY’S WILLFUL MISCONDUCT OR GROSS NEGLIGENCE.

Member Organizations in Competition. The Members are committed to fostering open competition, and MDISS does not intend to hinder such competition in any way. Each Member acknowledges that it may find competitors among the larger MDISS membership. Members that may be perceived to be competitors shall treat each other with respect in a most professional manner. All members agree to act in compliance with state, federal and international antitrust laws and regulations. Thereto: Member agrees not to communicate with the “competing” Member(s) in a manner that may violate such laws (which may include communicating prices, costs, production levels or other similar information).

SECTION 18 -- Amendment. Member agrees that MDISS is authorized to amend this Agreement subject however to the following provisions and further provided that such amendment does not impose any material obligations upon Member. Member will be given notice in accordance with Section 12 of this Agreement of any changes to this Agreement (except that only electronic mail notice shall be required). In the event that Member objects to any amendment to this Agreement, Member’s sole remedy shall be to terminate this Agreement within 10 business days after Member’s being advised of the amendment. Members will receive a pro rata refund of any fee paid by Member to MDISS that applies to the period after termination for amendments to this Agreement found to be unacceptable to Member. With respect to the subject matter hereof, this Agreement shall supersede any other prior agreement between you and any other MDISS member. MDISS members shall not enter into “side agreements” with other members regarding MDISS technologies, tools, services or practices without first obtaining written permission from MDISS. Except with respect to policies, guidelines, and procedures that may be adopted by MDISS, you and every Member agrees to comply with all applicable laws and regulations while participating in MDISS.

EXHIBIT A:
TERMS & CONDITIONS – MEMBERSHIP TIERS, PRICES AND BENEFITS

MDISS offers several tiers of membership; each tier is priced higher or lower in accordance with the number of benefits the Member receives. What follows is a list of all possible membership tiers. Match the membership tier you purchased to the chart here to determine the benefits to which you are entitled. All of the following lists are an enumeration of suggested partnership activities, and they do not represent a commitment to provide programs or services. MDISS programs and benefits are subject to change, and global standards initiatives are seasonal. That means some programs or benefits might not be active during the specific period of your membership. If a listed benefit is unavailable for any reason, MDISS will make commercially reasonable efforts to provide replacement benefits of similar value.

AA. If you purchased an MDISS “LEADERSHIP COUNCIL” Membership, your annual dues are $96,000 (in advance), and your benefits are listed below.

Access to MDRAP, the crowdsourced and expert-vetted medical device security evaluation and reporting platform from MDISS. MDRAP catalogs risk profiles and real-world performance data for thousands of different medical devices around the world.
Early Access to MDISS EMBASSY (beta Q1’18): the "linked-in" networking site for MDISS members to connect, collaborate and build relationships. Members have complete control over the level of sharing of their contact information and research interests. Access to the online MDISS ADVISOR, a growing collection of best-practices, training materials and acronym decoders collected from our most successful MDISS members. Subscription to MDISS ALERT, a private-distribution newsletter that delivers expert insider insights into the medical device market and medical device security issues.
Access to the MDISS DATA COMMONS, our growing database of medical devices, vulnerabilities, mitigations and best practices.
Admission to regular MDISS working group sessions AND to sensitive (CLOSED) sessions.
Admission to CLOSED MDISS steering group strategy sessions.
On-Demand DEEP DIVE WORKSHOPS with MDISS experts and your critical infrastructure teams targeting your most intractable device security and interop issues.
Speaking slots at MDISS-hosted events. EIGHT Comped Tickets (annually) to any MDISS event requiring a registration fee. Access to the MDISS membership database (subject to the level of opt-in by each individual).
“Most-Favored-Partner” Access to MDISS WHISTL (World Health Information Security Testing Labs) facilities around the world: our advanced connectivity and security testing environments specially designed for multi-medical device vetting and stress-testing. (Please note, WHISTL labs are independently owned and operated, and “members’ hours” and terms may vary from place to place). Promotion on MDISS Website as a LEADERSHIP organization, MDISS quotes for your press releases, and support for a joint press release announcing your Leadership stake in MDISS. MDISS will syndicate your blog posts and whitepapers as desired in MDISS blogs and social media. MDISS will provide expert Speakers for your Events at no charge, and you may propose panels with our expert speakers to supercharge your proposals for OEM conferences like RSA and BlackHat). You only need to cover coach-level travel expenses (if we’re not already going to be there anyway). AB. If you purchased an MDISS “HDO SENATE” Membership, your annual dues are $0 (Hospitals Join FREE), and your benefits are listed below.

Access to MDRAP, the crowdsourced and expert-vetted medical device security evaluation and reporting platform from MDISS. MDRAP catalogs risk profiles and real-world performance data for thousands of different medical devices around the world.
Early Access to MDISS EMBASSY (beta Q1’18): the "linked-in" networking site for MDISS members to connect, collaborate and build relationships. Members have complete control over the level of sharing of their contact information and research interests. Access to the online MDISS ADVISOR, a growing collection of best-practices, training materials and acronym decoders collected from our most successful MDISS members. Subscription to MDISS ALERT, a private-distribution newsletter that delivers expert insider insights into the medical device market and medical device security issues.
Access to the MDISS DATA COMMONS, our growing database of medical devices, vulnerabilities, mitigations and best practices.
Admission to regular MDISS working group sessions AND to sensitive (CLOSED) sessions.
Admission to CLOSED MDISS steering group strategy sessions.
On-Demand DEEP DIVE WORKSHOPS with MDISS experts and your critical infrastructure teams targeting your most intractable device security and interop issues.
Speaking slots at MDISS-hosted events. EIGHT Comped Tickets (annually) to any MDISS event requiring a registration fee. Access to the MDISS membership database (subject to the level of opt-in by each individual).
“Most-Favored-Partner” Access to MDISS WHISTL (World Health Information Security Testing Labs) facilities around the world: our advanced connectivity and security testing environments specially designed for multi-medical device vetting and stress-testing. (Please note, WHISTL labs are independently owned and operated, and “members’ hours” and terms may vary from place to place). Promotion on MDISS Website as a LEADERSHIP organization, MDISS quotes for your press releases, and support for a joint press release announcing your Leadership stake in MDISS. MDISS will syndicate your blog posts and whitepapers as desired in MDISS blogs and social media. MDISS will provide expert Speakers for your Events at no charge, and you may propose panels with our expert speakers to supercharge your proposals for OEM conferences like RSA and BlackHat). You only need to cover coach-level travel expenses (if we’re not already going to be there anyway).

AC. If you purchased an MDISS “WORKING GROUP COUNCIL”
Membership, your annual dues are $42,000 (in advance), and your benefits are listed below.

Access to MDRAP, the crowdsourced and expert-vetted medical device security evaluation and reporting platform from MDISS. MDRAP catalogs risk profiles and real-world performance data for thousands of different medical devices around the world.
Early Access to MDISS EMBASSY (beta Q1’18): the "linked-in" networking site for MDISS members to connect, collaborate and build relationships. Members have complete control over the level of sharing of their contact information and research interests. Access to the online MDISS ADVISOR, a growing collection of best-practices, training materials and acronym decoders collected from our most successful MDISS members. Subscription to MDISS ALERT, a private-distribution newsletter that delivers expert insider insights into the medical device market and medical device security issues.
Access to the MDISS DATA COMMONS, our growing database of medical devices, vulnerabilities, mitigations and best practices.
Admission to regular MDISS working group sessions AND to sensitive (CLOSED) sessions.
Discounted, $7500/day DEEP DIVE WORKSHOP pricing with MDISS experts and your critical infrastructure teams targeting your most intractable device security and interop issues.
THREE Comped Tickets (annually) to any MDISS event requiring a registration fee.
Discounted $500/day Access to MDISS WHISTL (World Health Information Security Testing Labs) facilities around the world: our advanced connectivity and security testing environments specially designed for multi-medical device vetting and stress-testing. (Please note, WHISTL labs are independently owned and operated, and “members’ hours” and terms may vary from place to place).

AD. If you purchased an MDISS “STARTUP MEMBERSHIP”, your annual dues are $20,100 (in advance), and your benefits are listed below.
Access to MDRAP, the crowdsourced and expert-vetted medical device security evaluation and reporting platform from MDISS. MDRAP catalogs risk profiles and real-world performance data for thousands of different medical devices around the world. Early Access to MDISS EMBASSY (beta Q1’18): the "linked-in" networking site for MDISS members to connect, collaborate and build relationships. Members have complete control over the level of sharing of their contact information and research interests. Access to the online MDISS ADVISOR, a growing collection of best-practices, training materials and acronym decoders collected from our most successful MDISS members. Subscription to MDISS ALERT, a private-distribution newsletter that delivers expert insider insights into the medical device market and medical device security issues. Access to the MDISS DATA COMMONS, our growing database of medical devices, vulnerabilities, mitigations and best practices. Discounted, $7500/day DEEP DIVE WORKSHOP pricing with MDISS experts and your critical infrastructure teams targeting your most intractable device security and interop issues. ONE Comped Tickets (annually) to any MDISS event requiring a registration fee. Discounted $500/day Access to MDISS WHISTL (World Health Information Security Testing Labs) facilities around the world: our advanced connectivity and security testing environments specially designed for multi-medical device vetting and stress-testing. (Please note, WHISTL labs are independently owned and operated, and “members’ hours” and terms may vary from place to place). AE. If you purchased an MDISS “ACADEMIC/GOVERNMENT MEMBERSHIP” your annual dues are $4,800 (in advance), and your benefits are listed below. Access to MDRAP, the crowdsourced and expert-vetted medical device security evaluation and reporting platform from MDISS. MDRAP catalogs risk profiles and real-world performance data for thousands of different medical devices around the world. Early Access to MDISS EMBASSY (beta Q1’18): the "linked-in" networking site for MDISS members to connect, collaborate and build relationships. Members have complete control over the level of sharing of their contact information and research interests. Access to the online MDISS ADVISOR, a growing collection of best-practices, training materials and acronym decoders collected from our most successful MDISS members. Subscription to MDISS ALERT, a private-distribution newsletter that delivers expert insider insights into the medical device market and medical device security issues. Access to the MDISS DATA COMMONS, our growing database of medical devices, vulnerabilities, mitigations and best practices. Discounted, $7500/day DEEP DIVE WORKSHOP pricing with MDISS experts and your critical infrastructure teams targeting your most intractable device security and interop issues. ONE Comped Tickets (annually) to any MDISS event requiring a registration fee. Discounted $250/day Access to MDISS WHISTL (World Health Information Security Testing Labs) facilities around the world: our advanced connectivity and security testing environments specially designed for multi-medical device vetting and stress-testing. (Please note, WHISTL labs are independently owned and operated, and “members’ hours” and terms may vary from place to place). AF. If you purchased an MDISS “PERSONAL MEMBERSHIP” your annual dues are $1,188 (in advance), and your benefits are listed below. Access to MDRAP, the crowdsourced and expert-vetted medical device security evaluation and reporting platform from MDISS. MDRAP catalogs risk profiles and real-world performance data for thousands of different medical devices around the world. Early Access to MDISS EMBASSY (beta Q1’18): the "linked-in" networking site for MDISS members to connect, collaborate and build relationships. Members have complete control over the level of sharing of their contact information and research interests. Access to the online MDISS ADVISOR, a growing collection of best-practices, training materials and acronym decoders collected from our most successful MDISS members. Subscription to MDISS ALERT, a private-distribution newsletter that delivers expert insider insights into the medical device market and medical device security issues. Access to the MDISS DATA COMMONS, our growing database of medical devices, vulnerabilities, mitigations and best practices. Discounted, $7500/day DEEP DIVE WORKSHOP pricing with MDISS experts and your critical infrastructure teams targeting your most intractable device security and interop issues. ONE Comped Tickets (annually) to any MDISS event requiring a registration fee. Discounted $250/day Access to MDISS WHISTL (World Health Information Security Testing Labs) facilities around the world: our advanced connectivity and security testing environments specially designed for multi-medical device vetting and stress-testing. (Please note, WHISTL labs are independently owned and operated, and “members’ hours” and terms may vary from place to place). EXHIBIT B: TERMS & CONDITIONS – MDRAP SOFTWARE LICENSE TERMS AND CONDITIONS B1. Member shall have the right to access MDRAP in accordance with MDISS terms and conditions for so long as Member’s membership is in good standing. B2. Use of MDRAP is wholly voluntary. In recognition of the fact that MDISS is providing Member with access to MDRAP without charge, to the maximum extent permitted by applicable law, MDISS will not be liable to Member for any personal injury, property or other damage, of any nature whatsoever, whether special, indirect, consequential, or compensatory (including, but not limited to business interruption, loss of use or loss of profits), directly or indirectly resulting from the publication, use of, or reliance upon MDRAP, even if advised of the possibility of such damages or if such possibility was reasonably foreseeable. B3. Member grants MDISS the right to use data entered into MDRAP by Member in furtherance of MDISS’ public health mission. MDISS will anonymize and aggregate any information used, unless Member provides written consent otherwise. Notwithstanding the foregoing, MDISS will not use any data designated as “Protected Health information” under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”). B4. Member recognizes that MDRAP was developed through a consensus process which brings together volunteers representing varied viewpoints and interests to achieve a final product. While MDISS administers the process, and establishes rules to promote fairness in consensus development, MDISS does not independently evaluate, test, or verify the accuracy of any of the information or the soundness of any judgments contained in MDRAP. Any information provided by MDRAP to MDISS is provided on an “as is” basis without any warranty of any kind, expressed or implied. B5. The existence of MDRAP does not imply that there are no other ways to perform a risk assessment of medical devices. Furthermore, the viewpoint expressed at the time MDRAP was approved and issued is subject to change brought about through developments in the state of the art and comments received from users of MDRAP. B6. In publishing and making MDRAP available, MDISS is not rendering professional or other services for, or on behalf of, any person or entity, nor is MDISS undertaking to perform any duty owed by any other person or entity to another. Any person utilizing MDRAP, should rely upon his or her own independent judgment in the exercise of reasonable care in any given circumstances or, as appropriate, seek the advice of a competent professional in determining the appropriateness of MDRAP’s assessments. B7. MDISS DISCLAIMS AND EXCLUDES ALL REPRESENTATIONS, WARRANTIES, AND CONDITIONS, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING BUT NOT LIMITED TO REPRESENTATIONS, WARRANTIES, OR CONDITIONS OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY OF DATA, QUALITY, SYSTEM INTEGRATION, SUITABILITY, OR THE ABSENCE OF ANY DEFECTS THEREIN, AND WARRANTIES ARISING FROM COURSE OF DEALING, COURSE OF PERFORMANCE AND USAGE OF TRADE. MDISS DOES NOT WARRANT THAT ACCESS TO, OR OPERATION OF, MDRAP WILL BE UNINTERRUPTED, SECURE OR ERROR-FREE, THAT ERRORS WILL BE CORRECTED, OR THAT MDRAP WILL SATISFY MEMBER’S OR ANY THIRD PARTY’S REQUIREMENTS. MDISS DOES NOT WARRANT OR REPRESENT THE ACCURACY OR CONTENT OF THE MATERIAL CONTAINED IN MDRAP. MDRAP IS SUPPLIED "AS IS.” B8. CONFIDENTIALITY. MDISS will maintain as confidential all Confidential Information (as defined below) of Member or its Members obtained under or in connection with this Agreement and will not divulge such information to any person (except to its own trustees, officers, employees and agents and then only to those such persons who need to know same in connection with performing under this Agreement) without Member’s prior written consent. This clause will not extend to information which was rightfully in the possession of MDISS prior to the commencement of the negotiations that led to this Agreement, which was already in the public domain or becomes so at a future date (otherwise than as a result of a breach of this clause or any other confidentiality agreement signed by MDISS), or which was independently developed by MDISS without use of Member’s Confidential Information. MDISS will ensure that its directors, officers, employees and agents are aware of and comply with the requirements of this clause. If requested, MDISS or its directors, officers, employees and agents will sign a confidentiality agreement in a reasonable form specified and provided by Member. These obligations of confidentiality will survive the termination or expiration of this Agreement. Member will maintain as confidential all Confidential Information (as defined below) of MDISS obtained under or in connection with this Agreement, and will not divulge such information to any person (except to its own employees or agents and then only to those employees or agents who need to know same in connection with performing under this Agreement) without MDISS's prior written consent. This clause will not extend to information which was rightfully in the possession of Member prior to the commencement of the negotiations that led to this Agreement, which was already in the public domain or becomes so at a future date (otherwise than as a result of a breach of this clause or any other confidentiality agreement signed by Member), or which was independently developed by Member without use of MDISS’s Confidential Information. Member will ensure that its employees or agents are aware of and comply with the requirements of this clause. If requested, Member or its employees or agents will sign a confidentiality agreement in a reasonable form specified and provided by MDISS. These obligations of confidentiality will survive the termination or expiration of this Agreement. In each case, the term “Confidential Information” shall mean any and all technical and non-technical information disclosed by a Party which may include without limitation: (a) patent and patent applications, (b) trade secrets, and (c) proprietary and confidential information, ideas, samples, media, techniques, sketches, drawings, works of authorship, models, inventions, know-how, processes, apparatuses, equipment, algorithms, software programs, software source documents, and formulae related to the current, future, and proposed products and services of each of the Party, such as information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, investors, employees, business and contractual relationships, business forecasts, sales and merchandising, and marketing plans.

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