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Revise Conditions for Access to the OPTN Computer System

eye iconAt a glance

Current policy

Last year, the Board passed the proposal to Establish Member System Access, Security Framework, and Incident Management and Reporting Requirements. These policies created ways to increase transplant hospital, organ procurement organizations (OPO), and histocompatibility lab information security. While these policies helped address issues observed in the transplant community and reach compliance, there still needs to be policy that requires OPTN membership as a condition of access, limits reasons for access, and requires business members to follow the same requirements.

Supporting media

Presentation

View presentation PDF link

Proposed changes

  • Require all members, with 3rd party vendors who access the OPTN Computer system through the member, to develop an Interconnection Security Agreement (ISA) with the OPTN
  • Require any business member who accesses the OPTN Computer System to follow the same information security requirements as other members
  • Require OPTN membership as a condition of access to the OPTN Computer System and reduce potential barriers to OPTN business membership 
  • Limit reasons for access to the OPTN Computer System
  • Feedback needed from the community:
    • Is the proposed transition plan feasible for members?
    • Are there any additional obstacles to completing the transition plan that members are aware of?

Anticipated impact

  • What it's expected to do
    • Apply information security requirements to ensure consistent information security requirements apply to all members accessing the OPTN computer system for security and safety of patient data
    • Improve access to the OPTN Computer System for approved OPTN membership
    • Limit reasons for access to the OPTN Computer System to facilitating organ transplantation, fulfilling OPTN Obligations, and quality assurance and performance improvement (QAPI)
    • Require all members with system interconnections to the OPTN Computer System to develop an Interconnection Security Agreement (ISA) with the OPTN
    • Require OPTN business members who access the OPTN Computer System to follow the same information security requirements that apply to other member types who access the OPTN Computer System
  • What it won't do
    • Create additional reasons to access the OPTN Computer System
    • Remove existing security requirements

Terms to know

  • OPTN business member: A business member must be an organization in operation for at least one year that engages in commercial activities with two or more active OPTN transplant hospital, OPO, or histocompatibility laboratory members.
  • Interconnection Security Agreement (ISA): This is the document that all members with system interconnections to the OPTN Computer System must develop with the OPTN.
  • Information security maturity: How advanced your system is in protecting against security threats.
  • OPTN Computer System: Platform used by transplant hospitals and organ procurement organizations to register transplant candidates, register organ donors, and create a computerized ranking of transplant candidates based upon donor and candidate medical compatibility and criteria defined in OPTN Policy.
  • Security incident: An occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Privacy Incident: A suspected or confirmed incident involving the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses Personally Identifiable Information (PII) or (2) an authorized user accesses PII for another than authorized purpose.

Click here to search the OPTN glossary

Read the full proposal (PDF)

Provide feedback

eye iconComments

Region 1 | 08/29/2024

Sentiment: 1 strongly support, 3 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose

Overall, the region supports the proposal. A member noted that ISAs would need to be executed between centers and business members. An attendee requested information and guidance for hospital information securities teams to complete the questionnaires and understand the requirements, especially those newer to supporting the transplant and HLA programs. One attendee agreed with the suggestion to increase the categories of people allowed to access the data and to make their access contingent on their role.

UAMS Medical Center | 08/28/2024

After reviewing the proposed changes, we mostly agree with revising the conditions for access to the OPTN computer system. We feel that if changes are made to the current conditions for access, transplant centers should be given ample time to make the necessary changes. The necessary changes should be easily identified, and support should be available to centers to ensure no interruption in care occurs. We agree that data security is critical but work in the OPTN computer system cannot be interrupted during these changes. Right now, the security review and team review required is very time consuming and has a high rate of redundancy. We feel that the proposal needs to be cleaned up significantly before additional layers of work are placed on transplant centers.

Region 8 | 08/27/2024

Sentiment: 6 strongly support, 13 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose

The region supports the proposal to allow third party vendors a pathway to OPTN membership. An attendee pointed out that more OPTN support is needed for the ISA process. They explained that transplant centers must bear the cost of resources, time, and expertise to complete an ISA, so they requested more information on what resources they need to complete the ISA and be in compliance with policy. An attendee commented that this proposal does not seem to significantly impact clinical research but recommended reassurance to the community that the process is not significantly more cumbersome with the proposed changes.

·        An attendee provided the following suggestions based on review of the current DUA with UNOS. The DUA should:

o  set expectations about data integrity/accuracy

o  ensure PHI is handled consistent with HIPAA requirements

o  set expectations about privacy authorized users will have while using the system

o  set parameters for system use (including limitations on 3rd party use)

o  set requirements for notification related to data breach

o  provide clarity on data ownership

o  make clear consequences for violating terms and dispute resolution / governing law.

·        Another member pointed out that the revision of reporting systems leaves the potential for communication gaps that could not only lead to inefficiencies but also may unintentionally exclude certain groups from providing input. For example, the effort to extend data collection into the pre-waitlist period. Forms will be submitted for community feedback through a pathway that is different than the long-established system of OPTN public comment. This could lead to a decrease in healthcare, transplant hospital, and hospital administration engagement. Which bolsters the concern in the healthcare community that transplant professionals hold a diminishing voice with a shift toward greater legislator management at the exclusion of medical professionals.

OPTN Organ Procurement Organization Committee | 08/22/2024

A member raised the question of entities that many OPOs and Transplant hospitals have agreements with that access donors in DonorNet will that be impacted?- Which was answered/confirmed they would have to apply as business partners in order to have access to that data.

Region 4 | 08/19/2024

Sentiment: 7 strongly support, 11 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Region 4 supported the proposal with several attendees commenting that there should be a standardized template for members to use and a standardized process. Attendees also commented that the OPTN should hold business members accountable. Some attendees agreed that cybersecurity is a threat and we have to take measures to keep our systems secure.

Region 2 | 08/16/2024

Sentiment: 7 strongly support, 14 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose 

Members of the region are, overall, supportive of the proposal.  The discussion emphasized the need to prioritize security of the OPTN Computer System, though concerns were raised about the potential complexity and inconvenience of repeated logins during critical work. If the proposed policy is approved, it is crucial for the OPTN to allow ample time for business members, including transplant centers, OPOs, and HLA labs, to align their membership status and establish secure interconnection agreements. This alignment is essential for maintaining the efficiency and reliability of donation and transplant systems, which ultimately benefits patients.  There was also a call for a mechanism that allows necessary access without being overly restrictive. Any changes should avoid being overly burdensome, recognizing that third-party companies often assist with organ offers due to the complexities of the current 24/7/365 organ allocation system. Simplicity in Data Use Agreements is encouraged to reduce administrative burdens, and while security and data protection are acknowledged as top priorities, the overall administrative load on users should be minimized to maintain system efficiency. 

She Gay | 07/31/2024

I frequently use the OPTN information to get updates to use in my speaking engagements as a volunteer with our OPO. The data is more difficult to obtain now that in the past but can be used with determination.

William Pelley | 07/31/2024

There is no sample ISA agreement. It would take me 180 days to work an unknown agreement through our systems. The amount of work effort dealing with the demands of UNOS/OPTN security assessments and surveys and never receiving answers to questions has never been taken in by UNOS/OPTN. These proposals should include the man hours required to perform these tasks at the Transplant Center Level. After all we are bearing all of the costs for these computer security assessments and work product. I estimate that I spent over 100 hours on a security assessment of the hospital's mainframe. And that included having to search for folks that could even understand the questions let alone answer them I am also struggling why any business needs access to the UNET system. We have a contract coordinator group that manages organ offers and of course we have our surgeons and physicians with READ only access. No one else gets access to our patient data, I don't care what the reasoning may be.