american thrombosis & hemostasis network

An “ATHN Affiliate” is a federally-funded hemophilia treatment center (HTC) or thrombosis site or other qualified provider organization that shares the vision, mission and values of ATHN, exemplifies the required characteristics of an ATHN Affiliate and commits to utilize the Lab Tracker/ its web-based version created by Ground Zero and hosted by the CDC, or other ATHN endorsed patient management software, which will allow the community to share HIPAA compliant non-identifiable patient data through ATHN.

ATHN will establish formal contractual relationships for data utilization with these organizations.  In turn, these organizations will play a distinct role in ATHN governance and will have access to specific projects and support services through ATHN.

ATHN Affiliates are central to the development of ATHN as a valued community resource. They help shape the direction of ATHN and may benefit from its projects and support services.  More specifically, ATHN Affiliates benefit from:

A Voice in ATHN Governance

• Guaranteed to be represented by at least six ATHN Affiliates on the ATHN Board
• Eligible to nominate and to be nominated for the ATHN Board of Directors or one of the ATHN committees
• Ability to serve on ATHN Project Review Panels
• Ability to vote on policies regarding data access, research agendas, criteria for becoming/remaining an ATHN Affiliate
• Right to determine disposition of data in the event of dissolution of ATHN

Access to Collaborative Projects and Studies

• A collaborating participant in the ATHN national database
• Full access to one’s own data, with access to the broader database per data access rule/regulations/policies
• Option to participate in special projects and studies
• Invitation to the ATHN annual meeting
• Eligibility for application for data manager support
• Potential to become principal investigator for ATHN projects
• Right to propose projects and/or take a leadership role in projects that may utilize the ATHN national database
• The support of centralized project management

Support Services

• Templates for development of institutionally accepted IRB submissions and patient consent forms for participation in ATHN
• Patient education/recruitment tools
• Eligibility for Data manager training
• Eligibility for Virtual help desk
• Quarterly update

Collaboration, competence, commitment and compliance are characteristics to be demonstrated by all ATHN Affiliates.  Evidence of these characteristics is listed below.

Collaboration

• Work cooperatively with other ATHN Affiliates, ATHN management and other participating entities in fulfilling projects and studies to which it has agreed to participate
• Respond in a timely manner to project inquiries
• Contribute to the continuous improvement of group processes, products and outcomes related to this important community resource

Competence

• Deliver multidisciplinary care to patients with bleeding and/or blood clotting disorders through a federally-funded hemophilia treatment center or thrombosis site, OR meet other criteria which may be published by ATHN
• Ensure that data managers are adequately trained in terms of data definitions, data standards and application systems and accurate, timely data submission

Commitment

• Use its best efforts to enroll patients into the ATHN database, achieving enrollment and minimum data requirements established by the network
• Maintain accurate and up-to-date core data for enrolled patients
• Designate a Principal Investigator to represent the affiliate organization in votes and to serve as the primary contact for communications.  An alternate communications contact may be designated as well.

Compliance

• Deploy Lab Tracker® -web created by Ground Zero and hosted by the CDC, or other ATHN endorsed patient management software, which will allow the community to share HIPAA compliant non-identifiable patient data through ATHN.
• Access to an Institutional Review Board (IRB) or willingness to utilize a central IRB adopted by ATHN
• Assure compliance with regulations related to IRB approvals, Patient Informed Consent, HIPAA Privacy and Security Rule.
• Adhere to minimum data standards, quality assurance standards, data utilization guidelines, training requirements, publication guidelines or other criteria which may be recommended by ATHN Affiliates and adopted as ATHN policy.

Each ATHN Affiliate will be expected to execute a letter agreement confirming the relationship.

Yes!  ATHN Affiliates will hold six (6) positions on the ATHN Board of Directors.  In addition, ATHN Affiliates will be able to influence policies regarding network operations such as data access, eligibility criteria for non-federally funded treatment centers, and even the disposition of data in the event of dissolution of ATHN.  ATHN committees and project review panels are open to ATHN Affiliates as well.

ATHN will support quality and consistency of data on a national level through HIPAA privacy and security compliant data management policies, procedures, training programs and support.  In addition, ATHN has committed to developing a process for evaluating and providing financial support for data managers at the local level so that all HTCs can contribute to a robust and accurate database.

Quite the contrary, we would hope that ATHN can collaborate with investigators who want to recruit study sites/patients from a nationwide network easily and efficiently.  As ATHN’s infrastructure is developed, its communications network, database, tools and processes should provide value add to projects.

Participation in special studies would be at the discretion of each ATHN Affiliate.  For special studies requiring incremental nursing time, patient visits or IRB submissions, ATHN would make every effort to secure funding that would compensate ATHN Affiliates for the added work.

There is no fee for becoming an ATHN Affiliate during this initial enrollment period.

ATHN, working with the CDC to secure and develop infrastructure resources, offers the greatest degree of protection and security for individual patient and center data with the maximum amount of flexibility.  As a federal agency, the CDC is limited in the services that it can legally provide.  The CDC cannot solicit private donations (raise funds) for research or other activities in the same way or as effectively as a private, community based organization like ATHN can.  However, the CDC has generously offered to provide the bleeding disorders community with access to state-of- the-art security and data protection by hosting the software which will allow ATHN Affiliates to pool their non-identifiable patient data to create a robust data source for research and other data needs of the bleeding disorders community at a fraction of the cost of private data hosting services.   To ensure that the CDC has no access to the data, there are strict limitations on physical access to the server and the database.  More importantly, however, the data that is stored at CDC will be encrypted using a code maintained separately by Ground Zero.  No ATHN Affiliate or individual patient protected health information data except defined data sets for which consent has been obtained will be accessible in any usable form by anyone except individual ATHN Affiliates.

For patients who have provided written consent, ATHN will receive a “Limited Data Set” that will be generated by Lab Tracker using pre-defined and agreed upon business rules.  The Lab Tracker Patient Management System will have powerful capabilities built in which will automatically transform the patient data into a non-identifiable form and send the resulting “Limited Data Set” to ATHN.  Limited Data Set is a type of de-identified data defined under the HIPAA Privacy Rule for the purposes of research. It permits covered entities to share this kind of non-identifiable patient data to researchers.  By definition, a Limited Data Set cannot include patient name, street address, telephone number or guardian information that would help to identify the patient.

CDC will not have access to any affiliated patient’s protected health information. Similar to the process currently used for patients who have provided written consent, the Lab Tracker Patient Management System’s capabilities will create a subset of the affiliate’s patient information into a pre-approved HIPAA compliant minimum necessary public health dataset and transmit that data to the CDC for public health surveillance as part of the Universal Data Collection (UDC) and Hemophilia Data Set (HDS) permitted under the HIPAA Privacy Rule.

No. The patient data hosted by CDC via Lab Tracker will be owned by the affiliates and not be used, controlled or accessed by the CDC or any other federal agency; therefore it is not a “federal system of records” which would subject it to this regulation. In addition, since this patient information will be protected by HIPAA, the Privacy Act will also not apply. The Privacy Act of 1974 applies to information in a system of federal records. The Privacy Act applies to information in a federal record, and HIPAA applies to covered health care entities. Since this patient information belongs to the health care provider and CDC will not have access to it; the HIPAA Privacy Rule provides the best protection of the patient’s privacy and confidentiality.