1. HIT Policy Committee
Information Exchange Workgroup
NwHIN Conditions for Trusted Exchange
Request For Information (RFI)
May 15, 2012
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2. Our Eight Questions
Actors, Accreditation and Validation Bodies, and Validation Entity Eligibility
1. Question 8: We solicit feedback on the appropriateness of ONC’s role in coordinating the governance mechanism
and whether certain responsibilities might be better delegated to, and/or fulfilled by, the private sector.
Question 9: Would a voluntary validation process be effective for ensuring that entities engaged in facilitating
electronic exchange continue to comply with adopted CTEs? If not, what other validation processes could be
leveraged for validating conformance with adopted CTEs? If you identify existing processes, please explain the focus
of each and its scope.
Question 10: Should the validation method vary by CTE? Which methods would be most effective for ensuring
compliance with the CTEs? (Before answering this question it may be useful to first review the CTEs we are
considering to adopt, see section “VI. Conditions for Trusted Exchange.”
Question 11: What successful validation models or approaches exist in other industries that could be used as a
model for our purposes in this context?
Question 13: Should there be an eligibility criterion that requires an entity to have a valid purpose (e.g., treatment)
for exchanging health information? If so, what would constitute a “valid” purpose for exchange?
Question 14: Should there be an eligibility criterion that requires an entity to have prior electronic exchange
experience or a certain number of participants it serves?
Question 15: Are there other eligibility criteria that we should also consider?
Question 16: Should eligibility be limited to entities that are tax-exempt under section 501(c)(3) of the IRC? If yes,
please explain why.
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3. Nationwide Health Information Network
Governance
Conditions of Trusted Exchange
• Conditions for Trusted Exchange (CTEs) – Three Domains:
– Safeguards: focus on the protection of individually identifiable health
information (IIHI) to ensure its confidentiality, integrity, and availability
and to prevent unauthorized or inappropriate access, use, or disclosure.
• Example [S-1]: An NVE must comply as if it were a covered entity, and must treat
all implementation specifications as “required.”
– Interoperability: focus on the technical standards and implementation
specifications needed for exchanging electronic health information.
• Example [I-2]: An NVE must follow required standards for establishing and
discovering digital certificates.
– Business Practices: focus on the operational and financial practices to
which NVEs would need to adhere in support of trusted electronic health
information exchange.
• Example [BP-2]: An NVE must provide open access to the directory services it
provides to enable planned electronic exchange.
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4. Accreditation and Validation Process
Overview
 Similar to the permanent certification program for HIT, the National Coordinator would approve a
single body to accredit and oversee validation bodies.
 Validation bodies would evaluate an entity’s conformance to adopted CTEs as opposed to a
particular product’s (e.g., EHR technology) certification to certification criteria.
 Certified HIT could be used by an entity as a way to demonstrate conformance with certain
adopted CTEs
 Accreditation body would be expected to conform to internationally accepted standards for
accreditation bodies
 Validation bodies - upon accreditation by the accreditation body and authorization from the National
Coordinator - would subsequently perform the validation of entities‘ conformance to adopted CTEs.
 Validation could use different methodologies (self-attestation, laboratory testing for
conformance, certification, accreditation) and could vary depending on CTE type and potential
methodology burden.
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5. Actors and Associated Responsibilities
8. ONC’s roles & delegation of responsibilities to the private sector.
Suggested Existing Authorities and/or
Proposed Role Lead Alternatives to Consider
1. Endorsing and adopting CTEs, publishing ONC In accordance with the National Coordinator‘s
guidance authority at section 3001(c)(1)(A) and
processes identified at section 3004 under the
PHSA, and publishing interpretative guidance
2. Facilitating the receipt of input from the HIT ONC In accordance with processes identified at
Policy and Standards Committees and other sections 3002(b)(3) and 3003(b)(2) of the
interested parties on: PHSA
• revisions to CTEs,
• new CTEs, and
• the appropriate retirement of CTEs
3. Selection and oversight processes for an ONC ONC would approve a single body to accredit
accreditation body and oversee “validation bodies”.
4. Authorizing and overseeing validation bodies ONC
responsible for validating that eligible entities have
met adopted CTEs
5. Administering a process to classify the readiness ONC [ONC would have to adopt specific
for nationwide adoption and use of technical certification criteria that could be used to
standards and implementation specifications to certify other types of HIT through established
support interoperability related CTEs certification program.
6. Overall oversight of all entities and processes ONC
established as part of the governance mechanism.
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6. ONC Role
8. Voluntary Nature of Process
Role Comments
We solicit feedback on the appropriateness of ONC’s
role in coordinating the governance mechanism and
whether certain responsibilities might be better delegated
to, and/or fulfilled by, the private sector.
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7. Validation Process
9. Voluntary Nature of Process
Role Comments
9(a) Would a voluntary validation process be effective for
ensuring that entities engaged in facilitating
electronic exchange continue to comply with adopted
CTEs?
9(b) What other validation processes could be leveraged
for validating conformance with adopted CTEs?
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8. Conditions for Trusted Exchange
Safeguards
[S-1]: An NVE must comply as if it were a covered entity, and must treat all implementation specifications as
“required.”
[S-2]: An NVE must only facilitate electronic health information exchange for parties it has authenticated and
authorized, either directly or indirectly.
[S-3]: An NVE must ensure that individuals are provided with a meaningful choice regarding whether their IIHI
may be exchanged by the NVE.
[S-4]: An NVE must only exchange encrypted IIHI.
[S-5]: An NVE must make publicly available a notice of its data practices describing why IIHI is collected, how it is
used, and to whom and for what reason it is disclosed.
[S-6]: An NVE must not use or disclose de-identified health information to which it has access for any
commercial purpose.
[S-7]: An NVE must operate its services with high availability.
[S-8]: If an NVE assembles or aggregates health information that results in a unique set of IIHI, then it must
provide individuals with electronic access to their unique set of IIHI.
[S-9]: If an NVE assembles or aggregates health information which results in a unique set of IIHI, then it must
provide individuals with the right to request a correction and/or annotation to this unique set of IIHI.
[S-10]: An NVE must have the means to verify that a provider requesting an individual’s health information
through a query and response model has or is in the process of establishing a treatment relationship with that
individual.
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9. Conditions for Trusted Exchange
Interoperability
[I-1]: An NVE must be able to facilitate secure electronic health information exchange
in two circumstances: 1) when the sender and receiver are known; and 2) when the
exchange occurs at the patient’s direction.
[I-2]: An NVE must follow required standards for establishing and discovering digital
certificates.
[I-3]: An NVE must have the ability to verify and match the subject of a message,
including the ability to locate a potential source of available information for a specific
subject.
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10. Conditions for Trusted Exchange
Business Practices
[BP-1]: An NVE must send and receive any planned electronic exchange message from
another NVE without imposing financial preconditions on any other NVE.
[BP-2]: An NVE must provide open access to the directory services it provides to enable
planned electronic exchange.
[BP-3]: An NVE must report on users and transaction volume for validated services.
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11. Validation Process
10. Validation Method
Role Comments
10 (a) Should the validation method vary by CTE?
10 (b) Which methods would be most effective for
ensuring compliance with CTEs?
Examples of validation methods from RFI: self-attestation, laboratory testing for conformance,
certification, accreditation
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12. Validation Process
11. Comparative Models
Role Comments
11. What successful validation models or approaches
exist in other industries that could be used as a
model for our purposes in this context?
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13. NwHIN Validated Entity (NVE) Eligibility
Criteria
Overview
The RFI considers the following criteria that NVEs must meet to be eligible:
Meet all solvency and financial responsibility requirements imposed by the statutes and regulatory
authorities of the State or States in which it, or any subcontractor performing some or all of its functions,
would serve.
Make some type of financial disclosure filing
Provide evidence that it has a surety bond or some other form of financial security
Have the overall resources and experience to fulfill its responsibilities in accordance with the CTEs
when performing health information exchange services
Have at least one year of experience
Serve a sufficient number of providers to permit a finding of effective and efficient administration;
however, no prospective NVE would be deemed ineligible if it only served providers located in a single
State
Have to be a valid business or governmental entity operating in the United States.
Have not had civil monetary penalties, criminal penalties, or damages imposed, or have been enjoined
for a HIPAA violation within two years prior to seeking validation
Not be listed on the Excluded Parties List System maintained by the General Services Administration
Not be listed on the List of Excluded Individuals and Entities maintained by the Office of Inspector
General
Would not be appropriate to limited to tax-exempt 501(c)(3) organizations.
Some of the eligibility criteria being considered may be inapplicable to fed/State governmental entities.
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14. Eligibility Criteria
13. Organizational Purpose
Role Comments
13 (a) Should there be an eligibility criterion that requires
an entity to have a valid purpose (e.g., treatment) for
exchanging health information?
13 (b) If so, what would constitute a valid purpose for
exchange?
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15. Eligibility Criteria
14. Prior Experience
Role Comments
14. Should there be an eligibility criterion that requires an
entity to have prior electronic exchange experience
or a certain number of participants it serves?
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16. Eligibility Criteria
15. Other Criteria to Consider
Role Comments
15. Are there other eligibility criteria that we should also
consider?
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17. Eligibility Criteria
16. Tax Exempt Status
Role Comments
16. Should eligibility be limited to entities that are tax-
exempt under section 501(c)(3) of the IRC? If yes,
please explain why.?
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