HIT Policy Committee - Nationwide Health Information Network - Governance Recommendations Appendeix - 121310

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Nationwide Health Information Network
Governance Workgroup
Appendix: Supporting Details to Recommendations

Presented to the HITPC on 12/13/10
Draft 12/10/10 v5
Pre-Decisional Draft
Pre-decisional DRAFT. For HITPC Consideration ± 12/13/10
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1. Governance principles and functions

2. NW-HIN as preferred approach
3. Federal, ONC and shared responsibilities
4. Conditions of Trust and Interoperability
5. Validation
6. Public comments
2
Recommendations to the HITPC 10/20/10
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1. Transparency and openness

± Maximize to extent possible in developing governance; in the
structures, standards, services and policies, including privacy
protections themselves; in information sharing, oversight,
enforcement and accountability.
± Support engagement of the general public and those
exchanging information.
2. Inclusive participation and adequate representation
± Explicit preference for inclusion of diverse stakeholders over
exclusion.
± Permit and encourage robust participation in governance by
diverse stakeholders, including consumers. If necessary for
scalability, support representative models.
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3. Effectiveness and efficiency

± Form should follow function. Functions should be conducted
with goal of maximizing efficiency and effectiveness.
± Responsiveness and minimization.
4. Accountability
± Participating stakeholders and governance mechanisms
should be accountable and, as part of the national health
agenda, be understood to have some responsibility to the
nation at large.
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5. Federated governance and devolution

± Multiple functions may be distributed across multiple entities,
with national-level coordination.
± Decisions should be made by those closest to the issue and with
the greatest stake in successful resolution and NW-HIN goals.
± Federal government should perform those functions that require
centralized governmental control, particularly in areas essential
to maintaining public trust and assuring the NW-HIN meets
stated national HIT goals.
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6. Clarity of mission and consistency of actions

± Rights, responsibilities and obligations should be well-
documented and clear to all stakeholders. Consistency in
decision-making is helpful for stakeholder planning, but should
not be an obstacle to innovation or improvement.
7. Fairness and due process

± Governance must be fair to those that participate or are
affected by governance decisions. Governance processes
should include due process to assure fairness and
responsiveness.
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È. Promote and support innovation
± Governance should be consistent with creating conditions for
innovation, and focus on those issues that require uniform
treatment. Administrative burdens should be minimized and
voluntary agreements, in principle, preferred.
± Degree of uniformity in policies and standards should reflect the
needs for that particular issue and consider where necessary to
enable and not inhibit innovation. Technical standards should not
set policy, but support and be in service to policy goals.
9. Evaluation, learning and continuous improvement
± Governance should be evaluated based upon appropriate
performance and effectiveness measures, with ongoing evaluation
and adaptations and improvements to meet evolving NW-HIN.
± Given critical nature of healthcare and sensitivity of health
information, particular attention should be paid to issues
implication safety. È
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Establish NW-HIN policies and Establish NW-HIN technical

eligibility criteria requirements
Governance Objectives:
- Engender trust
- Encourage interoperability
- Foster innovation
Assure compliance,
Oversee NW-HIN governance
accountability, enforcement
9
+ ## !m
] There should be a uniform set of NW-HIN policies and

practices that are followed as a condition of exchanging
health information through the NW-HIN and that should
be reflected in technical design.
] Privacy, security, interoperability, eligibility criteria, compliance
expectations and jurisdiction.
] There should be mechanisms to:
± Address gaps in policies and practices
± Coordinate to assure policies and technical requirements are
consistent.
] Necessary to assure that sufficient privacy protections
and safeguards are in place to facilitate and promote
nationwide exchange, interoperability and to remove
barriers to nationwide exchange of health information 10
++ #,*#

] Adopt technical requirements for the NW-HIN through a

recognized process that coordinates and harmonizes
standards and that provides for stakeholder input,
including consumers.
] There should be mechanisms to address:
± Transition processes as technical requirements change.
± Authorization of technical resources for use in NW-HIN (e.g.
provider directories, certificate authority, registries.)
] Necessary to assure that technical requirements are
established to accomplish interoperability and policy
objectives for trust, including a defined security level of
assurance.
11

-* #

] Assure that eligibility criteria are satisfied and that

compliance with conditions for trust and interoperability are
met, as well as clear accountability and appropriate
enforcement.
± Establish and conduct validation to determine eligibility and verify
compliance with policy and technical requirements as a condition of
exchanging information through the NW-HIN.
± Determine consequences of non-compliance with policies, practices
and technical requirements.
± Provide a mechanism to address disputes, concerns or complaints,
taking into account measures provided for under existing law.
± Determine how mechanisms for redress, remedies and sanctions
would be applied.
± Consider need for coordinated investigation, enforcement and
breach notification. 12
"#.++."#
+

] Oversight is necessary to assure governance

objectives are met and are effective and able to adapt
over time.
± Track or measure certain issues or activities in support of
overseeing the effectiveness and efficiency of NW-HIN
governance.
± Oversee ongoing compliance.
± Conduct ongoing assessments of risks and benefits for the
NW-HIN governance, including prevention of harm.
± Periodically evaluate the performance of the overall
governance mechanisms and incorporate the findings into
continuous improvement.
± Resolve disputes regarding decision rights among federated
governance functions.
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] ONC Definition: A set of - # and #" that enable
the Internet to be used for secure and meaningful exchange of health
information to improve health and health care.
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] What is NW-HIN?
± An environment of trust and interoperability created by NW-HIN standards,
services and policies, V
± A preferred approach for exchange of health information nationwide supported by
the federal government, with strong incentives to vigorously promote adoption.
] When is exchange considered NW-HIN and subject to NW-HIN
governance?
± When that exchange complies with applicable NW-HIN standards, services and
policies (i.e. NW-HIN conditions of trust and interoperability (COTIs); V
± When those exchanging health information assert they are doing so under the
auspices of NW-HIN.
] When is exchange not considered NW-HIN and, therefore, not
subject to NW-HIN governance?
± When not asserted to be NW-HIN compliant.
± If there is only compliance with a portion of the applicable NW-HIN requirements
(e.g. exchange complies with NW-HIN technical requirements, but not NW-HIN
policies, or vice versa)
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] Who is part of NW-HIN?

± Any entity, large or small, or aggregation of entities, large or small,
that engages in the exchange of health information, asserts itself
as being NW-HIN compliant and is recognized to have met NW-
HIN conditions of trust and interoperability (COTIs).
] Why would entities want to be part of NW-HIN?
± Entities will be more willing and able to exchange with unfamiliar
partners who are recognized as meeting NW-HIN COTIs.
± Provides a benchmark for entities who wish to qualify for Federal
contracts, exchange with federal entities, and be eligible for other
federally-supported incentives.
± Entities may believe that they would be advantaged competitively
in the marketplace if they meet widely recognized conditions of
trust and interoperability.
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##+ +#

] For the NW-HIN to be successful and to ensure the
public good, the federal government should:
± Provide strong federal leadership, support and engagement in
the NW-HIN environment and its governance.
± Establish fundamental requirements for trust and
interoperability.
] Other entities should have specific appropriate roles
with respect to NW-HIN governance.
] Certain aspects of governance (e.g. accountability,
enforcement, oversight) should apply across NW-HIN
governance roles.
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"# #
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] ONC should establish a national framework for

governance of the NW-HIN that:
± Assures trust and interoperability.
± Reflects ³governance of governances.´
± Is based upon the nine sound governance principles.
± Includes national-level coordination and oversight across a set
of core functions.
± Provides opportunities for broad stakeholder input, including
consumers.
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#
] The federal government should:

± Leverage existing governance and enforcement mechanisms
as applicable.
± Recognize existing state authorities across all relevant
domains, facilitating coordination and harmonization with
states and other entities as needed.
] Federal agencies should:
± Participate fully and directly in the NW-HIN, including in
appropriate governance mechanisms.
± Meet NW-HIN COTIs when exchanging in NW-HIN
environment.
± Condition federal information exchange upon compliance with
NW-HIN requirements.
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ONC specifically should:

] Facilitate coordination
± Across federal activities /authorities, and identify needs to
strengthen.
± Identify incentives that vigorously promote use of the NW-HIN.
± Optimize broad stakeholder input, including consumers.
] Establish core NW-HIN elements
± NW-HIN Conditions of Trust and Interoperability (COTIs).
± Criteria and mechanisms to verify compliance with NW-HIN COTIs.
] Oversee NW-HIN governance and assure accountability
± Monitor and highlight innovation and address governance barriers.
± Provide ongoing evaluation and continuous improvement.
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] There should be a defined set of conditions of trust and
interoperability established for the NW-HIN (NW-HIN COTIs):
± Include policies, eligibility criteria* and technical requirements for the
NW-HIN.
± Engender trust, promote interoperability, address barriers to
nationwide exchange while remaining technology agnostic.
] NW-HIN COTIs should provide a baseline and address the
need for variability:
± Universally required NW-HIN COTIs should apply across all NW-HIN
scenarios.
± Other NW-HIN COTIs may be required in particular circumstances.
] The Governance rule should establish an initial set of COTIs
and processes for adding and modifying.
* The federal government should determine whether any factor should
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Pre-decisional DRAFT. For HITPC Consideration ± 12/13/10 preclude an entity from eligibility, temporarily or permanently.
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] How should NW-HIN COTIs be developed and

maintained?
± Should COTIs be established only through rulemaking?
± Should categories of COTIs be established in the rule, with a
federally-guided process for developing and approving them?
± Should a non-governmental entity (e.g. similar to the role of
SDOs in HIPAA) do some or all of the developmental work,
following federally-set process requirements, and bring COTIs
to ONC for approval?
] How should final acceptance of the COTIs be
addressed?
] Through rulemaking?
] Through an approval process established in the rule?
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] When developing and maintaining NW-HIN COTIs,

obtain input from a broad range of stakeholder
communities, including consumers.
] Establish COTIs through a multi-phased process.
± NW-HIN COTIs that are available at the time of rulemaking
should be adopted for the NW-HIN.
± There should be a process for adding other NW-HIN COTIs.
± There should be a process for maintaining NW-HIN COTIs,
including those established in the rule itself and others adopted
for the NW-HIN.
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] Following is an example of a process in which NW-HIN

COTIs could be initiated, developed, proposed,
reviewed and approved through a combination of
rulemaking and other processes:
± Define categories of COTIs for which new/modified COTIs
should be subject to rulemaking.
± Work with other agencies having appropriate jurisdiction when
modifications in those agencies¶ rules are desired.
± Specify which categories of NW-HIN COTIs should be subject
to another process, including the criteria by which a candidate
NW-HIN COTI would be evaluated.
± Define a process by which proposed, new / modified
conditions would be reviewed and included as part of NW-HIN
COTIs by the federal government.
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2È
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] NW-HIN COTIs are established to assure trust and

interoperability. A mechanism should be established to
verify that the conditions have been satisfied (i.e. ³NW-
HIN Validation´).
] NW-HIN validation should:
± Be required for exchanging in NW-HIN environment and
asserting NW-HIN compliance.
± Include appropriate validation processes and criteria, including
process to address non-compliance.
± Maintain appropriate balance between assuring that COTIs
have been satisfied and cost and burden of validation.
* Validation is used to generally refer to the process for verifying compliance. This could include a broad
array of possible methods (e.g. self attestation, testing, certification of systems, accreditation of entities,
etc.) 29
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] NW-HIN validation is a process to verify that NW-HIN COTIs have been
satisfied.
± NW-HIN validation should leverage existing validation methods, processes
and entities where appropriate.
± Validation facilitated by other entities (e.g. by states, other networks, etc.) may
satisfy NW-HIN validation.
] There may be different methods of validation depending upon the nature
of the COTIs. For example:
± Validation methods for trust and interoperability will likely differ and should be
appropriate for the NW-HIN COTI.
] Validation of systems to assess system conformance with NW-HIN technical
requirements (e.g. testing, certification, etc.)
] Validation that an entity meets NW-HIN requirements (e.g. self-attestation, legal
agreements, accreditation, etc.)
] There may be different methods of validation depending upon the level of
certainty needed to assure that COTIs and other NW-HIN requirements
are met. 30

# !m
Establish
Oversee NW-
Establish NW- mechanism to
HIN validation
HIN validation authorize NW-
Federal efforts; serve as
process and HIN validation
³court of
criteria body(ies) /
appeals´
equivalency
Feedback Loop
Recognized Approve,
Oversee and
as authorized deny or
Validation enforce
NW-HIN revoke
Body(ies) ongoing
validating compliance
compliance
body recognition
Appeal decision
Validated Party 31

# !
] Federal responsibilities:
± Establish and maintain validation criteria.
± Assure the validation criteria reflect the COTIs.
± Establish a mechanism to authorize NW-HIN validation
body(ies) and a process by which existing and equivalent
validations are recognized.
± Maintain appropriate balance between assuring that COTIs
have been satisfied and cost and burden of validation.
± Coordinate and oversee NW-HIN validation body(ies) to assure
NW-HIN goals and principles of NW governance are met.
± Serve as ³court of appeals´ for decisions by validation
body(ies) to approve, deny, revoke recognition of compliance
32
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] Apply established and applicable eligibility criteria to determine

eligibility.
] Verify that practices are consistent with applicable NW-HIN
policies.
] Verify that systems used to exchange through the NW-HIN
environment meet NW-HIN COTIs, including technical
requirements.
] Issue validation decision to approve, deny, revoke NW-HIN
recognition of NW-HIN compliance.
] Investigate possible non-conformance with COTIs and take
appropriate remedial action including revoking NW-HIN
compliance recognition when warranted, with provision for
appeals.
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] Financial Services / Payment Card Industry

] HIPAA
] Federal Trade Commission
] Federal initiatives
] National Quality Forum (NQF)
] Lessons from NW-HIN Exchange
] Standards and Interoperability Framework
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· ..# ."#
*m# .
] Leverage and coordinate across existing federal

authorities.
] Provide strong federal leadership, engagement and
participation.
] Federal role needed to:
± Set national-level policy and adopt interoperability standards
only where critical to enable trust and interoperability for
nationwide exchange.
± Oversee and coordinate across a set of governance processes
that, together, comprise NW-HIN governance.
± Assure NW-HIN governance includes ability to evaluate, learn
and adapt on an ongoing basis.
36
· ..# ."#
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] Recognize that there will likely be a variety of

approaches and multiple levels of coordination,
validation, and enforcement:
± Different views expressed regarding need for national-level
validation mechanisms, such as certification and accreditation.
Some recommended it; others cautioned that it was premature
to do this.
± Need for national-level coordination across wide range of
stakeholders to build consensus and inform development of
NW-HIN requirements.
± Recognition that enforcement occurs at various levels, through
other federal authorities (e.g. FTC, OCR) states, local, and
exchange partners, often through contractual mechanisms.
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1.O +#"#.6
] Are there existing entities or processes performing a

particular governance function? If so:
± Does it accomplish the NW HIN governance objectives and
principles?
± Can it scale to meet NW-HIN needs?
] Which essential functions or activities are not currently
addressed, but are needed now to overcome barriers
and to promote exchange through the NW-HIN?
± Should the federal government perform that function directly or
delegate it?
± If delegated, to whom?
± If a new entity is needed, what type of structure / attributes
should it have?
3È
· .1.O$O%(O! O
] 234 Commenters (33 ± blog; 201 - E-mail)

] Need for public education and use of plain language
± Commenters generally seemed unclear over the function and
role of the NW-HIN.
] More emphasis should be placed on safety.
] Greatest concern was privacy and security of protected
health information (PHI), and need for strong privacy
and security protections, e.g. mechanisms for consent,
control, authorization, and explicit policies for data
reuse.
] Public comments varied but mainly sought to leverage
existing mechanisms where appropriate.
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· .1.O$O%(O! %
] Specific suggestions for:
± State / federal partnership.
± Need for national-level policies and standards, with input from
HITPC.
± National accreditation program for qualified entities.
± Public-private collaborative structure to act as a convener and
support adoption of NW-HIN.
] Suggestions for leveraging existing governance
structures:
± For policies and practices: FCC, state regulatory frameworks,
Exchange Coordinating Committee.
± For interoperability requirements: Standards Development
Organizations (SDOs).
± For validation: CCHIT, EHNAC, ONC-ATCB model.
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1.%
] Focus on federal and ONC responsibilities,

development and validation of NW-HIN COTIs
] Blog for additional public input (11/30/10)
± Which activities should be tightly held by the federal
government?
± Should there be an overarching entity to accredit NW-HIN
validation bodies?
± Is there a need for a governance mechanism in the near-term
to address implementation support and coordination? If so,
what type of entity should facilitate this?
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· .1.%$OO&O! O
] There should be a well formed committee to supervise

these standards or make the standards (and the
development process of standards) more open; a
proposal based approach.
] It is absolutely critical that standard file formats be
developed for any systems funded, in whole or part,
with federal dollars.
] Support for delegating areas of accreditation and
certification and using a more federated, governance of
governances, approach. Recognition that government
is not usually the best place for innovation to occur, but
acts best when it is a platform for innovation.
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· .1.%$OO&O! %
] Information should be communicated to all people involved.

Responsive governance shouldn¶t be confused with reactionary
approach.
] Government and non-government roles should be addressed
equally.
] Governance must remain tightly controlled at the federal level to the
extent that it sets policy and defines the principles for participation.
] There should be an overarching validation entity, with
implementation and day to day operation of certification /
accreditation handled by multiple other entities, many of which
already exist within and outside government.
] The federal government should certify these various entities as
valid certification / accreditation entities for HIT to assure trust in
the overall system.
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· .1.%$OO&O! &
] The federal government must establish an oversight

body that will be able to support current efforts being
made throughout the nation to implement HIT. At the
very least, individuals and entities adopting HIT should
be able to look for support and advice as to whether
what they are implementing is valid in terms of
governance structures and privacy and security
practices.
] There should be an overarching governance committee
that includes representatives across the various NW-
HIN projects, with representatives from the Security
and Trust developers.
44

+#"# 4
] Other models of governance suggested through

diverse input
± OMB HIT Task Force
± International models (UK and Canada)
± ISO ± OECD Principles of Corporate Governance
45

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Appendix: Supporting Details to Recommendations

1. Governance principles and functions

O @   

1. Transparency and openness

3. Effectiveness and efficiency

5. Federated governance and devolution

6. Clarity of mission and consistency of actions

7. Fairness and due process

Establish NW-HIN policies and Establish NW-HIN technical

] There should be a uniform set of NW-HIN policies and

] Adopt technical requirements for the NW-HIN through a

] Assure that eligibility criteria are satisfied and that

] Oversight is necessary to assure governance

] Who is part of NW-HIN?

] ONC should establish a national framework for

] The federal government should:

ONC specifically should:

] How should NW-HIN COTIs be developed and

] When developing and maintaining NW-HIN COTIs,

] Following is an example of a process in which NW-HIN

] NW-HIN COTIs are established to assure trust and

] Apply established and applicable eligibility criteria to determine

] Financial Services / Payment Card Industry

] Leverage and coordinate across existing federal

] Recognize that there will likely be a variety of

] Are there existing entities or processes performing a

] 234 Commenters (33 ± blog; 201 - E-mail)

] Focus on federal and ONC responsibilities,

] There should be a well formed committee to supervise

] Information should be communicated to all people involved.

] The federal government must establish an oversight

] Other models of governance suggested through

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