# Presentation: 435446

## American Health Information Community Successor 

**White Paper: **
**Summary of Public Comments**
**January 22, 2008**

## Table Of Contents

- Background and Overall Summary
- Comments on Key Attributes
- Vision, Purpose, and Scope
- Membership
- Board of Directors
- Rights and Obligations
- Protections and Incorporations
- Management Structure
- Comments on Transition

## Background and Overall Summary  

- In August 2007, HHS published a white paper for public comment that described options for the design and implementation of the American Health Information Community (AHIC) successor, also known as AHIC 2.0
- Fifty-four comments were received, each demonstrating a deep appreciation for the complexities in establishing the AHIC successor
- 48% were from representatives of membership organizations representing consumers, physicians, nurses, institutions, payers, and pharmacies
- 44% of those commenting on behalf of organizations served in the capacity of Vice-President or above (i.e., President, Executive Director, CEO, etc.)
- Most comments were received from organizations headquartered on the East Coast
- All but three organizations (94%) articulated support for the AHIC 2.0
- Most organizations offered constructive and useful suggestions on the proposed design and implementation plan for AHIC 2.0

## Most comments were received from organizations headquartered in Washington, DC, or on the East Coast

| DC | 18 |
| --- | --- |
| VA | 6 |
| N/A | 5 |
| MD | 4 |
| IL | 3 |
| NY | 3 |
| AZ | 2 |
| CA | 2 |
| NC | 2 |
| PA | 2 |
| WA | 2 |
| GA | 1 |
| IN | 1 |
| MN | 1 |
| OH | 1 |
| SC | 1 |

## An overwhelming number of commenting organizations expressed their support for the AHIC successor

**Support **
**94%**

- Oppose
- 6%

- Strong support for recognizing the complexity of the stakeholder landscape and attempting to include the broadest representation
- Strong support for ongoing Federal Government involvement in leadership, funding, and participation
- Strong support for AHIC 2.0 to link with HITSP, CCHIT, and other elements of the health care information technology (IT) landscape
- Of those who were not supportive, each made reference to strengthening the current AHIC

## Comments were received from the sectors identified in the white paper and from accreditation and IT organizations

| Sector | Responders |
| --- | --- |
| Clinicians | 13 |
| Consumers | 9 |
| IT Vendors | 8 |
| Institutional Providers | 6 |
| Pharmaceuticals & Devices | 4 |
| Ancillary Health Services | 3 |
| Others | 3 |
| Government | 2 |
| Health Information Exchange | 2 |
| Payers/ Health Plans | 2 |
| Accreditation | 1 |
| Certification | 1 |
| Employer/Purchasers | 0 |

## Table Of Contents

- Background and Overall Summary
- Comments on Key Attributes
- Vision, Purpose, and Scope
- Membership
- Board of Directors
- Rights and Obligations
- Protections and Incorporations
- Management Structure
- Comments on Transition

## Most organizations offered constructive suggestions for changing both the form and function of the AHIC successor

- The comments have been organized by the six key attributes described in the AHIC Successor White Paper:
- Vision, Purpose, and Scope
- Membership
- Board of Directors
- Rights and Obligations
- Protections and Incorporations
- Management Structure
- Each slide states an overall theme for the attribute and specific points made by commenters

## An explicit vision for the successor was not articulated, creating concerns about a lack of clear vision and strategy

- The vision expressed in the White Paper pertained to transitioning the current federally chartered advisory committee to a successor entity that will be an independent, sustainable public-private partnership
- However, an explicit vision was not articulated for the resulting organization, leaving some desiring further specificity of the goals, mission and precise activities of the successor to AHIC:
- Vision should include the development and implementation of the nationwide strategy for health IT interoperability
- Vision should include re-evaluation of priorities in order to make recommendations that inform the larger palette of issues
- There was general support for the need to articulate a clear vision for the successor organization that will drive development of a strategic framework:
- Develop a common vision and framework rather than focusing on discrete use cases
- Focus more broadly on strategy and implementation rather than just on outputs and recommendations
- Develop a top-to-bottom review of the health care system to identify and prioritize where connectivity is needed to advance interoperability

**Vision , Purpose and Scope . . .**

## Some stated the purpose does not go far enough, while others made suggestions concerning the scope and its priorities

- Suggestions about the scope and its priorities included:
- While the governmental role in the implementation of laws is recognized, clarity is needed regarding the successor’s purpose in establishing policy
- Establish a nationwide framework of policies for the exchange of interoperable health data that would drive the standards harmonization and certification processes
- Have a role in making critical recommendations concerning policies to encourage adoption and use of health IT
- Specify a role in guiding and influencing healthcare reform initiatives
- Ensure policies related to interoperability, access, privacy and security drive technical standards, not vice versa

**Vision , Purpose and Scope . . .**

## Some stated the purpose does not go far enough, while others made suggestions concerning the scope and its priorities

- Suggestions regarding expansion of scope included a focus on vulnerable populations, such as children and rural, racially, and ethnically diverse populations
- Promoting quality of care was suggested as another focus area for AHIC 2.0:
- Include programs designed to foster and improve quality improvement and reporting
- Ensure health IT and the NHIN can support quality efforts led by National Quality Forum (NQF) and AQA
- Improve quality of care through harmonization of standards that facilitate interoperability
- Charter of the AHIC successor organization should have as its explicit purpose the goal of fostering improvement of quality of care and quality care reporting
- Specific suggestions for expanding the development of use cases included:
- Population level analyses
- Drug safety and surveillance
- Matching patients to trials
- Accessing real-time outcomes of medical interventions
- Transfer and discharge between hospitals and long term care settings

**Vision , Purpose and Scope . . .**

## Some articulated specific concerns regarding privacy that should be addressed during the successor design phase

- Specific concerns included the definitions and the successor’s role in privacy and security:
- Need a correct definition of privacy and security
- Need to revisit patient identification issues with Congress
- Need to accurately define privacy within the charter
- Need to address issues related to privacy including improper monitoring of physicians by insurance companies
- Need to develop a national uniform standard for privacy based on HIPAA
- Need to have a role in making critical recommendations to secure the privacy of personal health information
- Questions and issues raised by a number of organizations include the following:
- Who will develop framework to ensure confidentiality, privacy, and security; on what timeline; and, how will the framework be integrated into the work of the successor?
- How will privacy groups and consumer groups be given increased roles in the development of privacy and security policies and practices?
- No recognition noted regarding the need to affirmatively restrict the use of data through the use of non-identifiable or less-identifiable data
- HIPAA’s guidelines are not specific enough to address the complexities of regional or inter-practice information exchange; legislation is required to ensure adherence to security and privacy rules

**Vision , Purpose and Scope . . .**

## Some articulated specific concerns regarding geographies that should be addressed by the successor organization

- Specific concerns regarding geographies included:
- A centralized structure is counter to the concept that the NHIN is a network of networks
- It was suggested that regional AHICs with a central board would engender participation and take into account regional differences and perspectives
- States should have an independent non-profit, public-private mechanism to serve as a primary state level HIE governance entity that is recognized by the State Government but not under government control

**Vision , Purpose and Scope . . .**

## The concept of a membership organization was questioned by some respondents

- Concerns about the membership model included:
- The membership model is unsustainable; affecting the priorities considered by an organization
- Money will buy influence; limiting the successor’s ability to advance broad goals
- Structure risks being more top down; missing realistic steerage from the bottom
- Structure with diverse stakeholders, proprietary interests and voting and non-voting classes is flawed and will result in dilution of leadership and overall effectiveness
- Financial requirements could significantly impede participation of consumers with limited resources and other valued stakeholders (safety-net providers, non-profits, local public health organizations, etc.)
- Membership model will result in the successor functioning as a trade association
- To promote seamless processes rather than sector concerns, create a federalist structure with regional AHICs whose members are community representatives within the designated regions

**Membership . . .**

## Most comments supported broad member representation and suggested changes to the sector structure

- Concerns and suggestions about member representation and the sector structure included:
- Membership sectors are unbalanced with representation from the philosophical end of the industry rather than those working on implementation issues
- Ensure full representation by organizations that are independent of funding by insurance or other industry sources
- Include health IT vendors and standards development communities to foster improved collaboration between physicians and technologists
- Add health IT and informatics as a potential tenth sector
- Quality improvement organizations and informatics should be represented as a membership sector
- Medical device regulatory agencies should participate
- HIE inclusion as a sector should be delayed until they grow in scope and stature relative to other membership sectors

**Membership . . .**

## Most comments supported broad member representation and suggested changes to the sector structure

- Concerns and suggestions about member representation and the sector structure included:
- Treat pharmacists as primary participants rather than in the ancillary heath services
- Nursing membership is a necessary membership sector
- Specify a separate physician sector, include physicians from small offices
- Emergency response organizations should be added
- Ensure representation of therapy providers such as physical therapists
- Create separate representation for clinical laboratory services.  There are special roles that lab data play in health care as well as data security and privacy concerns
- Include pathologists in the clinical laboratory membership sector
- Change the pharmaceutical/ devices sector name to those engaged in the manufacturing of health information technology systems and devices
- Represent all aspects of the public health and research community including private research institutes and non-profit disease research organizations
- Consider adding a separate sector on clinical and translational research
- Recommend that researchers are also well represented within the community of payers, providers, health plans, consumers, and government agencies
- Include representation from the molecular and genetics (pharmogenomics, virology, protemics) fields

**Membership . . .**

## The consumer membership sector was of special interest to many who responded with comments

- Suggestions about the consumer membership sector include:
- Consider reserving some seats for those who serve special populations both as providers and consumers
- Core safety net providers should be represented
- Federally Qualified Health Care Centers should be represented both with the membership and Board
- Include identification of aged, frail, and disabled representation within other sectors as well (clinicians, consumers, HIE, pharmaceutical, ancillary, etc.)
- Make consumer participation a top priority
- Enhanced consumer role in decision-making must be protected through governing rules and by-laws
- The ability for the consumer sector to organize themselves is more challenging than other sectors; emphasis should be placed on how the rights of the consumer will be represented

**Membership . . .**

## Some comments pertained to how the Board of Directors would be created

- Suggestions about the structure of the Board of Directors included:
- Each sector should have an equal number of seats represented on the Board to avoid dominance by any one sector
- Responsibility for electing sector representatives should rest with the respective sector; with any individual in good standing having eligibility for election
- Each sector should elect two board members who have responsibility to represent the full membership sector and not their own parochial viewpoints
- A small Board of Directors should be created, limiting participation to one member and one proxy from each of the major stakeholder areas
- Elected members may not always be objective and may try to defend their interests; recommend a combination of elected and appointed members
- How can a director that is employed, funded, and supported by a particular constituency, be expected to represent interests of others?
- Board should offer balanced representation that is not linked to membership fees; there should not be a link between Board representation and financial contributions
- A centralized infrastructure may be easier to control and less expensive to operate; however, it may not be representative of regional priorities or stakeholders

**Board of Directors . . .**

## Other comments were concerned about who would populate the Board of Directors

- Suggestions about the members of the Board of Directors included:
- Eligibility qualifications should require rural health care executive experience
- Recommendation for physician representation on the Board
- Recommendation for heath IT/informatics representation on the Board
- Recommendation for the research community to be represented on the Board
- Balanced formulas must be identified to ensure the needs of the aged, frail and disabled receive equal representation on the governing body as that of the acute and ambulatory populations
- Recommendation that core safety net providers, in particular Federally Qualified Health Centers (FQHCs), be represented on the Board
- Secondary data users should be on the Board during the initial stages and at the executive level to ensure systems are usable by a variety of end-users

**Board of Directors . . .**

## Transparency and accountability were the themes of most comments made about the AHIC process 

- Performance management and accountability suggestions included the need to clarify benchmarks that need to be achieved by AHIC and the timeframes for achieving these benchmarks
- Transparency of process was the theme of most process-specific comments, illustrative comments include the following:
- Ensure openness and transparency in decision-making; including sufficient notice of public meetings, opportunities for attendance and commenting by public and accessibility of clearly written publication materials
- Ensure the successor is fully subject to FACA to ensure transparency and accountability
- Use a consensus-based process to accomplish [AHIC 2.0] mission; avoiding arbitrary decisions
- Successor lacks essential public oversight and accountability; this task requires a strong, inclusive, open and accountable decision-making body
- Successor’s decision-making authority is unclear; the purpose and scope should clearly specify how AHIC’s leadership will extend beyond its advisory capacity related to setting standards to an action focused capacity, accountable for achieving AHIC priorities

**Rights and Obligations:  Transparency of Process . . .**

## The connection between Government as the largest purchaser and the success of AHIC was noted by most respondents

- Comments about the connection between Government as the largest purchaser and the success of AHIC included:
- When the connection to Government (the largest purchaser of care) is strong, there are a variety of financial incentives for adoption of health IT and for health information exchange
- If the successor’s influence on health care payment decisions diminishes, participation will be weak
- Recommendations generated by the successor will not receive the attention of policymakers that is needed to achieve the national goal of establishing a NHIN
- There would be little to attract and maintain "voluntary" participation within the private sector if Government action is not a formal requirement
- Specifically, validation and implementation of successor recommendations within its regulatory purview
- Without federal oversight, there is a risk that there will be no assurance of
- Inclusion of all stakeholders or transparency in operations;
- Funding for the entity that does not create potential conflicts of interest; and
- Clear accountability to Congress or the public at large
- If the Government fails to properly time its disengagement, it could hinder progress in health IT

**Rights and Obligations:  Role of Government . . .**

## Suggestions were made about the role of Government

- Suggestions about the role of Government included:
- The State and Federal interests must be aligned to ensure sustainability and viability of the regional health information exchanges
- Join forces and focus scarce resources on EHR adoption objectives
- Clarification is needed on how ONC will continue to be empowered and how strategies and resource allocation across agencies will be aligned and harmonized toward the shared vision
- Continued Government leadership and active participation in the AHIC successor was envisioned in different ways
- Equal partnership of Federal Government in the AHIC successor
- Key role of Government in the design and operations of the successor
- Active oversight and a participatory role as both payer and advocate for the public good
- Special representation from agencies that drive research such as the NIH, as well as agencies focused on child health issues
- Facilitate, support and fund the work of private sector volunteers
- Formal mechanism such as a federal advisory council for all affected Federal Government agencies to provide input

**Rights and Obligations:  Role of Government . . .**

## Membership fees as a fund source raised many concerns around risks to equitable representation of the broadest community

- Concerns about the idea of membership fees as a fund source included:
- Fees may represent a barrier to membership and organizations with limited fiscal and human resources; they will not have equal representation
- Need to structure dues so that all interested stakeholders can fully participate
- Lack of financial resources should not constrain organizations such as community health centers, non-profit entities, and patient advocacy groups from directly participating in the open membership structure
- Fee-based membership will be limited to large “deep-pocket” organizations who will control the health IT agenda
- A sliding scale dues structure should be employed so that not-for-profits and other small groups are not excluded from the decision-making process
- Subsidies [for fees] will be required; or no fees charged to organizations whose participation is essential and will not occur without support
- Suggestions about membership fees as a fund source included:
- The AHIC successor could subsidize travel and provide financial support for volunteers, resource-constrained organizations, and remote participation
- A tiered membership fee structure was recommended, such that organizations that do not conduct health care transactions pay only a minimal fee and will not be required to sign participation agreements

**Rights and Obligations:  Funding Model . . .**

## Non-fee-based funding sources were also discussed, with most believing that Government funding is the only viable source

- Comments about funding sources included:
- Funding should be viewed as an investment by primary long-term beneficiaries of health IT
- The Federal Government should be the cornerstone financial supporter
- Private sector purchasers/payers should follow their lead
- [Government grant] funding after the first year should be incentive-based
- The successor should be accountable for quantitative progress measures
- A secure and stable source of federal funding that is free from conflicts-of-interest is required to increase accountability and allow for appropriate focus on health IT policy
- Funding models could be based on potential savings captured from fraudulent or inadvertent claims that are reinvested in the health care system
- Seeking new and emerging funding sources will handicap the successor’s ability to develop uniform, coherent policies that are in the national interest and potentially inappropriately influence the development of priorities and recommendations

**Rights and Obligations:  Funding Model . . .**

## Although legal concerns were not the main focus of most stakeholder comments, some issues did surface  

- Two responders prefer that AHIC 2.0 not introduce legal impediments to adopting open source technology when implementing health IT
- Another cited the need to identify and address legal obstacles during transition, but did not specify what legal issues might arise
- One stakeholder noted that health IT must be built around the assumption that it will involve the practice of medicine across state lines; therefore, the legal issue of physician licensure must be addressed
- Questions regarding ownership of data and who controls how that data flows between providers and institutions were raised, as well as how the lack of data flow from other providers affects a physician's individual responsibility for patient outcomes
- Additionally, questions were raised regarding who is responsible for insuring data integrity, security and reliability and does the assumption of this responsibility also create some legal liability for patient outcomes

**Protections and Incorporation:  Legal Concerns . . .**

## Suggestions for refining the illustrative management structure will need to be considered during the design phase

- Suggestions for refinements to the illustrative management structure include:
- Include a technology advisory council to ensure readiness of vendor community to implement interoperability standards
- Continue the tradition of independence by inviting experts to AHIC 2.0 forums
- Form workgroups in the organization to address needs of children and others
- Ensure a role for volunteers in the work processes of the successor
- Appointment of a Chief Technology Officer (CTO) as opposed to a Senior Technology Officer
- Have the CTO attend Board meetings and direct any strategic initiatives and implementation of technology directives
- Appoint a Chief Privacy Officer (CPO) as opposed to a Senior Data Uses Officer to foster representation of consumer privacy interests
- Have the CPO report directly to the Board, the CEO, Congress, and the public

**Management Structure . . .**

## There was widespread support for maintaining and expanding linkages between the AHIC successor and other organizations

- Suggestions for addressing issues related to the linkages focused on carefully defining the role of the AHIC successor and other relevant organizations:
- Specify how the successor will work with CCHIT and HITSP, private-sector multi-stakeholder initiatives, NQF, and AQA
- Continue coordination with CCHIT and HITSP and expand collaboration with HL7, Continua Alliance, SAeH, organizations involved in the Health Information Security and Privacy Collaborative (HISPC), and CDISC
- Coordinate quality measurement efforts with NQF, HQA, AQA, Joint Commission, and AHRQ
- Continue coordination between the Federal Government, private payers, and states in HIE and health IT efforts
- Solicit views from industry stakeholders who are non-members and from experts as needed
- Issues and concerns raised were regarding the overlap and conflict with existing organizations as the successor may add another layer of bureaucracy
- The planning committee must clearly delineate the area of operation and linkage between all existing entities, to include:
- CCHIT, HITSP, ANSI, CAQH and NCVHS

**Management Structure . . .**

## A few stakeholders provided relevant models that the successor could utilize to develop its operating structure

- Suggestions for models for the operating structure included:
- An all-volunteer commission and work group structure similar to CCHIT would avoid disadvantages to consumers and favoring of corporations with largest profit margins
- The government role within a membership structure and for the service of government employees as board members should mirror NQF.
- NQF gives larger share of board seats to consumer representation
- The GAIN project is an example of a public-private-partnership: _[http://www.fnih.org/GAIN2/Overview_description.shtml](http://www.fnih.org/GAIN2/Overview_description.shtml)_
- FASBE is an example of a non-profit, public-private partnership funding model
- National Academies is an example of a business model that would support the goal of broadly representative stakeholders making recommendations within a system of checks and balances

**Management Structure . . .**

## Table Of Contents

- Background and Overall Summary
- Comments on Key Attributes
- Vision, Purpose, and Scope
- Membership
- Board of Directors
- Rights and Obligations
- Protections and Incorporations
- Management Structure
- Comments on Transition

## Organizations expressed their support for ensuring a successful transition process for the AHIC

- Suggestions for the transition process included:
- Transition period should include a status review of pending AHIC recommendations to determine which activities will be transitioned to successor
- Planning work should turn immediately to leadership recruitment, trust-building, and stakeholder engagement
- Planning board should clearly communicate, at the earliest time possible, the successor's plan to fully support current efforts at CCHIT
- In the federalist model, the planning team should be responsible for constructing the framework for “regional AHICs” and associated governance structure, as well as the central structure
- The planning team must re-examine, re-develop and re-word the guiding principles to become actionable statements that convey specific intent and advice for the representatives
- There were opposing views on the overlap between the AHIC and the successor organization:
- Overlap of AHIC and the successor organization could lead to decisional paralysis
- Ensure overlap between AHIC and successor to ensure smooth transition and help successor benefit from lessons learned

**Transition . . .**

## Only a few concerns were expressed about the timing, transparency, and participation in the transition process 

- Comments on timing
- Successor must quickly establish strong credibility within 18 months of operation by attracting a strong management team, attaining key milestones, and establishing deep and meaningful relationships with standards development and other organizations
- The implementation plan is unrealistic in its timeframe, precluding necessary work to design an entity that has sustainable long-term success
- Comments on transparency
- A request for public hearings and a comment period to gather input on the design of the successor organization should be established
- Comments on the planning board and planning participation
- Objective selection criteria and representatives from various sectors for the planning board should be identified to enhance the transparency of the process
- Inclusion of broader participation should begin in the earliest stages of transition and not be relegated to the actual date of transition
- Rural experts and advocates should be involved in the transition from the outset to assist in identifying obstacles and making recommendation to improve health IT adoption

**Transition . . .**