Interoperability Roadmap Public Comments

Priority Use Cases

AcademyHealth supports the efficient flow of clinical information for authorized reuse by the research community and works to improve the infrastructure and ecosystem needed for the dissemination and uptake of evidence-based findings by the health care system. To that end, we encourage ONC to consider policies that enhance—and do not unnecessarily restrict—the quality, availability, timeliness, and affordability of data and tools used to conduct and disseminate research.

Along those same lines, as ONC weighs the prioritization of use cases, AcademyHealth recommends supporting a governance framework that gives researchers appropriate access to identified and de-identified clinical and claims data for the production of robust, meaningful research and focuses on the role of patients in their own care—including facilitating access to their data for self-management and care across systems and settings (i.e., Appendix H use cases 2,19, 21, 56) and exchange of data among providers (i.e.,17), as well as promoting opportunities to participate in research—in addition to those cases that provide continued support for public and population health (i.e., 1, 4, 50, 51), measuring and reporting on care to improve quality and value (i.e., 10, 38), and facilitating discovery (i.e., 15, 16).

General: Critical Action for Near-Term Wins

AcademyHealth supports enhancing the evidence base and moving knowledge into action. We value ONC’s inclusion of calls to action (Table 4, pp. 53-54) for providers to collaborate more fully with research institutions, public health departments, and other partners to generate new knowledge that helps to fulfill the Triple Aim by recognizing the importance of research to improve health care and care delivery.

There are many promising examples of continuously learning health systems that are improving care while contributing new methods and approaches to facilitate meaningful interoperability. AHRQ-funded research networks such as Improve Care Now, CERTAIN, the Indiana Registry, and SAFTInet, in addition to ONC Beacon Communities in Michigan, Minnesota, and New Orleans offer a subset of relevant examples. All offer live demonstrations of systems working towards interoperability that can contribute new knowledge on critical health issues such as Crohn’s disease, surgical outcomes, dementia care, and pediatric asthma, among others. Similarly, AcademyHealth’s peer-reviewed, open access journal, eGEMs, was created with support from AHRQ for the express purpose of highlighting lessons learned from quality improvement and research efforts that promote the interoperability of systems needed to facilitate continuous learning and improvement.

Governance

The Roadmap rightly views the HIT ecosystem as a learning health system (LHS) and considers rules of engagement and governance as a fundamental building block for LHSs of the future. Of particular concern to the research community is the need for coordinated governance to facilitate data-sharing agreements among different institutions, including the need to agree on legal, policy, and procedural issues. Without these agreements, there are significant delays and many missed opportunities for collaboration. AcademyHealth is excited to see ONC define a need for public-private collaboration around shared governance (Table 1).

We encourage ONC to consider adaptation and support for partnership models that facilitate learning, collaboration, and sharing of successful governance models among researchers and other stakeholders to build learning health systems that improve patient care and outcomes. Such forums can broaden awareness and agreement among existing communities with the goal of coordinating governance processes.

The comments I'm submitting are on behalf of the SCO.

The IJIS Institute would like to commend the Office of National Coordinator (ONC) for developing a comprehensive national vision and a shared interoperability roadmap for building a learning health and care system. The publication of the health interoperability roadmap and the request for public comments is a great step forward in aligning interoperable standards for maximizing information sharing and we greatly appreciate this opportunity to comment.
The IJIS Institute has been working on justice and health information sharing through a number of BJA funded projects since 2013. As a result, we have a significant interest in providing input on the ONC Roadmap. We have therefore prepared this summary of our response to questions and priority recommendations. We have also attached a supplemental report containing the compiled input from those that IJIS works with from both the practitioner and industry communities. We hope that you find these recommendations and comments useful and look forward to further discussions.

I. Response to Questions
Question: Are the actions proposed in the draft interoperability Roadmap the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? What, if any, gaps need to be addressed? Are the right actors/stakeholders associated with critical actions?
In response to the above question set, the IJIS Institute believes that while the Roadmap may allude to linkages between health and criminal justice communities, there needs to be more explicit discussion about the potential for benefit between these two communities in order to realize the full potential for a learning health and care system and, at the same time, improving public safety outcomes. The potential is great for improved justice and health information exchange as both partners benefit from the exchange with the ultimate beneficiary of the information shared being our communities.
“Information sharing between the criminal justice and healthcare communities has the potential to enhance both public safety and health outcomes by reducing redundancies, enhancing continuity of care, and generating efficiencies in both domains.”
—Opportunities for Information Sharing to Enhance Health and Public Safety Outcomes,
A Report by the Criminal Justice and Health Collaboration Project
The health concerns of individuals who are involved in the criminal justice setting are and should be a part of the conversation in this Roadmap. Correctional institutions that house offenders have either internal or contracted health care providers who provide the same medical services as providers in our communities. Their need for obtaining and sharing health information is essential for good medical practice. The importance of the Roadmap identifying the need to develop interoperability between the health and justice domains in both the body of the Roadmap and in the use cases outlined in Appendix H cannot be overstated.

The IJIS Institute realizes the critical importance of having the right perspectives at the table when information sharing is the end goal. We are actively engaged in managing Project Interoperability, a collaborative, participatory, and transparent effort aimed at information interoperability across all aspects of government and the private sector. Information interoperability is the ability to transfer and use information in a consistent, efficient way across multiple organizations and IT systems. The goal of Project Interoperability is to help government and the private sector identify a baseline of terms, tools, and techniques to create an information sharing network in mission-agnostic terms and for any type of information sharing. Project Interoperability seeks to normalize the way information sharing technology is developed. If we’re all using different terms to achieve interoperability capabilities, we aren’t going to end up with interoperable systems, and we’re going to pay for duplicative systems and excessive costs.
Through this lens of interoperability, it becomes clear that the scope of the Roadmap must include the vital criminal justice component for true success. Information interoperability is important because it increases timely information sharing, can reduce costs and redundancy, and leverage best practices–all steps to improve decision making for government leaders, industry, and citizens. There are many key agencies and organizations that can assist in the broadening of the Roadmap’s scope to better encompass the criminal justice domain.

Question: Please submit 3 priority use cases from this list that should inform priorities for the development of technical standards, policies and implementation specifications.
In connection with the above discussion, it is important to add use cases for specific exchanges with the justice community in the final version. Health matters of individuals who are involved in the criminal justice setting are still health matters.

Of those use cases in the Roadmap, we have identified three that would be of significant value in justice/health exchanges due to their potential impact on public health and public safety: ONC-RM# 27, ONC-RM# 33, and ONC-RM# 44.

Question: How can ONC best recognize and support the industry-led governance effort?
The Roadmap is obviously very much health-centric. The criticality of including the viewpoints of other domains—law enforcement, criminal justice, corrections, and the courts in particular—cannot be stressed enough. There are many examples of a need for cross-domain and inter-disciplinary collaboration AND the desirability for an increased sense of urgency in adopting open information sharing and standardization.

Question: How can private health plans and purchasers support providers to send, find, or receive common clinical data across the care continuum through financial incentives? Should they align with federal policies that reinforce adoption of standards and certification?

Much of the work of Project Interoperability and the IJIS Institute involve the development, use, advocacy, and governance of information sharing and safeguarding standards. We have many examples of success realized and costs saved through the use of open standards. Incentives should be provided to align with federal policies that reinforce adoption of standards and certifications. A timeframe should be placed on the incentives and then penalties should be placed on non-compliant or non-adopters.

II. Priority Recommendations
We are pleased to provide a number of recommendations to promote a more holistic national approach in aligning and focusing the tangible actions and outcomes using interoperable information standards where there are clear intersection points in both the justice/public safety and health business domains.

Collaboration and Governance
The state-to-national cross collaboration between justice and health should be strengthened. It is critical that the states stay focused on interoperability with the federal government to ensure that government to government has a set of interoperable of standards. These interoperable standards with the health community also need to interoperate with the justice interoperable standards. This set of interoperable standards needs to address three critical areas transport; message structure and semantic interoperability. States do not have the incentives or funding to force or ensure this interoperability themselves across business domains—let alone sometimes within a given business domain. Additionally, national governance has tended to differ with commercial industry on building and implementing interoperability standards. While there are undoubtedly many reasons why the marketplace and related political dynamics may resist “open” health and care systems, it is crucial that ONC provides the example and incentives for standards-based, collaborative systems to the private sector health and care systems vendors and to all Health and Human Services agencies who procure and use these systems. A great example of a successful, interoperable collaborative standard is the National Information Exchange Model (NIEM) which has been widely adopted in justice and public safety nationwide (at federal, state, local and tribal levels) and is designed to accommodate an even wider-range of domains and subjects.

Implementation
Thirty-eight federal agencies were selected for 2015–2020 to begin using the interoperable standards to deliver and show the value within and across federal government programs (Social Security, Veterans Administration, U.S. Department of Homeland Security, etc.). The federal government needs to implement these interoperable standards proving the value across and within programs and departments. Once this is done, the value can be expanded to government-to-government (G2G) at the state, local, and tribal government levels. G2G incentives will be maximized by the federal government’s delivering on its commitments and showing the value of interoperability within and across federal government agencies. Cross-federal agency adoption of interoperable health standards will show leadership and drive the businesses/commerce to adopt the interoperable government standards. This will lead and incentivize the government to businesses/commerce (G2B) interoperability. This incentivized approach is similar to the way health-care (payer and provider) community was moved to adopt Centers for Medicare & Medicaid Services (CMS) rule changes. One candidate for a timely implementation would be comprehensive provider and resource directories (see 4.1.1).

Business Alignment
If the health care roadmap included a plan to clearly identify and/or include the business use cases between the justice and health business domains, then both the justice and health program offices could collaborate on funding, governance, and technical interoperability to provide a true breakdown in government stove-piped and siloed priorities and funding and promote cooperation and collaboration in solving and resolving local information sharing issues across and between the two domains. A clear national alignment of cross-domain business collaboration between the health vision and roadmap, and a justice vision and roadmap, could have national significance in resolving numerous business issues across the domains and programs. For example, successfully interfacing justice and health care information could promote more efficient court processing, increase reentry, and provide better cross-justice and health reporting and monitoring. ONC is encouraged to review and consider partnerships for cross-domain collaboration.

• Health is finalizing their use case priorities and Justice has done a similar exercise with the justice/health use cases. A formalized analysis should be done by a group of justice/health professions to build a priority set of cross business domain high priorities.

• Executive priorities and business alignments should be done separately (by business domains) and then coordinated (across business domains) to maximize funding and other government resources.

• Federal cross business domain granting organizations should be coordinated with the proper grant restrictions (business and interoperable technical standards) and governed properly to ensure the business priorities are achieved more quickly with stove piped funding sources.
Solid Interoperability Standards
By better understanding the cross-domain business objectives and tangibly or empirically measuring their impacts on each other, the nation will be able to better shape policy and law to build a more efficient and effective government. These empirical evidences will become more evident when the vision includes the cross-domain use cases, when roadmaps include them, and when vision and roadmap alignment across business domains begins to take place. Interoperable cross-domain standards must be encouraged, bridged, and forced by government grant funding for state, local, and tribal government to also force grant funding and move industry adoption. Once local implementations have been adopted, business domain programs will be able to report on and monitor the full impacts of the cross-domain issues. In turn, the reporting can be used to foster more specific changes to each business domain and its policies, law, and technologies.

The use of HL7 within NIEM should be used as a cross-governmental interoperable standard for data representation, message structure and semantic interoperability in exchanges between justice and health.
Providing interoperable open standards for accessing state and federal provider directories and consent sharing systems with the security and privacy trust solution will enable more efficient, effective and precise cross domain coordination and information sharing.

Ecosystem Security Privacy and Trust
The ONC roadmap must include a detailed health trustmark plan to drive the adoption and implementation of trust frameworks for organizations in the healthcare COI and its sub-communities.

Healthcare organizations need to be able to participate in multiple trust frameworks concurrently. In a scalable manner, with minimal cost and effort, the health trust plan must address the issues of componentization and reuse of trust framework requirements
The health trustmark plan must recognize and account for the following realities.
A typical healthcare organization needs to participate in trusted transactions with many other healthcare organizations within multiple healthcare sub-communities, utilizing multiple trust frameworks.

Some healthcare organizations need to participate in trusted transactions with other organizations that reside outside the healthcare community (e.g., justice agencies), utilizing trust frameworks defined by non-healthcare communities.
We strongly recommend that the ONC Roadmap address all of the trust requirements through the use of the GTRI Trustmark Framework as part of the ONC Roadmap's Rules of Engagement and Governance.

Supplemental Report Attachment
We have also attached a supplemental report containing the compiled input from those that IJIS works with from both the practitioner and industry communities.

Please see the attached letter.

April 3, 2015

Submitted online at http://www.healthit.gov/policy-researchers-implementers/interoperabilit…

Office of the National Coordinator for Health Information Technology
Department of Health and Human Services
Attention: Interoperability Roadmap Public Comments
Hubert H. Humphrey Building, Suite 729D
200 Independence Ave, S.W.
Washington, D.C. 20201

Public Comment on draft Shared Nationwide Interoperability Roadmap released January 30, 2015

Submitted by the Fenway Institute, the Center for American Progress, and nine other health research, health professional, and patient advocacy organizations

Dear Dr. DeSalvo:

We write to comment on Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0, released by ONC January 30, 2015.

As health care providers, researchers, educators, and advocates, we share your goal of creating “a nationwide learning health system—an environment that links the care delivery system with communities and societal supports in ‘closed loops’ of electronic health information flow, at many different levels, to enable continuous learning and improved health.” (8) We also agree that “standardized data elements, such as demographics,…will enable better matching and linking of electronic health information across all systems and platforms.” (10) Finally, we support the objectives included in ONC’s definition of interoperability:

…the ability of an system to exchange electronic health information with and use electronic health information from other systems without special effort on the part of the user…[T]his means all individuals, their families and their health care providers have appropriate access to electronic health information that facilitates informed decision-making, supports coordinated health management, allows individuals and caregivers to be active partners and participants in their health and care and improves the overall health of the nation’s population. (18, emphasis added)

We believe that in order for all of this to be true for lesbian, gay, bisexual and transgender (LGBT) Americans, it is essential that sexual orientation and gender identity (SO/GI) be added to the “Common Clinical Data Set for purposes of treatment” called for in the Nationwide Interoperability Roadmap (34). Knowledge of a patient’s sexual orientation or gender identity can be an important part of treatment. For example, transgender women who were assigned male sex at birth should be offered a prostate exam as appropriate. Gay and bisexual men and transgender women should be regularly tested for HIV, syphilis, and other STIs. We understand that draft Stage 3 meaningful use guidelines are not requiring collection of these data. However, we are suggesting that consistent with the Institute of Medicine’s recommendation in its groundbreaking 2011 report on LGBT health, the collection of sexual orientation and gender identity data is essential “to improve health and health care quality,” the stated goal of using a Common Clinical Data Set (34).

The questions developed by the CHARN network of community health centers and published in PLOS One in September 2014 should be considered as potential standards for SO/GI data collection that could be useful to better document and reduce LGBT health disparities.

Despite advances in legal protections for LGBT people that have occurred over the last several decades, many barriers to good health and high-quality health care remain. As recommended by both the Institute of Medicine and The Joint Commission, collecting data on sexual orientation and gender identity in health care settings is essential to providing high-quality, patient-centered care to LGBT individuals. Collecting SO/GI data is also an important part of learning more about and addressing LGBT health disparities. In recent years, LGBT health experts and health policymakers have reached consensus regarding the relative dearth of data on LGBT health and the importance of increasing SO/GI data collection in clinical settings and in electronic health records (EHRs) in order to better understand LGBT health disparities and inform interventions to reduce and eliminate them.

A growing body of research has documented LGBT health disparities in health and disease outcomes, , risk behaviors and factors, , rates of insurance coverage, , access to preventive care, , and access to culturally competent care.

Because most clinical records systems do not support the collection of structured SO/GI data, however, LGBT people are often invisible in care settings. This invisibility masks disparities and impedes the provision of important health care services for LGBT individuals, such as appropriate preventive screenings, assessments of risk for sexually transmitted infections such as HIV, and effective interventions for behavioral health concerns that may be related to experiences of anti-LGBT stigma and discrimination. Like all patients, LGBT people have many concerns related to their relationships, desire to have families, and issues of aging that occur in different stages of the life cycle. An opportunity to share information about their sexual orientation and gender identity in a welcoming environment will facilitate important conversations with clinicians who are in a position to be extremely helpful.

Two of the four near-term priorities articulated by ONC in the Roadmap are:

(2) improve technical standards and implementation guidance for sharing and using a common clinical data set; (3) enhance incentives for sharing electronic health information according to common technical standards, starting with a common clinical data set; (11)
We urge ONC to take this opportunity to add sexual orientation and gender identity to the list of demographic variables and clinical indicators listed in the Common Clinical Data Set on page 80 of the draft Shared Nationwide Interoperability Roadmap.
SO/GI questions proven effective in health care settings

In an effort to determine best practices for collecting SO/GI information, researchers affiliated with the Community Health Applied Research Network (CHARN)—a network of community health centers funded in 2009 to enhance applied health research—developed SO/GI questions and tested them at four health centers across the U.S. among both LGBT and heterosexual patients. The sample of 301 patients was predominantly heterosexual, and mostly Black and Latino. One third were patients at Beaufort Jasper Hampton Health Center in rural South Carolina. The questions were overwhelmingly accepted by the patients. The majority of participants—including most LGBT patients—felt the answer choices accurately reflected their identities, and most respondents felt that this information was “important for my medical provider to know about me.” Based on this research, we recommend the following questions:

1. Do you think of yourself as:
a. Straight or heterosexual
b. Lesbian, gay, or homosexual
c. Bisexual
d. Something else, please describe _____
e. Don’t know

2. What is your current gender identity? (Check all that apply.)
a. Male
b. Female
c. Transgender male/Trans man/Female-to-male (FTM)
d. Transgender female/Trans woman/Male-to-female (MTF)
e. Genderqueer, neither exclusively male nor female
f. Additional gender category/(or other), please specify_____
g. Decline to answer, please explain why_____

3. What sex were you assigned at birth on your original birth certificate? (Check one.)
a. Male
b. Female
c. Decline to answer, please explain why_____

Responding to SO/GI questions in a health care setting should always be voluntary. Providers and LGBT community members should be educated about the importance and purpose of gathering SO/GI information. It is important that clinical staff be trained in how to provide culturally competent and affirming care to LGBT patients, and how to ask about sexual orientation and gender identity as part of that process. Clinical or senior center staff should be trained in how to ask these questions in a way that is sensitive and affirming, and how to protect patient privacy and confidentiality. The National LGBT Health Education Center (www.lgbthealtheducation.org) offers online trainings and technical assistance to help health centers and hospitals provide culturally competent, affirming and nondiscriminatory care.

The Fenway Institute, the Center for American Progress, and the nine other health research, health professional, and patient advocacy organizations encourage you to add sexual orientation and gender identity to the Common Clinical Data Set in the draft Shared National Interoperability Roadmap. Please consider the questions developed by the CHARN network of community health centers and published in PLOS One in September 2014 as potential standards for SO/GI data collection that could be useful to better document and reduce LGBT health disparities.

We thank you for your time and attention to this matter and look forward to continuing to work with the Office of the National Coordinator to improve data collection in EHRs and increase health information exchange to improve health outcomes. Should you have any questions, please contact Sean Cahill at scahill@fenwayhealth.org, or at 617-927-6016.

Sincerely Yours,

Fenway Institute, Fenway Health

Center for American Progress

AIDS United

Center for HIV/AIDS Research, Education, and Policy
Mylrlie Evers-Williams Institute for Elimination of Health Disparities
University of Mississippi Medical Center
Jackson, MS

GLMA: Health Professionals Advancing LGBT Equality (formerly Gay and Lesbian Medical Association)

Human Rights Campaign

HIV Medicine Association

Los Angeles LGBT Center

National Association of Community Health Centers

National Partnership for Women and Families

Open Arms Healthcare Center
Jackson, MS

Please see uploaded PDF for citations

Our comments are enumerated in the submitted document.

Please find comments from the American Physical Therapy Association in the attached document.

The National Rural HIT Coalition supports the ONC Interoperability Roadmap. Rural health care providers have unique challenges that are directly impacted by improved EHR interoperability. These challenges include limited HIT workforce, geographically broad referral networks and a shortage of primary care and other providers. Rural communities will likely benefit more than urban from supporting and developing models for interoperability across the care continuum.

Priority Use Cases (Appendix H)
The Coalition feels the following use cases enumerated in the Roadmap are critical for rural health care.

#18. Patients have the ability to access their holistic longitudinal health record when and where needed.
Since patients who live in rural communities often need to receive specialty care in other communities, it is important that information is available both pre- and post-visit. By providing patients with the ability to access and consolidate their information there is not a need to rely on exchange between disparate systems. This should be seen as one option in an incremental approach, however, with the ultimate goal being full query-based exchange between providers across the health care spectrum.

#48. Patients routinely engage in mental health risk assessments using electronic communications such as eVisits and telemedicine.
Behavioral health and chemical dependency providers are in high demand and short supply, particularly in rural communities. The last several years have shown that many of these services can be provided via telemedicine when the barriers of limited internet connectivity, poor or nonexistent reimbursement, and health information exchange are overcome.

#52. At-risk patients engage in healthcare monitoring programs which can detect life threatening situations (such as patient down and unresponsive) using at-home monitoring devices and electronic communications such as eVisits and telemedicine.
Remote and at-home monitoring will become increasingly cost effective and useful in all communities, but particularly in rural communities where distance to providers may be greater and access to home health may be limited. The Coalition fully supports increasing the use of monitoring programs.

Suggested Use Cases
1. Critical data, such as demographic, allergy and medications can be exchanged between any providers across the care continuum. A more complete record can be exchanged between those systems that are able to, thus providing an incremental approach.
a. The Coalition believes that an incremental approach to interoperability will be more sustainable and will provide immediate benefit to patient safety. An approach that includes a data set that is focused on the minimum necessary to provide safe patient care during transfers and referrals while developing a more complete exchange methodology will be most useful.

2. Exchange of medical and behavioral information between state and federal correctional institutions and the private sector is encouraged. Electronic Health Records (EHRs) implemented in correctional institutions are required to be able to exchange information with the private sector.
a. A patient population that is often ignored, and is a large user of behavioral health services, is the previously incarcerated. Their medical and behavioral health information is currently not electronically sent to private sector providers. Since these are government run institutions and there is a limited number of EHRs in use in corrections, this should be a relatively simple task with major impact.

3. Emerging care delivery models, including convenient care provided in outpatient pharmacy settings, utilizes robust exchange between other providers as well as with the patient’s personal health record of choice.
a. With the transition from volume to value-based health delivery models in full swing, communities are becoming more creative in delivering necessary health care. For example, more outpatient pharmacies are implementing, or at least investigating, providing primary care (or convenient care). We feel that this is an important development that needs to be encouraged to share information electronically with other local providers, particularly in rural.

NaviNet strongly supports the increased interoperability as called for in the Roadmap document. However, we have significant concerns about the decision to defer consideration of the administrative/clinical intersection. Please see the attached for my rationale and specific recommendations to address this.

Thank you.

This bill will interfere with our ability to take care of patients by putting government and insurance companies first and permitting them to stop tests after they are ordered by providers due to real time access to charts which could cause serious harm to patients. It also would create a good opportunity for cyber attacks and give way too many people access to data and information about patients violating a right to privacy. It will be extremely costly and drive up costs for everyone. Please do not implement this system!