AAP Comments on the 2017 ISA are attached. Please contact myself or Patrick Johnson in the AAP DC office with any questions.

October 24, 2016
Office of the National Coordinator for Health IT
U.S. Department of Health and Human Services
200 Independence Ave, SW
Washington, DC 20201

Dear Office of the National Coordinator for Health IT,

The Alliance for Nursing Informatics (ANI) advances nursing informatics leadership, practice, education, policy and research through a unified voice of nursing informatics organizations. ANI has reviewed the Office of the National Coordinator for Health IT (ONC) Draft 2017 Interoperability Standards Advisory (ISA) for Public Comment. In that spirit we offer our comments as nursing stakeholders on the attached ONC ISA public comment template.

ANI responded to the 2016 ISA, which recommended the inclusion of new interoperability standards related to nursing concepts. We would like to emphasize our initial comments and highlight those areas that were not incorporated in the 2017 ISA, as well as add new comments. We appreciate the opportunity to contribute to the conversation on these important Interoperability Standards and their implementation, particularly as they relate to nursing data.

Sincerely,

Judy Murphy, RN, FACMI, FHIMSS, FAAN
ANI Co-chair
Email: murphyja@us.ibm.com

Charlotte Weaver, PhD, RN, MSPH, FHIMSS, FAAN
ANI Co-chair
E-mail: caweaver2011@gmail.com

Please see attached comments.

AEGIS would welcome an opportunity to share more than seven (7) years of Interoperability testing of Query specifications associated with NHIN and the work currently being done with Sequoia and the entire eHEX community. ONC and the entire Healthcare community can benefit from significant investment and experience in cloud based share service testing being conducted by Industry.

Attached on the comments of Health Level Seven (HL7) International on the current draft of ONC’s 2017 Interoperability Standards Advisory (Advisory).

On behalf of Integrating the Healthcare Enterprise USA (IHE USA), we are pleased to provide written comments to the Office of the National Coordinator for Health Information Technology (ONC) in response to the Draft 2017 Interoperability Standards Advisory. IHE USA appreciates the opportunity to leverage our members’ expertise in commenting on the Standards Advisory, and we look forward to continuing our dialogue with ONC on identifying, assessing, and determining the best available interoperability standards and implementation specifications. We feel that this effort will provide the necessary foundation for more rapidly advancing interoperability in our country.

IHE USA (www.iheusa.org) is a 501.c.3 not for profit organization founded in 2010. Its vision is to improve the quality, value, and safety of healthcare by enabling rapid, scalable, and secure access to health information at the point of care. IHE USA operates as a national deployment committee of IHE International in order to advance its mission to improve U.S. healthcare by promoting the adoption and use of IHE and other world-class standards, tools, and services for interoperability. IHE USA engages all levels of public and private sector participants to test, implement, and use standards-based solutions for all health information needs.

IHE USA is committed to supporting and educating all stakeholders to achieve interoperability leading to information exchange that improves the quality and cost effectiveness of healthcare delivery. We will continue to leverage our resources and volunteers to ensure they have access to the tools necessary to share health information in a secure and appropriate manner.

Historically, IHE USA has taken a lead role to support the development and deployment of consensus-based interoperability specifications. IHE USA and our parent organization, IHE International (www.ihe.net), began developing IHE Profiles, or technical specifications leveraging our committee-level interoperability expertise in 1997.

IHE USA has further ensured the proper implementation of IHE Profiles and now hosts the health IT industry’s largest, most rigorous interoperability testing events to achieve health information exchange and support widespread adoption and implementation of standards-based interoperable health IT systems.

Our primary observations on the Draft 2017 Interoperability Standards Advisory(ISA), focus on the following issues:

1. IHE USA applauds ONC’s focus on standards for “electronic health information created in the context of treatment.” However, given that the ISA contains several interoperability needs related to clinical research in Sections I and II, IHE USA recommends that the ISA Scope (within the Introductory part of the ISA document) be expanded to include interoperability standards and specifications related to secondary use of clinical data for clinical research purposes.

2. IHE USA is concerned that removal of the “Best Available” characteristic from the ISA standards and specifications will minimize the importance of the ISA as guidance to the industry, and does little to encourage implementers to adopt and align on the standards identified.
• Therefore, we recommend ONC consider stronger language to direct users to implement the standards identified in the ISA while also encouraging consideration of the emerging standards that will enable innovation.

3. IHE USA would like to highlight the importance of Data Provenance as an Interoperability Need. We would like to suggest to ONC that more research be conducted on appropriate standards to capture and preserve details of the data source and the systems that the data travelled though.
• IHE USA recommends that ONC conduct field analysis to better understand how provenance data is captured in existing information systems. We think that existing and emerging standards should focus on enabling capture and exchange of provenance information at the data element level to ensure traceability of data to a sufficiently granular level.
• Data provenance is an important topic that is continuing to increase in importance as new trends emerge. Statewide and regional Health Information Exchanges are stimulating increased exchange of health information; the amount of data is exponentially increasing; patient-generated data is playing an increasing role in patient care; the number of devices (FDA regulated and non-FDA regulated) that generate new data is increasing on a daily basis; and health information travels through parallel and/or serially connected information systems (and may be modified by the systems or humans on the way). All of these emerging and growing healthcare trends will depend on understanding source information in order to be adopted and effectively used by the healthcare community.
• IHE USA also recommends initiating a discussion with stakeholders to explore ways to indicate credibility of data sources (e.g. physician or nurse vs. medical device, health monitoring device, etc.)

4. As the richness and volume of data continues to grow and become available from sources other than the clinical setting, IHE USA recommends that ONC focus efforts on identifying standards for patient-generated health data such as patient-provided goals, notes, etc.
• We also recommend that efforts be made to identify interoperability standards for health tracking devices (devices that currently do not require FDA approval) to facilitate integration of data from such devices with EHR systems.

5. IHE USA suggests that ONC provide more clarification for implementers when an Interoperability Need lists more than one Standard or Implementation Guide.
• IHE USA recommends that, when multiple standards are listed, the ONC provide a list of preferences or additional guidance for conditions to use each. This was at times included in the “Limitations, Dependencies and Preconditions for Consideration” field, but should be done consistently throughout the ISA.
• Furthermore, IHE USA believes clarification is needed regarding the purpose of standards that are listed in the “Applicable Value Sets/Starter Sets” field that were not included in the main table. For example, some Interoperability Needs listed Value Sets that were drawn from the SNOMED CT code system, while SNOMED CT wasn’t mentioned as a standard in “Type” field. Is there a reason that these standards are not listed as main standards for the Interoperability Need?

6. IHE USA recommends aligning the standards included in the ISA with those listed in the 2015 ONC Certification rule.
• Currently, these standards are often listed in the “Limitations, Dependencies, and Preconditions for Consideration” field. IHE USA believes that since such standards are federally required, they should be listed within the tables for the applicable Interoperability Need.

The IHE USA detailed comments to the Draft 2017 Interoperability Standards Advisory are included in the attached Excel template and are being submitted in collaboration with HIMSS.

We appreciate the opportunity to submit these comments on the Draft 2017 Interoperability Standards Advisory. Our comments are intended to acknowledge the importance of each stakeholder’s role in advancing standards-based interoperability and health information exchange, and ensuring that each domain is invested in overcoming the inherent challenges, while further enhancing health IT’s pivotal role in enabling healthcare transformation.

We welcome the opportunity to meet with you and your team to discuss our comments in more detail. Please feel free to contact Joyce Sensmeier, MS, RN-BC, FAAN, President, IHE USA at 312-915-9281, or Celina Roth, Sr. Manager, IHE USA, at 312-915-9213, with questions or for more information.

Thank you for your consideration.

Sincerely,

Joyce Sensmeier, MS, RN-BC, FAAN
President, IHE USA

David S. Mendelson, MD
Co-chair, IHE International

Michael J. McCoy, MD
Co-Chair, IHE International

Please see attached.