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2015 Interoperability Standards Advisory

2015 Interoperability Standards Advisory Public Comments

ONC accepted public comments on the open draft of the 2015 Interoperability Standards Advisory. The comment period was open for approximately 90 days and ended at 5 pm ET on Friday, May 1st, 2015.

The 2015 Interoperability Standard Advisory represents the model by which the Office of the National Coordinator for Health Information Technology (ONC) will coordinate the identification, assessment, and determination of the best available interoperability standards and implementation specifications for industry use toward specific health care purposes. The 2015 Advisory’s scope focuses on clinical health information interoperability. The scope of future advisories may be expanded as necessary and appropriate to support the Interoperability Roadmap’s evolution as well as other national priorities. 

The advisory is meant to provide the industry with a single, public list of the standards and implementation specifications that can best be used to achieve a specific clinical health information interoperability purpose and also to prompt dialogue, debate, and consensus among industry stakeholders when more than one standard or implementation specification could be listed as the best available. 

Amy Groom
IHS Immunization Program Manager
Indian Health Service

Please accept the attached comments from the Indian Health Service.

Susan Otter
Director of Health Information Technology
Oregon Health Authority

See attachment. Thank you.

David Booth
Senior Software Architect
Sarah Lewandowski

Epic's comments for the 2015 Interoperability Standards Advisory.

Merle Bushkin
Founder & CEO
Health Record Corporation

General 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?"

No. The Roadmap provides for limited interoperability by 2017, more by 2020 and total interoperability by 2024. There is no need for any such delays. By taking a different approach, we can and do have total interoperability today. All we have to do is adopt it today.

There are six problems causing the projected delays. They include: technical data field standardization, patient identification, legal issues including consents and restraints against sending PHI across state lines, security and privacy issues, financial sustainability, and ease of use concerns.

ALL of these problems can be avoided by aggregating a patient's complete record from ALL her providers in any and all formats on a device she owns, carries with her and gives to any care provider she sees anytime, anywhere. These records and data can be managed by an application, also residing on the device, that allows her or any provider to search for and access any records or information stored on the device even without Internet access. They can be displayed in a browser as a searchable pdf document.

An example of such a system exists and is being used by consumers/patients today. It is called MedKaz®. It is described at medkaz.com and in a video at https://vimeo.com/126040751.

Didi Davis
Testing Program Director
Healtheway, Inc.

Please send any questions or items for clarification to Didi Davis, ddavis@healthewayinc.org. We look forward to continue collaboration with ONC staff through 2015 leading up to a new publication for 2016. Thank you for the opportunity to provide these comments.

Andy Riedel
Sr. Director, Federal Initiatives
NextGen Healthcare
Cheri Whalen
Regulatory Compliance
Cerner US Client Regulatory Council

May 1, 2015

Karen DeSalvo, MD
Office of the National Coordinator for Health Information Technology
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Suite 729-D
Washington, D.C. 20201

RE: Draft 2015 Interoperability Standards Advisory, Public Comment <Submitted Electronically>

Dear Dr. DeSalvo,

As the world’s largest publicly-traded health information technology company providing leading-edge solutions and services for health care organizations worldwide, Cerner’s mission is to contribute to the systemic improvement of health care delivery and the health of communities. Our solutions are used by more than 463,000 providers and are licensed at more than 18,000 facilities in 30 countries.
Cerner has partnered with 16 health care organizations who use the Cerner CEHRT systems, creating the Cerner US Client Regulatory Council. Our mission is to create a collaborative partnership amongst health care providers and software solutions that are powering the future of the health care industry with a focus on regulatory matters. The health care providers represented in our Council cover a spectrum of health care organizations including academic hospitals, multi-state organizations, state health plans, ambulatory providers, critical access hospitals, children’s hospitals and specialty providers. Collectively, these organizations are responsible for over 10 million patient healthcare records across the United States.
Our US Client Regulatory Council is pleased to provide a response to the proposed updates to the Draft 2015 Interoperability Standards Advisory. We applaud the ONC for its efforts to provide further instruction and lead the charge to provide data continuity across the EHR delivery landscape.
Our comments are set forth below.
Cheri Whalen, CHTS-IM, CHC
Engagement Leader – Regulatory Compliance Practice
Cerner Corporation

General Comments
• The intended use of the Interoperability Standard Advisory should be further defined, especially in relation to the regulation and the Interoperability Roadmap. We encourage ONC to recognize that such a list could be used as a mechanism to inform regulatory and legislative processes regarding clarification and definition of vocabulary, structure, services and transport.
• Backward compatibility should be defined and incorporated into the general accommodations and updated in the yearly revisions.
• We encourage the yearly updates to pay specific attention to the use of code sets which are universal and distinctly “mapable” to encourage the interoperability of data transfers. There are multiple EHR data capture & reportable data requirements which do not currently align, this advisory could bring additional continuity among the regulatory bodies as indicated in our first bullet point.
• We have deep concerns regarding the inclusion of Sexual Orientation and Gender Identity as a data element. The potential inclusion of these data elements as a requirement for EHR participation provides privacy concerns in the data collection workflow. Is this captured upon the admission of a patient? Does this mean the registration clerk is then asking our patient about their sexual orientation? We do not feel these data elements are necessary to provide quality clinical outcomes for our patient and we strongly advocate the removal of these data elements. To further this consideration, the IOM report Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 indicated they reviewed the sexual orientation and gender identity data elements, but did not select them for inclusion in all electronic health records. They found there was a lack of consensus in public comments whether they would be useful, the degree of sensitivity of the information and how it would be recorded.

Meg Marshall
Director, Health Policy
Cerner Corporation

Please find attached Cerner's comments. Thank you for the opportunity to provide input.

Thomas Sparkman
Vice President, Government Relations
American Clinical Laboratory Association

See Attached Comments

Shelley Rusincovitch
Project Leader in Applied Informatics and Architecture
Duke Translational Medicine Institute

Please see attached document.

Isabelle LeBlanc
Manager, Health Policy
Dolly A. Judge
Vice President, Government Affairs
Quest Diagnostics

Quest Diagnostics comments sumbitted by Freida Hall (freida.x.hall@questdiagnostics.com) on behalf of Dolly A. Judge

Mary Ann Chaffee
Senior Vice President

Surescripts' Comments on 2015 Interoperability Standards Advisory

Alex Lippitt
Senior Director, Interoperability and Standards
IHE International and IHE USA

Second try - IHE International and IHE USA 2015 Interoperability Standards Advisory Public Comment in-line changes and answers to questions