Introduction to the ISA

Comment

Dear Madam,…

Dear Madam,
Dear Sir,

On behalf of the IVD Industry Connectivity Consortium we are pleased to provide written comments to the Office of the National Coordinator for Health Information Technology (ONC) in response to the 2017 Interoperability Standards Advisory (ISA).

The IVD Industry Connectivity Consortium (IICC) is a global, nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics in clinical laboratories. This will improve healthcare efficiency and patient care.

The IICC has collaborated with several government bodies, including the US Food and Drug Administration (DMD/OIR/CDRH), US Centers for Disease Control and Prevention, and US Department of Health and Human Services (HHS) (ONC), National Institutes of Health (NIH), and industry organizations such as IHE International, HL7, Clinical & Laboratory Standards Institute, the College of American Pathologists, the Association of Public Health Laboratories (APHL), the Medical Device Innovation Consortium (MDIC), and the Regenstrief Institute to develop two standards that together allow for true Plug & Play connectivity of IVD instruments to Middleware and Laboratory Information Systems (LIS).

The IVD Industry Connectivity Consortium appreciates the opportunity to leverage our volunteers’ 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.

The IVD Industry Connectivity Consortium finds that it would be beneficial if ONC would add the and standards to the following proposed new sections:

  • Section II: Content/Structure Standards and Implementation Specifications > Interoperability Need: Identify linkages between vendor IVD test results and standard codes

 

Type

Standard/Implementation Specification

Standards
Process
Maturity

Implementation Maturity

Adoption Level

Federally
Required

Cost

Test Tool
Availability

Standard

Final

Production

1

No

Free

No

  • Section II: Content/Structure Standards and Implementation Specifications > Interoperability Need: Connectivity between instruments, middleware, and LIS systems

Type

Standard/Implementation Specification

Standards
Process
Maturity

Implementation Maturity

Adoption Level

Federally
Required

Cost

Test Tool
Availability

Standard

Final

Production

3

No

Free

Yes

 

  • LAW – Laboratory Analytical Workflow Profile – The LAW Profile defines the physical connection, message definitions (based on the HL7 Messaging Standard v2.5.1), and workflow definitions between instruments, middleware, and LIS systems in the laboratory. IICC collaborated with the IHE Pathology and Laboratory Medicine (PaLM) domain to develop the LAW Profile. LAW is already implemented by all major IVD companies, including Abbott Laboratories, Beckman Coulter, BD, bioMerieux, Data Innovations, Orchard Software, Ortho Clinical Diagnostics, Roche, Siemens Healthineers, Systelab, Sunquest, and Werfen Group.

For more information on LAW

  • LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results – Defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. LIVD assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code. LIVD was developed in collaboration with the members of the FDA IVD Semantic workgroup.

For more information on LIVD

Why are LAW and LIVD important for clinical laboratories?

The LAW Profile and LIVD specifications should have a significant positive impact on laboratory operations. Clinical laboratories are encouraged to ask their instrument, middleware, and LIS vendors about their current or planned support for the IICC/IHE Laboratory Analytical Workflow (LAW) and LIVD. The LAW Profile is currently being implemented by all major IVD companies.

  • LAW and LIVD will significantly reduce the time and cost involved with deploying, connecting, and updating instruments in the laboratory by eliminating the need for vendor customized connectivity implementations, favoring vendors that adopt the specifications and pass the savings to their customers.
  • Addresses all the shortcomings of outdated laboratory connectivity standards such as CLSI LIS1-A (ASTM 1391) and CLSI LIS2 (ASTM E1394).
  • LAW will be a global standard (CLSI AUTO16).
  • LAW and LIVD support federal guidelines on Meaningful Use.
  • Improves the integrity of patient data.
  • The LAW and LIVD specifications are available for download and do not require any licensing or fees for implementation.

The IVD Industry Connectivity Consortium (IICC) would also ask ONC’s support to make both standards “Federally Required” for federal agencies as well as commercial entities.

We appreciate the opportunity to submit comments on the 2017 ISA.  Our comments are intended to recognize 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.

Please feel free to me if you have any questions or to obtain more information.

Sincerely,

Serge Jonnaert, BiD
President, IVD Industry Connectivity Consortium -  
[email protected]
+1.949.259.3807
   / Board Member, At-Large - IHE International -
   / President, AERTWORKS® LLC –  

Premier healthcare alliance: Comments on ISA

Dear Dr. Rucker,

The Premier healthcare alliance is pleased to submit these comments in response to the Office of the National Coordinator’s (ONC) Request for Public Comments regarding the Interoperability Standards Advisory (ISA).

Premier is a leading healthcare improvement company, uniting an alliance of approximately 3,900 U.S. hospitals, hundreds of thousands of clinicians and more than 150,000 other provider organizations. Premier has one of the most comprehensive and largest healthcare databases in the industry. Premier works with its members on utilizing informatics, analytics, and data to improve care quality and patient safety, while achieving cost efficiencies. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost. Premier, a Malcolm Baldrige National Quality Award recipient, plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Specific comments in response to your questions are provided in the attached chart.

Premier shares the vision of achieving health information technology interoperability and the establishment and deployment of core standards and functions of health information technology (HIT) to enable an interoperable, learning health ecosystem. Premier appreciates ONC’s ongoing efforts to develop and enhance the ISA. However, the existence of standards and the publication of the ISA does not by itself ensure that application developers and HIT vendors implement and configure their software using the standards. Certainly, nationwide healthcare data exchange requires standards development and their timely adoption. Beyond exchange of data, however, interoperability requires data usability, understandability and development, recognition and adoption of common data sets, clinical terminologies and vocabularies and data definitions. Additionally, standards are needed for openly accessible electronic health record application program interfaces (APIs) to assure interoperability with other health information technologies and third party applications.

Premier hopes our comments (detailed in the attached letter) are helpful as you continue this important work. Premier stands ready to actively participate in ONC’s ongoing efforts to achieve nationwide interoperability. Please feel free to us for participation in your listening sessions, workgroups and other activities.

If you have any questions regarding our comments or need more information, please me or Meryl Bloomrosen, Senior Director, Federal Affairs, at [email protected] or 202.879.8012. We look forward to continued participation and dialogue. Thank you again for the opportunity to provide comments.

Sincerely,

Blair Childs

Senior vice president, Public Affairs

Premier healthcare alliance

 

Final Premier Comments on ONC 2017 Interoperability Standards Advisory_November 2017
ISA Response Allscripts.xls

NCPDP - Scope Comments

  • Modify the first paragraph to the following: Starting with the 2017 ISA, the ISA’s focus has expanded to more explicitly include public health and health research interoperability. Thus, its scope includes electronic health information created in the context of treatment, and subsequently used to accomplish a purpose for which interoperability is needed (e.g., a referral to another care provider, public health reporting, or research).
  • ONC may want to consider adding verbiage around the addition of the administrative/payment oriented transactions.

IHE QRPH Domain Standard Addition Request

On behalf of the Integrating the Healthcare Enterprise (IHE) Quality, Research & Public Health (QRPH) Domain, I would like to submit the following for addition to the Section II: Content/Structure Standards and Implementation Specifications under the II-R: Public Health Reporting area as an emerging standard.  

Interoperability Need: Requirement to submit data for the Title X Family Planning Annual Reporting process at an encounter level and in real time, in a standard format defined by OPA.

Type:                Emerging Standard

URL:

Standards Process Maturity: Balloted Draft

Implementation Maturity:    Pilot

Adoption Level:        1

Federally Required:        No

Test Tool Availability:        Feedback Requested

Cost:                Free

Other Notes for Consideration: OPA is currently engaged in an overhaul of their Family Planning Annual Reporting system, to enable the reporting of encounter level data from all of their Title X sites in a standard format and via a standard methodology. OPA is currently piloting two interoperability standards through this project and is intending to begin collecting data according to this new system in 2019.

 

AMA's comments to ONC on proposed 2018 ISA

On behalf of American Medical Association (AMA) I appreciate the ability to comment on ONC's Interoperability Standards Advisory (ISA).

Section I:  Vocabulary/Code Set/Terminology Standards and Implementation Specifications

Comment:

The AMA recommends that the ISA include a seventh characteristic to the interoperability need table to inform stakeholders of the presence and inclusion of the terminology’s guidelines.  The use of a terminology’s guidelines is critical for consistent application of the codes and semantic interoperability of the data being exchanged through the terminology.  Consistent use of codes further ensures comparability of data that can better quantify the value of care and determine outcomes.  The following shows how this additional characteristic would be included in the table.

 

Representing Medical Procedures Performed

Type

Standard Implementation/Specification

Guidelines

Standards Process Maturity

Implementation Maturity

Adoption Level

Federally required

Cost

Test Tool Availability

Standard

Final

Production

Image removed.

 

 

Free

N/A

Standard

CPT-4:

HCPCS:

Final

Production

Image removed.

 

 

$

N/A

Standard

Final

Production

Image removed.

 

 

Free

N/A

 

 

UCSF Center for Digital Health Innovation's Comments on 2018 ISA

Dear Dr. Rucker,

 

UC San Francisco’s Center for Digital Health Innovation submits these comments on the 2018 Reference Edition of the Interoperability Standards Advisory. We thank you for the opportunity to provide these comments.

 

Very truly yours,

 

Mark Savage

 

Mark Savage

Director, Health Policy

Center for Digital Health Innovation

University of California, San Francisco

 

E. [email protected]

C. 415.225.1676

O. 415.502.1997

UCSF Center for Digital Health Innovation comment letter on 2018 ISA (11-20-2017)

CDISC Requests from 2018 ONC ISA

Thank you for the opportunity to provide input on the 2018 Interoperability Standards Advisory (ISA) online document. Although the catalog focuses on the implementation needs of healthcare, it will play a role in ONC’s programs that support the 21st Century Cures Act. The Clinical Data Interchange Standards Consortium (CDISC) has engaged in projects with our fellow standards development organizations such as the Regenstrief Institute, IHE and HL7 over the past year to also help support 21st Century Cures Act and other initiatives at the intersection of care and research.

CDISC believes that, in order to realize the full impact of the bill, we as a society must invest in interoperation between existing healthcare and biomedical research standards and infrastructure. We thank the ONC for recognizing the importance of research as part of a learning health system through the inclusion of CDISC standards in the ISA. Our standards provide a consensus-based global language for protocol-driven clinical and translational research. They are also part of a larger tapestry of common research standards.

Many, if not most, major components of cancer-related research infrastructure in the United States are assets of or are being/have been funded by the United States National Cancer Institute (NCI). Their Enterprise Vocabulary Services (EVS) team manages dozens of commonly used semantic structures for research, including but not limited to CDISC terminology, and health. The following recommendations and requests are in support of expanding the ISA to include appropriate semantics to support ONC’s activities toward the 21st Century Cures Act. We recommend the following updates in support of cancer, and broader, research as it pertains to the coordination of multiple agencies involved with human health and research-based evolution:

  1. Section 1-Q Representing Analytic Data for Research Purposes: We request that the existing be updated to . This update refers to the specific controlled terminology packages rather than the overview page to all CDISC controlled terminologies. We also request the addition of the , as these terms include semantics from academic, federal and industry projects and would support semantic interoperability of research study concepts among systems.
  2. Section 1-Q Representing Analytic Data for Research Purposes: In order to support precision medicine, we recommend that (Enterprise Vocabulary Services) be added to the standard. These terminologies are final and have had modest adoption by the regulated research community. We further recommend that the ISA consider the addition of longstanding and newer ‘omics and phenotype standards that are being adopted by the global genomics community through the Global Alliance for Genomics and Health (GA4GH). HL7's Clinical Genomics group is also very involved in developing standards in this area, coordinating with GA4GH and CDISC. These standards have also been utilized by many diverse genomics efforts funded by the NCI. These include, but are not limited to the Human Phenotype Ontology, HGNC gene (and other molecular) identifiers and other ontologies hosted by the . These terminologies and ontologies are final, not required by the FDA and have moderate to high adoption.
  3. Section 1-Q Representing Analytic Data for Research Purposes: Many additional terminologies have been utilized by researchers from Cooperative Groups, research consortia and investigator-initiated trials. Cancer-related terminologies from these resources and others are found within the . The cancer terminologies are bound to common data elements within the , and these elements can help researchers to construct conformant data capture mechanisms linking data from health systems to research. These terminologies are final, not required by FDA and have moderate to high levels of community adoption.
  4. Section 1-Q Representing Analytic Data for Research Purposes: Terminology also exist for analysis datasets that are submitted to the United States Food and Drug Administration. As such we recommend the addition of the . The terminologies are final, required by the FDA and have had high levels of community adoption.
  5. Section II-S: Research - Integrate Healthcare and Clinical Research by Leveraging EHRs and other customessaywriters.info Systems while Preserving FDA’s Requirements: We request the addition of required, open and highly adopted CDISC standards – the and the . These standards have been utilized by diverse research teams from academia, patient advocacy groups, government and industry worldwide to aggregate data from many different real world data sources. In support of the 21st Century Cures Act and other indication-specific areas of integration of healthcare and clinical research data, we also request the inclusion of the implementation specification , which include multiple solid tumors along with dozens of other indications and conditions. There are multiple projects within the PhUSE, CDISC and other communities to map these implementation specifications to HL7 FHIR and other healthcare standards. These specifications are included in the FDA Technical Conformance Guide, but are not required, and their overall adoption is modest to moderate. Finally, we request the addition of the implementation specification , a provisional standard with modest adoption, the maturation of which is occurring in collaboration with HL7 Clinical Genomics Working Group to bridge semantics among clinical genomicists and trialists.
  6. Section II-S: Research - Submission of Clinical Research Data to FDA to Support Product Marketing Applications. We request that the adoption level of the CDISC SEND standard be updated from low to moderate. This required standard is being utilized for submissions to regulators for all pre-clinical genetic toxicology information. We also request the addition of the freely available, non-required standard and the implementation specification , a provisional standard with modest adoption.

We appreciate the ONC’s consideration of these requests and suggestions.

 

Lauren Becnel, Ph.D.

VP Strategy & Innovation

Clinical Data Interchange Standards Consortium (CDISC)

 

DoD / VA Interagency Program Office (IPO) comments on 2017 ISA

Thank you for allowing us an opportunity to provide comments on the 2017 as you prepare for the 2018 version.  Included within our comments are comments we also received from VHA representatives.  If there are any questions regarding our comments, please let me know.  This document is key to help move the Industry towards a more open and standard's based approach in exchanging Health information.

 

Very Respectfully,

Chris Hills

CRM_Advance Review 2018 ISA Reference Document_final