On Aug.t 22, 2016, the Office of the National Coordinator for Health Information Technology (ONC) at the US Department of Health and Human Services (HHS) issued a “Draft 2017 Interoperability Standards Advisory” (ISA) document. The document represents the framework by which ONC will coordinate the identification of and guidance on interoperability standards that enable meaningful exchange and utilization of electronic health record. The Draft 2017 ISA builds on Interoperability Advisory documents from 2015 and 2016 by refining existing standards and identifying new standards for health information exchange. The ISA document generally covers interoperability standards and implementation specifications in the following areas:
Clinical Vocabularies and Code Systems (e.g. SNOMED CT, ICD-10, RxNorm)
- Content and Structure (e.g. C-CDA, Cancer registry reports)
- Services (e.g. API, document query, document exchange)
With the August release, ONC also announced a 60-day comment period during which stakeholders could provide input to the Draft ISA.
The HIMSS Interoperability & Health Information Exchange (I&HIE) Committee convened a specialized Work Group that consisted of industry thought leaders, vendor representatives and subject matter experts to review the Draft 2017 ISA and formulate comments to the ONC before the Final 2017 ISA is issued in December 2016. The HIMSS Interoperability Standards Advisory Work Group met over eight weeks to consider the three interoperability areas, and prepare feedback with detailed comments to ONC that culminated in a response submitted on Oct. 23. Overall, the Work Group agreed that the ISA lays out important standards and implementation specifications that enable meaningful electronic exchange and utilization of health record, and identified several opportunities for improvement.
High-level recommendations from the HIMSS response include:
Expansion of ISA Scope:
In recent years, there has been significant focus to create an interoperable ecosystem within the clinical domain with similar efforts within the clinical research domain. However, enabling interoperability between clinical and clinical research fields is critical, since patient data within EHRs contain valuable information that can be used in clinical research to develop novel therapeutic approaches and improve clinical guidelines. Research outcomes can then be translated into the clinical environment to improve patient outcomes, thereby creating a Learning Health Ecosystem. The Draft 2017 ISA identified several interoperability standards related to clinical research, whereas the scope of the ISA was limited to interoperability standards in clinical care (patient treatment) only.
- The Work Group recommended that the ISA’s Scope be expanded to include interoperability standards for clinical research.
Removal of “Best Available” standards:
The Draft 2017 ISA discontinued use of the label “best available” as an overall concept for the ISA document. In 2015 and 2016 versions of the ISA, the “best available” characteristic was used to indicate ONC’s current assessment and prioritization of a standard or implementation specification for a given interoperability need.
The Work Group maintained that the removal of the “Best Available” characteristics minimizes the importance of the ISA as guidance to the industry, and doesn’t sufficiently encourage implementers to adopt and align to the identified standards.
- The Work Group recommended that ONC consider stronger language to direct implementers to use the standards identified in the ISA while also encouraging consideration of the emerging standards that will enable innovation.
Data provenance is an important topic in the healthcare industry today, as health information exchanges (HIEs) increasingly facilitate exchange of data that originates from physicians, caregivers, patients, medical devices, health monitoring devices and other sources. The user of the data (e.g. clinician) may view clinical summaries, where individual data components, such as vital signs, problems and procedures, come from different data sources. It is therefore relevant to preserve the details of the data source and the systems that data travelled through to enable the user to evaluate credibility and utility of data in the clinical decision making process.
- The Work Group recommended that ONC conduct field analysis to better understand how provenance data are captured in existing information systems and what standards should be used to enable capture and exchange of provenance information at the data element level to ensure traceability of data to a sufficiently granular level.
Patient-generated Data (PGD) and Data from Health-monitoring Devices:
Close to 85% of hospitals that have EHR systems in place also provide the ability for patients to add their own data to their record. Patient-generated data has the potential to strengthen patient engagement in the care management process and to improve collaboration with caregivers. In the last few years, there has also been an exponential growth of non-medical devices, such as pedometers, pulsometers and sleep monitors. The data from these devices can generate valuable information about patient habits and quality of life.
- The Work Group recommended that ONC focus efforts on identifying interoperability standards for data originating from patient and health-monitoring devices, since such data represent an integral part of the electronic health record.
While the ISA doesn’t cover all current and future standards for health information exchange, the document represents a resourceful and centralized national guidance that can facilitate innovation in health IT ecosystem.
Review the cover letter and detailed feedback provided in the HIMSS response in further detail here.