Draft 2017 Interoperability Standards Advisory
I-A: Allergies
I-D: Functional Status/Disability
I-G: Immunizations
I-J: Medications
I-M: Patient Clinical “Problems” (i.e., conditions)
I-P: Race and Ethnicity
I-S: Social Determinants
I-V: Vital Signs
I-B: Encounter Diagnosis
I-E: Health Care Provider
I-H: Industry and Occupation
I-K: Numerical References & Values
I-N: Preferred Language
I-Q: Research
I-T: Tobacco Use
I-C: Family Health History
I-F: Imaging (Diagnostics, interventions and procedures)
I-I: Lab Tests
I-L: Nursing
I-O: Procedures
I-R: Sexual Orientation and Gender Identity
I-U: Unique Device Identification
II-A: Admission, Discharge, and Transfer
II-D: Clinical Quality Measurement
II-G: Drug Formulary & Benefits
II-J: Images
II-M: Patient Education Materials
II-P: Representing clinical health information as a “resource”
II-S: Summary care record
II-B: Care Plan
II-E: Clinical Quality Reporting
II-H: Electronic Prescribing
II-K: Laboratory
II-N: Patient Preference/Consent
II-Q: Research
II-C: Clinical Decision Support
II-F: Data Provenance
II-I: Family health history (clinical genomics)
II-L: Medical Device Communication to Other Information Systems/Technologies
II-O: Public Health Reporting
II-R: Segmentation of sensitive information
III-A: “Push” Exchange
III-D: Healthcare Directory, Provider Directory
III-G: Query
III-B: Clinical Decision Support Services
III-E: Public Health Exchange
III-H: Resource Location
In the 2007 report, The Future of Disability in America, the Institute of Medicine (IOM) recommended that The National Center for Health Statistics, the U.S. Census Bureau, the Bureau of Labor Statistics, and other relevant government units involved in disability monitoring should adopt the International Classification of Functioning, Health and Disability (ICF) as their conceptual framework to provide a common, international language for data collection and research to inform policies and programs that promote the independence and integration into the community of people with disabilities (http://www.nationalacademies.org/hmd/Reports/2007/The-Future-of-Disabili...).
And, at the September 9, 2011 meeting, the Health IT Standards Committee (HITSC) approved recommendations to the National Coordinator/HHS on the assignment of code sets including: ICF for categories of function, LOINC for assessment instruments and SNOMED-CT for appropriate response to support the clinical concepts of functional status in the quality data model (https://www.healthit.gov/sites/default/files/standards-certification/HIT...).
To be consistent with above IOM recommendation and HITSC previously proposed code sets for functional status, we offer the following two comments:
1. We would support the SNOMED/LOINC observation paring approach, if they are to be developed using the language and concepts of the ICF framework; and
2. ONC should designate an entity to be responsible and ensure that the SNOMED/LOINC codes to be developed are consistent with the ICF framework.
For information concerning Social Security Administration’s medical policy of the disability programs, please contact Chery A. Williams, Director, Office of Medical Policy, Office of Disability Program at Cheryl.A.Williams@ssa.gov or call her at 410 966-4163. For HIT related matters, please contact Derek Wang at Derek.Wang@ssa.gov or call him at (410) 965-2662.
Attached please find our comments to the draft 2017 ISA. We appreciate the opportunity to provide input and look forward to participate in ongoing discussions and review to progress the ISA.
1. Sexual Orientation and Gender – SNOMED CT list of observable values is inadequate. NIH has issued a guidance document regarding well-being of sexual and gender minorities. (Attached).
1. NCI has reviewed and is generally supportive of the HL7 RCRIM submitted comments.
2. We appreciate the inclusion of Research sections in IQ and IIQ but look towards better integration of more of the ISA sections with research in the future to facilitate further integration of EHR and research data.
3. MedDRA is an FDA and international standard required for adverse event reporting (not exclusively in research). [Example: MedWatch]. It is widely used and mature. In this ISA, Adverse Events are mentioned only in sections IA (Allergy) and in IIQ (Research – Submit Adverse Event Report from EHR to Drug Safety Regulators). ONC should consider including a separate Adverse Events section in the next Standards Advisory.
4. We believe that an independent evaluation study of levels of adoption and maturity of the standards recommended or discussed in the ISA, in various use case settings, is needed and would benefit the users of the ISA. If current included standards are based on public comment only, there may be self-selection bias.
a. 11073 Nomenclature should be noted. As you can see, IHE PCD is referenced. Interestingly IHE PCD refers to the IEEE 11073-10101 Standard for its nomenclature, rather than LOINC. So one could "assume" that 10101 is acceptable from the ONC perspective, though we are not sure whether this is intentional or unintentional on the part of the ONC.
a. Please note in Implementation Specification that the 11073 PHD standards are being updated, so “IEEE 11073 PHD Harmonization Pattern for Unique Device Identifiers”?
a. Please note in Implementation Specification that the 11073 PHD standards are being updated, so “IEEE 11073 PHD Harmonization Pattern for Unique Device Identifiers”?
a. These comments were submitted for the 2015 ONC Advisory but were not incorporated:
i. PHD Comment: “The IEEE 11073 Personal Health Device Work Group believes that specifying LOINC alone within section ‘I-S: Vital Signs’ would be insufficient for devices that provide automated data. While there are many reasons why the IEEE 11073 coding system is necessary we recognize that LOINC was not specifically designed with the necessary rigor, precision, range and clarity that is required for personal health devices. As we have witnessed that translating to SNOMED has been problematic we believe LOINC will be even more difficult.”
ii. Continua Comment: “We believe that specifying LOINC alone would be a grievous mistake. We ask that this section (I-S: Vital Signs) be removed or that IHE-PCD be added. There are already many devices and systems implementations in the market and many are, or will soon be, certified by Continua that utilize the IHE-PCD framework. Changing this now presents significant problems for both Continua and IHE.”
a. Test Tool Availability is incorrect as Continua does provide a test tool.
b. Adoption level should indicate at least in the middle as there are many Continua certified devices (and many other non-certified implementations).
c. Implementation Maturity should not be ‘pilot’ as these standards are mature.
d. The Standard/Implementation Specification field should not both PoC and PHD (Point of care and Personal Health Devices).
e. There is no mention of IEEE 11073 Nomenclature. This nomenclature is recognized within the IHE/HL7 record-set.
a. Test Tool Availability is incorrect as Continua does provide a test tool.
b. Adoption level should indicate at least in the middle as there are many Continua certified devices (and many other non-certified implementations).
c. Implementation Maturity should not be ‘pilot’ as these standards are mature.
d. The Standard/Implementation Specification field should not both PoC and PHD (Point of care and Personal Health Devices).
e. There is no mention of IEEE 11073 Nomenclature. This nomenclature is recognized within the IHE/HL7 record-set.
Please add ITU H.810, H.811, H.812, and H.813 - a suite ITU standards for end-to-end, plug-and-play connectivity of personal connected health devices such as wireless blood pressure cuffs, weight scales, glucometers, and activity trackers that play a critical role in prevention and improved management of chronic condition – as an implementation specification for:
1) "III-A: “Push” Exchange: Interoperability Need: An unsolicited “push” of clinical health information to a known destination between individuals and systems" (page 60 of the Draft 2017 Interoperability Standards Advisory.)
2) "III-A: “Push” Exchange: Interoperability Need: Push Communication of Vital Signs from Medical Devices” (page 62 of the Draft 2017 Interoperability Standards Advisory.)
See attached excel document for comments on Sections I-V and III-A on behalf of Philips.
Comments from the Veterans Health Administration, Office of Informatics and Information Governance, Health Informatics, Knowledge Based Systems, Health Standards Team