Department of health and human services
Vocabulary standards for representing electronic health information
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- Bu səhifədəki naviqasiya:
- Standards for health information technology to protect electronic health information created, maintained, and exchanged – 45 CFR 170.210
- VII. Collection of Information Requirements
- Estimated Annualized Total Burden Hours
- Average Burden Hours per Response Total Burden Hours
Vocabulary standards for representing electronic health information – 45 CFR 170.207
URL: http://www.nlm.nih.gov/research/umls/Snomed/us_edition.html. Access requires a user account and license agreement. There is no monetary cost for a user account and license agreement. Summary: Systemized Nomenclature of Medicine – Clinical Terms (SNOMED CT®) is a comprehensive clinical terminology, originally created by the College of American Pathologists and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation. SNOMED CT® improves the recording of information in an EHR system and facilitates better communication, leading to improvements in the quality of care.
URL: http://loinc.org/downloads. Access requires registration, a user account, and license agreement. There is no monetary cost for registration, a user account, and license agreement. Summary: LOINC® was initiated in 1994 by the Regenstrief Institute and developed by Regenstrief and the LOINC® committee as a response to the demand for electronic movement of clinical data from laboratories that produce the data to hospitals, provider’s offices, and payers who use the data for clinical care and management purposes. The scope of the LOINC® effort includes laboratory and other clinical observations. The LOINC® database facilitates the exchange and pooling of results for clinical care, outcomes management, and research.
URL: http://www.nlm.nih.gov/research/umls/rxnorm/docs/rxnormfiles.html. Access requires a user account and license agreement. There is no monetary cost for a user account and license agreement. Summary: RxNorm provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software. By providing links between vocabularies commonly used in pharmacy management and drug interaction software, RxNorm can mediate messages between systems not using the same software and vocabulary. RxNorm now includes the National Drug File – Reference Terminology (NDF-RT) from the Veterans Health Administration, which is used to code clinical drug properties, including mechanism of action, physiologic effect, and therapeutic category.
URL: http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvx. This is a direct link. Summary: CDC’s National Center of Immunization and Respiratory Diseases developed and maintains HL7 Table 0292, Vaccine Administered (CVX). CVX includes both active and inactive vaccines available in the U.S. CVX codes for inactive vaccines allow transmission of historical immunization records; when paired with a manufacturer (MVX) code, the specific trade named vaccine may be indicated.
URL: http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp. This is a direct access link. Summary: The Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it by commercial distribution. Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which services as the universal product identifier for drugs. This standard is limited to the NDC vaccine codes identified by CDC at the URL provided.
URL: http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=mvx. This is a direct link. Summary: CDC’s National Center of Immunization and Respiratory Diseases developed and maintains HL7 Table 0227, Manufacturers of Vaccines (MVX). The MVX table includes both active and inactive vaccines available in the U.S. MVX codes allow transmission of historical immunization records. When MVX code is paired with a CVX code, the specific trade named vaccine may be indicated.
URL: https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.113883.6.238. This is a direct link. Summary: The Public Health Information Network (PHIN) VADS is a web-based enterprise vocabulary systems for accessing, searching, and distributing vocabularies used within the PHIN. PHIN VADS provides standard vocabularies to CDC and its public health partners in one place. It promotes the use of standards-based vocabulary to support the exchange of consistent information among public health partners.
URL: http://www.rfc-editor.org/info/rfc5646. This is a direct access link. Summary: RFC 5646 describes the structure, content, construction, and semantics of language tags for use in cases where it is desirable to indicate the language used in an information object. It also describes how to register values for use in language tags and the creation of user-defined extensions for private interchange.
URL: http://unitsofmeasure.org/trac/. This is a direct access link. The codes can be viewed in html or xml. Summary: The Unified Code of Units of Measure is a code system intended to include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with units. Standards for health information technology to protect electronic health information created, maintained, and exchanged – 45 CFR 170.210
URL: http://csrc.nist.gov/publications/fips/fips140-2/fips1402annexa.pdf. This is a direct link. Summary: Federal Information Processing Standards Publication (FIPS PUB) 140-2, Security Requirements for Cryptographic Modules, specifies the security requirements that are to be satisfied by the cryptographic module utilized within a security system protecting sensitive information within computer and telecommunications systems. The standard provides four increasing qualitative levels of security that are intended to cover the wide range of potential applications and environments in which cryptographic modules may be employed. VII. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide 60-day notice in the Federal Register and solicit public comment on a proposed collection of information before it is submitted to the Office of Management and Budget for review and approval. In order to fairly evaluate whether an information collection should be approved by the Office of Management and Budget, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: 1. Whether the information collection is necessary and useful to carry out the proper functions of the agency; 2. The accuracy of the agency’s estimate of the information collection burden; 3. The quality, utility, and clarity of the information to be collected; and 4. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. Under the PRA, the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section are to be considered. We explicitly seek, and will consider, public comment on our assumptions as they relate to the PRA requirements summarized in this section. To comment on the collection of information or to obtain copies of the supporting statements and any related forms for the proposed paperwork collections referenced in this section, e-mail your comment or request, including your address and phone number to Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office at (202) 690–6162. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 60 days. Abstract Under the ONC Health IT Certification Program, accreditation organizations that wish to become the ONC-Approved Accreditor (ONC-AA) must submit certain information, organizations that wish to become an ONC-ACB must submit the information specified by the application requirements, and ONC-ACBs must comply with collection and reporting requirements, records retention requirements, and submit annual surveillance plans and annually report surveillance results. In the Permanent Certification Program final rule (76 FR 1312-14), we solicited public comment on each of the information collections associated with the requirements described above (and included in regulation at 45 CFR 170.503(b), 170.520, and 170.523(f), (g), and (i), respectively). In the 2014 Edition final rule (77 FR 54275-76), we sought comment on these collection requirements again and finalized an additional requirement at § 170.523(f)(8) for ONC-ACBs to report to ONC a hyperlink with each EHR technology they certify that provides the public with the ability to access the test results used to certify the EHR technology. These collections of information were approved under OMB control number 0955-0013 (previous OMB control number 0990-0378). As discussed in more detail below, we estimate less than 10 annual respondents for all of the regulatory “collection of information” requirements under Part 170 of Title 45, including those previously approved by OMB and proposed in this proposed rule. Accordingly, the regulatory “collection of information” requirements under the ONC Health IT Certification Program described in this section are not subject to the PRA under 5 CFR 1320.3(c). We welcome comments on this conclusion and our supporting rationale for this conclusion as recited below. We also set out below proposed revisions to previously approved “collections of information” and potential new “collections of information” as well as our burden estimates for these “collections of information.” We propose to change the records retention requirement in § 170.523(g) from five years to six years. It is our understanding that a six-year records retention requirement aligns with current accreditation standards that ONC-ACBs follow. Therefore, we do not believe there will be any additional burden based on this proposed change. We propose in § 170.523(o) that ONC-ACBs provide ONC with a list of complaints received on a quarterly basis. We only request that ONC-ACBs indicate in their submission how many complaints were received, the nature or substance of the complaint, and the type of complainant (e.g., type of provider, health IT developer, etc.). Therefore, we believe ONC-ACBs will face little burden in complying with this new proposed requirement. For regulatory clarity in relation to new proposed ONC-ACB collection and reporting requirements, we have proposed to move all of the current ONC-ACB collection and reporting requirements in § 170.523(f) to § 170.523(f)(2). These collection and reporting requirements are specific to the certification of health IT to the 2014 Edition. We note that we have also proposed to add a data element to the list of collection and reporting requirements for 2014 Edition certifications. The data element is the reporting of any corrective action instituted under the proposed provisions of § 170.556 (see section IV.D.3 of this preamble; see also § 170.523(f)(2)(ix)). We propose to add a new ONC-ACB collection and reporting requirements for the certification of health IT to the 2015 Edition (and any subsequent edition certification) in § 170.523(f)(1). As proposed for § 170.523(f)(1), ONC-ACBs would be required to report on the same data elements they report to ONC under current § 170.523(f), the information contained in the publicly available test report, and additional data in an open data file format. These collection and reporting requirements are described in more detail in section IV.D.3, titled “Open Data Certified Health IT Product List (CHPL).” We do not anticipate any additional burden on ONC-ACBs for reporting similar information for 2015 Edition certifications as they do for 2014 Edition certifications. For the additional data that we propose they report, we believe that burden would be minimal as discussed below. For the purposes of estimating the additional potential burden for reporting under § 170.523(f)(1) and (2):
As stated above, we anticipate that there will be three ONC-ACBs participating in the ONC Health IT Certification Program as this is the current number of ONC-ACBs. Further, since the establishment of the ONC Health IT Certification Program in 2010, ONC has never had more than six applicants for ONC-ACB or ONC-ATCB status or selected more than six ONC-ACBs or ONC-ATCBs.261 Therefore, we have aligned the estimated number of respondents for the applicable regulation provisions (i.e., § 170.523(f)(1) and (2), (g), (i), and (o); and § 170.540(c)) with the current number of ONC-ACBs. We have also revised the estimated number of respondents for § 170.503(b) (applicants for ONC-Approved Accreditor (ONC-AA) status) based on past selection processes for the ONC-AA, which have included no more than two applicants. We have retained the same number of responses per respondent and average burden hours per response for the regulation provisions currently included in OMB control number 0995-0013, except for § 170.523(f) as specified above (now § 170.523(f)(2)). Our estimates for the total burden hours are expressed in the table below. Estimated Annualized Total Burden Hours
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