Department of health and human services

1^ XDR stands for Cross-Enterprise Document Reliable Interchange. XDM stands for Cross-Enterprise Document Media Interchange.

2^ CMS’ CEHRT definition would include the criteria adopted in the Base EHR definition. For more details on the CEHRT definition, please see the CMS EHR Incentive Programs proposed rule published elsewhere in this issue of the Federal Register.

3^ Technology needs to be certified to § 170.315(a)(1), (a)(2), or (a)(3).

4^ Technology needs to be certified to § 170.315(a)(1), (a)(2), or (a)(3).

5^ Technology needs to be certified to § 170.315(a)(1), (a)(2), or (a)(3).

6^ Technology needs to be certified to § 170.315(a)(14) or (a)(15).

7^ Technology needs to be certified to § 170.315(a)(14) or (a)(15).

8^ As discussed in the preamble for the “clinical quality measures – report” criterion, additional CQM certification policy may be proposed in or with CMS payment rules in CY15. As such, additional CQM certification criteria may be proposed for the Base EHR and/or CEHRT definitions.

9^ For the public health certification criteria in § 170.315(f), technology would only need to be certified to those criteria that are required to meet the options the provider intends to report in order to meet the proposed Objective 8: Public Health and Clinical Data Registry Reporting.

10^ Technology needs to be certified to § 170.315(h)(1) or (h)(2) to meet the proposed Base EHR definition.

11^ Technology needs to be certified to § 170.315(h)(1) or (h)(2) to meet the proposed Base EHR definition.

12^ http://www.whitehouse.gov/omb/circulars_a119

13^ http://www.healthit.gov/policy-researchers-implementers/direct-project

14^ http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework

15^ http://wiki.siframework.org/esMD+-+Author+of+Record and http://wiki.siframework.org/esMD+-+Provider+Profiles+Authentication

16^ http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework

17^ Copyright © 1998-2013, Regenstrief Institute, Inc. and the UCUM Organization. All rights reserved.

18^ Please see section IV.C.1 (“Privacy and Security”) for a detailed discussion of approach 1.

19^ http://www.hl7.org/special/committees/projman/searchableprojectindex.cfm?action=edit&ProjectNumber=922 and http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. Access to the current draft of the LOI Release 2 IG is freely available for review during the public comment period by establishing an HL7 user account.

20^ http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember. Access to the current draft of the eDOS IG, Release 2, Version 1.2 is freely available for review during the public comment period by establishing an HL7 user account.

21^ https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.113883.6.238#

22^ http://www.loc.gov/standards/iso639-2/php/code_list.php

23^ http://www.healthit.gov/policy-researchers-implementers/27-question-10-12-027

24^ http://www.healthit.gov/policy-researchers-implementers/43-question-11-13-043

25^ http://www.rfc-editor.org/info/rfc5646

26^ http://www.rfc-editor.org/info/rfc5646

27^ http://unitsofmeasure.org/trac/

28^ https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.113883.3.88.12.80.62

29^ The Health IT Standards Panel was established in 2005 as a strategic public-private partnership in contract with the U.S. Department of Health and Human Services to achieve a widely accepted and useful set of standards to enable and support widespread interoperability among healthcare software applications. The Health IT Standards Panel's contract with HHS concluded on April 30, 2010. http://www.hitsp.org/

30^ https://loinc.org/downloads/usage/units

31^ http://www.cdc.gov/growthcharts/clinical_charts.htm#Set1 and http://www.cdc.gov/growthcharts/clinical_charts.htm#Set2

32^ Infobutton” is typically the shorthand name used to refer to the formal standard’s name: HL7 Version 3 Standard: Context-Aware Retrieval Application (Infobutton)

33^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=208

34^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=283

35^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=22

36^ Please note a change to the naming convention to Version 42 and Version 43, as NCPDP accepted a change request to remove the period in version numbering.

37^ We refer readers to section III.A.2.d (“Minimum Standards” Code Sets) for further discussion of our adoption of SNOMED CT^® as a minimum standards code set and our proposal to adopt the September 2014 Release (U.S. Edition), or potentially a newer version if released before a subsequent final rule, as the baseline for certification to the 2015 Edition.

38^ These 8 codes are: current every day smoker, 449868002; current some day smoker, 428041000124106; former smoker, 8517006; never smoker, 266919005; smoker – current status unknown, 77176002; unknown if ever smoked, 266927001; heavy tobacco smoker, 428071000124103; and light tobacco smoker, 428061000124105.

39^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=301

40^ http://www.healthit.gov/policy-researchers-implementers/39-question-04-13-039

41^ http://www.healthit.gov/facas/sites/faca/files/HITPC_MUWG_Stage3_Recs_2014-04-01.pdf

42^ A UDI is a unique numeric or alphanumeric code that consists of two parts: (1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and (2)

a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: the lot or batch number within which a device was manufactured; the serial number of a specific device; the expiration date of a specific device; the date a specific device was manufactured; the distinct identification code required by 21 CFR 1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/.

43^ Specifically, the certification criterion supports the National Coordinator’s responsibility under the HITECH Act to ensure that the nation’s health IT infrastructure supports activities that reduce medical errors, improve health care quality, improve public health activities, and facilitate the early identification and rapid response to public health threats and emergencies. 42 U.S.C. 300jj–11(b)(2) & (7).

44^ ONC, HHS Health IT Patient Safety Action and Surveillance Plan (July 2013), http://www.healthit.gov/policy-researchers-implementers/health-it-and-patient-safety (hereinafter “Health IT Safety Plan”). The first objective of the Health IT Safety Plan is to use health IT to make care safer. See id. at 7. The Plan specifically contemplates that ONC will update its standards and certification criteria to improve safety-related capabilities and add new capabilities that enhance patient safety.

45^ 78 FR 58786.

46^ 21 U.S.C. 360i(f).

47^ See FDA, Global Unique Device Identification Database (GUDID) Guidance for Industry and Food and Drug Administration Staff (June 27, 2014), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf.

48^ Pursuant to 21 U.S.C. 360i(f), FDA must implement the Unique Device Identification System Final Rule with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the rule was finalized. Other implementation and compliance dates are detailed in the final rule. Compliance dates for UDI implementation will be phased in based on the existing risk-based classification of medical devices: September 2014 for devices classified by FDA at the highest risk level (Class III); September 2015 for implantable, life-supporting or life-sustaining devices; September 2016 for moderate risk (Class II) devices; and September 2018 for low risk (Class I) devices.

49^ For a detailed summary of the comments we received on our earlier implantable device list proposal, see the 2014 Edition, Release 2, final rule (79 FR 54458).

50^ 79 FR 54458.

51^ The Brookings Institution, Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation (December 2014) (available at http://www.brookings.http://www.brookings.edu/~/media/research/files/papers/2014/12/05%20medical%20device%20tracking%20system/udi%20final%2012052014).

52^ For example, the Brookings Institution and FDA convened a UDI Implementation Work Group comprising device manufacturers, payers, health IT developers, academics, clinicians, and other stakeholders to explore opportunities and challenges associated with capturing UDIs in claims, identifying steps for implementation and integration of UDIs within EHRs and other health care IT infrastructure, and utilizing UDIs as a tool for improved patient and provider connectivity. http://www.brookings.edu/about/centers/health/projects/development-and-use-of-medical-devices/udi. The Work Group held a series of expert workshops and in December 2014 published a detailed roadmap for effective UDI implementation. The Brookings Institution, Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation (December 2014) (available at http://www.brookings.http://www.brookings.edu/~/media/research/files/papers/2014/12/05%20medical%20device%20tracking%20system/udi%20final%2012052014). Concurrently, the HL7 Technical Steering Committee has established a UDI Task Force to ensure that UDI is implemented in a consistent and interoperable manner across the suite of HL7 standards. See http://hl7tsc.org/wiki/index.php?title=TSC_Minutes_and_Agendas. And through an S&I Framework Structured Data Capture Initiative, ONC, AHRQ, FDA, and NLM are collaborating with industry stakeholders to include UDI data for devices in health IT adverse event reporting. See http://wiki.siframework.org/Structured+Data+Capture+Initiative. AHRQ has already incorporated UDI and associated data attributes in its Common Formats for adverse event reporting. See AHRQ Data Dictionary, Common Formats Hospital Version 1.2, at 87, available at https://www.psoppc.org/c/document_library/get_file?p_l_id=375680&folderId=431263&name=DLFE-15061.pdf.

53^ http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm427496.htm; see also 21 U.S.C. 360i(f).

54^ U.S. Department of Health and Human Services, Office of Minority Health, 2011, HHS Action Plan to Reduce Racial and Ethnic Disparities: A Nation Free of Disparities in Health and Health Care (available at: http://www.minorityhealth.hhs.gov/npa/files/Plans/HHS/HHS_Plan_complete.pdf); U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, 2011, Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status (available at: http://aspe.hhs.gov/datacncl/standards/ACA/4302/index.pdf); and Institute of Medicine (IOM), November 2014, Washington, DC, The National Academies Press, 2014, Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 (available at: http://iom.edu/Reports/2014/EHRdomains2.aspx).

55^ We refer readers to section III.A.2.d (“Minimum Standards” Code Sets) for further discussion of our adoption of LOINC^® as a minimum standards code set and our proposal to adopt version 2.50, or potentially a newer version if released before a subsequent final rule, as the baseline for certification to the 2015 Edition.

56^ The answer is then scored from a scale of 1 (very hard) to 3 (not at all), and unknown answers are scored as a negative number.

57^ LOINC^® Component used for the table.

58^ Elo, A.-L., A. Leppänen, and A. Jahkola. 2003. Validity of a single-item measure of stress symptoms. Scandanavian Journal of Work, Environment & Health 29(6):444–451.

59^ Note that LOINC^® provides a translation table at https://loinc.org/downloads/usage/units that enumerates the UCUM syntax for a subset of UCUM codes that are commonly used in health IT that may be a useful reference for stakeholders.

60^ Note that LOINC^® provides a translation table at https://loinc.org/downloads/usage/units that enumerates the UCUM syntax for a subset of UCUM codes that are commonly used in health IT that may be a useful reference for stakeholders

61^ The Alcohol Use Disorders Identification Test C (AUDIT-C) is scored on a scale of 0 to 12. Each of the three AUDIT-C questions has 5 answer choices with points ranging from 0 to 4. A screen is considered positive for unhealthy alcohol use or hazardous drinking if the AUDIT-C score is 4 or more points for men or 3 or more points for women.

62^ Pantell et al., 2013

63^ We refer readers to section III.A.2.d (“Minimum Standards” Code Sets) for further discussion of our adoption of SNOMED CT^® as a minimum standards code set and our proposal to adopt the September 2014 Release (U.S. Edition), or potentially a newer version if released before a subsequent final rule, as the baseline for certification to the 2015 Edition.

64^ We refer readers to section III.A.2.d (“Minimum Standards” Code Sets) for further discussion of our adoption of SNOMED CT^® as a minimum standards code set and our proposal to adopt the September 2014 Release (U.S. Edition), or potentially a newer version if released before a subsequent final rule, as the baseline for certification to the 2015 Edition.

65^ IOM (Institute of Medicine). 2011. “Incorporating Occupational Information in Electronic Health Records: A Letter Report”. Available at: http://www.nap.edu/catalog.php?record_id=13207

66^ US Department of Health and Human Services. February, 2012. 2012 HHS Environmental Justice Strategy and Implementation Plan. Available at: http://www.hhs.gov/environmentaljustice/strategy.html

67^ CDC (2) (Centers for Disease Control and Prevention). 2012. Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA) Release 1.0, August 2012. Available at: http://www.cdc.gov/phin/library/guides/Implementation_Guide_for_Ambulatory_Healthcare_Provider_Reporting_to_Central_Cancer_Registries_August_2012.pdf

68^ A CDS Knowledge Artifact is the encoding of structured CDS content as a rule to support clinical decision making in many areas of the health care system, including quality and utilization measures, disease outbreaks, comparative effectiveness analysis, efficacy of drug treatments, and monitoring health trends.

69^ HL7 Implementation Guide: Clinical Decision Support Knowledge Artifact Implementation Guide, Release 1 (January 2013) (“HeD standard”)

70^ http://wiki.siframework.org/file/detail/implementation_guide_working_final_042413_lse_uploaded-1.docx

71^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=337

72^ This site may also include CDS interventions formatted to the Quality Improvement and Clinical Knowledge Model (QUICK) standard which we discuss in the preamble for the “Clinical quality measures – record and export” certification criterion.

73^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=334

74^ http://www.hl7.org/documentcenter/public/standards/dstu/HL7_DSS_IG%20_R1_1_2014MAR.zip

75^ http://wiki.siframework.org/Companion+Guide+to+Consolidated+CDA+for+MU2

76^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379. Access to the IG is freely available for review during the public comment period by establishing an HL7 user account.

77^ D’Amore JD, et al. J Am Med Inform Assoc 2014;21:1060–1068

78^ http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Rev7-0_Vol2b_FT_2010-08-10.pdf

79^ http://www.healthit.gov/sites/default/files/hitpc-transmittal-letter-priv-sectigerteam-020211.pdf

80^ http://www.healthit.gov/FACAS/sites/default/files/standards-certification/8_17_2011Transmittal_HITSC_Patient_Matching.pdf

81^ Despite its inclusion of the word “gender,” “Administrative Gender” is generally used in standards to represent a patient’s “sex,” such as male or female. See: http://ushik.ahrq.gov/ViewItemDetails?system=hitsp&itemKey=83680000

82^ http://www.ihe.net/Technical_Frameworks/

83^ http://www.caqh.org/pdf/CLEAN5010/258-v5010.pdf

84^ http://www.caqh.org/pdf/CLEAN5010/258-v5010.pdf

85^ http://www.itu.int/rec/T-REC-E.123-200102-I/e

86^ http://www.itu.int/rec/T-REC-E.164-201011-I/en

87^ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=186

88^ PCAST Report to the President: Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward, http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf

89^ http://wiki.siframework.org/Data+Provenance+Initiative

90^ http://wiki.hl7.org/index.php?title=HL7_Data_Provenance_Project_Space and http://gforge.hl7.org/gf/project/cbcc/frs/?action=FrsReleaseBrowse&frs_package_id=240

91^ Standards including HL7 Clinical Documentation Architecture Release 2 (CDA R2), HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1, and HL7 Version 2 Vocabulary & Terminology Standards (all are normative standards)

92^ D’Amore JD, et al. J Am Med Inform Assoc 2014;21:1060–1068

93^ We are proposing to keep the “New Prescription” transaction for testing and certification.

94^ NCPDP’s Structured and Codified Sig Format Implementation Guide v1.2 is adopted within SCRIPT v10.6.

95^ Liu H, Burkhart Q and Bell DS. Evaluation of the NCPDP Structured and Codified Sig Format for e-prescriptions. J Am Med Inform Assoc. 2011 Sep-Oct;18(5):645-51

96^ NCPDP’s Structured and Codified Sig Format Implementation Guide v1.2 is within the NCPDP SCRIPT v10.6 standard.

97^ http://www.ncpdp.org/NCPDP/media/pdf/SCRIPTImplementationRecommendationsV1-29.pdf

98^ AAP Council on Clinical Information Technology Executive Committee, 2011-2012. Policy Statement - Electronic Prescribing in Pediatrics: Toward Safer and More Effective Medication Management. Pediatrics 2013; 131;824.

99^ http://www.ncpdp.org/NCPDP/media/pdf/wp/DosingDesignations-OralLiquid-MedicationLabels.pdf

100^ http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm188762.htm#overdoses