United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-10-16 article Part II Rules and Regulations D09002ee1c7f700fd D09002ee1c7f701c1 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Office of the Secretary originator org United States Government Agency or Subagency This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or "2015 Edition") and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs. 80 FR 62602 https://www.govinfo.gov/app/details/FR-2015-10-16/2015-25597 2015-25597 fr16oc15-23 RIN 0991-AB93 4150-45-P https://www.govinfo.gov/app/details/FR-2015-10-16/2015-25597 https://www.govinfo.gov/content/pkg/FR-2015-10-16/html/2015-25597.htm https://www.govinfo.gov/content/pkg/FR-2015-10-16/pdf/2015-25597.pdf Computer Technology Electronic Health Record Electronic Information System Electronic Transactions Health Health Care Health Information Technology Health Insurance Health Records Hospitals Incorporation by Reference Laboratories Medicaid Medicare Privacy Reporting and Recordkeeping Requirements Public Health Security 158 p. 62602 62759 80 FR 62602 Title 45 Part 170 45 CFR Part 170 RIN 0991-AB93 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications; Federal Register Vol. 80, Issue RULE 2015-25597 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 2016-01-14 4150-45-P 2015-25597 Final rule.

This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or "2015 Edition") and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.

These regulations are effective January 14, 2016, except for Sec. 170.523(m) and (n), which are effective on April 1, 2016. Michael Lipinski, Office of Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151. Computer Technology Electronic Health Record Electronic Information System Electronic Transactions Health Health Care Health Information Technology Health Insurance Health Records Hospitals Incorporation by Reference Laboratories Medicaid Medicare Privacy Reporting and Recordkeeping Requirements Public Health Security 2015 Edition Health Information Technology Certification Criteria, 2015 Edition Base Electronic Health Record Definition, and ONC Health IT Certification Program Modifications , http://accessgudid.nlm.nih.gov/ http://accessgudid.nlm.nih.gov/docs http://chainonline.org/research-tools/improving-hit-prescribing-safety/ http://csrc.nist.gov/drivers/documents/FISMA-final.pdf http://csrc.nist.gov/publications/drafts/800-163/sp800_163_draft.pdf http://csrc.nist.gov/publications/fips/fips140-2/fips1402annexa.pdf http://csrc.nist.gov/publications/fips/fips140-2/fips1402annexa.psf http://csrc.nist.gov/publications/fips/fips180-4/fips-180-4.pdf http://csrc.nist.gov/publications/nistpubs/800-111/SP800-111.pdf http://csrc.nist.gov/publications/nistpubs/800-57/sp800-57_part1_rev3_general.pdf http://csrc.nist.gov/publications/nistpubs/800-92/SP800-92.pdf http://gforge.hl7.org/gf/project/cbcc/frs/?action=FrsReleaseBrowse&frs_package_id=240 http://ghr.nlm.nih.gov/spotlight=thegeneticinformationnondiscriminationatgina http://healthit.gov/policy-researchers-implementers/2015-edition-draft-test-procedures http://healthit.gov/sites/default/files/policy/onc-acb_cy16annual_surveillance_guidance.pdf http://healthit.hhs.gov http://ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_IG_DAF_National%20Extension_Rev1.0_PC_2015-06-01.pdf http://loinc.org/ http://loinc.org/downloads http://nvlpubs.nist.gov/nistpubs/FIPS/NIST.FIPS.180-4.pdf http://pe.usps.gov/cpim/ftp/pubs/Pub28/pub28.pdf http://perspectives.ahima.org/wp-content/uploads/2014/12/PatientMatchingAppendixA.pdf http://projectcypress.org/ http://static1.1.sqspcdn.com/static/f/1340919/26054983/1426686689687/Report+on+DirectTrust+Interoperability+Testing.pdf?token=A0DNBiAqjJ2YzuhUTn4vnBMrtVI%3D http://unitsofmeasure.org/trac/ http://wiki.directproject.org/Best+Practices+for+Content+and+Workflow http://wiki.directproject.org/file/view/Applicability%20Statement%20for%20Secure%20Health%20Transport%20v1.2.pdf/556133893/Applicability%20Statement%20for%20Secure%20Health%20Transport%20v1.2.pdf http://wiki.directproject.org/file/view/Applicability+Statement+for+Secure+Health+Transport+v1.2.pdf http://wiki.directproject.org/file/view/Implementation+Guide+for+Delivery+Notification+in+Direct+v1.0.pdf http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force http://wiki.hl7.org/index.php?title=Consolidated_CDA_R2.1_DSTU_Update http://wiki.hl7.org/index.php?title=HL7_Data_Provenance_Project_Space http://wiki.ihe.net/index.php?title=Healthcare_Provider_Directory http://wiki.siframework.org/Clinical+Quality+Framework+Initiative http://wiki.siframework.org/file/view/esMD%20AoR%20Level%201%20Implementation%20Guide%20v5%20FINAL.docx/539084894/esMD%20AoR%20Level%201%20Implementation%20Guide%20v5%20FINAL.docx http://wiki.siframework.org/file/view/esMD%20Use%20Case%201%20Implementation%20Guide%20v24%20FINAL.docx/539084920/esMD%20Use%20Case%201%20Implementation%20Guide%20V24%20FINAL.docx http://wiki.siframework.org/LCC+Pilots+WG http://www.astm.org/Standards/E2147.htm http://www.bls.gov/oes/current/oes151132.htm http://www.cdc.gov/MedicationSafety/protect/protect_Initiative.html#MedicationErrors http://www.cdc.gov/nssp/documents/guides/erratum-to-the-cdc-phin-2.0-implementation-guide-august-2015.pdf http://www.cdc.gov/nssp/documents/guides/syndrsurvmessagguide2_messagingguide_phn.pdf http://www.cdc.gov/phin/resources/vocabulary/index.html http://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf http://www.cdc.gov/vaccines/programs/iis/technical-guidance/hl7.html http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Taxonomy.html http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396592.xls http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396595.doc http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416106.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIIssuingAgencies/default.htm http://www.genomebc.ca/education/articles/genomics-vs-genetics/ http://www.gpo.gov/fdsys/pkg/CFR-2013-title45-vol1/xml/CFR-2013-title45-vol1-sec164-501.xml http://www.gpo.gov/fdsys/pkg/FR-2011-05-31/pdf/2011-13297.pdf http://www.gs1.org/gln http://www.healthit.gov/facas/calendar/2014/05/07/policy-certification-hearing http://www.healthit.gov/FACAS/sites/default/files/standards-certification/8_17_2011Transmittal_HITSC_Patient_Matching.pdf http://www.healthit.gov/facas/sites/faca/files/HITPC_LTPAC_BH_Certification_Recommendations_FINAL.pdf http://www.healthit.gov/facas/sites/faca/files/HITSC_PSWG_2015NPRM_Update_2014-06-17.pdf http://www.healthit.gov/facas/sites/faca/files/TransmittalLetter_LTPAC_BH_Certification.pdf http://www.healthit.gov/policy-researchers-implementers/32-question-11-12-032 http://www.healthit.gov/policy-researchers-implementers/45-question-12-13-045 http://www.healthit.gov/policy-researchers-implementers/authorized-testing-and-certifications-bodies http://www.healthit.gov/policy-researchers-implementers/certification-bodies-testing-laboratories http://www.healthit.gov/policy-researchers-implementers/direct-project http://www.healthit.gov/policy-researchers-implementers/standards-interoperability-si-framework http://www.healthit.gov/providers-professionals/security-risk-assessment http://www.healthit.gov/sites/default/files/9-5-federalhealthitstratplanfinal_0.pdf http://www.healthit.gov/sites/default/files/pdf/privacy/privacy-and-security-guide.pdf http://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf http://www.healthit.gov/standards-advisory http://www.hhs.gov/healthcare/facts/blog/2014/09/improving-health-care-delivery.html http://www.hhs.gov/ocr/office/index.html http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brguidance.html http://www.hhs.gov/ocr/privacy/hipaa/faq/health_information_technology/570.html http://www.hl7.org/documentcenter/public/standards/dstu/CDAR2_IG_CCDA_CLINNOTES_R1_DSTUR2.1_2015AUG.zip http://www.hl7.org/documentcenter/public/standards/dstu/HL7_DSS_IG%20_R1_1_2014MAR.zip http://www.hl7.org/documentcenter/public_temp_369DCAB9-1C23-BA17-0CAF31D63E2D1A3E/standards/vocabulary/vocabulary_tables/infrastructure/vocabulary/vs_AdministrativeGender.html http://www.hl7.org/documentcenter/public_temp_369DCAB9-1C23-BA17-0CAF31D63E2D1A3E/standards/vocabulary/vocabulary_tables/infrastructure/vocabulary/vs_NullFlavor.html http://www.hl7.org/implement/standards/product_brief.cfm?product_id=20 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=208 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=22 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=283 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=286 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=301 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=308 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=337 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=35 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=354 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=374 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=375 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=385 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=398 http://www.hl7.org/participate/onlineballoting.cfm?ref=nav#nonmember http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1183 http://www.idmanagement.gov/sites/default/files/documents/FBCA%20Certificate%20Policy%20v2.27.pdf http://www.ietf.org/rfc.html http://www.ihe.net/ http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Rev7-0_Vol2b_FT_2010-08-10.pdf http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD.pdf http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_Suppl_HPD.pdr http://www.ihe.net/uploadedFiles/Documents/ITI/IHE_ITI_TF_Vol4.pdf http://www.ihtsdo.org/resource/resource/84 http://www.ismp.org/Tools/tallmanletters.pdf http://www.itu.int/en/pages/default.aspx http://www.itu.int/rec/T-REC-E.123-200102-I/e http://www.itu.int/rec/T-REC-E.164-201011-I/en http://www.ncpdp.org/NCPDP/media/pdf/SCRIPTImplementationRecommendationsV1-29.pdf http://www.ncpdp.org/NCPDP/media/pdf/wp/DosingDesignations-OralLiquid-MedicationLabels.pdf http://www.nih.gov/precisionmedicine/ http://www.nist.gov/customcf/get_pdf.cfm?pub_id=909701 http://www.nist.gov/healthcare/usability/upload/EUP_WERB_Version_2_23_12-Final-2.pdf http://www.nist.gov/itl/fips.cfm http://www.nist.gov/manuscript-publication-search.cfm?pub_id=907312 http://www.nlm.nih.gov/research/umls/rxnorm/docs/rxnormfiles.html http://www.nlm.nih.gov/research/umls/Snomed/us_edition.html http://www.phdsc.org/ http://www.phdsc.org/standards/payer-typology.asp http://www.phdsc.org/standards/pdfs/SourceofPaymentTypologyVersion5.0.pdf http://www.rfc-editor.org/info/rfc5646 http://www.samhsa.gov/disorders http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf http://www.whitehouse.gov/omb/circulars_a119 http://www.who.int/genomics/geneticsVSgenomics/en/ http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvx http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=mvx http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=ndc https://buildsecurityin.us-cert.gov/ https://ecqi.healthit.gov/ecqm https://loinc.org/downloads/usage/units https://nppes.cms.hhs.gov/NPPES/Welcome.do https://phinvads.cdc.gov/vads/SearchVocab.action https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.113883.6.238# https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Downloads/TaxonomyCrosswalk.pdf https://www.cms.gov/regulations-and-guidance/legislation/ehrincentiveprograms/ecqm_library.html https://www.federalregister.gov/articles/2015/06/09/2015-13510/acceptance-and-approval-of-non-governmental-developed-test-procedures-test-tools-and-test-data-for https://www.ftc.gov/tips-advice/business-center/guidance/careful-connections-building-security-internet-things https://www.ftc.gov/tips-advice/business-center/guidance/mobile-app-developers-start-security https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CCUQFjAA&url=http%3A%2F%2Fwiki.siframework.org%2FStructured%2BData%2BCapture%2BInitiative&ei=l3KiVYW-MIKU-AH0kbjwCg&usg=AFQjCNFOieJjmvmMPbgBjd2zJ3igsdJVbw&sig2=GESy7uftrinE-ohpXqMQjw https://www.healthit.gov/FACAS/sites/faca/files/HITSC_Certification_NPRM_TSSWG_Comments_2015-05-20.pdf https://www.ncpdp.org/NCPDP/media/pdf/StandardsMatrix.pdf https://www.whitehouse.gov/sites/default/files/docs/pmi_privacy_and_trust_principles_july_2015.pdf https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative www.healthit.gov www.nucc.org www.wpc-edi.com Vol. 80, no. 200 Office of the Federal Register, National Archives and Records Administration 2015-10-16 continuing daily deposited born digital 647 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-10-16 P0b002ee18dbc65c7 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16oc15 https://www.govinfo.gov/app/details/FR-2015-10-16 https://www.govinfo.gov/content/pkg/FR-2015-10-16/pdf/FR-2015-10-16.pdf https://www.govinfo.gov/content/pkg/FR-2015-10-16/xml/FR-2015-10-16.xml fdlp 62429 63070 DGPO 2015-10-16 2024-06-02 FR-2015-10-16 machine generated eng FR FR-2015-10-16 80 200