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 2016_register executive 2016-10-19 article Part III Rules and Regulations D09002ee1c7f34c3c D09002ee1c7f34d1d 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 modifications and new requirements under the ONC Health IT Certification Program ("Program"), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)'s role in the Program. The final rule creates a regulatory framework for ONC's direct review of health information technology (health IT) certified under the Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The final rule also sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Program. In addition, it includes provisions for expanded public availability of certified health IT surveillance results. 81 FR 72404 https://www.govinfo.gov/app/details/FR-2016-10-19/2016-24908 2016-24908 fr19oc16-14 RIN 0955-AA00 4150-45-P https://www.govinfo.gov/app/details/FR-2016-10-19/2016-24908 https://www.govinfo.gov/content/pkg/FR-2016-10-19/html/2016-24908.htm https://www.govinfo.gov/content/pkg/FR-2016-10-19/pdf/2016-24908.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 68 p. 72404 72471 81 FR 72404 Title 45 Part 170 45 CFR Part 170 RIN 0955-AA00 ONC Health IT Certification Program: Enhanced Oversight and Accountability; Federal Register Vol. 81, Issue RULE 2016-24908 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 2016-12-19 4150-45-P 2016-24908 Final rule.

This final rule finalizes modifications and new requirements under the ONC Health IT Certification Program ("Program"), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)'s role in the Program. The final rule creates a regulatory framework for ONC's direct review of health information technology (health IT) certified under the Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The final rule also sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Program. In addition, it includes provisions for expanded public availability of certified health IT surveillance results.

These regulations are effective December 19, 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 ONC Health IT Certification Program: Enhanced Oversight and Accountability , http://beta.bls.gov/dataViewer/view/timeseries/CEU6054151108 http://content.healthaffairs.org/content/30/3/481.abstract http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html http://www.bls.gov/oes/current/naics5_541380.htm#15-0000 http://www.healthit.gov/policy-researchers-implementers/45-question-12-13-045 http://www.healthitsafety.org/uploads/4/3/6/4/43647387/roadmap.pdf http://www.hhs.gov/about/news/2013/04/25/certification-for-electronic-health-record-product-revoked.html http://www.hhs.gov/news/press/2015pres/09/20150902c.html http://www.iso.org http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883 http://www.nist.gov/nvlap/nvlap-fee-policy.cfm http://www.whitehouse.gov/omb/circulars_a119 https://questions.cms.gov/faq.php?isDept=0&search=decertified&searchType=keyword&submitSearch=1&id=5005 https://www.healthit.gov/healthitcomplaints https://www.healthit.gov/policy-researchers-implementers/onc-health-it-certification-program-guidance https://www.healthit.gov/sites/default/files/fdasia_healthitreport_final.pdf https://www.healthit.gov/sites/default/files/final_onc_cj_fy_2017_clean.pdf https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf Vol. 81, no. 202 Office of the Federal Register, National Archives and Records Administration 2016-10-19 continuing daily deposited born digital 513 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-10-19 P0b002ee191c4b5e3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19oc16 https://www.govinfo.gov/app/details/FR-2016-10-19 https://www.govinfo.gov/content/pkg/FR-2016-10-19/pdf/FR-2016-10-19.pdf https://www.govinfo.gov/content/pkg/FR-2016-10-19/xml/FR-2016-10-19.xml fdlp 71977 72480 DGPO 2016-10-19 2024-06-01 FR-2016-10-19 machine generated eng FR FR-2016-10-19 81 202