Department of health and human services

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

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

AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking with comment period.

SUMMARY: This notice of proposed rulemaking introduces a new edition of certification criteria (the 2015 Edition health IT certification criteria or “2015 Edition”), proposes a new 2015 Edition Base EHR definition, and proposes to modify 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 would also establish the capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) 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.

DATES: To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on [INSERT DATE 60 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER].

ADDRESSES: You may submit comments, identified by RIN 0991-AB93, by any of the following methods (please do not submit duplicate comments). Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

 Federal eRulemaking Portal: Follow the instructions for submitting comments. Attachments should be in Microsoft Word, Microsoft Excel, or Adobe PDF; however, we prefer Microsoft Word. http://www.regulations.gov.

 Regular, Express, or Overnight Mail: Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Attention: 2015 Edition Health IT Certification Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W., Washington, D.C. 20201. Please submit one original and two copies.

 Hand Delivery or Courier: Office of the National Coordinator for Health Information Technology, Attention: 2015 Edition Health IT Certification Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W., Washington, D.C. 20201. Please submit one original and two copies. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.)

Enhancing the Public Comment Experience: To facilitate public comment on this proposed rule, a copy will be made available in Microsoft Word format. We believe this version will make it easier for commenters to access and copy portions of the proposed rule for use in their individual comments. Additionally, a separate document will be made available for the public to use to provide comments on the proposed rule. This document is meant to provide the public with a simple and organized way to submit comments on the certification criteria, associated standards and implementation specifications, and respond to specific questions posed in the preamble of the proposed rule. While use of this document is entirely voluntary, we encourage commenters to consider using the document in lieu of unstructured comments or to use it as an addendum to narrative cover pages. Roughly 30% of the public comments submitted to our past two editions of certification criteria proposed rules used the provided template, which greatly assisted in our ability to rapidly process and more accurately categorize public comments. Because of the technical nature of this proposed rule, we believe that use of the document may facilitate our review and understanding of the comments received. The Microsoft Word version of the proposed rule and the document that can be used for providing comments can be found at http://www.regulations.gov as part of this proposed rule’s docket and on ONC’s website (http://www.healthit.gov).

Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. Please do not include anything in your comment submission that you do not wish to share with the general public. Such information includes, but is not limited to: a person’s social security number; date of birth; driver’s license number; state identification number or foreign country equivalent; passport number; financial account number; credit or debit card number; any personal health information; or any business information that could be considered proprietary. We will post all comments that are received before the close of the comment period at http://www.regulations.gov.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov or the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W., Washington, D.C. 20201 (call ahead to the contact listed below to arrange for inspection).

FOR FURTHER INFORMATION CONTACT: Michael Lipinski, Office of Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

Commonly Used Acronyms

API Application Programming Interface

CAH Critical Access Hospital

CDA Clinical Document Architecture

CDC Centers for Disease Control and Prevention

CDS Clinical Decision Support

CEHRT Certified Electronic Health Record Technology

CFR Code of Federal Regulations

CHPL Certified Health IT Product List

CLIA Clinical Laboratory Improvement Amendments

CMS Centers for Medicare & Medicaid Services

CQM Clinical Quality Measure

EHR Electronic Health Record

HHS Department of Health and Human Services

HISP Health Information Service Providers

HIT Health Information Technology

HITPC HIT Policy Committee

HITSC HIT Standards Committee

HL7 Health Level Seven

IG Implementation Guide

LOINC^® Logical Observation Identifiers Names and Codes

ONC Office of the National Coordinator for Health Information Technology

SNOMED CT^® Systematized Nomenclature of Medicine Clinical Terms

Table of Contents

I. Executive Summary

A. Purpose of Regulatory Action

B. Summary of Major Provisions

1. Overview of the 2015 Edition Health IT Certification Criteria

2. Base EHR Definition and Certified EHR Technology Definition

3. The ONC Health IT Certification Program and Health IT Module

C. Costs and Benefits

II. Background

A. Statutory Basis