HHS Interim Final 45 CFR Part 170, Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology

Page

1

of

136

BILLING CODE: 4150-45-P

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary45 CFR Part 170

RIN 0991-AB58

Health Information Technology: Initial Set of Standards, ImplementationSpecifications, and Certification Criteria for Electronic Health Record TechnologyAGENCY:

Office of the National Coordinator for Health Information Technology,Department of Health and Human Services.

ACTION:

Interim final rule.

SUMMARY

: The Department of Health and Human Services (HHS) is issuing thisinterim final rule with a request for comments to adopt an initial set of standards,implementation specifications, and certification criteria, as required by section 3004(b)(1)of the Public Health Service Act. This interim final rule represents the first step in anincremental approach to adopting standards, implementation specifications, andcertification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use. The certificationcriteria adopted in this initial set establish the capabilities and related standards thatcertified electronic health record (EHR) technology will need to include in order to, at aminimum, support the achievement of the proposed meaningful use Stage 1 (beginning in2011) by eligible professionals and eligible hospitals under the Medicare and MedicaidEHR Incentive Programs.

Page

2

of

136

DATES

: Effective Date: This interim final rule is effective [INSERT DATE 30 DAYSAFTER PUBLICATION IN THE FEDERAL REGISTER]. The incorporation byreference of certain publications listed in the rule is approved by the Director of theFederal Register as of [INSERT DATE 30 DAYS AFTER PUBLICATION IN THEFEDERAL REGISTER].Comment Date: To be assured consideration, written or electronic comments mustbe received at one of the addresses provided below, no later than 5 p.m. on [INSERTDATE 60 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER].

ADDRESSES:

Because of staff and resource limitations, we cannot accept commentsby facsimile (FAX) transmission. You may submit comments, identified by RIN 0991-AB58, by any of the following methods (please do not submit duplicate comments).

•

Federal eRulemaking Portal: Follow the instructions for submitting comments.Attachments should be in Microsoft Word, WordPerfect, or Excel; however, weprefer 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:HITECH Initial Set Interim Final Rule, Hubert H. Humphrey Building, Suite729D, 200 Independence Ave, S.W., Washington, DC 20201. Please submit oneoriginal and two copies.

•

Hand Delivery or Courier: Office of the National Coordinator for HealthInformation Technology, Attention: HITECH Initial Set Interim Final Rule,Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave, S.W.,Washington, DC 20201. Please submit one original and two copies. (Because

Page

3

of

136

access to the interior of the Hubert H. Humphrey Building is not readily availableto persons without federal government identification, commenters are encouragedto leave their comments in the mail drop slots located in the main lobby of thebuilding.)Inspection of Public Comments: All comments received before the close of the commentperiod will be available for public inspection, including any personally identifiable orconfidential business information that is included in a comment. Please do not includeanything in your comment submission that you do not wish to share with the generalpublic. Such information includes, but is not limited to: a person’s social securitynumber; date of birth; driver’s license number; state identification number or foreigncountry equivalent; passport number; financial account number; credit or debit cardnumber; any personal health information; or any business information that could beconsidered to be proprietary. We will post all comments received before the close of thecomment 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 U.S. 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, DC 20201(call ahead to the contact listed below to arrange for inspection).

FOR FURTHER INFORMATION CONTACT:

Steven Posnack, Policy Analyst, 202-690-7151

SUPPLEMENTARY INFORMATION:Acronyms