[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Proposed Rules]
[Pages 16834-16835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Parts 170 and 171

RIN 0955-AA01


21st Century Cures Act: Interoperability, Information Blocking, 
and the ONC Health IT Certification Program

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

ACTION: Proposed rule; extension of comment period.

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SUMMARY: On March 4, 2019, the Department of Health and Human Services 
(HHS) published a proposed rule that would implement certain provisions 
of the 21st Century Cures Act, including conditions and maintenance of 
certification requirements for health information technology (health 
IT) developers under the ONC Health IT Certification Program (Program), 
the voluntary certification of health IT for use by pediatric health 
care providers, and reasonable and necessary activities that do not 
constitute information blocking. The comment period for the rule was 
scheduled to close on May 3, 2019. This document extends the comment 
period for the

[[Page 16835]]

proposed rule by 30 days to June 3, 2019.

DATES: The comment period for the proposed rule published March 4, 
2019, at 84 FR 7424, is extended. Comments must be received on or 
before June 3, 2019.

ADDRESSES: You may submit comments, identified by RIN 0955-AA01, 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: 21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program Proposed Rule, Mary E. Switzer Building, Mail 
Stop: 7033A, 330 C Street SW, Washington, DC 20201. Please submit one 
original and two copies.
     Hand Delivery or Courier: Office of the National 
Coordinator for Health Information Technology, Attention: 21st Century 
Cures Act: Interoperability, Information Blocking, and the ONC Health 
IT Certification Program Proposed Rule, Mary E. Switzer Building, Mail 
Stop: 7033A, 330 C Street SW, Washington, DC 20201. Please submit one 
original and two copies. (Because access to the interior of the Mary E. 
Switzer 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 on ONC's website (http://www.healthit.gov). 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 (``public comment 
template'') is available on ONC's website (http://www.healthit.gov) for 
the public to use in providing comments on the proposed rule. This 
document is meant to provide the public with a simple and organized way 
to submit comments on proposals 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. We believe that use of the document may 
facilitate our review and understanding of the comments received.
    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, Mary E. Switzer Building, Mail Stop: 
7033A, 330 C Street SW, Washington, DC 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: In the ``21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program'' proposed rule that appeared in the March 4, 
2019 Federal Register (84 FR 7424), we solicited public comments on 
proposals to implement certain provisions of the 21st Century Cures 
Act, including conditions and maintenance of certification requirements 
for health information technology (health IT) developers under the ONC 
Health IT Certification Program (Program), the voluntary certification 
of health IT for use by pediatric health care providers, and reasonable 
and necessary activities that do not constitute information blocking. 
The comment period for the rule was scheduled to close on May 3, 2019. 
This document extends the comment period for the proposed rule by 30 
days until June 3, 2019.
    To date, we have received comments from organizations with broad 
stakeholder representation requesting that we extend the 60-day comment 
period for the proposed rule. For example, we have received comments 
requesting more time from clinicians, hospitals, health IT developers 
and developer associations, professional societies, researchers, 
quality improvement organizations, health plans, and patient advocacy 
organizations. The commenters have stated that due to the depth and 
complexity of the policies proposed, it is critical for the public to 
have extended time in providing sufficient and thoughtful comments to 
advance shared goals and shape the interoperability landscape. Based on 
these public comments and the stated goals of the proposed rule to 
improve interoperability and patient access to health information for 
the purposes of promoting competition and better care, we are extending 
the comment period for the proposed rule for an additional 30 days.

    Dated: April 18, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-08178 Filed 4-19-19; 8:45 am]
BILLING CODE 4150-45-P