Notice of Availability: Office of the National Coordinator for Health Information Technology (ONC) Interim Guidance Regarding the Recognition of Certification Bodies, 44296-44297 [06-6689]
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Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices
treating physician, but inaccessible to a
clerical employee who does not need
such access to accomplish their job.
Security also involves ensuring that data
have not been altered or tampered with.
b. Reliability goes to the accessibility
and consistency with which data is
retrieved and displayed. For example,
the physician should be able to easily
and consistently access laboratory test
results through some consistent display
mechanism that can be counted on to be
available whenever it is needed.
At HHS’ request, the CCHITrecommended ambulatory EHR
certification criteria were presented to
the American Health Information
Community (AHIC) on May 16, 2006.
After consideration, the AHIC
recommended that the Secretary
recognize CCHIT identified ambulatory
EHR certification criteria that CCHIT
recommended for use in 2006. This
recommendation informed the
Secretary’s decision to recognize these
criteria.
The Secretary also based his decision
to recognize these criteria on the need
for such criteria in the Departments
recently published final rules for
exceptions to the physician self-referral
law and safe harbors to the Antikickback statute for electronic
prescribing and EHR arrangements (RIN
#0938–AN69 and 0991–AB36
respectively). These rules are premised
on:
1. HHS having recognized one or
more EHR certifying bodies, and
2. HHS having recognized criteria for
the certification of EHRs.
A separate notice of availability has
been published in the Federal Register
to notify the public about the
availability of a certification Guidance
Document that provides interim
guidance on the recognition of
certification bodies. This document is
also available at https://www.hhs.gov/
healthit. The CCHIT criteria that the
Secretary has recognized serve to
establish the initial EHR certification
criteria that are referenced in the final
physician self-referral law and Antikickback statute rules.
The Secretary also based his decision
to recognize the CCHIT criteria on a
belief that providers will be more
willing to invest in health IT if there is
a way of ensuring that the products
would perform as advertised. Stories
abound about providers making large
investments in EHRs only to discover
that they do not meet their
functionality, interoperability security
and/or reliability needs. Certification
could respond to investment fears
generated by stories about failed
investments. A reduction of such fears
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could further the Department’s goal of
higher rates of sustained health IT
adoption and interoperability.
Finally, the Secretary’s decision to
recognize these criteria was informed by
the fact that the criteria have been
validated through prototype testing.
Any criteria not fully validated by the
Pilot Test (fewer than 10% fell in this
category) were not considered for
recognition.
In light of the consensus basis, HHS
reliance, industry impact and
demonstrated utility of the CCHIT
criteria for functionality,
interoperability, security and reliability,
the Secretary has recognized these
criteria. He has delegated authority to
ONC to coordinate and oversee the
incorporation of these criteria in
relevant activities among Federal
agencies and other partner
organizations, as appropriate.
FOR FURTHER INFORMATION CONTACT: John
W. Loonsk, M.D. at (202) 205–0242.
Dated: August 1, 2006.
Karen Bell,
Acting Deputy National Coordinator for
Health IT.
[FR Doc. 06–6690 Filed 8–1–06; 1:25 p.m.]
BILLING CODE 4150–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Availability: Office of the
National Coordinator for Health
Information Technology (ONC) Interim
Guidance Regarding the Recognition
of Certification Bodies
AGENCY:
Office of the Secretary, HHS.
Authority: EO 13335 (‘‘Incentives for the
Use of Health Information Technology and
Establishing the Position of the National
Health Information Technology
Coordinator’’) and Pub. L. 109–149
(‘‘Departments of Labor, Health and Human
Services, and Education, and Related
Agencies Appropriations Act, 2006).
SUMMARY: This notice provides the
public with information about the
availability of a Certification Guidance
Document (CGD) at https://www.hhs.gov/
healthit. The CGD explains the factors
that ONC will use to determine whether
or not to recommend to the Secretary of
the Department of Health and Human
Services (the Secretary) that he
recognize a body for certification. Once
recognized, that body will have
Recognized Certification Body (RCB)
status. The CGD will serve as guide for
ONC as it evaluates applications for
RCB status and seeks to provide all of
the information a body would need to
apply for and obtain such status. By
publishing the CGD, HHS will ensure a
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transparent and open process as a basis
for these recommendations.
To encourage a more widespread
adoption of interoperable health
information technology, the Department
of Health and Human Services (HHS)
published two final rules in August
2006 regarding certain arrangements
involving the donation of interoperable
electronic health records (EHR)
technology to physicians and other
health care practitioners or entities. The
first, published by the Centers for
Medicare & Medicaid Services (CMS),
promulgated an exception to the
physician self-referral prohibition. The
second, published by the Office of
Inspector General (OIG), established a
safe harbor under the anti-kickback
statute. In order for the donation of EHR
technology to be protected under the
exception and safe harbor provisions of
these rules, the technology must be
interoperable. The exception and safe
harbor provide that EHR software will
be ‘‘deemed to be interoperable if a
certifying body recognized by the
Secretary has certified the software no
more than 12 months prior to the date
it is provided to the [physician/
recipient].’’ Both rules become effective
60 days after publication.
The Department will utilize notice
and comment rulemaking to formalize
and finalize the policies and procedures
that will govern whether ONC will
recommend to the Secretary a body for
RCB status. In the meantime, this
guidance document identifies the
factors to be considered by the Secretary
in granting such recognition. In
addition, the guidance sets forth an
interim procedure that certifying bodies
should follow in obtaining recognition
by the Secretary. Until such time as the
Department formalizes the procedure, a
certifying body will be considered
‘‘recognized by the Secretary’’ if it has
become an RCB in accordance with the
interim guidance. The guidance
document seeks to reduce uncertainty
about key aspects of the certification
body recognition process.
Public comment may be
submitted on or before October 3, 2006.
Comments may be submitted via e-mail
to RCB-comments@hhs.gov or in written
form to the address below.
DATES:
Steven Posnack, Program
Analyst, Department of Health and
Human Services, Office of the National
Coordinator for Health Information
Technology, 330 C Street, SW., Switzer
Building, Room 4090, Washington, DC
20201.
Please refer to this guidance
document when submitting comments.
ADDRESSES:
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Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices
FOR FURTHER INFORMATION CONTACT:
ACTION:
Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Steven Posnack at 202–690–7151.
Dated: July 31, 2006.
Karen Bell,
Acting Deputy National Coordinator for
Health IT.
[FR Doc. 06–6689 Filed 8–1–06; 1:25 pm]
BILLING CODE 4150–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
Statement of Organization, Functions,
and Delegations of Authority
PART J (Agency for Toxic Substances
and Disease Registry) of the Statement
of Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (50 FR 25129–25130, dated
June 17, 1985, as amended most
recently at 70 FR 72839–72840, dated
December 7, 2005) is amended to reflect
the reorganization of the Agency for
Toxic Substances and Disease Registry
(ATSDR).
Section T–B, Organization and
Functions, is hereby amended as
follows:
Delete item (11) of the functional
statement for the Office of
Communications (JAA4), Office of the
Director (JAA), Office of the
Administrator (JA), and insert the
following: (11) provides publicationsrelated activities including preparing
articles and drafting news releases,
distributing publications, and
bibliographic services, and.
Delete item (8) of the functional
statement for the Office of
Communications (JAA4), and renumber
the remaining items accordingly.
Dated: July 21, 2006.
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 06–6676 Filed 8–3–06; 8:45 am]
BILLING CODE 4160–70–M
SUMMARY: The Department of Health and
Human Services (HHS) gives notice
concerning the final effect of the HHS
decision to designate a class of
employees at the Pacific Proving
Grounds, Enewetak Atoll, as an addition
to the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. On June 26, 2006,
as provided for under 42 U.S.C.
7384q(b), the Secretary of HHS
designated the following class of
employees as an addition to the SEC:
Department of Energy (DOE) employees or
DOE contractor or subcontractor employees
who worked at the Pacific Proving Grounds
(PPG) from 1946 through 1962 for a number
of work days aggregating at least 250 work
days, either solely under this employment or
in combination with work days within the
parameters (excluding aggregate work day
requirements) established for other classes of
employees included in the SEC, and who
were monitored or should have been
monitored.
This designation became effective on
July 26, 2006, as provided for under 42
U.S.C. 7384l(14)(C). Hence, beginning
on July 26, 2006, members of this class
of employees, defined as reported in
this notice, became members of the
Special Exposure Cohort.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
Dated: August 1, 2006.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 06–6681 Filed 8–3–06; 8:45 am]
BILLING CODE 4163–19–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
gechino on PROD1PC61 with NOTICES
Centers for Disease Control and
Prevention
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
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Centers for Disease Control and
Prevention
Decision To Evaluate a Petition To
Designate a Class of Employees at
General Atomics (Also Known as GA,
and/or Division of General Dynamics,
and/or John Jay Hopkins Laboratory
for Pure and Applied Science), La
Jolla, Laboratory for Pure and Applied
Science), La Jolla, California, To Be
Included in the Special Exposure
Cohort
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) gives notice as
required by 42 CFR 83.12(e) of a
decision to evaluate a petition to
designate a class of employees at
General Atomics (also known as GA,
and/or Division of General Dynamics,
and/or John Jay Hopkins Laboratory for
Pure and Applied Science), to be
included in the Special Exposure Cohort
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. The initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: General Atomics.
Location: La Jolla, California.
Job Titles and/or Job Duties:
Potentially worked in the locations:
Æ Building 2 (Science laboratories A,
B, and C).
Æ Building 9 (Experimental Building).
Æ Building 10 (Maintenance).
Æ Building 11 (Service Building).
Æ Building 21.
Æ Building 22.
Æ Building 23 (Hot Cell Facility).
Æ Building 25.
Æ Building 26.
Æ Building 27 (Experimental Area
Building #1).
Æ Building 27–1 (Experimental Area
Building #1).
Æ Building 30 (LINAC Complex).
Æ Building 31 (HTGR–TCF).
Æ Building 33 (Fusion Building).
Æ Building 34 (Fusion Doublet III).
Æ Building 37 (SV–A).
Æ Building 39 (SV–B).
Æ SV–D.
Period of Employment: January 1,
1960 through December 31, 1969.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 71, Number 150 (Friday, August 4, 2006)]
[Notices]
[Pages 44296-44297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6689]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of Availability: Office of the National Coordinator for
Health Information Technology (ONC) Interim Guidance Regarding the
Recognition of Certification Bodies
AGENCY: Office of the Secretary, HHS.
Authority: EO 13335 (``Incentives for the Use of Health
Information Technology and Establishing the Position of the National
Health Information Technology Coordinator'') and Pub. L. 109-149
(``Departments of Labor, Health and Human Services, and Education,
and Related Agencies Appropriations Act, 2006).
SUMMARY: This notice provides the public with information about the
availability of a Certification Guidance Document (CGD) at https://
www.hhs.gov/healthit. The CGD explains the factors that ONC will use to
determine whether or not to recommend to the Secretary of the
Department of Health and Human Services (the Secretary) that he
recognize a body for certification. Once recognized, that body will
have Recognized Certification Body (RCB) status. The CGD will serve as
guide for ONC as it evaluates applications for RCB status and seeks to
provide all of the information a body would need to apply for and
obtain such status. By publishing the CGD, HHS will ensure a
transparent and open process as a basis for these recommendations.
To encourage a more widespread adoption of interoperable health
information technology, the Department of Health and Human Services
(HHS) published two final rules in August 2006 regarding certain
arrangements involving the donation of interoperable electronic health
records (EHR) technology to physicians and other health care
practitioners or entities. The first, published by the Centers for
Medicare & Medicaid Services (CMS), promulgated an exception to the
physician self-referral prohibition. The second, published by the
Office of Inspector General (OIG), established a safe harbor under the
anti-kickback statute. In order for the donation of EHR technology to
be protected under the exception and safe harbor provisions of these
rules, the technology must be interoperable. The exception and safe
harbor provide that EHR software will be ``deemed to be interoperable
if a certifying body recognized by the Secretary has certified the
software no more than 12 months prior to the date it is provided to the
[physician/recipient].'' Both rules become effective 60 days after
publication.
The Department will utilize notice and comment rulemaking to
formalize and finalize the policies and procedures that will govern
whether ONC will recommend to the Secretary a body for RCB status. In
the meantime, this guidance document identifies the factors to be
considered by the Secretary in granting such recognition. In addition,
the guidance sets forth an interim procedure that certifying bodies
should follow in obtaining recognition by the Secretary. Until such
time as the Department formalizes the procedure, a certifying body will
be considered ``recognized by the Secretary'' if it has become an RCB
in accordance with the interim guidance. The guidance document seeks to
reduce uncertainty about key aspects of the certification body
recognition process.
DATES: Public comment may be submitted on or before October 3, 2006.
Comments may be submitted via e-mail to RCB-comments@hhs.gov or in
written form to the address below.
ADDRESSES: Steven Posnack, Program Analyst, Department of Health and
Human Services, Office of the National Coordinator for Health
Information Technology, 330 C Street, SW., Switzer Building, Room 4090,
Washington, DC 20201.
Please refer to this guidance document when submitting comments.
[[Page 44297]]
FOR FURTHER INFORMATION CONTACT: Steven Posnack at 202-690-7151.
Dated: July 31, 2006.
Karen Bell,
Acting Deputy National Coordinator for Health IT.
[FR Doc. 06-6689 Filed 8-1-06; 1:25 pm]
BILLING CODE 4150-24-P
