Notice of Availability: Secretarial Recognition of Certain Certification Commission for Healthcare Information Technology (CCHIT) Functionality, Interoperability, Security and Reliability Criteria for Ambulatory Electronic Health Records, 44295-44296 [06-6690]
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Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices
notice is hereby given that the Federal
Accounting Standards Advisory Board
(FASAB) has issued an exposure draft,
Interpretation: Items Held for
Remanufacture.
The proposed Interpretation would
clarify the principles governing the
classification, valuation and reporting of
items that are in the process of major
overhaul or remanufacture for sale or for
internal use. The Exposure Draft is
available on the FASAB home page
https://www.fasab.gov/exposure.html.
Copies can be obtained by contacting
FASAB at (202) 512–7350. Respondents
are encouraged to comment on any
party of the exposure draft.
Written comments are requested by
October 16, 2006, and should be sent to:
Wendy M. Comes, Executive Director,
Federal Accounting Standards Advisory
Board. 441 G Street, NW., Suite 6814,
Mail Stop 6K17V, Washington, DC
20548.
FOR FURTHER INFORMATION CONTACT:
Wendy Comes, Executive Director, 441
G Street, NW., Washington, DC 20548,
or call (202) 512–7350.
Authority: Federal Advisory Committee
Act, Pub. L. 92–463.
Dated: August 1, 2006.
Charles Jackson,
Federal Register Liaison Officer.
[FR Doc. 06–6677 Filed 8–3–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FEDERAL RESERVE SYSTEM
gechino on PROD1PC61 with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR Part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
22:39 Aug 03, 2006
Jkt 208001
Board of Governors of the Federal Reserve
System, August 1, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E6–12608 Filed 8–3–06; 8:45 am]
BILLING CODE 6210–01–S
BILLING CODE 1610–01–M
VerDate Aug<31>2005
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than August 31,
2006.
A. Federal Reserve Bank of Atlanta
(Andre Anderson, Vice President) 1000
Peachtree Street, N.E., Atlanta, Georgia
30309:
1. Piedmont Community Bank Group,
Inc., Gray, Georgia; to become a bank
holding company by acquiring 100
percent of the voting shares of Piedmont
Community Bank, Gray, Georgia.
Notice of Availability: Secretarial
Recognition of Certain Certification
Commission for Healthcare
Information Technology (CCHIT)
Functionality, Interoperability, Security
and Reliability Criteria for Ambulatory
Electronic Health Records
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: By this document we are
informing the public of the Secretary’s
recognition of certain Certification
Commission for Healthcare Information
Technology (CCHIT) criteria for
ambulatory EHR functionality,
interoperability, security and reliability
standards. This list of recognized
criteria is available by clicking the
applicable link at https://www.hhs.gov/
healthit.
The CCHIT was created in 2004 by an
industry coalition of the American
Health Information Management
Association (AHIMA), the Health
PO 00000
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Fmt 4703
Sfmt 4703
44295
Information and Management Systems
Society (HIMSS) and the National
Alliance for Health Information
Technology. CCHIT’s mission is to
accelerate the adoption of HIT by
creating an efficient, credible and
sustainable product certification
program.
During the three comment cycles that
generated the ambulatory EHR criteria
that the Secretary has recognized,
CCHIT received over 1500 comments
from a wide range of stakeholders.
Further outreach was achieved through
the establishment of several large Town
Hall presentations with attendances in
the range of 500–1000 at Healthcare
Information Management Systems
Society (HIMSS) conferences as well as
at more than thirty smaller
presentations to a variety of
associations, organizations and the press
gatherings.
CCHIT grouped its ambulatory EHR
certification criteria recommendations
into three groups, ‘‘functionality,’’
‘‘interoperability’’ and ‘‘security/
reliability.’’ For ease of understanding,
the Secretary broke the security and
reliability recommendations into
separate categories. Definitions of these
categories, and an example that
illuminates the various functions of
each category are as follows:
1. Functionality criteria identify
minimum required and provisional
product features for documenting and
managing a typical patient encounter.
For example, a physician needs to be
able to access his/her patient’s
laboratory test results, so an example of
a functional requirement is that an EHR
would need to provide the capability of
displaying laboratory test results.
2. Interoperability criteria establish
standards for how products interact
with other products within and across
care settings. For example, to ensure
interoperability, the physician EHR
noted above would need to be able to
receive laboratory test results from
another physician’s (within care
settings) as well as from laboratory
systems (across care settings).
3. Security and reliability criteria are
designed to help the security inspector
assess a product’s ability to protect,
manage and audit access to sensitive
patient data. For clarity, we have broken
these criteria into the two separate
categories, security and reliability.
a. Security 1 addresses the appropriate
access to data by appropriate parties and
the protection of data from improper
manipulation. For example, laboratory
test results should be accessible to a
1 HHS notes that the requirements of the HIPAA
Security Rule continue to be applicable.
E:\FR\FM\04AUN1.SGM
04AUN1
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44296
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
VerDate Aug<31>2005
22:39 Aug 03, 2006
Jkt 208001
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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Fmt 4703
Sfmt 4703
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:
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 71, Number 150 (Friday, August 4, 2006)]
[Notices]
[Pages 44295-44296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6690]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of Availability: Secretarial Recognition of Certain
Certification Commission for Healthcare Information Technology (CCHIT)
Functionality, Interoperability, Security and Reliability Criteria for
Ambulatory Electronic Health Records
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: By this document we are informing the public of the
Secretary's recognition of certain Certification Commission for
Healthcare Information Technology (CCHIT) criteria for ambulatory EHR
functionality, interoperability, security and reliability standards.
This list of recognized criteria is available by clicking the
applicable link at https://www.hhs.gov/healthit.
The CCHIT was created in 2004 by an industry coalition of the
American Health Information Management Association (AHIMA), the Health
Information and Management Systems Society (HIMSS) and the National
Alliance for Health Information Technology. CCHIT's mission is to
accelerate the adoption of HIT by creating an efficient, credible and
sustainable product certification program.
During the three comment cycles that generated the ambulatory EHR
criteria that the Secretary has recognized, CCHIT received over 1500
comments from a wide range of stakeholders. Further outreach was
achieved through the establishment of several large Town Hall
presentations with attendances in the range of 500-1000 at Healthcare
Information Management Systems Society (HIMSS) conferences as well as
at more than thirty smaller presentations to a variety of associations,
organizations and the press gatherings.
CCHIT grouped its ambulatory EHR certification criteria
recommendations into three groups, ``functionality,''
``interoperability'' and ``security/reliability.'' For ease of
understanding, the Secretary broke the security and reliability
recommendations into separate categories. Definitions of these
categories, and an example that illuminates the various functions of
each category are as follows:
1. Functionality criteria identify minimum required and provisional
product features for documenting and managing a typical patient
encounter. For example, a physician needs to be able to access his/her
patient's laboratory test results, so an example of a functional
requirement is that an EHR would need to provide the capability of
displaying laboratory test results.
2. Interoperability criteria establish standards for how products
interact with other products within and across care settings. For
example, to ensure interoperability, the physician EHR noted above
would need to be able to receive laboratory test results from another
physician's (within care settings) as well as from laboratory systems
(across care settings).
3. Security and reliability criteria are designed to help the
security inspector assess a product's ability to protect, manage and
audit access to sensitive patient data. For clarity, we have broken
these criteria into the two separate categories, security and
reliability.
a. Security \1\ addresses the appropriate access to data by
appropriate parties and the protection of data from improper
manipulation. For example, laboratory test results should be accessible
to a
[[Page 44296]]
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.
---------------------------------------------------------------------------
\1\ HHS notes that the requirements of the HIPAA Security Rule
continue to be applicable.
---------------------------------------------------------------------------
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 CCHIT-recommended 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 Anti-kickback 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 Anti-
kickback 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 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
