Scientific Information Request on Health Information Exchange, 51567-51569 [2014-20425]
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Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: August 20, 2014.
Richard Kronick,
Director.
[FR Doc. 2014–20423 Filed 8–28–14; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment From
Patient Safety Services, LLC
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of Delisting.
AGENCY:
The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b–21 to b–26, (Patient Safety
Act) and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR Part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70732–
70814, provide for the formation of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of health care
delivery. The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of NHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
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Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
AHRQ has accepted a notification of
voluntary relinquishment from Patient
Safety Services, LLC of its status as a
PSO, and has delisted the PSO
accordingly.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on July 30, 2014.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.AHRQ.gov/listed.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130; Email: pso@
AHRQ.hhs.qov.
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
the PSO’s listing expires. Section
3.108(d) of the Patient Safety Rule
requires AHRQ to provide public notice
when it removes an organization from
the list of federally approved PSOs.
AHRQ has accepted a notification
from Patient Safety Services, LLC, PSO
number P0129, to voluntarily relinquish
its status as a PSO. Accordingly, Patient
Safety Services, LLC was delisted
effective at 12:00 Midnight ET (2400) on
July 30, 2014.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov/
index.html.
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51567
Dated: August 20, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–20424 Filed 8–28–14; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Health Information Exchange
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Scientific
Information Submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review of
Health Information Exchange, which is
currently being conducted by the
Evidence-based Practice Centers for the
AHRQ Effective Health Care Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
AHRQ is conducting this systematic
review pursuant to Section 1013 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173, and Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
DATES: Submission Deadline on or
before September 29, 2014.
ADDRESSES: Online submissions: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submit-scientificinformation-packets/. Please select the
study for which you are submitting
information from the list to upload your
documents. Email submissions: SIPS@
epc-src.org.
SUMMARY:
Print Submissions
Mailing Address: Portland VA
Research Foundation, Scientific
Resource Center, ATTN: Scientific
Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503–220–
8262 ext. 58653 or Email: SIPS@epcsrc.org.
E:\FR\FM\29AUN1.SGM
29AUN1
51568
Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices
The
Agency for Healthcare Research and
Quality has commissioned the Effective
Health Care (EHC) Program Evidencebased Practice Centers to complete a
review of the evidence for Health
Information Exchange.
The EHC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Health Information
Exchange, including those that describe
adverse events. The entire research
protocol, including the key questions, is
also available online at: https://effective
healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/
?pageaction=display
product&productID=1943.
This notice is to notify the public that
the EHC Program would find the
following information on Health
Information Exchange helpful:
• A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
• For completed studies that do not
have results on ClinicalTrials.gov,
please provide a summary, including
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
• A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
• Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution will be very
beneficial to the EHC Program. The
contents of all submissions will be made
available to the public upon request.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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Materials submitted must be publicly
available or can be made public.
Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EHC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EHC Program Web site and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.AHRQ.gov/
index.cfm/ioin-the-email-list1/.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions. The entire
research protocol, is also available
online at: https://effectivehealth
care.AHRQ.gov/search-for-guidesreviews-and-reports/
?pageaction=display
product&productID=1943.
The Key Questions
The draft Key Questions (KQs)
developed during Topic Refinement
were available for public comment from
February 6 to February 26, 2014. The
comments did not lead to significant
changes but were helpful in identifying
additional factors of interest in KQ 4
and KQ 5, and for clarifying the wording
of the questions.
Based on the public comments and
subsequent discussions with AHRQ, the
following changes of note were made to
the KQs:
• KQ 4: Added ‘‘provider type’’ to KQ
4b. Added an additional sub question of
‘‘Do level of use and primary uses vary
by data source?’’
• KQ 5: Added an additional sub
question of ‘‘How does usability vary by
health care settings or systems?’’
The revised KQs are as follows:
KQ 1: Is health information exchange
(HIE) effective in improving clinical (e.g.
mortality and morbidity), economic
(e.g., costs and resource use, the value
proposition for HIE) and population
(e.g., syndromic surveillance) outcomes?
• Does effectiveness vary by type of
HIE?
• Does effectiveness vary by health
care settings and systems?
• Does effectiveness vary by IT
system characteristics?
• What evidence exists that the lack
of HIE leads to poorer outcomes?
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KQ 2: What harms have resulted from
HIE? (e.g., violations of privacy, errors in
diagnosis or treatment from too much,
too little or inaccurate information, or
patient or provider concerns about
HIE)?
• Do harms vary by type of HIE?
• Do harms vary by health care
settings and systems?
• Do harms vary by the IT system
characteristics?
KQ 3: Is HIE effective in improving
intermediate outcomes such as patient
and provider experience, perceptions or
behavior; health care processes; or the
availability, completeness, or accuracy
of information?
• Does effectiveness in improving
intermediate outcomes vary by type of
HIE?
• Does effectiveness in improving
intermediate outcomes vary by health
care settings and systems?
• Does effectiveness in improving
intermediate outcomes vary by IT
system characteristics?
• What evidence exists that the lack
of HIE leads to poorer intermediate
outcomes?
KQ 4: What is the current level of use
and primary uses of HIE?
• Do level of use and primary uses
vary by type of HIE?
• Do level of use and primary uses
vary by health care settings and systems,
or provider type?
• Do level of use and primary uses
vary by IT system characteristics?
• Do level of use and primary uses
vary by data source?
KQ 5: How does the usability of HIE
impact effectiveness or harms for
individuals and organizations?
• How usable are various types of
HIE?
• What specific usability factors
impact the effectiveness or harms from
HIE?
• How does usability vary by health
care settings or systems?
KQ 6: What facilitators and barriers
impact implementation of HIE?
• Do facilitators and barriers that
impact implementation vary by type of
HIE?
• Do facilitators and barriers that
impact implementation vary by health
care settings and systems?
• Do facilitators and barriers that
impact implementation vary by IT
system characteristics?
KQ 7: What facilitators and barriers
impact use of HIE?
• Do facilitators and barriers that
impact use vary by type of HIE?
E:\FR\FM\29AUN1.SGM
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Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices
• Do facilitators and barriers that
impact use vary by health care settings
and systems?
• Do facilitators and barriers that
impact use vary by IT system
characteristics?
KQ 8: What factors influence
sustainability of HIE?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Setting)
Populations
Any individual or group of health
care providers, patients, managers,
health care institutions, or regional
organizations.
Intervention
Heath Information Exchange (HIE).
HIE is defined as the electronic sharing
of clinical information among users
such as health care providers, patients,
administrators or policy makers across
the boundaries of health care
institutions, health data repositories,
States and others, typically not within a
single organization or among affiliated
providers, while protecting the integrity,
privacy, and security of the information.
Comparators
• Time period prior to HIE
implementation
• Locations (geographic or
organizational without HIE)
• Situations in which HIE is not
available, akin to ‘‘usual care’’ in a
clinical study
• Comparisons across types of HIE
• Comparisons of the characteristics
of the different settings, health care
system, and IT systems in which HIE is
used
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Outcomes (specified for each Key
Question)
KQ 1: Effectiveness is defined in
terms of clinical outcomes (e.g.,
mortality and morbidity), economic
outcomes (e.g., costs and resource use,
the value proposition for HIE) and
population outcomes (e.g., syndromic
surveillance for the identification of
trends or clusters).
KQ 2: Harms include unintended
negative consequence or adverse events
experienced by individuals, institutions,
or organizations. Harms from HIE may
include negative outcomes or the risk of
negative outcomes resulting from
information that is wrong, not provided
in a timely manner, or in formats that
inhibit its identification,
comprehension, and use. Harms also
may result from too much information
as well as lack of information. Harms
can also include negative impacts on
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Jkt 232001
attitudes (e.g., patients not trusting the
privacy will be protected, clinicians’
concerns about legal liability).
KQ 3: Intermediate outcomes include
outcomes such as provider and patient
experience and perceptions; changes in
provider behavior and health care
processes; and changes in the
availability, completeness, or accuracy
of information.
KQ 4: Level of use is the rate of HIE
use by individuals, health care
institutions, or regional organizations.
KQ 5: Usability focuses on the
function of the HIE in terms of the
interaction between users and HIE and
their ability to navigate and accomplish
tasks.
KQ 6: Implementation of HIE is
defined as the realization of an HIE
project such that the exchange of data is
operational.
KQ 7: Use is the incorporation of the
HIE into the workflow and decisions of
patients, providers or organizations.
KQ 8: Sustainability is long-term
maintenance, and improvement or
expansion of HIE, after the
implementation period.
Timing
No minimum duration of time lapsed
from implementation of HIE to the
measurement of outcomes.
Settings
Any aspect of the setting in which
health information is exchanged for the
purpose of improving health or health
care decisions that is hypothesized to
impact effectiveness, use, usability or
sustainability. This may include the
type(s) of clinical environments (e.g.,
ambulatory care, hospital, nursing
home, etc.), payment/reimbursement
model(s) (e.g., fee-for-service, managed
care setting, risk/value-based model
such as an accountable care
organization, etc.), and legislative
requirements (e.g., participation in HIE
required to participate in Medicaid).
Dated: August 20, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–20425 Filed 8–28–14; 8:45 am]
BILLING CODE 4160–90–M
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51569
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10147, CMS–
2540–10, CMS–265–11, CMS–10106 and
CMS–10537]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by September 29,
2014.
SUMMARY:
When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
ADDRESSES:
E:\FR\FM\29AUN1.SGM
29AUN1
]]>Agencies
[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51567-51569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Health Information Exchange
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Scientific Information Submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review of Health
Information Exchange, which is currently being conducted by the
Evidence-based Practice Centers for the AHRQ Effective Health Care
Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review. AHRQ is conducting
this systematic review pursuant to Section 1013 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, Public
Law 108-173, and Section 902(a) of the Public Health Service Act, 42
U.S.C. 299a(a).
DATES: Submission Deadline on or before September 29, 2014.
ADDRESSES: Online submissions: https://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the
study for which you are submitting information from the list to upload
your documents. Email submissions: src.org">SIPS@epc-src.org.
Print Submissions
Mailing Address: Portland VA Research Foundation, Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 58653 or Email: src.org">SIPS@epc-src.org.
[[Page 51568]]
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Effective Health Care (EHC) Program
Evidence-based Practice Centers to complete a review of the evidence
for Health Information Exchange.
The EHC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Health Information Exchange, including those that
describe adverse events. The entire research protocol, including the
key questions, is also available online at: https://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1943.
This notice is to notify the public that the EHC Program would find
the following information on Health Information Exchange helpful:
A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
For completed studies that do not have results on
ClinicalTrials.gov, please provide a summary, including the following
elements: Study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution will be very beneficial to the EHC Program. The
contents of all submissions will be made available to the public upon
request. Materials submitted must be publicly available or can be made
public. Materials that are considered confidential; marketing
materials; study types not included in the review; or information on
indications not included in the review cannot be used by the EHC
Program. This is a voluntary request for information, and all costs for
complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EHC Program Web
site and available for public comment for a period of 4 weeks. If you
would like to be notified when the draft is posted, please sign up for
the email list at: https://effectivehealthcare.AHRQ.gov/index.cfm/ioin-the-email-list1/.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions. The entire research
protocol, is also available online at: https://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1943.
The Key Questions
The draft Key Questions (KQs) developed during Topic Refinement
were available for public comment from February 6 to February 26, 2014.
The comments did not lead to significant changes but were helpful in
identifying additional factors of interest in KQ 4 and KQ 5, and for
clarifying the wording of the questions.
Based on the public comments and subsequent discussions with AHRQ,
the following changes of note were made to the KQs:
KQ 4: Added ``provider type'' to KQ 4b. Added an
additional sub question of ``Do level of use and primary uses vary by
data source?''
KQ 5: Added an additional sub question of ``How does
usability vary by health care settings or systems?''
The revised KQs are as follows:
KQ 1: Is health information exchange (HIE) effective in improving
clinical (e.g. mortality and morbidity), economic (e.g., costs and
resource use, the value proposition for HIE) and population (e.g.,
syndromic surveillance) outcomes?
Does effectiveness vary by type of HIE?
Does effectiveness vary by health care settings and
systems?
Does effectiveness vary by IT system characteristics?
What evidence exists that the lack of HIE leads to poorer
outcomes?
KQ 2: What harms have resulted from HIE? (e.g., violations of privacy,
errors in diagnosis or treatment from too much, too little or
inaccurate information, or patient or provider concerns about HIE)?
Do harms vary by type of HIE?
Do harms vary by health care settings and systems?
Do harms vary by the IT system characteristics?
KQ 3: Is HIE effective in improving intermediate outcomes such as
patient and provider experience, perceptions or behavior; health care
processes; or the availability, completeness, or accuracy of
information?
Does effectiveness in improving intermediate outcomes vary
by type of HIE?
Does effectiveness in improving intermediate outcomes vary
by health care settings and systems?
Does effectiveness in improving intermediate outcomes vary
by IT system characteristics?
What evidence exists that the lack of HIE leads to poorer
intermediate outcomes?
KQ 4: What is the current level of use and primary uses of HIE?
Do level of use and primary uses vary by type of HIE?
Do level of use and primary uses vary by health care
settings and systems, or provider type?
Do level of use and primary uses vary by IT system
characteristics?
Do level of use and primary uses vary by data source?
KQ 5: How does the usability of HIE impact effectiveness or harms for
individuals and organizations?
How usable are various types of HIE?
What specific usability factors impact the effectiveness
or harms from HIE?
How does usability vary by health care settings or
systems?
KQ 6: What facilitators and barriers impact implementation of HIE?
Do facilitators and barriers that impact implementation
vary by type of HIE?
Do facilitators and barriers that impact implementation
vary by health care settings and systems?
Do facilitators and barriers that impact implementation
vary by IT system characteristics?
KQ 7: What facilitators and barriers impact use of HIE?
Do facilitators and barriers that impact use vary by type
of HIE?
[[Page 51569]]
Do facilitators and barriers that impact use vary by
health care settings and systems?
Do facilitators and barriers that impact use vary by IT
system characteristics?
KQ 8: What factors influence sustainability of HIE?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Setting)
Populations
Any individual or group of health care providers, patients,
managers, health care institutions, or regional organizations.
Intervention
Heath Information Exchange (HIE). HIE is defined as the electronic
sharing of clinical information among users such as health care
providers, patients, administrators or policy makers across the
boundaries of health care institutions, health data repositories,
States and others, typically not within a single organization or among
affiliated providers, while protecting the integrity, privacy, and
security of the information.
Comparators
Time period prior to HIE implementation
Locations (geographic or organizational without HIE)
Situations in which HIE is not available, akin to ``usual
care'' in a clinical study
Comparisons across types of HIE
Comparisons of the characteristics of the different
settings, health care system, and IT systems in which HIE is used
Outcomes (specified for each Key Question)
KQ 1: Effectiveness is defined in terms of clinical outcomes (e.g.,
mortality and morbidity), economic outcomes (e.g., costs and resource
use, the value proposition for HIE) and population outcomes (e.g.,
syndromic surveillance for the identification of trends or clusters).
KQ 2: Harms include unintended negative consequence or adverse
events experienced by individuals, institutions, or organizations.
Harms from HIE may include negative outcomes or the risk of negative
outcomes resulting from information that is wrong, not provided in a
timely manner, or in formats that inhibit its identification,
comprehension, and use. Harms also may result from too much information
as well as lack of information. Harms can also include negative impacts
on attitudes (e.g., patients not trusting the privacy will be
protected, clinicians' concerns about legal liability).
KQ 3: Intermediate outcomes include outcomes such as provider and
patient experience and perceptions; changes in provider behavior and
health care processes; and changes in the availability, completeness,
or accuracy of information.
KQ 4: Level of use is the rate of HIE use by individuals, health
care institutions, or regional organizations.
KQ 5: Usability focuses on the function of the HIE in terms of the
interaction between users and HIE and their ability to navigate and
accomplish tasks.
KQ 6: Implementation of HIE is defined as the realization of an HIE
project such that the exchange of data is operational.
KQ 7: Use is the incorporation of the HIE into the workflow and
decisions of patients, providers or organizations.
KQ 8: Sustainability is long-term maintenance, and improvement or
expansion of HIE, after the implementation period.
Timing
No minimum duration of time lapsed from implementation of HIE to
the measurement of outcomes.
Settings
Any aspect of the setting in which health information is exchanged
for the purpose of improving health or health care decisions that is
hypothesized to impact effectiveness, use, usability or sustainability.
This may include the type(s) of clinical environments (e.g., ambulatory
care, hospital, nursing home, etc.), payment/reimbursement model(s)
(e.g., fee-for-service, managed care setting, risk/value-based model
such as an accountable care organization, etc.), and legislative
requirements (e.g., participation in HIE required to participate in
Medicaid).
Dated: August 20, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-20425 Filed 8-28-14; 8:45 am]
BILLING CODE 4160-90-M
