Federal Register, Volume 76 Issue 137 (Monday, July 18, 2011)

[Federal Register Volume 76, Number 137 (Monday, July 18, 2011)]
[Notices]
[Pages 42164-42167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18014]

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DEPARTMENT OF VETERANS AFFAIRS

Announcement of Competition Under the America COMPETES
Reauthorization Act of 2011

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

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SUMMARY: To encourage widespread use of Blue Button personal health
records (PHRs) outside Federal health care programs to benefit Veterans
who receive care from non-VA providers, the Secretary of Veterans
Affairs (VA) announces a prize competition under Section 105 of the
America COMPETES Reauthorization Act of 2011, Public Law 111-358
(2011).

DATES: Competition begins July 18, 2011, and ends when a winner is
announced or on October 18, 2011, whichever occurs first, unless the
term of the contest is extended as provided in this Notice.

FOR INFORMATION CONTACT: James M. Speros at the Office of the
Secretary, Department of Veterans Affairs at (202) 461-7214. (Note:
This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: In collaboration with other Federal agencies
and non-governmental entities the Department of Veterans Affairs (VA)
developed and has implemented an online PHR functionality known as Blue
Button\SM\. VA's Blue Button\SM\ PHR allows Veterans who are registered
users of VA's My HealtheVet internet portal to download extracts of
their own medical information to their home computers. Blue Button\SM\;
PHR downloads can be printed or saved on computers and portable storage
devices. Veterans can then choose to share this data with other health
care providers, caregivers, or people they trust.
The Department of Defense has implemented a Blue Button\SM\ PHR for
beneficiaries of its Tricare program and patients in the Military
Health System; the Centers for Medicare and Medicaid Services has
implemented a Blue Button\SM\ PHR that allows Medicare beneficiaries to
download data about claims for Medicare-covered services. Other health
benefit plans, health insurers and health service providers offer Blue
Button\SM\ PHRs to their patients and customers.
Blue Button\SM\ PHRs provide a simple, convenient, and secure means
for storing personal health data in an internet-based service
(including the download and upload of this information). Blue
Button\SM\ PHRs are currently used by more than 350,000 people--
including 300,000 Veterans who receive care through the VA health
system. VA believes Blue Button\SM\ PHRs have now been sufficiently
tested and proven useful to be made available for use throughout the
United States by Veterans who receive their care from non-VA facilities
and providers and by the public generally.
Blue Button\SM\ PHRs keep the kind of information that patients
need when they ``fill in the clipboard'' when visiting a physician or
other licensed health care provider. Blue Button\SM\ PHRs may also
include clinical information from a sponsoring physician's clinical
electronic health records. Some PHRs are compilations of data that
patients receive from multiple

[[Page 42165]]

physicians, other care providers, health plans, or hospitals.
VA's health care system currently provides care to approximately
eight million Veterans; some of these Veterans and the remainder of the
28 million Veterans in the United States receive some or all of their
care from providers outside the VA health care system. VA believes all
Veterans--not just those who receive all their care from VA--would
benefit from and should have access to a Blue Button\SM\ PHR which is
interoperable with the VA Blue Button\SM\ PHR. Making a Blue Button\SM\
PHR available to all Veterans advances VA's mission of improving the
health care and health status of Veterans.
VA anticipates that Blue Button\SM\ PHRs will both empower patients
and be useful both within and outside the Federal government. Users can
include governmental and non-governmental health plans, health systems,
hospitals, physicians, and other clinical providers. Blue Button\SM\
PHRs can help professionals and hospitals provide Veterans and other
patients with an electronic copy of specified health information,
including clinical summaries of office visits and discharge
instructions. Blue Button\SM\ PHRs can also support electronic exchange
of key clinical information between care providers when authorized by
patients.
In addition to enhancing provider and health plan relationships
with patients, the use of Blue Button\SM\ PHRs may help licensed health
care providers and organizations to achieve the meaningful use of
electronic health records, as set forth in 42 CFR 496.6(d)(12), (14)
and (15) (professionals), and 42 CFR 496(f)(11), (12) and (13)
(hospitals).

Competition Details

Subject of the competition. The objective of this competition is
the widespread installation and actual use of a simple internet-based
application which allows physicians and other licensed clinical
professionals (LCPs) to sponsor and offer to their patients, including
Veterans, a Blue Button\SM\ personal electronic health record (PHR).
Amount of the prize. The prize to be awarded to the winner of this
competition is $50,000.

Competition Rules

(1) Basis on which the winner will be selected. The winner of this
competition will be the first entrant that can document that:
(a) It has created an internet-based application which allows LCPs
to sponsor and offer to their patients, including Veterans, a Blue
Button\SM\ PHR, and
(b) The Blue Button\SM\ PHR application has actually been installed
on public-facing internet sites by 25,000 LCPs within the United States
and is actually available for use by all patients of those LCPs,
including Veterans.
(i) To qualify as an installation sponsored by an LCP, the Blue
Button\SM\ PHR application must be installed on the LCP's internet site
or the Internet site of the organization with which the LCP is
affiliated, must be freely accessible to all patients of the LCP,
including Veterans, and must be operable at the time of judging.
(ii) If the Blue Button\SM\ PHR application is installed on the
internet site of an organization with which the LCP is one of multiple
LCP practitioners, then the total number of LCPs affiliated with the
organization will be counted toward the required number of
installations if it is freely accessible and usable by all patients who
receive services from the organization. Important: Before a prize is
awarded to them, participants will be required to submit a written
approval and confirmation of installation from any LCP organization
through which 100 or more practitioners will be offering the Blue
Button\SM\ PHR. The written approval and confirmation must be signed by
the chief executive officer or equivalent of the LCP organization.
(c) The Blue Button\SM\ PHR application meets the following
criteria:
(i) It provides patients with a simple, convenient and secure means
for entering and storing their personal health data and retrieving that
data via download.
(ii) It supports downloads in, at a minimum, in ASCII and .pdf
formats. The ASCII download format will be identical to and
interoperable with the VA ASCII-based Blue Button\SM\ text file and can
read and write to the VA format. This format can be found at http://www.va.gov/bluebutton.
(iii) LCPs and LCP organizations can easily install the application
and make it available to patients as an internet-based service.
(iv) The Blue Button\SM\ and related Service Marks are used
exclusively to identify the application and all of its components and
functionalities.
(1) To install the application, the sponsoring LCP or LCP
organization (1) Agrees to VA Blue Button\SM\ end user license terms
and to transmittal to VA of information necessary to identify the LCP
or LCP organization as an end-user licensee. The application must
support automated transmission of such identifying information to VA.
(2) See ``Intellectual Property,'' below, for additional
information about the Blue Button\SM\ Service Marks.
(v) The application can and does verify the identity of a recipient
of any health information and the authority of the recipient to receive
any data in the PHR, and, specifically, shall comply with the HIPAA
Security Rule, i.e., 45 CFR 164.312(a) (access control), 45 CFR
164.312(c)(1) (data integrity), and 45 CFR 164.312(e)(1) (transmission
security).
(d) The Blue Button\SM\ PHR application may also, but is not
required to:
(i) Include additional data fields based on the nature or types of
clinical services provided by the sponsoring LCP or LCP organization,
or
(ii) Offer additional functions, such as allowing LCPs or LCP
organizations to export clinical information to a patient's PHR;
allowing patients to electronically transmit PHR data to their LCP or
LCP organization; and allowing LCPs or LCP organizations, when
authorized by a patient, to electronically transfer the patient's PHR
data via NHIN Direct to another LCP or health institution.
(2) Alternate basis for selecting winner.
(a) If the competition judge decides that no single entrant has met
all required criteria for winning the contest, VA may determine that
two or more, and up to 10, participants who have in the aggregate
installed the Blue Button\SM\ PHR application on the internet sites of
25,000 LCPs, either individually or through LCP organizations, should
be declared winners and share the prize.
(b) In the absence of an individual winner, VA will rank entries
from highest to lowest based on the number of verified LCP
installations, and if 25,000 LCP installations, either individually or
through LCP organizations, can be achieved by aggregating two or more,
up to a maximum of 10 of the entries, starting from the top-ranked
entry, the entrants will be eligible to share in the prize, if,
(i) All Participants submit an entry on or before October 18, 2011
or the end of the contest if extended by formal announcement;
(ii) Entries meet all requirements of this contest except only the
requirement for 25,000 installations by a single entrant.
(c) If VA determines that multiple entries should be declared
winners and share the prize, the prize amount will be prorated among
the winning entries based on the number of verified installations, and
in no event will the

[[Page 42166]]

total amount of all prizes awarded exceed $50,000.
(3) Definitions. For purposes of this competition:
(a) A ``LCP'' is an individual licensed to provide health care and
health services, without direction or supervision and who qualifies for
and has received a National Provider Identifier (NPI) from the Centers
for Medicare and Medicaid Services. Examples of LCPs include
physicians, psychologists, dentists, and, when delivery of health care
or services without supervision is authorized by the individual's
license, nurse practitioners, physician's assistants, certified nurse-
midwives and licensed independent social workers.
(b) A LCP may be ``affiliated'' with an organization (LCP
organization) with or through which the LCP actively engages in the
practice of the health profession for which the LCP is licensed.
Examples include multi-physician practice groups, partnerships or
professional corporations in which the principals are actively engaged
in the practice of medical or health care. Membership in or engagement
in professional or trade associations are not ``affiliations'' which
qualify for this competition.
(4) Contest period.
(a) This contest will begin on July 18, 2011.
(b) This contest will end on the earlier of:
(i) The date VA announces a winning entry has been submitted, or
(c) October 18, 2011, unless VA extends the period of this contest
by notice published in the Federal Register on or before October 18,
2011.
(d) If no winning entry is submitted on or before October 18, 2011
or during any extension of the period of this contest, the prize will
not be awarded.
(5) To participate in this competition, contestants must:
(a) Obtain from VA a license to use the Blue Button\SM\ and related
Service Marks (Marks) in connection with this competition and
otherwise. This license must be obtained prior to any use of the Blue
Button\SM\ and related Marks.
(i) VA will issue a non-exclusive royalty-free license to use the
Blue Button\SM\ and related Marks to any participant or end user who
requests a license via www.va.gov/bluebutton/apps/license, provides the
required identifying information and agrees to VA's license terms.
(ii) Important: Participants who use the Blue Button\SM\ and
related Marks, whether in connection with this competition or otherwise
prior to obtaining a license from VA, or who use the Marks other than
as authorized under license terms, are disqualified from this
competition and not eligible to win any prize.
(iii) See ``Intellectual Property,'' below, for additional
information about the Blue Button\SM\ Service Marks.
(b) Submit an entry via http://challenge.gov/VAi2/198-blue-button-for-all-americans which includes each of the following in the
electronic formats specified:
(i) A narrative describing the participant's PHR application, its
functionality and its installation at the required number of LCP- or
LCP organization-sponsored Internet sites. The narrative will state the
date and time when the participant obtained a license to use the Blue
Button\SM\ and related Marks and the serial number of the Blue
Button\SM\ use license issued by VA. The narrative will be in a format
completely compatible with Microsoft Word 2007, not exceeding five 8\1/
2\ x 11'' pages in length using Arial or Calibri 11 point font and one-
inch margins.
(ii) A link to a Web site from which VA can download the
application, in source or object code at the option of the participant.
By submitting an entry in this competition, participant expressly
authorizes VA, its employees and agents to download, install and use
the application for purposes of determining whether the submitted
application meets the requirements of this competition.
(iii) A listing of all LCPs and LCP organizations who or which have
installed the participant's application identified by the Blue
Button\SM\ Marks, and made it freely available for use by the LCP's
patients, including Veterans.
(1) The listing will be in a format completely compatible with
Microsoft Excel 2007 and contain the information set forth in the
template found at http://challenge.gov/VAi2/198-blue-button-for-all-americans. This information will be used to verify that the required
number of LCPs or LCP organizations have installed the participant's
application, and may be used to support licensing of VA's Blue
Button\SM\ Marks to each end user.
(iv) Information necessary to contact the participant in the event
the participant is an apparent winner or there are questions about the
information submitted, including name, street address, e-mail address
and telephone number.
(6) Eligibility to participate in the competition. To be eligible
to win a prize in this competition, an individual or entity:
(a) In the case of an individual, must be a citizen or permanent
resident of the United States; and if an entity, must be incorporated
in and maintain a primary place of business in the United States.
(b) Must have complied with all requirements of this Notice and all
requirements established by Section 105 of the America COMPETES Act of
2011, Public Law 111-358.
(c) May not be a Federal entity or Federal employee acting within
the scope of his or her employment.
(d) Must agree to assume any and all risks and waive any claims
against the Federal government and its related entities, except in case
of willful misconduct, for any injury, death, damage, or loss of
property revenue or profits, whether direct, indirect, or
consequential, arising from their participation in this competition,
whether the injury, death, damage or loss arises through negligence or
otherwise. Provided, however, that participants will not be required to
waive claims against VA arising out of the unauthorized use of or
disclosure by the agency of the intellectual property, trade secrets or
confidential information of the participant.
(i) Participants shall be responsible for obtaining their own
insurance to cover claims by any third party for death, bodily injury,
or property damage, or loss resulting from an activity carried out in
connection with or participation in the competition.
(7) Procedures for obtaining additional information.
(a) During the period of this competition, VA will operate and
maintain a moderated blog at http://challenge.gov/VAi2/198-blue-button-for-all-americans to which participants may submit questions and
receive official guidance from VA.
(b) VA may choose not to respond to any question or comment or to
delete questions or comments which it determines are not relevant to
the competition.
(c) All participants are bound by official guidance on the blog if
posted prior to submission of a participant's entry.
(8) Judge and Judging Procedures.
(a) The judge of this competition will be the Director of the VA
Innovation Initiative, acting in his or her official capacity. If the
judge is disqualified or unable to fulfill his or her duties, VA
reserves the right to substitute another official as judge. Notice of
such substitution will be published in the Federal Register. Specific
tasks related to the judging process may be delegated to other VA
employees.
(b) VA may use any technical means it determines suitable to test
the functionality and usability of the

[[Page 42167]]

entrant's Blue Button^SM PHR application.
(c) VA may use any analytical means it determines suitable to
determine whether the entrant's Blue Button^SM PHR
application has been installed by, and is freely available to patients
of, the required number of LCPs or LCP organizations. The methods VA
may use include but are not limited to assessment of a statistical
sample of internet site addresses submitted by an entrant, the results
of which may be generalized to the entire population. As provided in
Section 3(b)(ii), above, internet sites must be operable at the time of
judging.
(d) Determination of whether a participant is the ``first'' to
document it has met all of the criteria for selection as a winner of
this competition will be based on the date and time of VA's receipt of
the submission of the entries. If two apparently winning entries are
submitted at exactly the same date and time, the entry of the entrant
which first obtained a license to use the Blue Button^SM
Marks will be designated the ``first'' entry.
(e) VA will use the information submitted in the entry to contact
an apparent winner. If VA is unsuccessful in contacting the apparent
winner after a minimum of 10 attempts over the course of a 10-day
period, it may disqualify the participant and either (1) Award the
prize to another participant or (2) terminate this competition without
awarding any prize.
(f) Prior to final designation as the winner of this competition,
the apparent winner will be required to submit documentation:
(i) If an individual, that the person is a citizen or permanent
resident of the United States; and if an entity, that is it
incorporated in and maintains a place of business in the United States;
(ii) Of written approval and confirmation of installation signed by
the chief executive officer or equivalent of any LCP organization
through which 100 or more practitioners are offering the Blue
Button^SM PHR; and
(iii) Of financial account information sufficient to support
electronic transfer of the prize amount consistent with VA fiscal
policy and the issuance of an IRS Form 1099. The information submitted
will be used for these purposes only.
(g) Decisions of the judge are final.
(9) Intellectual property.
(a) The winner of the competition will, in consideration of the
prize to be awarded, grant to VA a perpetual non-exclusive, royalty-
free license to use any and all intellectual property pertaining to the
winning entry (Winning IP) for any governmental purpose, including the
right to permit such use by any other agency or agencies of the Federal
government. All other rights to the Winning IP will be retained by the
winner of the competition.
(b) VA may, in its sole and exclusive discretion, choose to
negotiate with any non-winning entrant for a license to use any
intellectual property developed by a participant for this competition.
(c) ``Blue Button,'' the Blue Button logo and the slogan ``Download
My Data'' are Service Marks (Marks) of the Department of Veterans
Affairs, an agency of the United States Government (reg. app. pending),
which reserves all rights pertaining to its Marks. Any unlicensed use
of the Blue Button^SM Marks or use inconsistent with the
terms of license issued by or on behalf of VA constitutes infringement
of VA's intellectual property and subjects the infringer to all
penalties provided by law.
(i) ``Use,'' as used in Sections 6 and 10(c) above, means use in
commerce of any reproduction, counterfeit, copy, or colorable imitation
of the Blue Button^SM Marks in connection with the sale,
offering for sale, distribution, or advertising of any goods or
services related to the electronic storage or transmittal of health or
health-related data. Use also means application of any reproduction,
counterfeit, copy, or colorable imitation of the Blue
Button^SM Marks to labels, signs, prints, packages, wrappers,
receptacles or advertisements intended to be used in commerce upon or
in connection with the sale, offering for sale, distribution, or
advertising any goods or services related to the electronic storage or
transmittal of health or health-related data.
(d) Additional information about the Blue Button^SM PHR
functionality is available at http://www.va.gov/bluebutton/, http://www.myhealth.va.gov/, and http://www.whitehouse.gov/open/innovations/BlueButton.

Dated: July 13, 2011.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
[FR Doc. 2011-18014 Filed 7-15-11; 8:45 am]
BILLING CODE 8320-01-P