[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45355-45357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Requirements and Registration for ``The Million 
Hearts Risk Check Challenge''

AGENCY: Office of the National Coordinator for Health Information 
Technology, HHS.

AWARD APPROVING OFFICIAL: Farzad Mostashari, National Coordinator for 
Health Information Technology.

ACTION: Notice.

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SUMMARY: In communities across America, there are thousands of 
convenient and inexpensive ways to know your risk for heart-related 
conditions--often, all it takes is making an appointment for a 
screening with your doctor or pharmacies. But, according to recent 
studies, up to 1 in 3 people at risk for cardiovascular disease (CVD) 
have not been screened and are therefore less likely to take 
preventative action. Through an initiative sponsored by Million Hearts 
and the Office of the National Coordinator for Health IT, we are 
reaching out to the millions of Americans who have significant risks 
for CVD and do not know it, and those that suspect it but have not yet 
overcome the inertia to act on their concern. By connecting these 
individuals to pharmacies for lipid and blood pressure screenings, we 
are intending to make it easy for them to turn their back-of-mind 
worries into personal knowledge and then help them hook into the 
delivery system if necessary.
    This new campaign and technology product will follow three steps:
    1. Reach out to individuals across the country, taking special aim 
at those who may be at risk for CVD and don't know it.
    2. Conduct a ``light'' health risk assessment that roughly 
estimates risk in an engaging interface and then ``hooks'' the user by 
showing that with the addition of LDL and BP readings, the accuracy of 
the risk assessment could be much more robust. This is done to drive 
folks to scale the next hurdle: The BP and blood test.
    3. Direct individuals to nearby, convenient options for biometric 
screenings. National pharmacies and others will offer locations and 
special offers for this step.
    The statutory authority for this challenge competition is Section 
105 of the America COMPETES Reauthorization Act of 2010 (Public L. 111-
358).

DATES: Effective on July 27, 2012. Challenge submission period ends 
October 31, 2012, 11:59 p.m. et.

FOR FURTHER INFORMATION CONTACT: Adam Wong, 202-720-2866.

SUPPLEMENTARY INFORMATION:

Subject of Challenge Competition

    The purpose of the challenge is threefold:
    1. Encourage further testing (specifically lipids and BP), 
especially for those with some risk,
    2. Encourage lifestyle changes for those at some risk, and
    3. Encourage seeing a health professional if they are at high risk.
    In order to engage individuals about their heart risk, and then 
connect them with nearby options for a biometric screening, we require 
a new consumer app. Developers will have access to, and will need to 
hew closely to, two sources of content when responding to the challenge 
and designing the app:
    1. A new Application Programming Interface (API) for conducting the 
``light'' health risk assessment over a consumer-facing interface, 
hosted by Archimedes and built using their Indigo product.
    2. Locations (and specific descriptors) of places where individuals 
can go for a lipid and blood pressure screening, made available through 
flat files from Million Hearts and a new API hosted by Surescripts.
    Each of these source APIs are described in more detail at the 
challenge registration sites. Unlike some other challenges, HHS would 
like to formally ``sponsor'' the winning app. For this reason, it will 
be important (and it is part of the reviewing criteria) for applicants 
to follow the inputs and outputs of the two APIs specifically.
    The app should begin with a ``light'' health risk assessment, 
designed to engage individuals by asking them personal questions about 
their health. To conduct the ``light'' health risk assessment, the app 
should ask questions to follow the required inputs of the Archimedes 
API (see registration sites and https://demo-indigo4health.archimedesmodel.com and https://demo-indigo4health.archimedesmodel.com/IndiGO4Health/IndiGO4Health). The app 
should also ask whether the individual has recent data on their blood 
pressure and cholesterol measurements (biomarker data). Once an 
individual has entered complete data including blood pressure and 
cholesterol measurements, the app should generate and communicate the 
individual's risk.
    In the case that the user does not enter blood pressure and 
cholesterol values, after prompting individuals about the importance of 
a blood pressure and lipid screening, the app should then prompt them 
to enter their address (or use a device-enabled technology for getting 
their latitude and longitude such as the iPhone's ``current location'' 
feature). The app should send individuals the closest locations where 
they can go for a risk screening in a map-like output. Screening 
locations will be provided from two sources.
    1. Through an API from the Surescripts Corporation. This API will 
be located on the Surescripts network, where it can be accessed by 
developers working on responding to this challenge, and available for 
free to the winning app throughout the campaign period. See 
registration sites for specific detail on the API. This information 
will also be available via the Million Hearts Challenge Web site.
    2. Flat file, which the developers will receive from participating 
cities and/or HHS, and will be expected to make available to users via 
the app.

[[Page 45356]]

    Developers should create an app that uses locations from both 
sources, and which feeds the closest locations back to the individual.
    After connecting individuals with the screening locations, the app 
should do everything it can to get them to complete the screening. 
Periodically after connecting individuals to the screening locations, 
the app should follow-up on whether they have completed their lipid and 
blood pressure screening. Once the individuals indicate that they have 
completed their screening, the app should prompt them to enter the 
values from the blood pressure and lipid screening. Based on these 
values, and based on the Archimedes API, the app should then update the 
risk score and the communication of this risk to the individual.
    After communicating the risk, the app should provide information 
about possible approaches to reducing that risk relevant to that 
individual. The Archimedes API will provide a series of possible 
interventions associated and associated risk reduction values.
    Along with their app submission, entrants must submit a plan for 
how they will operationalize and sustain their product, and how many 
users they are capable of supporting, throughout the length of a 12-
month promotional campaign associated with this product. The winning 
app may have the opportunity to be heavily promoted in a campaign 
supported by the Department of Health and Human Services, the Million 
Hearts Initiative, and their partners. As a focal point of this 
campaign, Million Hearts will maintain a Web site that will route 
consumers to apps that it sponsors. The Web site will be promoted 
prominently throughout the campaign. The winning app may have the 
opportunity to receive routings from this Web site.
    Although apps are not likely to collect personally identifiable 
health information, submissions should consider relevant privacy and 
security issues, laws, and policies, and ensure apps include 
appropriate privacy and security protections where necessary.

Eligibility Rules for Participating in the Competition

    To be eligible to win a prize under this challenge, an individual 
or entity--
    (1) Shall have registered to participate in the competition under 
the rules promulgated by the Office of the National Coordinator for 
Health Information Technology.
    (2) Shall have complied with all the requirements under this 
section.
    (3) In the case of a private entity, shall be incorporated in and 
maintain a primary place of business in the United States, and in the 
case of an individual, whether participating singly or in a group, 
shall be a citizen or permanent resident of the United States.
    (4) May not be a Federal entity or Federal employee acting within 
the scope of their employment.
    (5) Shall not be an HHS employee working on their applications or 
submissions during assigned duty hours.
    (6) Shall not be an employee of Office of the National Coordinator 
for Health IT.
    (7) Federal grantees may not use Federal funds to develop COMPETES 
Act challenge applications unless consistent with the purpose of their 
grant award.
    (8) Federal contractors may not use Federal funds from a contract 
to develop COMPETES Act challenge applications or to fund efforts in 
support of a COMPETES Act challenge submission.
    An individual or entity shall not be deemed ineligible because the 
individual or entity used Federal facilities or consulted with Federal 
employees during a competition if the facilities and employees are made 
available to all individuals and entities participating in the 
competition on an equitable basis.
    Entrants must agree to assume any and all risks and waive claims 
against the Federal Government and its related entities, except in the 
case of willful misconduct, for any injury, death, damage, or loss of 
property, revenue, or profits, whether direct, indirect, or 
consequential, arising from my participation in this prize contest, 
whether the injury, death, damage, or loss arises through negligence or 
otherwise.
    Entrants must also agree to indemnify the Federal Government 
against third party claims for damages arising from or related to 
competition activities.
    A contingency for entering the contest and submitting an app is 
that the winning app must be available for free, to all users, until 
December 31, 2013. This includes hosting and maintaining the Web 
service in a scalable format, providing technical support with bug 
fixes, and so on.

Registration Process for Participants

    To register for this challenge participants should either:
    [ssquf] Access the www.challenge.gov Web site and search for ``The 
Million Hearts Risk Check Challenge''.
    [ssquf] Access the ONC Investing in Innovation (i2) Challenge Web 
site at:
    [cir] http://www.health2con.com/devchallenge/challenges/onc-i2-challenges/.
    [cir] A registration link for the challenge can be found on the 
landing page under the challenge description.

Amount of the Prize

    [ssquf] $5,000 each for up to five finalists
    [ssquf] $100,000 to the winner
    Awards may be subject to Federal income taxes and HHS will comply 
with IRS withholding and reporting requirements, where applicable.

Payment of the Prize

    Prize will be paid by contractor.

Basis Upon Which Winner Will Be Selected

    The ONC review panel will make selections based upon the following 
criteria:
    1. How well the apps follow the specific input and output 
requirements of the two APIs
    2. Effectiveness in getting individuals to answer all the questions 
for the initial risk assessment
    3. Effectiveness in communicating initial risk to individuals, 
based on guidelines provided by Archimedes API
    4. Effectiveness in encouraging further testing (specifically 
lipids and BP), especially for those with some risk
    5. Effectiveness in communicating final risk to individuals, based 
on guidelines provided by Archimedes API
    6. Effectiveness in encouraging lifestyle changes for those at some 
risk
    7. Effectiveness in encouraging seeing a health professional if 
they are at high risk
    8. How user-friendly, engaging, and accessible the app is, for the 
largest and most demographically-diverse group of people possible. 
Which app is the most likely to get the largest number of people to 
know their full cardiovascular risk?
    9. Submissions will be judged for their operating plans for the 
year, and their likelihood of the submitter in successfully maintaining 
the app to support the campaign. Has the entrant provided a viable plan 
for initial and ongoing technical capacity to meet projected usage as 
well as for support, maintenance and enhancement of the application?
    10. Demonstration of submitter's current or prior ability to engage 
consumers.

Additional Information

    Ownership of intellectual property is determined by the following:
    [ssquf] Each entrant retains title and full ownership in and to 
their submission.

[[Page 45357]]

Entrants expressly reserve all intellectual property rights not 
expressly granted under the challenge agreement.
    [ssquf] By participating in the challenge, each entrant hereby 
irrevocably grants to Sponsor and Administrator a limited, non-
exclusive, royalty free, worldwide, license and right to reproduce, 
publically perform, publically display, and use the Submission to the 
extent necessary to administer the challenge, and to publically perform 
and publically display the Submission, including, without limitation, 
for advertising and promotional purposes relating to the challenge.
    [ssquf] The winning app must be available for free, to all users, 
until December 31, 2013. This includes hosting and maintaining the Web 
service in a scalable format, providing technical support with bug 
fixes, and so on.

    Authority:  15 U.S.C. 3719.

    Dated: July 17, 2012.
Farzad Mostashari,
National Coordinator for Health Information Technology.
[FR Doc. 2012-18593 Filed 7-30-12; 8:45 am]
BILLING CODE 4150-45-P