[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)]
[Notices]
[Pages 33742-33745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Requirements and Registration for ``My Air, My 
Health Challenge''

AGENCY: Office of the National Coordinator for Health Information 
Technology, HHS. National Institute of Environmental Health Sciences, 
National Institutes of Health, HHS. Award Approving Official: Farzad 
Mostashari, National Coordinator for Health Information Technology.

ACTION: Notice.

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SUMMARY: Environmental and public health are closely related and 
complementary fields--and their future depends on a closer 
understanding of those connections. New portable sensors have the 
potential to transform the way we measure and interpret the influence 
of pollution on health. These technologies can provide a picture that 
is more detailed and more personal, with dramatic implications for 
health care, air quality oversight, and individuals' control over their 
own environments and health.
    The U.S. Environmental Protection Agency (EPA) and U.S. Department 
of Health and Human Service (HHS) [National Institute of Environmental 
Health Sciences (NIEHS) and Office of the National Coordinator for 
Health Information Technology (ONC)] envision a future in which 
powerful, affordable, and portable sensors provide a rich awareness of 
environmental quality, moment-to-moment physiological changes, and 
long-term health outcomes. Health care will be connected to the whole 
environment, improving diagnosis, treatment, and prevention at all 
levels.
    Many of the first steps toward this future have already been taken. 
Prototype projects have developed portable air quality and physiologic 
sensors, and experimental analysis tools for handling data that is 
higher quantity, but often lower quality, than more traditional 
monitoring techniques. The ``My Air, My Health Challenge'' aims to 
build on this foundation. We are seeking solutions that integrate data 
from portable physiological and air quality monitors, producing a 
combined picture that is meaningful and usable. The statutory authority 
for this challenge competition is Section 105 of the America COMPETES 
Reauthorization Act of 2010 (Pub. L. 111-358) and section 103 of the 
Clean Air Act, 42 U.S.C. 7403. This challenge addresses the mission of 
the NIEHS to conduct and support programs with respect to factors in 
the environment that affect human health, directly or indirectly. 42 
U.S.C. 285.

DATES: Phase 1: Effective on June 6, 2012. Submission period ends 
October 5, 2012, 11:59 p.m. et. Phase 2: Effective on November 19, 
2012. Submission period ends May 19, 2013, 11:59 p.m. et.

FOR FURTHER INFORMATION CONTACT: Denice Shaw, EPA, 202-564-1108; Adam 
Wong, ONC, 202-720-2866.

SUPPLEMENTARY INFORMATION:

Subject of Challenge Competition

    The ``My Air, My Health Challenge'' is a multidisciplinary call to 
innovators and software developers (``Solvers'') to enable near-real-
time, location-specific monitoring and reporting of air pollutants and 
potentially related physiological parameters, using a personal/portable 
integrated system to assess connections between the two (``sensor 
systems''). The system must link air-pollutant concentrations with 
physiological data, provide geocoded and time-stamped files in an easy-
to-use format, and transmit this data via existing networks to a 
central data repository provided by EPA and HHS.
    The challenge is structured in 2 phases:
    Phase 1--Project Plan (no more than 15 pages, not including 
appendices that may consist of diagrams/schematics, bibliography, and 
other supplementary materials).
    1. Propose a plausible link between health outcomes and airborne 
pollutants (chemical species and/or particulates), and provide evidence 
to support a plausible and physiologically meaningful relationship 
between airborne pollutants and physiological metrics in a defined 
population.
    2. Propose a prototype design and development plan for an 
integrated multi-sensor and data management system that may be easily 
worn or carried by individuals within the defined target community/
population.
    3. Conceptualize data generation, management (may include 
processing & on-board storage), and transmission functionality of the 
device.
    4. Propose a small-scale proof-of-concept study to validate the 
proposed prototype.
    5. Study design process must include input from the target 
community/population.
    Phase 2--Proof-of-Concept Pilot Project.
    6. Finalists attend an event for feedback, questions, and business/
entrepreneurial resources prepared by Challenge sponsors (EPA, HHS ONC, 
NIEHS).
    7. Solvers develop the proposed prototype and execute experimental 
validation of the system to bring together data from personal air 
quality and physiological monitors, showing how these types of data and 
sensors can be integrated for practical use by health and environmental 
agencies, and by individual citizens. Proof-of-concept data must 
illustrate the accuracy and precision of the raw data and of any 
processed data produced by the system.
    Level of Focus for Health/Pollution connections: Systems must track 
airborne pollutants and physiological parameters for a known or 
plausible health-pollution link. Solvers must be able to justify their 
chosen combination with research citations and to optimize the air 
sampling parameters (volume, frequency, etc.) and physiological 
measurement parameters to provide resolution appropriate to the 
specific pollutant, or combination of pollutants, and related health 
implications. Challenge Sponsors will provide examples of such links 
for illustrative purposes (appended to the challenge announcement), but 
will not limit Solvers to these particular cases.
    Sensor development: Solvers are not expected to develop novel 
sensors for this challenge, but are not restricted to commercially 
available sensors. They may use sensors that are currently in the 
development or piloting stage, but must show that the sensor will be 
ready to use in functional tests--at least at a small scale--in time 
for the Phase 2 proof-of-concept demonstration. Instruments must be 
well characterized in terms of precision, accuracy and sensitivity. 
Integrated sensor systems must be able to transmit data to the central 
repository (in real time, or store and forward) using existing data 
networks (e.g. 3G, LTE, or WiFi), or able to connect with personal 
devices (e.g., smart phones) that have such capability. Solvers must 
enable appropriate calibration and error checking capabilities, 
although these need not be onboard the portable monitoring components.
    Data Requirements and Constraints: Data transmitted by the 
integrated devices to a centralized data repository must enable the 
following to be understood from transmitted data:
    1. Indicators of device functionality, including any results of 
automated

[[Page 33743]]

system diagnostics, calibrations, or error logs
    2. The device unique identifier, including any paired communication 
device identifier (particularly important if bidirectional 
communication functionality is proposed)
    3. Date and time the data were collected/measurements made (start 
and end timestamp)
    4. The location of the device during data collection (geocode)--if 
sampling occurs over several minutes or longer Solvers should consider 
that users may be using transportation and that analysis should ideally 
show locations between sample start and end
    5. Raw measurement data (quantitative or semi-quantitative) as well 
as any processed data or combined
    6. Quality control metrics indicating, for instance, whether the 
device is being worn/carried or functioning correctly. Error checking 
can occur either prior to or after data transmission, but is an 
essential component.
    The preferred data transmission file format is comma separated 
value (.csv) or variants thereof. Alternatively, encrypted binary files 
are also acceptable. Encryption keys/codes should be provided to the 
Challenge Sponsors so that data can be accessed at the central data 
repository.
    Pollutant Focus: Solvers will be required to include at least one 
air pollution metric--although at their discretion they may include 
multiple air pollution metrics and/or other environmental metrics such 
as noise level and UV exposure. The focus, however, will be on chemical 
and/or particulate air pollutants.
    Physiological Parameter Focus: Solvers will be required to include 
at least one physiological metric--although at their discretion they 
may include multiple physiological metrics and/or other person-oriented 
metrics such as behaviors and social interactions. The focus, however, 
will be on physical parameters (e.g., heart rate, breathing, pulse 
oxygenation), and their connection to pollutants.
    Physical Guidelines for Sensors: At least one component of the 
sensor system must be wearable or carryable, and all components should 
have a minimal burden and be minimally obtrusive. The overall sensor 
system must focus on personal and local metrics (i.e., measuring air 
quality in the immediate vicinity of the wearer). Wearable components 
must be the right size and weight for their target audience (e.g., no 
more than 300 g for a child). Sampling frequency and area must be 
appropriate to the pollutants and physiological metrics of interest, as 
well as to the context of data collection (e.g., by walkers, cyclists 
or passengers on public transportation). The sensor system must include 
an on-board data buffer for when network access is unavailable, and may 
also at the Solver's discretion include personal media to which data 
may be downloaded for permanent or temporary storage. Open source 
hardware and software are desired but not required.
    Measurement Guidelines for Sensors: Accuracy, detection limit, 
measurement range, and sensitivity of all sensors must be at sufficient 
resolution to record health-relevant changes in air pollutant(s) and 
physiological marker(s). If processing of the data is required in order 
to achieve this (e.g., normalization, increasing signal-to-noise 
ratios), the Solver must include the algorithm and its scientific basis 
(i.e., previously collected data and/or appropriate citations) in their 
report. Alternatively, centralized processing that enables parsing of 
local data, in order to increase data robustness and reduce false 
positive signals, may be used. If such an approach is determined to be 
useful, Solvers must outline suitable strategies and/or boundary 
criteria. In either case, solvers must communicate the overall 
uncertainty level of the final system output
    Community Involvement: The sensor system must address a need in a 
specific community or population. In addition to scientific evidence 
supporting that need, Solvers must also seek and document community 
input. Representatives of the affected community should provide 
feedback on the pilot project both during conceptualization (Phase 1), 
and throughout the pilot study (Phase 2). This is not intended to 
override the Solvers' scientific judgment on technical issues, but to 
ensure that the project is respectful of local knowledge, community 
identity, and needs. Projects must include feedback to the community 
regarding both technical success (e.g., whether sensors performed as 
planned) and results (e.g., any correlations found in the data).
    Scaling and Future Plans: While Phase 2 requires only a small-scale 
proof-of-concept project, final submissions for this phase must include 
a description of how the project could or will be extended and 
expanded. In general, Solvers are asked to propose concrete next steps 
that might be carried out with more time or resources available.

Eligibility Rules for Participating in the Competition

    To be eligible to win a prize under this challenge, an individual 
or entity shall have complied with all the requirements under this 
section and Federal Register Notice.
    This challenge is open to any Solver who is (1) an individual or 
team of U.S. citizens or permanent residents of the United States who 
are 18 years of age and over, or (2) an entity incorporated in and 
maintaining a primary place of business in the United States. Foreign 
citizens can participate as employees of an entity that is properly 
incorporated in the U.S. and maintains a primary place of business in 
the U.S. Solvers may submit more than one entry.
    Eligibility for Phase 2 is conditional upon being selected as a 
Phase 1 Finalist. Eligibility for a prize award is contingent upon 
fulfilling all requirements set forth herein. An individual, team, or 
entity that is currently on the Excluded Parties List (https://www.epls.gov/) will not be selected as a Finalist or Winner.
    Employees of EPA, HHS, and the reviewers or any other company or 
individual involved with the design, production, execution, or 
distribution of the challenge and their immediate family (spouse, 
parents and step-parents, siblings and step-siblings, and children and 
step-children) and household members (people who share the same 
residence at least three (3) months out of the year) are not eligible 
to participate.
    An individual or entity may not be a Federal entity or Federal 
employee acting within the scope of their employment. Federal employees 
seeking to participate in this challenge outside the scope of their 
employment should consult their ethics official prior to developing a 
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.
    Federal grantees may not use Federal funds to develop COMPETES Act 
challenge applications unless consistent with the purpose of their 
grant award. (Grantees should consult with their cognizant Grants 
Management Official to make this determination.) 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.

[[Page 33744]]

    Liability and Indemnification: By participating in this 
competition, Solvers 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 participation in this competition, whether 
the injury, death, damage, or loss arises through negligence or 
otherwise. By participating in this competition, Solvers agree to 
indemnify the Federal Government against third party claims for damages 
arising from or related to competition activities.
    Insurance: Based on the subject matter of the competition, the type 
of work that it will possibly require, as well as an analysis of the 
likelihood of any claims for death, bodily injury, or property damage, 
or loss potentially resulting from competition participation, Solvers 
are not required to obtain liability insurance or demonstrate financial 
responsibility in order to participate in this competition.

Registration Process for Participants

    To register for this challenge participants may do any of the 
following:
    [ssquf] Access the www.challenge.gov Web site and search for the 
``My Air, My Health 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.
    [ssquf] Access the Innocentive challenge Web site at 
www.innocentive.com/myairmyhealth.

Amount of the Prize

    [ssquf] Phase 1: $15,000 each for up to four Finalists who are 
selected to move on to Phase 2.
    [ssquf] Phase 2: $100,000 to the Winner.
    Awards may be subject to Federal income taxes.

Payment of the Prize

    HHS and EPA prizes awarded under this competition will be paid by 
electronic funds transfer and may be subject to Federal income taxes. 
HHS and EPA will comply with the Internal Revenue Service withholding 
and reporting requirements, where applicable.

Basis Upon Which Winner Will Be Selected

    The review panel will make selections based upon the following 
criteria in Phase 1:
    [ssquf] Strength of evidence and/or argumentation regarding the 
linkage between air pollutant and physiological effect.
    [ssquf] Potential significance of technology and eventual benefit 
to target population(s).
    [ssquf] Viability of proposed sensor technologies to detect and 
quantify pollutants and their effects, and provide physiologically 
relevant health and air quality data.
    [ssquf] Viability of the proposed data reporting technology 
(communication to a centralized data repository provided by EPA and 
HHS)
    [ssquf] Viability of the proposed project plan.
    [ssquf] Viability of the proposed instrument design as a wearable/
portable device.
    [ssquf] Viability of the proposed proof-of-concept study (low 
complexity is preferred).
    [ssquf] Appropriate use of community input in designing proof-of-
concept study.
    The review panel will make selections based upon the following 
criteria in Phase 2:
    [ssquf] Sensors: Successful technical collection of both health and 
environmental data
    [ssquf] Data Reporting: Successful formatting and transmission of 
data
    [ssquf] Data processing and evaluation
    [ssquf] Community Involvement and Interaction

Additional Information

    Intellectual Property Rights: Upon submission, each Solver warrants 
that he or she is the sole author and owner of the work, that the work 
is wholly original with the Solver (or is an improved version of an 
existing work that the Solver has sufficient rights to use--including 
the substantial improvement of existing open-source work) and that it 
does not infringe any copyright or any other rights of any third party 
of which Solver is aware. Each Solver also warrants that the work is 
free of malware.
    (a) Copyright. By participating in this competition, each Solver 
hereby grants to the Federal government an irrevocable, paid-up, 
royalty-free, nonexclusive worldwide license to reproduce, distribute 
copies, display, create derivative works, and publicly post, link to, 
and share, the work or parts thereof, including any parts for which it 
has obtained rights from a third party, in any medium, for Federal 
purposes. User warrants that it has obtained rights to any parts of the 
work not authored by Solver adequate to convey the aforementioned 
license. (b) Inventions. Finalists hereby grant to the Federal 
government a nonexclusive, nontransferable, irrevocable, paid-up 
license to practice or have practiced for or on behalf of the United 
States any invention throughout the world made by Finalists that, if 
patented, would cover the submission or its use.

Privacy, Data Security, Ethics, and Compliance

    Solvers are required to identify and address privacy and security 
issues in their proposed projects, and describe specific solutions for 
meeting them.
    In addition to complying with appropriate policies, procedures, and 
protections for data that ensures all privacy requirements and 
institutional policies are met, use of data should not allow the 
identification of the individual from whom the data was collected. 
Solvers are responsible for compliance with all applicable federal, 
state, local, and institutional laws, regulations, and policy. These 
may include, but are not limited to, HIPAA, HHS Protection of Human 
Subjects regulations, and FDA regulations. If approvals (e.g., from 
Institutional Review Boards) will be required to initiate project 
activities in Phase 2, it is recommended that solvers apply for 
approval at or before the Phase 1 submission deadline.
    The following links are intended as a starting point for addressing 
regulatory requirements, but should not be interpreted as a complete 
list of resources on these issues:

HIPAA

    Main link: http://www.hhs.gov/ocr/privacy/index.html.
    Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.
    Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.
    Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.

Human Subjects--HHS

    Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html.
    Protection of Human Subjects Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
    Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html.
    Institutional Review Boards & Assurances: http://www.hhs.gov/ohrp/assurances/index.html.

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Human Subjects--FDA

    Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
    Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.

Consumer Protection--FTC

    Bureau of Consumer Protection: http://business.ftc.gov/privacy-and-security.


    Authority: 15 U.S.C. 3719.

    Dated: May 31, 2012.
Farzad Mostashari,
National Coordinator for Health Information Technology.
[FR Doc. 2012-13834 Filed 6-6-12; 8:45 am]
BILLING CODE 4150-45-P