[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)] [Notices] [Pages 33737-33739] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2012-13819] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Requirements and Registration for ``Blue Button Mash Up 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. ----------------------------------------------------------------------- SUMMARY: The Office of the National Coordinator for Health Information Technology (ONC) and the Department of Veterans Affairs are working to empower individuals to be partners in their health through health information technology (health IT). Giving patients access to information about them related to the care they receive from doctors and other healthcare providers is in itself valuable, but it is also important to enable patients to use that information to make informed decisions. Individuals should be able to access and use their basic health information together with other information to take action: To better understand their current health status, use decision support software to choose treatments, anticipate and consider the costs of different options, and target and modify the everyday behaviors that have the greatest impact on their health. Inspired by the well-known ``three- part aim'' for improvement of the health care system, this challenge requires participants to help individuals to take action based on combining their health information with additional information that puts it into a more meaningful context. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358). DATES: Effective on June 5, 2012. Challenge submission period ends September 5, 2012, 11:59 p.m. et. FOR FURTHER INFORMATION CONTACT: Adam Wong, 202-720-2866; Wil Yu, 202- 690-5920. SUPPLEMENTARY INFORMATION: [[Page 33738]] Subject of Challenge Competition This challenge builds on a prior Blue Button challenge to make personal health information more usable and meaningful for the individual consumer or patient. Apps must be platform neutral. The challenge is broken into two parts: 1. App Development: Entrants must submit an app that makes the best use of Blue Button downloaded personal health data and combines it with other types of data. Apps must include data from at least two of the three part aim categories below. 2. Reach: The app must be able to garner high patient engagement rates. Entrants will therefore have to demonstrate a partnership with a personal health information data holding organization (such as a provider, payor, or Personal Health Record vendor--see healthit.gov/pledge for a definition of a data holding organization) to achieve wide distribution among patients. Applying the Three Part Aim: To participate in the challenge, entrants must mash up Blue Button data--data about a patient which the patient can download directly using a health plan's, doctor's or hospital's Blue Button function--with information from two or more of the three part aim categories. Below are examples of types of contextual data that would qualify for purposes of this contest. Entrants can use data sets from the categories below or similar data sets. Components of the Three Part Aim Part 1: Better Care Interactions With the Healthcare System Assist individuals in choosing high quality care that is relevant to their individual needs by including ratings for physician comparisons, hospital comparisons, or other care quality data. Assist individuals in identifying providers, practices, and hospitals that are health information technology enabled by using information from CMS related to Meaningful Use or other sources. Support individuals in understanding their current state of health by combining clinical data and medical claims data to create a comprehensive list of the individual's medical conditions. Support individuals in understanding their current medication regimen by aggregating clinical data from doctors/hospitals, prescription claims data, and downloaded clinical data to create a single comprehensive list of medications. Part 2: Better Care for Oneself Outside of the Healthcare System Provide support to help an individual meet some of their personally stated health goals, (for example related to healthy eating, exercise, social support, or other virtual or geographically based resources). Provide an easily understood representation of an individual's health status in comparisons to others of a similar demographic (age, gender, ethnicity, or otherwise), and make recommendations for actionable things an individual could do toward better health outcomes based on their comparative health data. Extrapolate how healthy behavior change can lead to positive health outcomes over time (for example show potential weight loss and reduced risk of cardiac illness from adding two 30 minute walks per week) Part 3: Reduced Costs Provide information related to costs of relevant health care services (treatments, procedures, medication formularies, etc.) and/or financial savings likely to accrue from behavior changes. Create algorithms that exhibit cost savings to the individual and/or the health care system if the individual makes healthy living interventions, or different cost related choices in their health care. 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. Registration Process for Participants To register for this challenge participants should either: Access the www.challenge.gov Web site and search for the ``Blue Button Mash Up Challenge''. 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 First Prize: $45,000. Second Prize: $20,000. Third Prize: $10,000. 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: Effectively integrate Blue Button data that incorporates elements from two or more of the sections described [[Page 33739]] above (special consideration will be given to apps and tools that incorporate data from all three components of the three-part aim). Integrate patient-centered design and usability concepts to drive high patient adoption and engagement rates. Innovation--how is the data mashed up in innovative ways to contextualize the individual's Blue Button downloaded data. Provide a one page implementation plan for how this app solution will be implemented for scalability, including details for marketing and promotion. Existing or modified apps should show an uptake in their initial user base demonstrating the potential for market penetration based on Blue Button data contextualization capabilities. Additional Information Ownership of intellectual property is determined by the following: Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. 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. Authority: 15 U.S.C. 3719. Dated: May 31, 2012. Farzad Mostashari, National Coordinator for Health Information Technology. [FR Doc. 2012-13819 Filed 6-6-12; 8:45 am] BILLING CODE 4150-45-P
[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)] [Notices] [Pages 33739-33740] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2012-13826] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Requirements and Registration for ``Health Data Platform Metadata Challenge'' AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice. ----------------------------------------------------------------------- Award Approving Official: Farzad Mostashari, National Coordinator for Health Information Technology. SUMMARY: As part of the HHS Open Government Plan, the HealthData.gov Platform (HDP) is a flagship initiative and focal point helping to establish learning communities that collaboratively evolve and mature the utility and usability of a broad range of health and human service data. HDP will deliver greater potential for new data driven insights into complex interactions of health and health care services. To augment the HDP effort, seven complementary challenges will encourage innovation around initial platform- and domain-specific priority areas, fostering opportunities to tap the creativity of entrepreneurs and productivity of developers. The ``Health Data Platform Metadata Challenge'' requests the application of existing voluntary consensus standards for metadata common to all open government data, and invites new designs for health domain specific metadata to classify datasets in our growing catalog, creating entities, attributes and relations that form the foundations for better discovery, integration and liquidity. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358). DATES: Effective on June 5, 2012. Challenge submission period ends October 2, 2012, 11:59 p.m. et. FOR FURTHER INFORMATION CONTACT: Adam Wong, 202-720-2866; Wil Yu, 202- 690-5920. SUPPLEMENTARY INFORMATION: Subject of Challenge Competition The W3C has a number of standard vocabulary recommendations for Linked Data publishers, defining cross domain semantic metadata of open government data, including concept schemes, provenance, statistics, organizations, people, data catalogs and their holdings, linked data assets, and geospatial data, in addition to the foundational standards of the Web of Data (such as HTTP, XML, RDF and various serializations, SPARQL, OWL, etc). Other voluntary consensus standards development organizations are also making valuable contributions to open standards for Linked Data publishers, such as the emerging GeoSPARQL standard from the Open Geospatial Consortium. In some cases, the entities and relations in these vocabulary standards are expressed using UML class diagrams as an abstract syntax, then automatically translated into various concrete syntaxes like XML Schemas and RDF Schemas, which also makes many of the standards from the Object Management Group easy to express as RDF Schemas, such as those that describe business motivation (including but not limited to vision, mission, strategies, tactics, goals, objectives), service orientation, process automation, systems integration, and other government specific standards. Oftentimes there exist domain specific standards organizations, with standards products that express domain specific entities and relations, such as those for the health or environmental sectors. The Data.gov PMO has recently stood up a site to collect these standards when expressed as RDF Schemas for use by the growing community of Government Linked Data publishers, which includes HHS/CMS, EPA, DOE/NREL, USDA, and the Library of Congress. The challenge winner will demonstrate the application of voluntary consensus and de facto cross domain and domain specific standards, using as many of the HHS datasets available on healthdata.gov as possible. There are two objectives: 1. Apply existing standards as RDF Schemas from voluntary consensus standards organizations (W3C, OMG, OGC, etc.) for expressing cross domain metadata that is common to all open government data. 2. Design new HHS domain specific metadata based on the data made available on healthdata.gov where no RDF Schema is otherwise given or available. When designing new metadata expressed as RDF Schemas, designers should: Leverage existing data dictionaries expressed as natural language in the creation of new conceptual schemas, as provided by domain authorities; Observe best practices for URI's schemes that is consistent with existing healthdata.gov work (such as the Clinical Quality Linked Data release from HDI 2011); and Organize related concepts into small, compose-able component vocabularies. Turtle syntax for RDFS and RDF is preferred. The contributed code will be given an open source license and managed by HHS on github.com, with copyright and attribution to the developer(s) as appropriate, and will ideally be used to populate vocab.data.gov. 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 [[Page 33740]] 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. Registration Process for Participants To register for this challenge participants should either: Access the www.challenge.gov Web site and search for the ``Health Data Platform Metadata Challenge''. 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] First Prize: $20,000. [ssquf] Second Prize: $10,000. [ssquf] Third Prize: $5,000. 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: Metadata: The number of cross domain and domain specific voluntary consensus and defacto standard schemas, vocabularies or ontologies that are (re)used or designed and applied to HHS data on healthdata.gov. Data: The number of datasets that the standards based cross domain metadata and schema designed domain specific data is applied to. Linked Data: The solution should use best practices for the expression of metadata definitions and instance data identification, leveraging the relevant open standards, including but not limited to foundational standards (RDF, RDFS, SPARQL, OWL), and other defacto vocabularies and ontologies such as those listed here as required, with the expectation that existing standards will be reused to the fullest extent possible. Components: Leveraging software components that are already a part of the HDP is preferable, but other open source solutions may be used. Tools: Use of automation and round trip engineering that enable multiple concrete syntax realization from abstract syntax of cross domain and/or domain specific metadata is desirable, with no expectation that the tools must be open source or otherwise contributed to HDP as part of this challenge submission. Only newly designed domain specific RDF Schemas, their composition cross domain standards based RDF Schemas, and their application to various datasets are expected to be submitted for this challenge. Tool functionality may be highlighted to explain implementations as desired. Best practices: Where any new schemas and software code is created, they should exemplify design best practices and known software patterns, or otherwise establish them. Documentation: Articulation of design using well known architecture artifacts. Engagement: Willingness to participate in the community as a maintainer/committer after award. Additional Information The virtual machines and codebase outputs from innovations demonstrated by challenge participants will be made publically available through HHS Github repositories (see https://github.com/hhs/) as release candidates for further community refinement as necessary, including open source licensing and contributor attribution as appropriate. Authority: 15 U.S.C. 3719. Dated: May 31, 2012. Farzad Mostashari, National Coordinator for Health Information Technology. [FR Doc. 2012-13826 Filed 6-6-12; 8:45 am] BILLING CODE 4150-45-P
[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)] [Notices] [Pages 33740-33742] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2012-13830] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Requirements and Registration for ``Health Data Platform Simple Sign-On Challenge'' AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice. ----------------------------------------------------------------------- Award Approving Official: Farzad Mostashari, National Coordinator for Health Information Technology. SUMMARY: As part of the HHS Open Government Plan, the HealthData.gov Platform (HDP) is a flagship initiative and focal point helping to establish learning communities that collaboratively evolve and mature the utility and usability of a broad range of health and human service data. HDP will deliver greater potential for new data driven insights into complex interactions of health and health care services. To augment the HDP effort, seven complementary challenges will encourage innovation around initial platform- and domain-specific priority areas, fostering opportunities to tap the creativity of entrepreneurs and productivity of developers. The ``Health Data Platform Simple Sign-On Challenge'' will improve community engagement by providing simplified sign on (SSO) for external users interacting across multiple HDP technology components, making it easier for community collaborators to contribute, leveraging new approaches to decentralized authentication. [[Page 33741]] The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358). DATES: Effective on June 5, 2012. Challenge submission period ends October 2, 2012, 11:59 p.m. et. FOR FURTHER INFORMATION CONTACT: Adam Wong, 202-720-2866; Wil Yu, 202- 690-5920. SUPPLEMENTARY INFORMATION: Subject of Challenge Competition Healthdata.gov is leveraging a variety of open source infrastructure components including the Drupal 7 content management system, the CKAN data portal, the Solr search engine, and the community edition of the Virtuoso (as a RDF database and SPARQL endpoint query service). Going forward, the HDP team intends to realize an architecture similar to the Linked Data Integration Framework (LDIF) and leverage tools in the LOD2 stack where possible, beginning with Ontowiki to be used as Virtuoso editor, most likely followed by SILK for cross domain correlation. HDP would like to enable service requestors to be authenticated using WebID from the W3C. Some of the current and upcoming HDP infrastructure components support aspects of WebID functionality already while others do not. A number of WebID libraries are available, written in various languages. This challenge winner will present a replicable open source virtual machine environment demonstrating how HDP components (with an initial emphasis on Virtuoso,\1\ Drupal 7,\2\ CKAN,\3\ OntoWiki,\4\ and Solr,\5\) can provide and/or consume WebID's, contributing to simplified sign-on for humans and machines. The developer designs how their code might utilize each component as a WebID identity provider or relying party, presumably leveraging existing capabilities to the fullest extent possible. The end result will demonstrate seamless integration across a number of HDP components, without introducing any external service dependencies that couldn't be operated by HHS. The contributed code will be given an open source license and managed by HHS on github.com, with copyright and attribution to the developer(s) as appropriate. --------------------------------------------------------------------------- \1\ http://virtuoso.openlinksw.com/dataspace/dav/wiki/Main/. \2\ http://www.acquia.com/Drupal-7. \3\ http://ckan.org/. \4\ http://lod2.eu/Project/OntoWiki.html. \5\ http://lucene.apache.org/solr/. --------------------------------------------------------------------------- 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. Registration Process for Participants To register for this challenge participants should either: Access the www.challenge.gov Web site and search for the ``Health Data Platform Simple Sign-On Challenge''. 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 First Prize: $20,000. Second Prize: $10,000. Third Prize: $5,000. 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: Coverage: The more integrated components the better, with an emphasis on leverage existing work and capabilities of each component. Coupling: The level with which any integrated components can be removed without affecting the remaining component functionality. Performance: The lowest latency and best responsiveness of the component interactions as demonstrated by test cases. Elegance: How the design deals with both human and application agents that interact with different interfaces, and how each is managed across infrastructure components. Documentation: Articulation of design using well known architecture artifacts and executable test cases. Engagement: Willingness to participate in the community as a maintainer/committer after award. Additional Information The virtual machines and codebase outputs from innovations demonstrated by challenge participants will be made publically available through HHS Github repositories (see https://github.com/hhs/) as release candidates for further community refinement as necessary, including open source licensing and contributor attribution as appropriate. Authority: 15 U.S.C. 3719. [[Page 33742]] Dated: May 31, 2012. Farzad Mostashari, National Coordinator for Health Information Technology. [FR Doc. 2012-13830 Filed 6-6-12; 8:45 am] BILLING CODE 4150-45-P
[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)] [Notices] [Pages 33742-33745] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2012-13834] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. [[Page 33745]] 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/OfficeofMedicalProductsand Tobacco/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
Bernd Pulch 