Posted By: Food and Drug Administration
Category: Software/Apps Skill: Software/Apps Interest: Public Safety Partnership With: Substance Abuse and Mental Health Services Administration
National Institute on Drug Abuse
Submission Dates: 9 a.m. ET, Sep 23, 2016 - 11:59 p.m. ET, Nov 07, 2016
In 2014, nearly two million Americans aged 12 or older either abused or were dependent on opioid painkillers, and 61% of drug overdose deaths involved either an opioid painkiller or heroin. Naloxone is an antidote for an opioid overdose, whether from prescription opioids or heroin. It is a prescription drug with few side effects that rapidly reverses the effects of opioid overdoses. Although most frequently used in emergency rooms and on ambulances, many states have recently taken steps to make it easier for people in the general public, including family and friends of drug users, to carry and administer naloxone.
Despite the increasing availability of naloxone, people carrying naloxone are often unaware when an overdose occurs nearby. Currently, there are no mechanisms to alert carriers of naloxone to a person in need of the medication. This is where you come in!
FDA is hosting the 2016 FDA Naloxone App Competition to encourage computer scientists, public health advocates, clinical researchers and entrepreneurs to develop creative solutions to this problem. Specifically, we are looking for innovative ideas for a smartphone app that connects people experiencing an opioid overdose to nearby carriers of naloxone. We are most interested in concepts that are readily scalable, free or low-cost to the end-user, and take advantage of existing systems for naloxone distribution and use.
How does the Competition work?
- You register. See more information about registration below.
- You decide whether and how you want to participate in one of our first-ever FDA code-a-thons on Oct. 19-20, 2016! There are options for in-person and virtual participation – learn more in the Rules section.
- You refine your concept after the code-a-thon, and then send in your submission – more details about that below.
- The submissions are judged, and the entrant with the highest score wins $40,000!
Want to learn more about the Competition? Click on the Rules tab for all the terms and conditions of the Competition. You can also learn more in the official Federal Register Notice that announced the Competition – Click Here!
Want to learn more about the code-a-thon?
Recording of Day 1 Presentations: https://collaboration.fda.gov/p66yrjt2b1e/
Recording of Day 2 Presentations: https://collaboration.fda.gov/p316i6sm4c4/
Recording of Team Presentations: https://collaboration.fda.gov/p7wn61s5yjc/
Still have questions? Email us! The Frequently Asked Questions document has also recently been updated: click here!
Send us any additional questions at NaloxoneApp@fda.hhs.gov. You can also feel free to open up a discussion thread in the Discussions tab.
Note: Effective November 18, 2016, FDA Chief of Staff Tom Kraus is the award approving official for the 2016 FDA Naloxone App Competition, replacing FDA Associate Commissioner for Medical Products and Tobacco Rachel Sherman in this role.
Associate Commissioner/ FDA Public Health Strategy and Analysis, Food and Drug Administration
Associate Director for Digital Health/ Center for Devices and Radiological Health, Food and Drug Administration
Deputy Director/ National Institute on Drug Abuse
Medical Officer/Food and Drug Administration
Information Technology Supervisor/Food and Drug Administration
Chief Information Officer Technical Advisor/Food and Drug Administration
Innovation - 25%
Uniqueness and innovation in use of software and data analytics to fulfill the mandatory requirements; variety and value of additional features.
Usability - 25%
Use of design elements to increase utilization among both people at risk of opioid overdose and naloxone carriers; ease of navigation; appropriate use of an interface to support the app in achieving desired outcome.
Functionality - 25%
Potential to enhance the frequency and speed of naloxone administration by the carriers to the overdose victims.
Adaptability - 25%
Potential for app to be tailored to the practical environment (e.g., urban, rural) of an individual community.
Thanks for all your enthusiasm and your submissions! The submission window is now closed. All eligible submissions will be judged, and a winner will be announced by the end of the calendar year. Stay tuned!
Solution: OD Help
Description: OD Help’s concept is a simple, easy-to-use mobile app designed to connect potential opioid overdose victims with a crowd-sourced network of naloxone carriers. OD Help can easily be tailored for use in rural or urban areas by expanding or contracting the radius within which naloxone carriers are sought. An additional innovative feature of OD Help is the optional interface with a breathing monitor to detect when a victim’s breathing rate is dangerously low, a sign of an opioid overdose. Hence, if the victim is alone and unable to call for help, OD Help will detect the diminished breathing and alert a naloxone carrier of the potential overdose. Other features of OD Help include: only alerting people in one’s support network and allowing naloxone carriers to disable alerts when they are unable to respond. The app also provides instructions on how to correctly diagnose an overdose and administer naloxone and helps contact emergency medical services when help is required.
Add to the Discussion
Opioid Panic Button
Naloxone Solution – System Green
Butterfly by Charm City Coders
NalNow: a crowdsourced mobile app that engages and empowers local communities to quickly bring naloxone to those who need it
OhioHealth and Pillar Technology Present: OpiAlert
POPPI – Public Overdose Protection and Pharmaceutical Intervention
UNDOPE by Patrick Barrett
Edward Ingraham’s Save A Life mobile application
Kids Help Too!
Official Rules, Terms and Conditions
The 2016 FDA Naloxone App Competition (the competition), announced on Sept. 20, 2016 in the Federal Register, encourages computer programmers, public health advocates, clinical researchers, entrepreneurs, and innovators from all disciplines to create teams focused on the development of innovative strategies to combat the rising epidemic of opioid overdose. Specifically, the competition invites submissions for an app that increases the likelihood of timely naloxone administration by connecting opioid users experiencing an overdose with nearby naloxone carriers. FDA is most interested in concepts that are readily scalable, free or low-cost to the end-user, and take advantage of existing systems for naloxone distribution and use. FDA’s expectation is that any app developed through the competition will be used only with FDA-approved naloxone products.
As explained in the Federal Register Notice, announcing the competition, FDA is sponsoring the competition under section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-258). FDA will be provided with technical expertise by the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). NIDA and SAMHSA will each provide one (1) judge with experience in relevant fields including drug use and misuse, clinical trial design, development of mobile medical applications, and public health. Additionally, NIDA and SAMHSA will provide information to competition entrants at the code-a-thon on key issues, including (1) patterns of opioid use and misuse, (2) characteristics of populations at risk of opioid overdose, and (3) data collection and evaluation considerations.
The Federal Register Notice stated, “To be eligible to win a prize under this Challenge, an entrant (individual or entity): Shall have registered and entered a submission on http://www.Challenge.gov and http://www.YouTube.com under the rules promulgated by FDA.” Additionally, the notice points entrants to these rules for additional details on required components of a submission, and the minimum requirements for the proposed app. Accordingly, this document sets forth the official rules, terms and conditions (rules) that apply to the 2016 FDA Naloxone App Competition. These rules and should be read carefully before submitting a proposal.
Registration for the competition will open Sept. 23, 2016 and will close Oct. 7, 2016. To register, visit http://www.Challenge.gov, search for the 2016 FDA Naloxone App Competition, and follow the instructions. FDA strongly encourages entrants to register as teams, though individual registrations will be accepted. Throughout the competition, all interested parties will have online access to background information regarding the opioid epidemic and the public health recommendations for the safe and appropriate use of naloxone.
The competition will be conducted in two phases. Phase 1 will consist of a code-a-thon at the U.S. Food and Drug Administration (FDA) campus in Silver Spring, Maryland, for registered entrants to develop concepts and initial prototypes for an app that alerts carriers of naloxone to a nearby opioid overdose. Entrants are encouraged, but not required, to participate in the code-a-thon. Entrants will receive an email confirming registration and participation in the code-a-thon, if applicable. The code-a-thon will occur on Oct. 19-20, 2016. The code-a-thon event space is limited to the first 50 individuals who indicate interest in on-site participation during the registration process. There will be a virtual component to the code-a-thon for the first 100 individuals who indicate interest in remote participation during the registration process. At the code-a-thon, federal agency subject matter experts will provide background information to entrants on topics including, but not limited to the opioid epidemic, public health, and mobile medical applications and medical device development. All code developed through the code-a-thon will be made open-source and publicly accessible on the GitHub platform, a web-based code repository.
In Phase 2, all registered entrants will independently refine their concepts into a functional prototype, a video of which will be uploaded to YouTube (http://www.YouTube.com). The video URL will be submitted, accompanied by a short summary/description of the prototype as detailed below, on http://www.Challenge.gov by the submission deadline of Nov. 7, 2016. Entrants will be permitted to submit questions before and during the code-a-thon to FDA, NIDA, and SAMHSA subject matter experts with backgrounds in opioids, drug use, public health, and mobile medical devices. All entrants will have access to submitted questions and their answers, which will be publicly posted online. Submissions will be evaluated by a panel of judges appointed by FDA based on the criteria set forth in these rules.
The winning submission will be awarded a prize of $40,000. The prize awarded under this competition will be paid by electronic funds transfer and may be subject to federal income taxes. FDA will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. The total prize pool for the FDA Naloxone App Competition will be $40,000. FDA reserves the right to not award a prize if no submission is deemed worthy. FDA also reserves the right to suspend, postpone, terminate, cancel, or otherwise modify the competition, or any entrant’s participation in the competition, at any time at the discretion of the agency.
During all phases of app development, all entrants should consider strategies to minimize legal risk and maximize regulatory compliance, including for the developer and the end-user. To ensure adequate consideration of potential liability, privacy and regulatory concerns, FDA strongly encourages all entrants to obtain independent legal counsel.
Entrants may not test or evaluate their app using real people, including opioid users and naloxone carriers, during the competition. Following the competition, entrants may consider seeking grant funding from the NIDA Small Business Innovation Research (SBIR) program, to further develop competition concepts through testing and evaluation. As with all other National Institutes of Health funding applications, NIDA staff will provide dedicated assistance and guidance about the NIH grant submission process, including submissions for the NIDA SBIR grants. The SBIR grant program is open to all small businesses (which may include competition entrants) that meet applicable eligibility requirements set forth in the SBIR funding opportunity announcement. More information is available at http://grants.nih.gov/grants/guide/pa-files/PA-16-302.html. For competition entrants and projects that meet all applicable SBIR requirements, the NIDA SBIR program may provide the opportunity to further develop Competition concepts through field testing and evaluation.
As stated in the Federal Register Notice, to be eligible to win a prize under this competition, an individual or entity:
- Must have completed and submitted a registration form on http://www.Challenge.gov;
- Must create an account on Challenge.gov, and must have entered a submission on Challenge.gov, including a link to a YouTube video, under these rules promulgated by FDA;
- Must have complied with all the requirements under the Federal Register Notice and these rules;
- Must be (1) an individual or team of U.S. citizens or permanent residents of the United States each of whom 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.; and
- May not be a federal entity or federal employee acting within the scope of their employment. 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. 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.
Employees of FDA, NIDA, SAMHSA, their affiliates, and/or any other individual or entity associated with the development, evaluation, or administration of the competition as well as members of such persons’ immediate families (spouses, children, siblings, parents), and persons living in the same household as such persons, whether or not related, are not eligible to participate in the competition.
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 their participation in a competition, 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. Entrants are not required to obtain liability insurance or demonstrate financial responsibility in order to participate in the competition.
By participating in the competition, each entrant agrees to comply with and abide by these rules and the decisions of FDA and/or the individual judges, which shall be final and binding in all respects.
By participating in the competition, each entrant agrees to follow all applicable local, state, and federal laws and regulations.
Submissions must be received during the submission period, which begins on Sept. 23, 2016, and ends at 4:00 pm EST on Nov. 7, 2016. Each entrant must complete all of the required fields in the competition submission form in accordance with these rules. FDA reserves the right to disqualify any submission that FDA deems inappropriate.
Entrants may enter individually or as part of a team. Teams are strongly encouraged, and may be assembled from previously established firms or entities. Proposals may involve pre-existing technology or applications that an individual or team wish to redesign for the purposes of this competition. Individuals and/or team members must be clearly identified on the submission form in order to be eligible for the competition. Teams must designate a single individual as the primary contact and who will be authorized to bind the team or entity (“Lead”). The lead will be wholly responsible for the management and use of any prize monies awarded. In the event a dispute regarding the identity of the individual or team submitting the entry cannot be resolved to the satisfaction of FDA, the affected entry will be deemed ineligible.
All entry information and materials, including any copy of the submission, will be retained by FDA and will not be returned. Proof of submission is not considered proof of delivery to or receipt of such entry. Furthermore, FDA shall have no liability for any submission that is lost, intercepted, or not received by FDA. FDA further assumes no liability or responsibility for any error, omission, interruption, deletion, theft, destruction or unauthorized access to, or alteration of, submissions.
Minimum requirements for the proposed app are:
- Use of crowd-sourcing technology to identify one or more individuals in close proximity to the overdose who could administer naloxone;
- Minimize the time required to identify one or more individuals in close proximity to the overdose that could deliver naloxone to an individual experiencing an opioid overdose; and
- Compatibility with multiple platforms, including Android and iOS.
All written, digital, or recorded materials must be in English. Submissions are required to include a video of the functional app prototype and a supporting summary document. The video must be uploaded to http://www.YouTube.com and be no more than five (5) minutes in duration. The video must demonstrate a functional prototype of the application, including any planned interfaces between the app and existing systems or datasets. The summary document must be submitted on http://www.Challenge.gov and not exceed three (3) pages. The summary document is required to include:
- A description of the entrant(s), including relevant fields of expertise;
- A summary of the concept for the app, including identification of the target audience;
- A general description of the proposed technical design, including an explanation of any planned interfaces between the app and existing systems or datasets; and
- The URL for the uploaded YouTube video.
Data Security Policy
Drug use and abuse are sensitive topics that require careful consideration of privacy and confidentiality issues. The submissions must not contain any data about real people, and entrants may not use data from or about actual people in development of the app.
A mobile medical application intended to facilitate treatment of opioid overdose is considered to be a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The winning app developed through this Competition, therefore, would be a device under FDA’s jurisdiction. However, as described in the 2015 FDA Guidance for Industry on Mobile Medical Applications (available at: http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf), FDA does not intend to enforce regulatory requirements under the Federal Food, Drug and Cosmetic Act for certain mobile medical apps.
Representations and Warranties/Indemnification
By participating in the competition, each entrant represents, warrants, and covenants as follows:
- The entrant – whether an individual, team or entity – is the sole author, creator, and owner of the submission;
- The submission is not the subject of any actual or threatened litigation or claim;
- The submission does not and will not violate or infringe upon the intellectual property rights, privacy rights, publicity rights, or other legal rights of any third party;
- The submission does not and will not contain any harmful computer code (sometimes referred to as “malware,” “viruses” or “worms”); and
- The Submission, and entrants’ use of the Submission, does not and will not violate any applicable laws or regulations, including, without limitation, applicable export control laws and regulations of the U.S. and other jurisdictions.
If the Submission includes any third party works (such as third party content or open source code), entrant must be able to provide, upon the request of FDA, documentation of all appropriate licenses and releases for such third party works. If entrant cannot provide documentation of all required licenses and releases, FDA reserves the right to disqualify the applicable Submission, or seek to secure the licenses and releases for the benefit of FDA, and allow the applicable Submission to remain in the Competition. FDA also reserves all rights with respect to claims based on any damages caused by participant’s failure to obtain such licenses and releases.
Entrants – whether an individual, a team or an entity – will indemnify, defend, and hold harmless FDA, NIDA and SAMHSA, from and against all third party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to or arising from entrant’s Submission or any breach or alleged breach of any of the representations, warranties, and covenants of entrant hereunder.
FDA reserves the right to disqualify any Submission that FDA, in its discretion, deems to violate these Rules.
Intellectual Property and Copyright License
To receive the prize, entrants will not be required to transfer their intellectual property rights to FDA. Each entrant retains any applicable intellectual property rights not expressly granted under this Agreement. By participating in the Competition, each entrant hereby irrevocably grants to FDA, and any third-parties acting on FDA’s behalf an irrevocable, paid up, non-exclusive, royalty-free, worldwide license and right to reproduce, publicly perform, publicly display, and use the entrant’s submission for government purposes, and to publicly perform and publicly display the entrant’s submission video, including, without limitation, for advertising and promotional purposes relating to the Competition.
Additionally, each participant at the code-a-thon will be required to provide FDA with an open source version of the code written by the participant at the code-a-thon to be posted on the GitHub source code repository and made publicly available under the Creative Commons license, CCO 1.0 Universal (CCO 1.0, Public Doman Dedication). For a summary and full text of the CCO 1.0 Universal license, see https://creativecommons.org/publicdomain/zero/1.0/. The GitHub source code repository is accessible at https://github.com.
By participating in the Competition, each entrant hereby irrevocably grants to FDA the right to use such entrant’s name, likeness, image, and biographical information in any and all media for advertising and promotional purposes relating to the Competition, as stated in these Rules.
FDA reserves the right to disqualify any entrant who is found to be tampering with the entry process or the operation of the Competition or Competition website or other Competition-related websites, to be acting in violation of these Rules, or to be acting in an unsportsmanlike or disruptive manner, or with the intent to disrupt or undermine the legitimate operation of the Competition, or to annoy, abuse, threaten, or harass any other person. FDA reserves the right to seek damages and other remedies from any such person to the fullest extent permitted by law.
A panel of judges with experience in the fields of mobile medical application development, public health, and/or regulatory science chosen by FDA will select the highest-performing entrant from the pool of eligible submissions. The judging will be fair and impartial, and based upon the following evaluation criteria, with equal weighting:
- Innovation: Uniqueness and innovation in use of software and data analytics to fulfill the mandatory requirements; variety and value of additional features (weight 25 percent).
- Usability: Use of design elements to increase utilization among both people at risk of opioid overdose and naloxone carriers; ease of navigation; appropriate use of an interface to support the app in achieving desired outcome (weight 25 percent).
- Functionality: Potential to enhance the frequency and speed of naloxone administration by the carriers to the overdose victims (weight 25 percent).
- Adaptability: Potential for app to be tailored to the practical environment (e.g., urban, rural) of an individual community (weight 25 percent).
The evaluation criteria are to be applied in the sole discretion of the individual judges and are subject to modification by FDA. By participating in the competition, each entrant into the Competition agrees to be bound by and not challenge the final decisions of FDA and the judges.
When notification of the winner is completed, or as soon as is practical thereafter, the videos of the highest performing submissions will be posted on the competition website for public viewing. The judging scores will not be posted.
Attempts to notify the winning entrant will be made using the contact information provided on the competition registration form. FDA is not responsible for e-mail or other communication problems of any kind. If, despite reasonable efforts, an entrant does not respond within three (3) days of the first notification attempt regarding selection as winner of the Competition, or if the notification is returned as undeliverable to such entrant, that entrant may forfeit his, her or its status and an alternate winner may be selected, or the applicable prize may go unawarded.
If any potential prize winner is found to be ineligible, or has not complied with these rules, or declines the applicable prize for any reason prior to award, such potential prize winner will be disqualified and an alternate winner may be selected, or the applicable prize may go unawarded.
General Liability Release
By participating in the competition, each entrant hereby agrees that:
- FDA shall not be responsible or liable for any losses, damages, or injuries of any kind (including death) resulting from participation in the competition or any competition-related activity, or from entrants’ acceptance, receipt, possession, use, or misuse of any prize; and
- Entrants will indemnify, defend, and hold harmless FDA, NIDA, and SAMHSA from and against all third party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to or arising from entrant’s participation in the competition.
Without limiting the generality of the foregoing, FDA is not responsible for incomplete, illegible, misdirected, misprinted, late, lost, postage-due, damaged, or stolen entries or prize notifications; or for lost, interrupted, inaccessible, or unavailable networks, servers, satellites, Internet Service Providers, websites, or other connections; or for miscommunications, failed, jumbled, scrambled, delayed, or misdirected computer, telephone, cable transmissions or other communications; or for any technical malfunctions, failures, difficulties, or other errors of any kind or nature; or for the incorrect or inaccurate capture of information, or the failure to capture any information.
These rules cannot be modified except by FDA. All decisions by FDA regarding adherence to these rules are final. The invalidity or unenforceability of any provision of these rules shall not affect the validity or enforceability of any other provision. In the event that any provision is determined to be invalid or otherwise unenforceable or illegal, these rules shall otherwise remain in effect and shall be construed in accordance with their terms as if the invalid or illegal provision were not contained herein.
The failure of FDA to exercise or enforce any right or provision of these rules shall not constitute a waiver of such right or provision.
All issues and questions concerning the construction, validity, interpretation, and enforceability of these Rules shall be governed by and construed in accordance with U.S. federal law as applied in the federal courts of the District of Columbia if a complaint is filed by any party against FDA.
Winner List/Contact Information
To obtain a list of finalists and winner after the conclusion of the Competition or a copy of these Rules, send a self-addressed envelope with the proper postage affixed to:
FDA Office of Public Health Strategy and Analysis
c/o Marisa Cruz
10903 New Hampshire Avenue
Bldg 32, Rm 4220
White Oak, MD 20993
Please specify “Winner List” or “Official Rules” and the name of the Competition in your request.
Please contact us at NaloxoneApp@fda.hhs.gov should you have any comments or questions about these Rules.