Reporting Device Adverse Events Challenge

Submission Deadline

Submissions are Closed

Contact

Challenge Team

Prizes

  • First Prize $25,000 + Demo at an industry conference to be determined + 2 free passes to the Health 2.0 Spring Conference + Prize amount includes travel to the conference
  • Second Prize $10,000
  • Third Prize $5,000
  • Note Awards may be subject to Federal income taxes and HHS will comply with IRS withholding and reporting requirements, where applicable.
First Place

IOSTREAM

Team Members

Doug Brown

The MedDAERS system by IOSTREAM is a web-portal for health professionals and consumers to voluntarily report the adverse events, product problems and product use errors associated with medical devices. Submitted reports are converted into electronic versions of the MedWatch 3500 form. The website has two entry points -- the first is for users who wish to fill out and submit voluntary reports, the second is those with login credentials and is used to view the XML formatted voluntary reports that have been submitted.

Background

Medical devices will play an increasingly large role in the monitoring and collecting of patient data with the spread of electronic health records. As patients take a more direct role in managing their health care, devices that are implanted or used in the hospital, clinic, or home must be easy to use and monitor. The reporting of adverse events related to these devices is a logical area to start.

The United States has a limited system for the post-market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The US Food and Drug Administration (FDA) operates the Manufacturer and User Facility Device Experience (MAUDE) database, which catalogs reports of adverse events involving medical devices used in all settings going back to 1991. Although MAUDE includes a wealth of data, the passive surveillance used to collect the data has a number of limitations. First, as is typical of other passive systems, variable and significant underreporting of adverse events is common. Second, submitted data is highly variable in quality and is largely de-identified, making it difficult to analyze trends on a patient or provider level. Finally, MAUDE data is updated only on a monthly basis, which makes real-time tracking of adverse events impossible and delays the recognition of emerging device issues.

In order to improve the post-market surveillance of medical devices it is important to innovate beyond the MAUDE database concept. In particular, a system is needed that would: 1.) increase the rate of reporting of adverse events and, more importantly, improve the quality of the reported data; 2.) collect and analyze more information that characterizes both patients receiving medical devices and the providers distributing or implanting those devices to make it possible to identify trends better; and 3.) make the data much more dynamic with continuous updating to identify trends in real-time.

Description

The “Reporting Device Adverse Events Challenge” asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. This application would:

  • Make it easy for patients to report adverse events that occur with any medical device to their provider;
  • Enable providers to import relevant EMR or PHR data to the patient report and, in turn, submit it to the MAUDE system;
  • The application only needs to be able to download data from one or more systems and does not need to be fully integrated across all EMR/PHR platforms;
  • Capture useful demographic and other relevant information from each patient including age, gender, race, relevant diagnoses, and following physician;
  • Capture information about the type of device used, the individual who implanted or distributed the device, and where the implantation or distribution occurred;
  • Be platform-agnostic and easily accessible; and
  • Leverage and extend NwHIN standards and services including, but not limited to, transport (Direct, web services), content (Transitions of Care, CCD/CCR), and standardized vocabularies

Timeline

  • Submission Period Begins: 12:01 AM ET, Monday, September 12, 2011
  • Submission Period for Entries Ends: 11:59 PM ET, Friday, February 3, 2012
  • Evaluation Process Begins: Monday, February 6, 2011
  • Evaluation Process Ends: Friday, February 17, 2011
  • Winner notified: Monday, February 20, 2011

Review Panel

    • Terrie Reed
    • Food and Drug Administration
    • Shannon Brownlee
    • New America Foundation
    • Kathy Kenyon
    • HHS

Evaluation Criteria

Each submission will be evaluated according to the following criteria. Winning entries should:

  1. Effectiveness of the system in facilitating adverse event reporting
  2. Usability and design from the standpoint of all stakeholders
  3. Ability to integrate with electronic health records and other data sources
  4. Creativity and Innovation
  5. Leverage NwHIN standards including transport, content, and vocabularies

Submission Requirements

To register for this challenge participants should:

  • Access the ONC Investing in Innovation (i2) Challenge website at:
  • Access the www.challenge.gov website and search for the “Reporting Device Adverse Events Challenge”.
  • A registration button and related link for the challenge can be found at the top of the right hand column of this page. Teams are asked to register to help Health 2.0 and the challenge sponsor anticipate resources needed to manage the project.
  • Registered teams may receive updates from Health 2.0 and the Sponsor during the submission period that provide useful information with regards to the competition.
  • There are no additional forms or steps required after submission of the registration form. Instructions on how to submit an entry will be sent prior to the close of the submission deadline. Teams are not bound or limited by the proposal description submitted in the registration form and may update or modify their projects as needed prior to final submission.

Participating Teams

iHealth Ventures
BREF
Goli
Team Dewdrop
IOSTREAM
VENARC

Terms & Conditions

Reporting Device Adverse Events Challenge

OFFICIAL RULES

NO PURCHASE OR PAYMENT NECESSARY TO ENTER OR TO WIN. A PURCHASE WILL NOT IMPROVE YOUR CHANCES OF WINNING. VOID WHERE PROHIBITED.

SPONSOR: The sponsor of this Challenge is the Office of the National Coordinator for Health Information Technology (“Sponsor“).

ADMINISTRATOR: The administrator of the Challenge is Health 2.0, LLC, 650 Delancey St, #221, San Francisco, CA 94107 (“Administrator“)

CHALLENGE DESCRIPTION: The Challenge begins at 12:01 AM Eastern Time on Monday, September 12, 2011 and ends at 11:59 PM Eastern Time on Friday, December 2, 2011 (“Challenge Period“). The Challenge tasks developers with developing an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. Three winning applications will be selected based on the evaluation criteria set forth below. The teams that submit the winning applications will win: 1.) First Place - $25,000, a demo at an industry conference, 2 free passes to the Health 2.0 Spring Conference, 2.) Second Place – $10,000, 3.) Third Pace – $5,000. Entry into the Challenge does not constitute entry into any other challenge or promotion, including, without limitation, other similar challenges or promotions offered by Sponsor and/or Administrator. By participating in the Challenge, each entrant unconditionally accepts and agrees to comply with and abide by these Official Rules and the decisions of Sponsor, Administrator, and/or the individual advisors, which shall be final and binding in all respects.

ELIGIBILITY: To be eligible to win a prize under this challenge, an individual or entity: (a) Shall have registered to participate in the competition under the rules promulgated by Office of the National Coordinator for Health Information Technology; (b) Shall have complied with all the requirements under this section; (c) 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, participating in a group, shall be a citizen or permanent resident of the United States and 18 years old or older as of the time of entry; and (d) 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. Employees of Sponsor, Administrator, each of their affiliates, and/or any other individual or entity associated with the development, evaluation, or administration of the Challenge 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 Challenge.

HOW TO ENTER: To enter: (a) develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. (“Submission“); (b) go to the website located at www.health2challenge.org (the “Challenge Website“), complete the Official Application Form to officially register for the competition; (c) once registered you will receive additional instructions to submit your entry, a video demonstrating the Submission’s capabilities and functionality, and an electronic slide presentation describing the submission according to the instructions posted on the Challenge Website. You may only enter as part of a team. Teams must include no less than two (2) people and each team member must be clearly identified on the team’s Official Entry Form to be eligible. All participants are required to provide written consent to the rules upon or before submitting an entry. Submissions must be received during the Challenge Period to be eligible. Administrator is the official timekeeper for the Challenge. No substitutions of new versions of Submissions will be accepted under any circumstances once the original Submission is submitted for consideration. In the event of a dispute regarding the identity of the individual or team who actually submitted the entry cannot be resolved to Sponsor’s and/or Administrator’s satisfaction, the affected entry will be deemed ineligible. Except as otherwise stated in these Official Rules, personal information collected in connection with the Challenge will be used by Sponsor in accordance with Sponsor’s privacy policy and by Administrator in accordance with Administrator’s privacy policy available on the Website and with any additional consent given by an entrant at the time of entry. All entry information and materials, including any copy of the Submission submitted to Sponsor, become the property of Sponsor and will not be acknowledged or returned. Proof of submission is not considered proof of delivery to or receipt of such entry. Furthermore, Sponsor and Administrator shall have no liability for any Submission that is lost, intercepted, or not received by Sponsor and/or Administrator. Sponsor and Administrator assume no liability or responsibility for any error, omission, interruption, deletion, theft, or destruction or unauthorized access to, or alteration of, Submissions.

REPRESENTATIONS AND WARRANTIES/INDEMNIFICATION: By participating in the Challenge, each entrant represents, warrants, and covenants as follows: (a) entrant is the sole author, creator, and owner of the Submission; (b) the Submission is not the subject of any actual or threatened litigation or claim; (c) 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; (d) the Submission does not and will not contain any harmful computer code (sometimes referred to as “malware,” “viruses” or “worms”); and (e) 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 Sponsor and/or Administrator’s request, all appropriate licenses and releases for such third party works. In the event entrant cannot provide all required licenses and releases, Sponsor reserves the right, in Sponsor’s sole discretion, to disqualify the applicable Submission, or seek to secure the licenses and releases for Sponsor’s benefit and allow the applicable Submission to remain in the Challenge. Entrants will indemnify, defend, and hold harmless Sponsor and Administrator 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. Sponsor and/or Administrator reserves the right to disqualify any Submission that Sponsor and/or Administrator, in its sole discretion, deems to violate these Official Rules.

SUBMISSION LICENSE: Each entrant retains title and full ownership in and to their Submission. Entrant expressly reserves all intellectual property rights not expressly granted under this 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, publicly perform, publicly display, and use the Submission to the extent necessary to administer the challenge, and to publicly perform and publicly display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

PUBLICITY RELEASE: By participating in the Challenge, in addition to any other grants granted herein or which may be granted in any other agreement entered into between Sponsor and/or Administrator, on the one hand, and any entrant in the Challenge, on the other hand, each entrant hereby irrevocably (a) grants to Sponsor and Administrator the right to use such entrant’s name, likeness, image, and biographical information in any and all media for any purpose, including, without limitation, advertising and promotional purposes relating to the Challenge and (b) releases Sponsor and Administrator from any liability with respect thereto.

U.S. GOVERNMENT SUPPORT, RIGHTS, AND WAIVER: Sponsor and Administrator are administering the Challenge with the support of the U.S. Department of Health & Human Services pursuant to the American COMPETES Reauthorization Act (the “Act“). Subsection (j) of section 24 of the Act establishes that the Government is prohibited from acquiring an interest in intellectual property developed by a participant in a prize competition, such as the Challenge, without the written consent of the participant. Registered participants shall be required to 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. Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the head of the Office of the National Coordinator for Health Information Technology, for claims by (a) a third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered participant’s insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and (b) the Federal Government for damage or loss to Government property resulting from such an activity.

WINNER SELECTION/EVALUATION CRITERIA: A panel of advisors will select three winning Submissions from among all eligible entries based on the following evaluation criteria:

  • Effectiveness of the system in facilitating adverse event reporting
  • Usability and design from the standpoint of all stakeholders
  • Ability to integrate with electronic health records and other data sources
  • Creativity and Innovation
  • Leverage NwHIN standards including transport, content, and vocabularies

The evaluation criteria are to be applied in the sole discretion of Sponsor and the individual advisors. By participating in the Challenge, each entrant into the Challenge acknowledges and agrees that such evaluations may differ from person to person and agrees to be bound by and not challenge the final decisions of Sponsor and the individual advisors.

NOTICE TO WINNERS: Attempts to notify potential winners will be made using the contact information provided on the winner’s Official Entry Form. Sponsor and Administrator are not responsible for e-mail or other communication problems of any kind. If, despite reasonable efforts, a potential winner does not respond within five (5) days of the first notification attempt (or a shorter time as exigencies may require), or if the prize or prize notification is returned as unclaimed or undeliverable to such potential winner, such potential winner will forfeit his or her prize and an alternate winner may be selected. If any potential prize winner is found to be ineligible, or if he or she has not complied with these Official 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. Sponsor may successively attempt to contact up to two (2) potential prize winners in accordance with such procedure, and if there is still no confirmed prize winner after such attempts have been made, if any, the applicable prize may go unawarded.

ANTICIPATED NUMBER OF ENTRANTS: Many will enter, three winning submissions will be selected. Actual odds of winning depend on the number of eligible entries received. Sponsor and Administrator cannot accurately predict the number of entrants who will participate in the Challenge.

PRIZES: The winning teams will receive: 1.) First Place - $25,000, a demo at a national conference to be determined, 2 free passes to the Health 2.0 Spring Conference, 2.) Second Place – $10,000, 3.) Third Pace – $5,000.

GENERAL PRIZE CONDITIONS: The potential winner may be required to execute an Affidavit of Eligibility, a Liability Release and (where imposing such condition is legal) a Publicity Release (collectively “Prize Claim Documents). If a winner fails or refuses to sign and return all Prize Claim Documents within five (5) days of Sponsor’s and/or Administrator’s request (or a shorter time as exigencies may require), the winner may be disqualified and an alternate winner may be selected. No more than the advertised number of prizes will be awarded. Prizes will be delivered only to an address in the U.S. No cash alternative or substitution or transfer of prizes will be allowed, except Sponsor reserves the right in its sole discretion to substitute prizes of comparable value, in whole or in part, for any reason. THE WINNER IS RESPONSIBLE FOR REPORTING AND PAYING ANY INCOME TAXES OR OTHER TAXES THAT MAY APPLY TO ACCEPTING A PRIZE; SPONSOR AND ADMINISTRATOR ARE NOT RESPONSIBLE FOR AND WILL NOT PAY ANY SUCH TAXES.

DATES/DEADLINES: Because of the unique nature and scope of the Challenge, Sponsor and Administrator reserve the right, in addition to those other rights reserved herein, to modify any dates or deadlines set forth in these Official Rules or otherwise governing the Challenge.

GENERAL LIABILITY RELEASE/FORCE MAJEURE: Each entrant agrees that Sponsor and Administrator (a) shall not be responsible or liable for any losses, damages, or injuries of any kind (including death) resulting from participation in the Challenge or any Challenge-related activity, or from entrants’ acceptance, receipt, possession, use, or misuse of any prize, and (b) have not made any warranty, representation, or guarantee, express or implied, in fact or in law, with respect to any prize, including, without limitation, regarding such prize’s merchantability or fitness for a particular purpose. Entrants will indemnify, defend, and hold harmless Sponsor and Administrator 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 Challenge. Sponsor and Administrator assumes no responsibility for any damage to an entrant’s computer system which is occasioned by accessing the Website or other Challenge-related websites or participating in the Challenge, or for any computer system, phone line, hardware, software, or program malfunctions, or other errors, failures, delayed computer transmissions, or network connections that are human or technical in nature. Without limiting the generality of the foregoing, Sponsor and Administrator are 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. Sponsor and Administrator each reserve the right in their sole discretion to disqualify any individual who is found to be tampering with the entry process or the operation of the Challenge or Website or other Challenge-related websites, to be acting in violation of these Official Rules, or to be acting in an unsportsmanlike or disruptive manner, or with the intent to disrupt or undermine the legitimate operation of the Challenge, or to annoy, abuse, threaten, or harass any other person, and Sponsor and Administrator each reserve the right to seek damages and other remedies from any such person to the fullest extent permitted by law. In the event an insufficient number of eligible entries are received or Sponsor and/or Administrator is prevented from awarding the prize or continuing with the Challenge as contemplated herein by any event beyond its control, including, without limitation, fire, flood, natural or man-made epidemic, earthquake, explosion, labor dispute or strike, act of God or public enemy, satellite or equipment failure, riot or civil disturbance, terrorist threat or activity, war (declared or undeclared) or any federal state or local government law, order, or regulation, public health crisis, order of any court or jurisdiction, or other cause not reasonably within Sponsor’s control (“Force Majeure“), Sponsor and/or Administrator shall have the right to modify, suspend, or terminate the Challenge. If the Challenge is terminated for Force Majeure before expiration of the Challenge Period, Sponsor and/or Administrator will (if reasonably possible) select a winner from all eligible, non-suspect entries received as of the date of the event giving rise to the termination. These Official Rules cannot be modified or amended in any way except in a written document issued in accordance with the law by a duly authorized representative of both Sponsor and Administrator. The invalidity or unenforceability of any provision of these Official 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 Official 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.

GOVERNING LAW/JURISDICTION: All issues and questions concerning the construction, validity, interpretation, and enforceability of these Official Rules or the rights and obligations of entrants, Sponsor and/or Administrator in connection with the Challenge shall be governed by and construed in accordance with the laws of the State of California without giving effect to any choice of law or conflict of laws rules or provisions. Any legal claims arising from or relating to the Challenge or these Official Rules must be brought in the federal or state courts located in San Francisco, California.

WINNERS LIST/OFFICIAL RULES: To obtain any legally-required winners list (after the conclusion of the Challenge) or a copy of these Official Rules, send a self-addressed envelope with the proper postage affixed to: Health 2.0, LLC, Attn: Health 2.0 Developer Challenges, 650 Delancey Street #221, San Francisco, CA 94107. Please specify “winners list” or “Official Rules” and the name of the specific Challenge in your request.

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