[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57045-57046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Requirements and Registration for ``Reporting 
Device Adverse Events Challenge''

    Authority:  15 U.S.C. 3719.

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

ACTION: Notice.

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SUMMARY: Medical devices will play an increasingly large role in the 
monitoring and collection of patient data with the spread of electronic 
health records. 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 ``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.
    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 September 12, 2011.

FOR FURTHER INFORMATION CONTACT:
Adam Wong, 202-720-2866.
Wil Yu, 202-690-5920.

SUPPLEMENTARY INFORMATION: 
    Subject of Challenge Competition: 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. The application would make it easy for patients to report adverse 
events to their provider, support the download of information from EMR 
or PHR systems to populate the adverse event report and provide high 
quality data, capture useful information including patient demographics 
and device data that is easily accessible to all stakeholders 
(patients, providers, manufacturers, and researchers) using current 
technologies including PC-based browsers, mobile phones, and tablets, 
and leverage NwHIN standards and services including transport, content, 
and vocabularies.
    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

[[Page 57046]]

promulgated by 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; and
    (4) 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.
    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--
    (1) 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
    (2) the Federal Government for damage or loss to Government 
property resulting from such an activity.
    Participants must be teams of at least two people.
    All participants are required to provide written consent to the 
rules upon or before submitting an entry.
    Dates:
     Submission Period Begins: 12:01 a.m., E.D.T., September 
12, 2011.
     Submission Period Ends: 11:59 p.m., E.D.T., December 2, 
2011.
    Registration Process for Participants:
    To register for this challenge participants should:
     Access the http://www.challenge.gov Web site and search 
for the ``Reporting Device Adverse Events Challenge''.
     Access the ONC Investing in Innovation (i2) Challenge Web 
site at:
    [cir] http://www.health2challenge.org/category/onc/.
    [cir] A registration link for the challenge can be found on the 
landing page under the challenge description.
    Amount of the Prize:
     First Prize: $25,000.
     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.
    Basis Upon Which Winner Will Be Selected:
    The judging panel will make selections based upon the following 
criteria:
    1. Effectiveness in facilitating adverse event reporting.
    2. Usability and design.
    3. Ability to integrate with electronic health records and other 
data sources.
    4. Creativity and Innovation.
    5. Use of NwHIN standards and services.
    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.

    Dated: September 8, 2011.
Farzad Mostashari,
National Coordinator for Health Information Technology.
[FR Doc. 2011-23702 Filed 9-14-11; 8:45 am]
BILLING CODE 4150-45-P