[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]
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