[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Notices]
[Pages 62951-62953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24918]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information 
Technology


Announcement of Requirements and Registration for ``Market R&D 
Pilot Challenge''

    Authority: 15 U.S.C. 3719.

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

    Award Approving Official: Dr. Karen DeSalvo, National Coordinator 
for Health Information Technology.

ACTION: Notice.

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SUMMARY: Developers and innovators have many great ideas and products 
that could improve the U.S. health care system and make life better for 
patients and care providers. However, effecting actual change is 
extremely difficult due to the high barriers to entry in the health IT 
space. Once an innovative new product has been developed, it needs to 
be tested in real-life care settings. But providers can be hesitant to 
host this testing for a myriad of reasons--they may have had bad 
experiences in the past, be anxious about deploying new tools that may 
disrupt their workflows, or be wary of encountering more problems than 
the solution solves. Without this testing, it cannot be determined how 
well the product actually works, making it difficult for the developers 
to identify the changes that need to be made to the product to make it 
more effective. Furthermore, without evidence of the uses a product can 
provide it is that much harder to acquire the venture funding that can 
fuel further advancement and lead to successful entry in the 
marketplace.
    The Market R&D Pilot Challenge is intended to help bridge this gap 
by bringing together health care organizations (``Hosts'') and 
innovative companies (``Innovators'') through pilot funding awards and 
facilitated matchmaking. The Challenge seeks to award pilot proposals 
in three different domains: Clinical environments (e.g., hospitals, 
ambulatory care, surgical centers), public health and community 
environments (community-based personnel such as public health 
departments, community health workers, mobile medical trucks, school- 
and jail-based clinics), and consumer health (e.g., self-insured 
employers, pharmacies, laboratories). Hosts and Innovators will submit 
joint pilot proposals, with the winners, as determined by an expert 
panel, proceeding to implement their pilots.
    The Challenge's primary goals are to:
     Encourage early collaboration between entrepreneurs, 
medical and public health personnel, patients, and the research 
community to link innovation in health IT to innovation in care 
delivery;
     De-risk early stage health IT and digital health products 
for future clinical testing and investment;
     Encourage uptake of and ensure the market is aware of ONC 
standards and functions within certified electronic health record 
technologies; and
     Explore evidence collection methods and relevant metrics 
for early stage health IT products that may better match agile software 
development.
    The statutory authority for this challenge competition is Section 
105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-
358).

DATES: 
    Applicants:

 Challenge launch: October 20, 2014.
 Matchmaking events: Early December, 2014 to mid-January, 2015.
 Submissions due: March 2, 2015.
 Winners announced: April 30, 2015.

    Winners:

 Pilot preparation and setup: May-July, 2015.

[[Page 62952]]

 Pilots begin: August, 2015.
 Pilots complete: January, 2015.

FOR FURTHER INFORMATION CONTACT: Adam Wong, [email protected] 
(preferred), 202-720-2866.

SUPPLEMENTARY INFORMATION:

Subject of Challenge Competition

    The Market R&D Pilot Challenge will have up to six winners, 
preferably spread across each of the three Host domains: Clinical 
environments, public health and community environments, and consumer 
health.
    The Challenge is a multi-step process that builds on ONC's previous 
prize challenges.

1. Learn About the Challenge

    The challenge Web site will be the primary source for finding all 
information about the challenge, and will be updated regularly with the 
newest information. ONC will hold an informational Webinar to provide 
details about the program and answer questions; the Webinar will be 
recorded and made available for those who miss it.

2. Find a Match

    The organizers will facilitate matchmaking to help Innovators and 
Hosts connect to discuss potential pilots through in-person and virtual 
events. Potential applicants are not required to participate in this 
process in order to submit a proposal. Interested Innovators and Hosts 
will submit an application form to be considered to participate in the 
facilitated matchmaking sessions. Hosts make the final selection about 
which Innovators they will meet with in person; Innovators will be 
officially notified of these meetings prior to the sessions. We 
encourage Innovators to reach out independently to health care service 
organizations and stakeholders for potential partnerships.

3. Submit Joint Proposal

    A Host and an Innovator will apply as a pair by submitting a joint 
pilot proposal. Applications without a Host or Innovator co-applicant 
will not be accepted. A panel of expert judges will review proposals 
and select up to 6 winning proposals to each receive a $50,000 award. 
Winners will be announced on a Webinar where they'll present their 
pilot proposals.
    In addition to a description and budget of the pilot, the joint 
proposal will require general information about the Host and Innovator; 
description and demo video of the Innovator's technology; and letters 
of intent from the Host and Innovator.

4. Winners: Prepare and Implement Pilot Project

    Pilot planning and implementation support services will be provided 
over a series of Webinars. The selected winners will then implement and 
run their pilot projects over a period of 6-9 months.

5. Issue Deliverable and Promote Results

    Upon completion of the pilot, the winners will be required to issue 
a deliverable that contributes to the public knowledge base, such as a 
white paper or open data set, or to open technology, such as an API or 
open source tool. Winners will also have the opportunity to present 
their pilot projects at a major health event or conference.
    Applicants are strongly encouraged to address the following ONC 
priority areas:

 Standards/Data Formats
 Interoperability & Exchange
 Care Coordination/Transitions of Care
 Patient/PHR Portals
 Medication Management
 Blue Button
 Patient Generated Health Data
 Underserved Communities

Eligibility Rules for Participating in the Competition

    Host Eligibility: The Host must be a health care organization 
operating in a clinical environment, (e.g., hospital, ambulatory care, 
surgical center), public health and community environment (community-
based personnel such as public health department, community health 
worker, mobile medical truck, school- and jail-based clinic), or 
consumer health (e.g., self-insured employer, pharmacy, laboratory) and 
must meet the following eligibility criteria:

     Ability to allocate time and resources to plan and 
implement the pilot project
     Allocate one business-minded internal lead to shepherd 
project from the initial application through the pilot's implementation

    Innovator Eligibility: The Innovator, an early-stage health care 
technology company, must have a readily available tech-based product 
focused on improving health care that can be tested in the Host setting 
and meet the following criteria:

 Demonstration of financial stability, managerial capacity, and 
scalability
 Maximum number of 50 employees
 Less than $10,000,000 in venture capital funding raised

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 the 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.

Submission Requirements

    In order for an Innovator's application to be eligible to win this 
Challenge, it must meet the following requirements:
    1. No HHS or ONC logo--The product must not use HHS' or ONC's logos 
or

[[Page 62953]]

official seals and must not claim endorsement.
    2. Functionality/Accuracy--A product may be disqualified if it 
fails to function as expressed in the description provided by the user, 
or if it provides inaccurate or incomplete information.
    3. Security--Submissions must be free of malware. Contestant agrees 
that ONC may conduct testing on the product to determine whether 
malware or other security threats may be present. ONC may disqualify 
the product if, in ONC's judgment, the app may damage government or 
others' equipment or operating environment.

Registration Process for Participants

    To register for this Challenge, participants can access http://www.challenge.gov and search for ``Market R&D Pilot Challenge.''

Prize

     Up to six Host/Innovator teams will each win $50,000 
prizes (50% to be disbursed following award, 50% to be disbursed upon 
completion of pilot)
     Total: up to $300,000 in prizes

Payment of the Prize

    Prize will be paid by contractor.

Basis Upon Which Winner Will Be Selected

    The review panel will make selections based upon the following 
criteria:

 Pilot proposal and design
 Pilot budget and scale
 Potential for health impact
 Relevance to ONC priorities
 Potential of Innovator's product
 Team experience and strength of match
 Proposed public deliverable

Additional Information

    General Conditions: ONC reserves the right to cancel, suspend, and/
or modify the Contest, or any part of it, for any reason, at ONC's sole 
discretion.
    Intellectual Property: 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: October 9, 2014.
Dr. Karen DeSalvo,
National Coordinator for Health Information Technology.
[FR Doc. 2014-24918 Filed 10-20-14; 8:45 am]
BILLING CODE 4150-45-P