ARRA Strategic Health IT Advanced Research Projects (SHARP)

To competitively-awarded cooperative agreements to establish Strategic Health IT Advanced Research Projects (SHARP).

The awardees will conduct research focusing on where breakthrough advances are needed to address well-documented problems that have impeded adoption of health IT and to accelerate
progress towards achieving nationwide meaningful use of health IT in support of a high-performing, learning health care system.

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.




Program Accomplishments

Fiscal Year 2009: No Current Data Available Fiscal Year 2010: No Current Data Available Fiscal Year 2011: No Current Data Available

Uses and Use Restrictions

ONC expects to award four cooperative agreements to support establishment of Strategic Health IT Advanced Research Projects (SHARP) sites for a project period of four years.

Each such research site will have a two-part mission:

(1) to implement a collaborative, interdisciplinary program of research addressing a specific focus area from the list provided below, addressing short-term as well as long-term challenges; and
(2) to develop and implement a cooperative program between researchers, patient groups, health care providers, and other health IT sector stakeholders to transition the results of research into practice.

Each site will focus on areas where breakthrough improvements are needed to address well-documented problems that have impeded adoption of health IT and thereby accelerate progress on the pathway towards achieving the goals outlined in the strategic plan for health IT developed by the National Coordinator pursuant to PHSA Section 3001(c)(3) as added by the Recovery Act, specifically including the nationwide achievement of meaningful use of health IT to achieve transformational improvement of the health care system.

Each site will implement a collaborative, inter-disciplinary research program addressing one of the specific focus area(s) listed below.

An eligible entity may, apply for funding in separate applications to establish more than one site, and thus it is possible a single eligible entity ("institution") may receive more than one award under this program.

Regardless of the total number of institutions funded to establish sites under this program, it is expected that the all of the awardees will collaborate with each other, as there will be numerous points of intersection among the sites" agendas.



Within its focus (listed below) area, each site will carry out at least the following set of activities:
• Initially define and subsequently update or redefine on a yearly basis, the key issues and research challenges within their respective area(s) of focus.

The research areas identified will be those that significantly address barriers and solutions to achieving widespread adoption and meaningful use of health IT.

Projects to address the identified issues will be mapped to either a short-term (< 2 years) or long-term (4 years) timeframe.

Because this is a cooperative agreement, recipients shall plan and allow for collaboration with ONC and other federal staff with relevant expertise - as identified or approved by ONC - in establishing and updating the definition of key issues and research challenges in the site s focus area;
• Conduct ambitious research addressing these key issues and challenges.

This work will draw on the scientific methods and expertise of researchers and practitioners in diverse fields;
• Collect specific, uniform data about the research activities and track progress toward milestones;
• Facilitate practical and efficient processes that enable translation of research into health care and public health innovations, facilitating the transition of multidisciplinary research outcomes into new healthcare products and services both the short- and long-term;
• Partner with industry to rapidly transfer short term results of this research into health IT products;
• Publish and otherwise disseminate these research findings, preferably in open source journals that maximize the accessibility of this knowledge to the entire health IT community
• Participate in an external evaluation; and
• Select desired, measurable outcomes specific to the chosen research issue and methods for attaining results.

Research focus areas

In no particular order, the four foci for research identified below will be addressed by this program.

The areas have been assigned numbers for ease of reference.

Appendix B provides further detail about each of these areas.
1.

Security of Health Information Technology - This research area addresses the challenges of developing security and risk mitigation policies and the technologies necessary to build and preserve the public trust as health IT systems become ubiquitous.
This research area is responsive to paragraphs (1), (4), (5), and (6) of the PHSA 3011(a), as added by the Recovery Act, through the following activities:
• Promoting the development and implementation of health information technology solutions that will support the electronic exchange and use of health information in a secure, private manner;
• Promoting the development and implementation of technologies and best practices that enhance the protection of health information by all holders of individually identifiable health information;
• Enhancing the capabilities and functionalities of tools to support privacy and security of individually identifiable health information as it is exchanged and used; and,
• Supporting and enhancing the assurance of privacy needed providers and patients widespread acceptance of telemedicine and robust participation in clinical data repositories and registries.
2.

Patient-Centered Cognitive Support - This research area addresses the challenge of harnessing the power of health IT so that it integrates with, enhances and supports clinicians reasoning and decision making, rather than forcing them into a mode of thinking that is natural to machines but not to people.
PHSA 3011(a), as added by the Recovery Act, directs the support of health IT architecture that will support the use of health information in an accurate manner.

Additionally, paragraphs (3) and (5) of the same subsection of the statute authorize use of funding appropriated under PHSA Section 3018, as added by the Recovery Act, to disseminate training and information on best practices to integrate health IT into a provider s delivery of care, and to promote the use of clinical data repositories and registries.

All of these paragraphs ((1), (3), and (5) of PHSA 3011(a) as added by the Recovery Act) point to longstanding challenges that require new and creative research related to the accurate and effective use of electronic health information to enhance the safety, quality, efficacy, and thus the overall value of care.



3.

Healthcare Application and Network Platform Architectures - This research area focuses on the development of architectures that are necessary to achieve electronic exchange and use of health information in a secure, private and accurate manner.

PHSA 3011(a)(1), as added by the Recovery Act, authorizes support of health IT architecture that will support "the nationwide electronic exchange and use of health information in a secure, private, and accurate manner".

This research focus specifically supports the development of new and improved architectures and technology infrastructure needed to achieve the goals outlined in the plan for health IT by the National Coordinator in support of PHSA 3001(c)(3), as added by the Recovery Act, and to support measures for determination of meaningful use of health IT by providers over time (required by Social Security Act (SSA) Sections 1848(o) and 1866(n), as added by Title IV in Division B of the Recovery Act).



4.

Secondary Use of EHR Data - This research area focuses on strategies to enhance the use of health IT in improving the overall quality of health care.

PHSA 3011(a), as added by the Recovery Act, states that the Secretary shall invest in the infrastructure necessary to allow for and promote the electronic exchange and use of health information for each individual in the United States consistent with the goals outlined in the strategic plan developed by the National Coordinator.

PHSA 3001(c)(3), as added by the Recovery Act, directs that the National Coordinator shall, "in consultation with other appropriate Federal agencies (including the National Institute of Standards and Technology), update the Federal Health IT Strategic Plan (developed as of June 3, 2008) to include specific objectives, milestones, and metrics with respect to" a specific set of topic areas.

The current Federal Health IT Strategic Plan (developed as of June 3, 2008), as referenced in the statute, advances "secondary use" as a key mode of information technology use to transform health care.

This is consistent with, and will be updated and expanded upon pursuant to the direction of PHSA 3001(c)(3)(i), (vii) and (vii), as added by the Recovery Act, to add to the updated strategic plan such objectives, milestones, and metrics with respect to:
• (Reference: PHSA 3001(c)(3)(i)) - the electronic exchange and use of health information and the enterprise integration of such information.
• (Reference: PHSA 3001(c)(3)(vii)) - strategies to enhance the use of health IT in improving the quality of health care, reducing medical errors, reducing health disparities improving public health, increasing prevention and coordination with community resources, and improving the continuity of care among health care settings.
• (Reference: PHSA 3001(c)(3)(viii)) - the specific plans for ensuring that populations with unique needs, such as children, are appropriately addressed in the technology design, as appropriate.

Eligibility Requirements

Applicant Eligibility

Any entity submitting an application for this award must be a U.S.-based:

• public or private institution of higher education; or
• other public or private institution or organization with a research mission.

Beneficiary Eligibility

This Funding Opportunity Announcement (FOA) will result in new competitively-awarded cooperative agreements to establish Strategic Health IT Advanced Research Projects (SHARP). The awardees will conduct research focusing on where breakthrough advances are needed to address well-documented problems that have impeded adoption of health IT and to accelerate progress towards achieving nationwide meaningful use of health IT in support of a high-performing, learning health care system.

Credentials/Documentation

No Credentials or documentation are required. This program is excluded from coverage under OMB Circular No. A-87.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

OMB Circular No. A-102 applies to this program. OMB Circular No. A-110 applies to this program. Application procedures will be specified in individual program announcements. Applicants should consult with the office or official designated as the contact for additional information on the application procedures.

Award Procedures

Following objective review of applications, those applicants whose applications have been selected by the Secretary of HHS (or designee) for funding will receive a Notice of Award signed by an HHS Grants Management Officer. The Notice of Award, which is sent to the applicant s Authorized Organizational Representative, is the only official notification of award. Unsuccessful applicants will be advised by letter.

Deadlines

Jan 25, 2010

Authorization

American Recovery and Reinvestment Act of 2009 (Public Law 111-5) (Recovery Act), Title XIII, Part A, Section 3011.

Range of Approval/Disapproval Time

From 30 to 60 days.

Appeals

Not Applicable.

Renewals

Not Applicable.

Assistance Considerations

Formula and Matching Requirements

Statutory formulas are not applicable to this program.
Matching requirements are not applicable to this program.
MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

ONC expects to award four cooperative agreements to support establishment of Strategic Health IT Advance Research Projects (SHARP) for a project period of four years. See the following for information on how assistance is awarded/released: PHSA 3012(c)(5), as added by ARRA, specifies that the Secretary may provide financial support to any regional center created under PHSA 3012(c) for a period not to exceed 4 years. Awards are expected to be for two, 2-year budget periods and a four year project period. The Funding Opportunity Announcement provides additional details on how assistance is awarded/released.

Post Assistance Requirements

Reports

Reporting and Registration Requirements under Section 1512 of the Recovery Act:

(a) This award requires the recipient to complete projects or activities which are funded under the Recovery Act and to report on use of Recovery Act funds provided through this award.

Information from these reports will be made available to the public.

(b) The reports are due no later than ten calendar days after each calendar quarter in which the recipient receives the assistance award funded in whole or in part by the Recovery Act.


(c) Recipients and their first-tier recipients must maintain current registrations in the Central Contractor Registration (www.ccr.gov) at all times during which they have active federal awards funded with Recovery Act funds.

A Dun and Bradstreet Data Universal Numbering System (DUNS) Number (www.dnb.com) is one of the requirements for registration in the Central Contractor Registration.

(d) The recipient shall report the information described in Section 1512(c) using the reporting instructions and data elements that will be provided online at www.FederalReporting.gov and ensure that any information that is pre-filled is corrected or updated as needed.

The frequency of interim progress reports and financial status reports will be identified in the program announcement and will be submitted no later than 30 days following the end of the reporting period to which they pertain.

The final progress report and final financial status report are due no later than 90 days after the end of the project period.

ARRA reporting and agency programmatic reporting provisions will require awardees to evaluate performance in view of stated objectives.

No cash reports are required.

The awardee shall submit annual progress reports related to their projects and overall site performance.

A specific Performance Report format will be finalized between the awardee and ONC following the award date.



In accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are incorporated into this award by reference.

Failing to comply with these requirements may result in suspension or termination of the award and/or ONC"s recovery of award funds.


Quarterly Financial and Programmatic Reporting: Consistent with the Recovery Act s emphasis on accountability and transparency, reporting requirements under Recovery Act programs will differ from and expand upon HHS s standard reporting requirements for grants and cooperative agreements.

In particular, Section 1512(c) of the Recovery Act sets out detailed requirements for quarterly reports that must be submitted within 10 days of the end of each calendar quarter.



Recovery Act-Required Performance Measures - To assist in fulfilling the accountability objectives of the Recovery Act, as well as the Department s responsibilities under the Government Performance and Results Act of 1993 (GPRA), Public Law 103-62, applicants who receive funding under this program must provide data that measure the results of their work.

Expenditure reports are not applicable.

The awardee shall submit annual progress reports related to their projects and overall Center performance.

A specific Performance Report format will be finalized between the awardee and ONC following the award date.



In accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are incorporated into this award by reference.

Failing to comply with these requirements may result in suspension or termination of the award and/or ONC"s recovery of award funds.


Quarterly Financial and Programmatic Reporting: Consistent with the Recovery Act s emphasis on accountability and transparency, reporting requirements under Recovery Act programs will differ from and expand upon HHS s standard reporting requirements for grants and cooperative agreements.

In particular, Section 1512(c) of the Recovery Act sets out detailed requirements for quarterly reports that must be submitted within 10 days of the end of each calendar quarter.



Recovery Act-Required Performance Measures - To assist in fulfilling the accountability objectives of the Recovery Act, as well as the Department s responsibilities under the Government Performance and Results Act of 1993 (GPRA), Public Law 103-62, applicants who receive funding under this program must provide data that measure the results of their work.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. The recipient shall comply with audit requirements of OMB Circular A-133. Information on the scope, frequency, and other aspects of the audits can be found on the Internet at www.whitehouse.gov/omb/circulars;

Records

Grantees are required to maintain grant records for a minimum of 3 years from the submission date of the final financial report. If any litigation, claim, negotiation, audit or other action involving the record has been started before the expiration of the 3-year period, the records shall be retained until the completion of the action and resolution of all issues which arise from it or until the end of the regular 3-year period, whichever is later.

Financial Information

Account Identification

75-0130-0-1-551.

Obigations

(Cooperative Agreements (Discretionary Grants)) FY 09 $0; FY 10 est $60,000,000; FY 11 est $0 - Awards will be in the form of a cooperative agreement with a 4-year project period. Under this type of award, ONC will work collaboratively with each site to accomplish the goals of the award. Each cooperative agreement will anticipate a total budget of between $10 million and $18 million over the full 4-year project period.

Range and Average of Financial Assistance

Awards may range from $10,000,000 - $18,000,000
Average award will be $15,000,000.

Regulations, Guidelines, and Literature

This program is subject to the provisions of 45 CFR Part 74 and the HHS Grants Policy Statement located at: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm. There are no program regulations.

Information Contacts

Regional or Local Office

None.

Headquarters Office

Wil Yu, 200 Independence, SW , Washington, District of Columbia 22209 Email: wil.yu@hhs.gov Phone: (202) 690-5920.

Criteria for Selecting Proposals

Specific, detailed criteria for determining the merit of applications will be made available in the program announcements for this program. In general, all applicants are required to demonstrate capability to achieve the goals, purposes, and objectives of the program consistent with applicable statutory provisions.



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