Research Partnerships to Support Telehealth OpportunitiesAmerican Telemedicine Association

Business and Finance SIG

Kenyon Crowley MBA, MSIS, CPHIMSSeptember 11, 2013

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Goals Understand potential academic partnership

opportunities How it may create value Sample engagements Nuances Funding support for collaboration

Strategy

TechnologyPolicy

About CHIDSMission Research, analyze, and recommend solutions to

challenges surrounding the introduction and integration of information and decision technologies into the health care system

Improve the practice and delivery of health care by offering researched solutions that impact safety, quality, access, efficiency, and ROI

Partner Ecosystem Federal and state agencies (HHS, NSF, DOD, State of

MD) Private corporations (Children’s National, J&J, CareFirst

BlueCross BlueShield, Cisco, Small and Mid-Size firms) Not-for-profits (CDT, eHealth Initiative)Resources Renowned scholars from multiple disciplines Research fellows, students, partners

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Research Focus Areas

Impact and Comparative

Effectiveness of Health Information

Systems

New Models of Care (ACO, HIE,

PCMH, Care Transitions)

Healthcare Analytics (Data-

driven Health Services Insights,

Modeling, Operations)

Consumers, Quality &

Transparency, and Social Media

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Telehealth landscape Growing market Lots of solutions

New and different types of solutions (sensors, mobile health, integrated systems, automated decision support, health gaming)

Reimbursement improving Mixed messages on efficacy Design and usability varied

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University collaborations Technology research and development Evaluations Pilots and clinical trials Teaming on grants and contracts

Impact

Research

Teaching

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Product development Integrating cutting edge science and expertise for

new or enhanced products Push and pull User-centered design

University Labs + Centers

Industry Liaison

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Evaluations What is the effectiveness, impact and value of this solution? Economic

How does solution affect drivers of revenues and costs Clinical

How is disease management, care quality, safety or other measures influenced by the solution

Process How well does solution fit into existing or emerging systems What system changes may be appropriate What solution changes may be appropriate Time and motion studies, Workflow analysis, Efficiency metrics

Usability How do we rate against usability heuristics How do users perceive our product In the solution's environment (not only in a lab)

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Pilots & Clinical Trials Design and management

Methods Site selection Agreements & regulations Cohort management

RCT is gold standard, but other options are available Data Analysis Institutional Review Board (IRB) navigation

IRB is a committee designated by an institution to help assure the protection of the rights and welfare of human subjects. If sponsored by HHS: Federal regulations at 45 CFR Part 46 must be followed.

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University Tech Transfer Role Brings solutions to marketplace Pay to Protect IP – patents, trademarks, copyrights. Assist in the development of Business Plans and

commercialization strategy. Assist in getting additional grant funding to further

develop IP Create start-up company when appropriate vehicle for

commercialization. Assist in raising financing for company. Negotiate agreements with licensees.

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LicensingTypical Agreement Terms and Conditions: Licensing (to start-ups or large corporations):

- royalty paid to university based upon sales attributable to IP – typically around 5% of sales.

Milestones – if license is exclusive then minimum royalties typically apply as well as development milestones (especially in drug development).

This relates to University-licensed IP; licensing is not required typically for a University research partner managing or supporting a pilot or other evaluation of 3rd party’s product

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What’s in it for the researchers Additional funding to do research Royalties (Ranges broadly) Peer acknowledgement Equity in start-up

Does little to get tenure other than as a result of the papers that may be published on the on-going research, and sometimes publishing in itself is a huge problem in commercialization.

Younger profs focus is usually getting tenure, which is gained through- Publishing papers- Doing more research- Teaching

Commercialization of IP is not always high on their list – has implications for businesses who want to license/buy the IP and move the IP forward in conjunction with the researchers.

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Funding collaborations

Federal Funding State-based Programs* SBIR/STTR

Supports economic development, scientific excellence and technological innovation through the investment of Federal research funds

Must be small business concern (< 500 employees)

Next round: HHS (NIH, FDA, CDC): December 5

Demonstration projects, building evidence base NIH, AHRQ, HRSA R21 Next round Oct 16

MIPS The Maryland Industrial Partnerships

(MIPS) program accelerates the commercialization of technology in Maryland by jointly funding collaborative R&D projects between companies and University System of Maryland faculty.

Telehealth successes: WellDocs, TelCare

TEDCO Provides Mentoring, Funding, and

Networking opportunities to Entrepreneurs

*Many states have similar programs

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It takes an ecosystem…

Innovation and ValueCustomers

Employees

Scientific Community

Partners

Other Stakeholders

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Questions + Contact Kenyon Crowley

Deputy Director, CHIDSkcrowley@rhsmith.umd.eduTel 919-649-2279www.rhsmith.umd.edu/chids@healthIT

Thank you!

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Appendix

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Algorithms and modeling sample Modeling ICU systems and throughput Predictive models for early identification of diabetes “jumpers” Fraud identification algorithms University role:

Assess and document the effectiveness and value of solution Explore, refine and test next generation advances to the predictive

model Assess behavioral aspects and usability of current approach and

recommend improvements

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PHR + secure messaging pilot sample Assess pilot implementation of secure messaging

and PHR University role

Design research and analytical strategy Advise vendor on data management Manage trial Publish results and lessons learned

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Mobile EHR for Cardiologists design sample Company has an existing basic EHR and is seeking to build a

specialty-specific product Market assessment by MBA team Software requirements by research group University role:

Financial and qualitative assessment of potential markets Design, manage and conduct focus groups including cardiologists and

cardiac nurses Assess policy: meaningful use, standards, relevant market

developments Document technical, functional requirements

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STTR Applicant is a Small Business Concern Formal Cooperative R&D Effort

Minimum 40% by small business Minimum 30% by U.S. research institution

U.S. Research Institution College or University Other non-profit research organization Federal R&D center

Phase 1 normally does not exceed $100,000 total costs for 1 year. Phase II awards normally do not exceed $750,000 total costs for 2

years. Intellectual Property Agreement

Allocation of IP rights and rights to carry out follow-on R&D and commercialization

Principal Investigator’s primary employment may be with either the Small Business Concern or the research institution

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Small Business Concern Organized for-profit U.S. business 500 or fewer employees, including affiliates Must be:

At least 51% U.S.- owned by individuals and independently operated

or At least 51% owned and controlled by another (one) business concern that

is at least 51% owned and controlled by one or more individuals Three Phase potential Principal Investigator’s primary employment must be with the Small

Business Concern

SBIR