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Research Partnerships to Support Telehealth Opportunities
American Telemedicine Association
Business and Finance SIG
Kenyon Crowley MBA, MSIS, CPHIMS
September 11, 2013
Goals
 Understand potential academic partnership
opportunities
 How it may create value
 Sample engagements
 Nuances
 Funding support for collaboration
2
Strategy
TechnologyPolicy
About CHIDS
Mission
 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
3
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, O
perations)
Consumers,
Quality &
Transparency, and
Social Media
4
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
5
University collaborations
 Technology research and development
 Evaluations
 Pilots and clinical trials
 Teaming on grants and contracts
Impact
Research
Teaching
6
Product development
 Integrating cutting edge science and expertise for
new or enhanced products
 Push and pull
 User-centered design
University
Labs +
Centers
Industry
Liaison
7
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)
8
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.
9
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.
10
Licensing
Typical 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
11
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.
12
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
13
It takes an ecosystem…
14
Innovation
and Value
Customers
Employees
Scientific
Community
Partners
Other
Stakeholders
Questions + Contact
 Kenyon Crowley
Deputy Director, CHIDS
kcrowley@rhsmith.umd.edu
Tel 919-649-2279
www.rhsmith.umd.edu/chids
@healthIT
Thank you!
15
Appendix
16
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
17
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
18
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
19
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
20
 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
21

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Research Partnerships to Support Telehealth Opportunities

  • 1. Research Partnerships to Support Telehealth Opportunities American Telemedicine Association Business and Finance SIG Kenyon Crowley MBA, MSIS, CPHIMS September 11, 2013
  • 2. Goals  Understand potential academic partnership opportunities  How it may create value  Sample engagements  Nuances  Funding support for collaboration 2
  • 3. Strategy TechnologyPolicy About CHIDS Mission  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 3
  • 4. 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, O perations) Consumers, Quality & Transparency, and Social Media 4
  • 5. 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 5
  • 6. University collaborations  Technology research and development  Evaluations  Pilots and clinical trials  Teaming on grants and contracts Impact Research Teaching 6
  • 7. Product development  Integrating cutting edge science and expertise for new or enhanced products  Push and pull  User-centered design University Labs + Centers Industry Liaison 7
  • 8. 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) 8
  • 9. 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. 9
  • 10. 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. 10
  • 11. Licensing Typical 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 11
  • 12. 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. 12
  • 13. 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 13
  • 14. It takes an ecosystem… 14 Innovation and Value Customers Employees Scientific Community Partners Other Stakeholders
  • 15. Questions + Contact  Kenyon Crowley Deputy Director, CHIDS kcrowley@rhsmith.umd.edu Tel 919-649-2279 www.rhsmith.umd.edu/chids @healthIT Thank you! 15
  • 17. 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 17
  • 18. 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 18
  • 19. 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 19
  • 20. 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 20
  • 21.  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 21

Editor's Notes

  1. 64 of 310 studies met one or more of the criteria and were selected for the review. The breakdown of studies was unevenly distributed by condition as follows: heart failure/stroke (22 studies), diabetes (22), multiple LTCs (7), depression (4), hypertension (4), COPD (3) and older people (2).Results:  show that the evidence for the positive impact of telehealth is promising, but mixed. Only a few studies showed any negative impact, yet about one-third reported that telehealth had made no  positive difference over usual care. Of the two-thirds of studies which did demonstrate positive benefits oOctober 1, 2012, Maryland will become the 13th state to require private sector insurance companies to pay for telehealth services. Maryland joins California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, New Hampshire, Oklahoma, Oregon, Texas and Virginia in mandating that private payers cover telehealth services that are considered medically necessary and would otherwise be covered when provided face-to-face.r trends, few could claim that their results were statistically significant.
  2. 100+ labs and centersBasic science to complex systemsLimited number of apps are constructed on design principles that are theoretically derived, and little is known about their effectiveness.
  3. Economic example: Communication inefficiencies, CiscoProcess Example: Impact of nursing call systems, VoceraClinical example: Comorbidities in remote diabetes careUsability: HCIL work
  4. STTR differs from SBIR in three important aspects:The SBC and its partnering institution are required to establish an intellectual property agreement detailing the allocation of intellectual property rights and rights to carry out follow-on research, development or commercialization activities.STTR requires that the SBC perform at least 40% of the R&amp;D and the single partnering research institution to perform at least 30% of the R&amp;D.Unlike the SBIR program, STTR does not require the Principal Investigator to be primarily employed by the SBC.The programs’ goals are to:Stimulate technological innovationFoster technology transfer through cooperative R&amp;D between small businesses and research institutions;Increase private sector commercialization of innovations derived from federal R&amp;DMust be small business concern (&lt; 500 employees)3 PhasesReference: http://grants.nih.gov/grants/funding/sbirsttr1/2013-2_SBIR-STTR-topics.pdf
  5. Background: Personal health records (PHRs) are an important tool for empowering patients and stimulating health action. To date, the volitional adoption of publicly available PHRs by consumers has been low. This may be partly due to patient concerns about issues such as data security, accuracy of the clinical information stored in the PHR, and challenges with keeping the information updated. One potential solution to mitigate concerns about security, accuracy, and updating of information that may accelerate technology adoption is the provision of PHRs by employers where the PHR is pre-populated with patients’ health data. Increasingly, employers and payers are offering this technology to employees as a mechanism for greater patient engagement in health and well-being.Objective: Little is known about the antecedents of PHR acceptance in the context of an employer sponsored PHR system. Using social cognitive theory as a lens, we theorized and empirically tested how individual factors (patient activation and provider satisfaction) and two environment factors (technology and organization) influence patient intentions to use a PHR among early adopters of the technology. In technology factors, we studied tool empowerment potential and value of tool functionality. In organization factors, we focused on communication tactics deployed by the organization during PHR rollout.Methods: We conducted cross-sectional analysis of field data collected during the first 3 months post go-live of the deployment of a PHR with secure messaging implemented by the Air Force Medical Service at Elmendorf Air Force Base in Alaska in December 2010. A questionnaire with validated measures was designed and completed by 283 participants. The research model was estimated using moderated multiple regression.Results: Provider satisfaction, interactions between environmental factors (communication tactics and value of the tool functionality), and interactions between patient activation and tool empowerment potential were significantly (P&lt;.05) associated with behavioral intentions to use the PHR tool. The independent variables collectively explained 42% of the variance in behavioral intentions.Conclusions: The study demonstrated that individual and environmental factors influence intentions to use the PHR. Patients who were more satisfied with their provider had higher use intentions. For patients who perceived the health care process management support features of the tool to be of significant value, communication tactics served to increase their use intentions. Finally, patients who believed the tool to be empowering demonstrated higher intentions to use, which were further enhanced for highly activated patients. The findings highlight the importance of communication tactics and technology characteristics and have implications for the management of PHR implementations.
  6. The STTR Program is structured in three phasesPhase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&amp;D efforts and to determine the quality of performance of the small businesses prior to providing further Federal support in Phase II. STTR Phase I awards normally do not exceed $100,000 total costs for 1 year.Phase II. The objective of Phase II is to continue the R/R&amp;D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the Phase II project proposed. Only Phase I awardees are eligible for a Phase II award. STTR Phase II awards normally do not exceed $750,000 total costs for 2 years.Phase III. The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&amp;D activities. The STTR program does not fund Phase III. In some Federal agencies, Phase III may involve follow-on non-STTR funded R&amp;D or production contracts for products, processes or services intended for use by the U.S. Government.