This document discusses potential opportunities for research partnerships between universities and industry in the area of telehealth. It outlines several types of partnerships that could be pursued, including technology research and development, evaluations of telehealth solutions, pilots and clinical trials, and university involvement in product development. It also discusses how such partnerships could provide funding for researchers, intellectual property licensing arrangements, and various federal and state funding programs that support commercialization collaborations.
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
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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
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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
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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
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6. University collaborations
Technology research and development
Evaluations
Pilots and clinical trials
Teaming on grants and contracts
Impact
Research
Teaching
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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
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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)
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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.
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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.
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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
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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.
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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
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14. It takes an ecosystem…
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Innovation
and Value
Customers
Employees
Scientific
Community
Partners
Other
Stakeholders
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
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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
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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
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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
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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
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Editor's Notes
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.
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.
Economic example: Communication inefficiencies, CiscoProcess Example: Impact of nursing call systems, VoceraClinical example: Comorbidities in remote diabetes careUsability: HCIL work
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&D and the single partnering research institution to perform at least 30% of the R&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&D between small businesses and research institutions;Increase private sector commercialization of innovations derived from federal R&DMust be small business concern (< 500 employees)3 PhasesReference: http://grants.nih.gov/grants/funding/sbirsttr1/2013-2_SBIR-STTR-topics.pdf
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<.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.
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&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&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&D activities. The STTR program does not fund Phase III. In some Federal agencies, Phase III may involve follow-on non-STTR funded R&D or production contracts for products, processes or services intended for use by the U.S. Government.