The Big Tent

CTSI 2016 NIH Renewal Proposal Launchpad

Digital Health Sciences Virtual Core

UCSF Digital Health Sciences Virtual Core

An Open mHealth-compatible Rapid Development Platform & Services

Problem Digital and connected health technologies promise to reduce health care costs and improve health outcomes. Many CTSA researchers have digital health ideas they want to pursue and test, but their institutions are not able to fully provide the resources and expertise they need to build initial prototypes and/or to conduct clinical research using digital technologies.

Solution: The UCSF Digital Health Sciences Virtual Core

The Virtual Core will be a joint effort of CTSI and the Center for Digital Health Innovation (CDHI) to provide “one-stop shopping” for researchers to quickly develop, prototype, field test, and evaluate digital health technologies. The novel technical approach that can be scaled across CTSAs and beyond is to exploit Open mHealth[1], an emerging standard for integrating mobile apps and data, and to build open source Open mHealth-compatible modules for clinical research. The Core will offer 3 major services on a recharge basis to UCSF, participating CTSAs, and other partners:

  1. Rapid Development Services – CDHI is currently choosing a rapid development platform, any of which can be “future-proofed” through use of Open mHealth and other standards. Researchers will work with UCSF developers to script user interaction (e.g., data capture screens, account setup, informed consent, protocol set-up (e.g., n-of-1), reminders, etc.). Development will leverage shared APIs and modules from the growing Open mHealth community, which includes companies (e.g., Qualcomm Life, Ginger.io), health systems (e.g., Kaiser), research centers (e.g., NSF-funded Calit2), and innovation projects (e.g., XPrize). This community is building open APIs to commercial data clouds (e.g., Jawbone, RunKeeper). Use of Open mHealth and other shared code will thus reduce unnecessary duplication while promoting reuse and rapid innovation.
  2. Hosting Services -- UCSF will host the development platform, server, and secure data store with full access control privileges for UCSF and external users. Partners may also host their own data store, platform, and/or server depending on local needs while still benefiting from shared software.
  3. Consultation, Grants, and Resources – The Core will partner with campus entities and other CTSAs to coordinate: 1) technical, design, and methodological consultation services; 2) pilot grants to UCSF researchers under the RAP and T1 Catalyst mechanisms; 3) recruitment assistance and opportunities (e.g., with SF HIP); and 4) streamlined processes (e.g., IRB templates, industry MOUs).

Partners: Potential UCSF partners include QB3, ITA, ISU, and many others. CTSA interest includes UC Davis (on participatory research and business processes), USC, and Cornell (they are hosting their own platform). Industry interest includes Ginger.io, and J&J, (which could link with the Clinical Trials Consortium). Connections to Qualcomm, Intel, etc. open opportunities around devices. From the community, Quantified Self is interested in collaborating around “citizen science,” which could involve SFHIP as well. While UCSF will lead the development of software and methods for core clinical research needs (e.g., recruitment, informed consent, n-of-1 studies, standardized variables, connection to EHRs), other partners can develop their own areas of expertise by contributing or curating open source code or research methods (e.g., mental health, health disparities, longitudinal studies, etc.). By design, this effort can be scaled across additional partners nationally and internationally (e.g., for global health).

Innovation: This proposal is unique in developing and disseminating reusable modules for digital health and clinical research while tapping into open resources from across the mHealth ecosystem. Northwestern’s Purple Robot also offers a scripting and sensor data acquisition platform, but is Android only and is a closed solution that does not ensure integrated mHealth solutions.  

Projected Impact: UCSF will establish clear leadership in the digital health sciences. It will likely lead to new academic-industry collaborations, and will increase the innovation and output of researchers across CTSAs. Finally, through Open mHealth, the resulting software, methodologies, and best practices will reach beyond academia to maximize CTSA’s and NIH‘s ultimate impact on human health.



[1] Open mHealth is a non-profit funded by RWJF and co-founded by Ida Sim, UCSF CTSI’s Co-Director of Biomedical Informatics.

Comments

Ida

 

I think I understand how this proposal describes a set of tools different from what is currently being developed at UCSF but could you discuss how you see the Virtual Core fitting into the current mHealth and Center for Digital Health Innovation initiatives. 

 

Education also has a strong interest in these areas and the School of Medicine's new Bridges Curriculum is being built around a core of quality improvement work in research and health care and are thinking about how all of our digital health work comes together to create a strong core. 

 

Kevin 

Hi Kevin,

 

This proposal is being developed in close coordination with CDHI. The technical services will be delivered through CDHI, the informatics and clinical research methodology from CTSI, and consultation services and other resources will be jointly delivered by CTSI and CDHI. We are working to streamline a single portal to help UCSF and external people easily navigate and access all digital health related services and resources, whether from CTSI, CDHI, or any other part of campus. It'll be a work in progress!

 

As for educational applications, the Virtual Core will certainly support educational solutions, and the support for prototyping and evaluation will offer opportunities for testing both educational and clinical solutions in training environments. We'd love to make deeper links with your office.

 

Thanks for your comments!

Ida

Ida - this is fabulous!  This infrastructure and support are critical to support rapid, thoughtful development of tools in the digital health space.  We will be somewhat novel in providing this service — overlap with the Center for Digital Health Innovation is big but funding to allow CTSI to build out the support and platform services (especialy the critical consultion service) will be critical.  I also recommend adding funding to expand the digital health portion of the T1 Catalyst program and awards for pilot funding.  Thanks - Leslee

 

Thanks, Leslee. I will include additional funding for pilot awards in this proposal, and consider additional mechanisms that would allow faculty to take the most advantage of this Core.

This sounds like a really interesting service!  If the goal is to bring in new investigators, it will be critical to provide some level of support outside the recharge system (e.g., 5 hours free consultation, free creation of first prototype). It also might be helpful to create a webinar or offer a class through CTSI for those who are new but interested to help them get started. 

In collaboration with CDHI, we are considering a series of short instructional videos on selected digital health topics, complemented by targeted webinars. These efforts would not be part of this proposal but would certainly dovetail with it.

Very exciting proposal! I am looking forward to discussing it further at the CTSI retreat. While this proposal describes some new and innovative approaches, I'm curious about how this program would work alongside the CDHI and mLabs. One issue, which I would love to see addressed/added is more design support for researchers and a discussion about the importance of considering a design strategy in the development of mobile tools.

I fully agree that good design is critical to successful solutions. We will work with CDHI and the Office of Technology, Innovation, and Alliances to develop a cadre of external design experts that faculty can easily work with through standing business agreements. Moreover, the Open mHealth community will be generating open source visualization modules that UCSF developers can reuse and customize. 

The idea of a digital health sciences virtual core is important and highly relevant to the proliferation of mobile devices and ubiquitous communications. As I understand it, the proposal centers the Core on the "ohmage" data management and mobile application platform, and considers "researchers" to be the target customer. 

 

1. Up front, it would be good to establish a customer focus by uncovering what researchers want or need in the way of development and support services. Then we can determine what unique contributions UCSF can make. The description of Rapid Development Services could then be more specific about what technical support UCSF would want to offer. For example, rapid development services could range from a software toolkit with an integrated development environment and necessary tools with a basic user guide, to an education program (classes, workshops) on best practices for developing digital health technology, to a technical support program for actual development and even a consulting service in architectural design. 

 

2. The proposal mentions prototyping, field testing and evaluation of digital technologies but subsequent services seem to be focused on software development assistance and application and data hosting. Prototyping and field testing would involve hardware, to start. 

 

a) To what extent would UCSF be involved in hardware design and prototyping, which would require hardware-related knowledge and expensive equipment and manufacturing facilities?

 

b) Does the proposal envision UCSF offering a field for testing, e.g., recruit participants?

 

c) Or does the reference to evaluation mean we would like to develop some sort of testing or certification program for digital health technologies? 

 

3. Because the mobile world changes extremely quickly, it would be good to consider other potential platforms or adopt a strategy capable of supporting other platforms as they develop. 

 

4. The concept of a Digital Health Sciences Resource Center seems to differ from that of the other two services in that it seems more of a referral center or clearinghouse, whereas Rapid Development and Hosting are directly related to the development of digital health technologies. Could it be a separate proposal?

Thanks, Greg. Great points.

 

1. There was a previous survey of the digital health development needs of UCSF staff, faculty, and students that informed this proposal. We should do another needs assessment in coordination with CDHI.

 

2a. This proposal was not envisioned to include hardware design and prototyping. We have many contacts to digital device companies that may be interested in providing sample units for testing. Those are business relationships that we can explore over time.

 

2b. Recruitment is always a challenge. We would work with Participant Recruitment Services in CTSI to identify opportunities. For cardiovascular projects, the Health eHeart project is a possible option as well. This work would be separate from this specific proposal. 

 

2c. CDHI is developing a program for field testing apps and solutions, catering mostly to external companies for starters. The Digital Health Sciences Core can support that work by providing reusable modules for "embedded evaluation" (e.g., informed consent, randomization, standardized symptom collection) of commercial apps/solutions.

 

3. The Open mHealth initiative is aimed at specifically the problem of rapid change and evolution: to provide a common open architecture for the digital health ecosystem that is future-proofed by design. The ISU development shop in the School of Medicine has evaluated a number of development platforms -- ohmage is only one of them but has the virtue of being Open mHealth compatible. The Core should certainly be designed to not be locked into ohmage or any other platform, and Open mHealth's open architecture would support such a platform-agnostic approach.

 

4. Good point. The Resource Center will be joint with CDHI also, and can be a separate but complementary effort (like recruitment, for example). For purposes of CTSA renewal, however, it may be strategic to show how Consultation Services from several CTSAs can be leveraged to enhance the impact of the Virtual Core for the wider CTSA consortium.    

COMMENTS FOR THE CTSI RETREAT DISCUSSION


The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad

Digital Health Sciences Virtual Core

Ida Sim


1. Summarize the problem being addressed.  Please make sure this is NOT disease-specific.

Many researchers at UCSF and beyond have digital health ideas they want to pursue and test, but their institutions are not in a position to fully provide the resources and expertise they need to build initial prototypes and/or to conduct clinical research using digital technologies

 

2.    Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

Virtual core will use ‘ohmage’ and openmHealth platforms to

  1. Provide framework for prototyping and field testing & rapid development services
  2. Consolidate consulting and other resources under a ‘resources core’.

 3.    What partners are involved in the solution?

Potentially other CTSAs – UC Davis & Cornell interested.  Industry, J&J and Ginger.io interested.


4.    What is the potential impact?

UCSF will establish clear leadership in the digital health sciences.

It will likely lead to new academic-industry collaborations, and will increase the innovation and output of researchers across the CTSA consortium.

Through Open mHealth, the software, methodologies, and research results facilitated by the Virtual Core will reach beyond academia to maximize CTSA’s and NIH‘s ultimate impact on health.

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad

Notes

 

1.     How do we maximize impact and broad applicability of the proposal?

Go beyond just the ohmage platform.

Communicate options that are available and how to get them. Navigation services type guidance.

Articulate what the assets are, what’s the faculty resource center and what can it do, what technologies are available, and how to get them. Make it one-stop-shopping.

Expand pilot awards from $30k to $100k and money to study the efficacy.

Create an app store for these technologies, develop knowledge store of technical and any policy best practices/lessons learned in digital health work with NIH and other governing bodies.

Share the model with other universities to start their own, then possibly partner with them.

 

2.     What foundation exists on campus already that will ensure success of the initiative?

 Center for Digital Health Innovation - 30 iPhone apps, two survey systems, 3M funding, resource center chancellor

Existing partnerships with companies like Genentech  Qualcomm for development and use of digital health apps for collecting study data.

Existing app store should be leveraged and communicated by CTSI.

 

3.     What creative and/or innovative partnerships could be leveraged to ensure success?

 Leverage programs like Catalyst to bring scientists and industry together. Leverage other contacts with researchers to funnel them to Digital Health Sciences Virtual Core.

Leverage relationships with other universities (CTSA, BRAID, Global Alliance on Genetics) to increase the pool of available development and application resources.

Get Mike Blum and Ida Sim together.

Innovation technology fund should also be leveraged.

 

"Get Mike Blum and Ida Sim together."  -- LOL :)  CTSI's on it...

The Virtual Core is envisioned to support early prototyping and testing of apps and solutions, drawing on a growing Open mHealth library of open APIs and reusable code. Once a solution is more finalized, it should be developed on a robust commercial platform if it is to be deployed in the marketplace. That going-to-market phase will needs support from UCSF  (e.g., app store, etc) -- any effort along these lines will be in conjunction with CDHI, T1 Catalyst, and QB3 and will be separate from this proposal. 

 

This Virtual Core will be working in very close coordination with all the campus and external entities mentioned in this very helpful comment. The Core is also structured to be exportable to other institutions (in fact, Cornell CTSA plans to do a version of this starting this fall). Thanks!

COMMENTS FROM CTSI RETREAT, GROUP 8-1:

1. How do we maximize impact and broad applicability of the proposal?

 

Clarify that EMR, genomic data and desktop platforms are included in opportunities, not limited to mobile technologies; HOWEVER  a focus on mHealth might be attractive.

 

Clarify that the platform will strengthen the link between industry and academia; the “bridging environment”.

 

Describe that this core doesn’t own the projects, but “seeds” possibilities for success.  Another mechanism to help ideas get into the door could help.

 

How is the discovery distinguished to the individual, yet open to use by other investigators?  Breaking out the technology into components that are generalizable and can be used by others.  Open mHealth is a library with all of the components in it.  You may want to license some components and leave others open.

 

Examples of how patterns or components have been used could be powerful for providing exemplars, including in clinical research. 

 

Access to expertise and resources for developing apps is an attractive idea for investigators.  Perhaps SOS could help incentivize this; perhaps asking how people propose what piece of their code or technological innovation will be provided to the university or other sponsors in exchange for support.

 

Important to develop research methodologies and tools for supporting work in mHealth.  CDHI will support frontlines innovators, but there is growing interest in consultation—both getting and paying for. 

 

We lack evaluation tools for impact, usability, etc. of tools and methodologies.

The way we do science is different from how we develop software.  Some challenges: implementation science; not asking the right questions, for example. 

 

A year might be a reasonable timeline for developing a pilot iteration of the software development process.

 

Ohmage could provide a platform for gathering data re: behavior to influence development of mHealth innovations to predict how features will work with populations.

 

Part of the process should be to help build the connection to industry translation/ adoption to polish, be ready of use.


2.     What foundation exists on campus already that will ensure success of the initiative?

 

SFHIP can help support engagement with local community collaborators to identify apps that people want to use for improvement of community health.

 

Consultation services could help inform the development of this new service.

 

SOS can function to disseminate pilot funds

 

CDHI

 

Catalyst Awards can help move successful prototypes beyond pilot phase

 

 3.     What creative and/or innovative partnerships could be leveraged to ensure success?

 

SFHIP can help support engagement with local community collaborators to identify apps that people want to use for improvement of community health.

 

Tapping expertise of other CTSAs via consultation.

Tapping recruitment services across other CTSAs.

Cornell, UCSD, UCSC are interested. UC Braid network or CTSA network. Corporations, or UCB could provide technical support, potentially.

Industry partners could provide support for development (pilot?) - There has already been an example of private industry interest in partnering for their clinical trials.

From today's panel discussion (8-2), it seems that CDHI is already providing rapid development services in a flexible, low-cost way. It is integrating software modules already available in the marketplace for researchers, and working with business technology partners to enhance existing software and develop new features. CDHI also seems well-funded and positioned to garner more funds.

 

CTSI need not duplicate these services. Our panel found opportunities for expansion by supporting CDHI's work, articulating it to UCSF researchers, outlining clear avenues for engaging with CDHI, and helping to broadcast its products. 

 

We also discussed capturing the CDHI "model" for possible use as best practices for organizations outside UCSF. 

The technical approach proposed here is fundamentally different from ISU's current services (ISU being the development shop aligned with CDHI), and shows far greater promise for leading to better integrated data and solutions for more effective health care and research (see http://www.jmir.org/2012/4/e112/#ref11). This proposal is being developed with CDHI and ISU, and we will ensure that all services will be coordinated and complemented, not duplicated.  

The synergy between the CDHI and the proposed Digital Health Science Core are many.  While the CDHI was initiated with generous funding from the Chancellor and external donors, additional funding will be critical to provide ongoing and expanding services to the researchers, developers and clinicians who are well poised to develop and test digital health innovations.  I think we can use the CTSI-supported Core to expand the CDHI infrastructure, adding critical funding to develop MORE services that are more ACCESSIBLE to UCSF (and then extramural) researchers and clinicians.  

 

Specifically, we need to increase the staff of technology experts to guide our content and research experts (who may not yet be sophisticated in digital health) through the development and testing of new technology.   The consultation service is essential and critical.  Funding to provide staff for pre-award development is necessary so investigators can eventually bring in grant funding (to support the core/CHDI) and even royalties from sales.   I also recommend adding funding to expand awards for pilot funding (maybe add to the existing and successful digital health portion of the T1 Catalyst program). 

 

In addition to open standards, this proposed program (or perhaps others at UCSF) could give a focus to information security. Mobile devices are proliferating but their security frameworks, where they exist, and human behavior about deploying the devices expose risks to the data they store, transfer, and maintain.

Commenting is closed.