This document summarizes a panel discussion on commercializing digital health and education technologies. The panel included representatives from universities, digital health companies, law firms, and banks. Key points discussed included: - Universities like UCSF are actively licensing their technologies and have founded over 90 companies based on their research. - Digital health companies discussed how their platforms use passive smartphone data and behavioral analytics to help manage chronic conditions like diabetes. - Lawyers on the panel discussed FDA regulations for mobile medical apps and key intellectual property issues for digital health technologies. - Banks discussed trends in digital health investment and how they support startups in the space.

1. Commercializing Software IP: High
Tech, Digital Health & Education
Digital Health:
The Smartest Use of Your Phone
November 13, 2013

2. PANELISTS
• Debbie Alexander, Senior Licensing Officer,
University of California, San Francisco
• Mickey Brandis, Head of Legal, Ginger.io
• Holly McGarraugh, VP Business Development and
Strategic Alliances, Glooko
• Monisha Perkash, CEO & Co-founder, LUMO
BodyTech
• JC Simbana, Director, Silicon Valley Bank
• Michael Swit, Special Counsel, FDA Law Practice,
Duane Morris LLP
• Soody Tronson, Founder and IP Counsel, STLGip

3. Debbie Alexander, Senior Licensing
Officer, University of California, San
Francisco
The Office of Innovation, Technology & Alliances coordinates the University of
California, San Francisco’s efforts in forging collaborations and licensing technologies
that translate cutting-edge science on campus into therapies and products that
directly benefit patients worldwide. More than 97 products are currently sold based
on UCSF technology, with 13 more in clinical development. In addition, more than 90
companies have been founded based on UCSF technology.
Debbie has been managing intellectual property at UCSF since 2009 and specializes in the
rapidly-growing area of dHealth innovations. Debbie was previously a Scientific Curator at
TAIR, the worldwide Arabidopsis database; and also performed postdoctoral research at
Stanford University. Debbie holds a DPhil in Plant Sciences from the University of Oxford and
a BSc in Molecular Biology and Biochemistry from Durham University.

4. 4
Nursing: #4
(#1 in research)
Pharmacy: #1
School of Dentistry
#2 in funding
Graduate School
Programs in top 10
Medicine: #4
Medical Center: #7
UCSF is among the top biomedical research
institutions in the world
–2,400
faculty
–4,400
students
(including
postdocs)
from 94
countries

5. 5
Relationship
Development
Sponsored
Research
Invention
Disclosure &
Patents
Invention
Development
Licensing &
Entrepreneur
Resources
Office of Innovation, Technology &
Alliances , UCSF

6. UCSF Apps

7. Mickey Brandis, Head of Legal,
Ginger.io
Ginger.io is a leader in behavioral analytics for
healthcare. The Ginger.io platform uses passive
smartphone data to enable providers to deliver timely
interventions to their high risk patients. It has been
deployed as a population health management system
across a variety of chronic conditions including
diabetes, cardiovascular disease, and co-morbid
depression.
Prior to Ginger.io, Mickey served on the executive team and as general counsel at public and
venture-backed technology companies in Silicon Valley. He also practiced law at various law
firms, including Fenwick & West, the Sedgwick firm, and Katten, Muchin & Zavis. Mickey also
served a presidential appointment in President Clinton’s administration, where he was
responsible for defense policy and arms control negotiations. He received his BA in
International Relations from U.C. Davis and his JD from Santa Clara University.

8. Confidential & proprietary. © 2013
Behavioral Analytics for Population Health

9. Patient
Smartphone
App
Behavior
Patterns
Data
Collection
Location
Communication
Sensors
Self Reported
Socialization
Activity
Quality-of-Life
Health
Status
Patient &
Caregiver Alerts
Provider
Dashboard
Analytics EngineApp Dashboard
The Platform
Confidential & proprietary. © 2013

10. Holly McGarraugh, VP Business
Development and Strategic Alliances,
Glooko
Glooko’s FDA 510(k) cleared, HIPAA compliant diabetes
management system is modernizing diabetes
management by breaking barriers in technology and
building bridges between patients and providers.
Holly has been focused on diabetes and medical devices for 25 years. Molly was previously
an executive at TheraSense which was acquired by Abbott Diabetes Care. As an early
employee at LifeScan, she held roles in Sales, Marketing, Service and QA/RA. Holly was also
the CEO of Apieron, an asthma management device company. Holly has an MEd from
Vanderbilt University.

11. Meters: 25 and growing
- Connects with all major
glucose meters … >80%
coverage
- Coming soon: Pumps
- Next: CGM and other sensors
Device Agnostic Diabetes Management Platform
Glooko Confidential-
10/2013
Mobile Devices: 27 and growing
- Apple devices: iPhone, iPod touch,
and iPad
- Android: All major models
- Coming soon: Bluetooth connectivity

12. Our mission is to transform the way patients and their healthcare team
interact and manage their diabetes by leveraging the power of a
mobile platform and population health tools to improve outcomes.
FDA 510(k) cleared
- December 23, 2012 (v1)
- April 29, 2013 (v2)
- Android October 19, 2013
Mobile Based Diabetes Management Services
Glooko Confidential-10/2013

13. Provider Organizations
- Clinic Reports/Graphs
- P4P/Quality $’s
- Patient Dashboard
- Provider Dashboard
Diabetes
Devices
Mobile
Devices
Payers/Employers
- Population Health
Management
- Target high-risk, high cost
individuals
Device & Pharma Co’s
- Co-Branded for patients
/providers/payers
- Clinical trial solutions
- Faster, lower cost product
development
Patient Tracking:
Engagement/Education
- Glucose readings
- Food/carbs
- Medication
- Activities
Overview:
Care team now has information to regularly and efficiently
adjust the care plan
Glooko Confidential-8/13

14. Glooko Confidential-10/2013
Patient Smartphone
Options:
• iOS/iPhone smart
connector
• Android smart
connector
• Bluetooth LE
Adapter
Provider or Patient Web Views,
API’s with EHR, Disease Mgt, Pharma
Clinical Trial Systems, etc.

15. Provider Dashboard –
Population Health Search
Glooko Confidential-10/2013

16. Monisha Perkash, CEO & Co-founder,
LUMO BodyTech
The company uses smart sensors and software to help
people improve their health. Their first product is the
LUMOback posture and activity sensor which has
recently received notable coverage in outlets such as
the Wall Street Journal, Oprah Magazine, and Fox News.
LUMO is backed by Madrona Ventures, Eric Schmidt's
Innovation Endeavors, and Jerry Yang's AME Cloud
Ventures.
Monisha previously served as CEO and Co-Founder of TuitionCoach (acquired by
SimpleTuition in 2009), where she oversaw the financing, launch, and general management
of the start-up. After the acquisition, she stayed on with SimpleTuition as VP Products. She
has also held leadership positions at Siebel Systems, Pensare, and AmeriCorps. Monisha has
an MBA from Stanford and a BA from Yale. She enjoys spending time with her family, playing
tennis, skiing, running, and dancing.

17. LUMO BodyTech

18. LumoBack Posture & Activity
Feedback System

19. The LumoBack Sensor Vibrates
When You Slouch

20. • Time spent in good and bad posture.
• Time sitting and standing.
• Number of steps, distance, and
calories.
• Sleeping positions and total sleep
time
The LumoBack App Tracks Your
Activities

21. JC Simbana Director,
Healthcare and Digital Health Practice
Silicon Valley Bank
Banking the world's most innovative companies and exclusive
wineries, SVB's diverse financial services, knowledge, global
network, and world class service increase our clients'
probability of success. With $23 billion in assets and more than
1,600 employees, we provide commercial, international and
private banking through 34 locations worldwide. Forbes
Magazine ranks us among America's Best Banks and Fortune
considered SVB one of the best places to work.
JC Simbana leads the early stage Healthcare and Digital Health practice for SVB's Entrepreneur Services Group
which provides banking and lending services to early-stage startups, organizes events to connect startups and
VCs, and assists startups with their fundraising process. With over fifteen years of experience in venture banking
and equity research, Mr. Simbana has worked with entrepreneurs in the biotech, medical device, diagnostics,
tools, and health tech sectors and has helped several startups secure angel and VC financing.
Mr. Simbana is on the board of directors of Life Science Angels and is actively involved with Asia, Springboard, DC-
to-VC, QB3, Thiel Foundation's 20 Under 20 Fellowship, and Breakout Labs as a mentor, speaker, judge and
connector.

24. 24
Pharma/ Physician/Hospitals Patients Insurance Govt
LS Co’s Providers
Admin
Social
Data /
Analytics
mHealth
EMRs/PH
Rs
Remote
Patient
Monitoring
(12 deals)
$102MM
Hospital
Adminstration
(8 deals)
$79MM
Analytics /Big Data
(7 deals)
$78MM
EHR
(8 deals)
$69MM
Wellness
(6 deals)
$62MM
Investment Themes

25. Michael Swit, Special Counsel, FDA
Law Practice, Duane Morris LLP
Before joining the firm in March 2012, Michael served
for seven years as Vice President at The Weinberg
Group, a premier international scientific and regulatory
consulting firm. He has addressed vital FDA legal and
regulatory issues since 1984, both in private law
practice with two other major law firms, and as vice
president and general counsel of Par Pharmaceutical, a
top public generic/specialty drug firm.
From 1994 to 1998, he was CEO of FDANews.com, a premier publisher of regulatory
newsletters and specialty information products for the life sciences. Michael has taught and
written on many topics relating to FDA and served on the Food & Drug Law Journal Editorial
Board. He earned his A.B., magna cum laude, at Bowdoin College, and his law degree at
Emory University.

27. Basics of Medical Device Regulation and Mobile Medical Apps
Is it a medical
device under
Section
201(h) of
FFDCA?
How does the
FDA MMA
Guidance
Categorize
Your App?
Enforcement
Discretion
Subject to
FDA
Regulatory
Oversight
How does the
FDA MMA
Guidance
Apply to Your
App?
How does the
FDA MMA
Guidance
Apply to Your
App?
Go forth and
sell??
But, what does
“Enforcement
Discretion”
mean?
Has FDA
classified, by
regulation, a
device that
matches your
app?
Follow that
regulation
Possible
solution – “de
novo” request
Automatically
in Class III
How does the
FDA MMA
Guidance
Apply to Your
App?
Follow that
Regulation
510 (k)
Exempt
PMA
Go forth and
sell!
But, don’t
forget the FTC
Contrivances, including software,
that are intended to treat,
diagnose or prevent disease or
“affect the body of man” and are
not metabolized or depend on
chemical action to work
NO
YES NO
YES

28. Duane Morris: FDA & mHealth Practices
• FDA
– Drugs & Biologics
– Devices
– Food
– Dietary Supplements
• mHealth aka Digital aka Mobile Health
– HIPAA ‒ FCC ‒ Reimbursement ‒ Cybersecurity
– Privacy ‒ Practice of Medicine ‒ IP ‒ Licensing

29. Soody Tronson, Founder and IP
Counsel, STLGip
STLGip is a Silicon Valley boutique intellectual property law firm
specializing in patents, trademarks, technology transactions, and
strategic counseling. The firm works with domestic and
international clients and partners, including universities and
government agencies and many chambers in Silicon Valley. The
firm is small, AND, has a great reach, both domestically and
internationally, as well as the flexibility to act quickly.
Soody is a seasoned professional with over 25 years of experience in law, technology, and
management. She is a frequent lecturer at domestic and international forums. She instructs
courses on IP & licensing and entrepreneurship at UCSC and Stanford as well as other
domestic and international organizations. She is volunteer mentor and adviser with many
domestic and international organizations. She is the Co-Chair of the LES/SVC and a member
of the Board of Directors at Palo Alto Area Bar Association.
Previously she was IP Counsel at the law firms of HellerEhrman and Townsend and
Townsend, and in house with Hewlett-Packard and a General Counsel of a successfully
acquired MedDevice Company. Prior to law, she spent 10 years as engineer/scientist at HP
and Schering Plough.

30.  Intellectual Property
 IP Strategy
 Patent & Trademark Prosecution and Counseling
 Innovation Training and Mining
 Transactions
 Technologies & Industries
 Retained General Counsel
 Market Strategy
Value
Process

31. Digital Health and IP:
Does it Matter?
8114021
8517912
Akamai/McKesson
Inducement, Infringement
6,757,898