Clearprotocol investorpitchdeck

Copyright 2019-2020 Clear Protocol, Inc., all rights reserved. Clear Protocol®,
US Utility Patent 10,318,928B1; other patents pending. www.ClearProtocol.com Page 1 of 8
Clear Protocol®
An Automated Validation System for Clinical Practice
1. Introduction
Contemporaneous validation of clinical practice is recognized as critically
important. However, often this is not completed, because most clinical
interventions happen alongside a patient, and devices that could be used, such as
personal computers, iPads®, or smart phones, are impractical due to potential
hand contamination, the inconvenience of being out of reach, out of view,
interruption, and distraction. For example, in Figure 1 two clinicians are attempting to
use a portable electronic device with a typical IT product by a major US vendor.
Clinicians should be able to validate essentially all their daily medical
procedures, without having to manipulate a computing device. A solution to this
problem "…has the ability to significantly impact improvements in quality,
safety, efficiency, and effectiveness of health care." 1 (AHRQ, 2019)
1 The statement was made in reference to Clinical Decision Support (CDS), the area of Healthcare IT for
Clear Protocol®
● Note that they are distracted,
interrupted, away from patients.
● How long can a person hold a laptop
like that?
● How long will it take before the
clinicians can get back to patients?
● Won’t this cause physical and mental
fatigue?
● Will all their comments and
observations go into the EHR?
● Will the next shift see it?
Figure 1. Clinicians using an “ advanced
healthcare IT ”: 3M’s Clinical Documentation
Improvement (CDI)!
Image and quoted text retrieved from
https://www.3m.com/3M/en_US/health-information-
systems-us/ November 22nd, 2019`

2. Our Vision
The digital solution we have developed is Clear Protocol®, an enterprise level
hardware and software system that uses electronic wearables. The objective is to
give clinicians an effective tool to validate clinical guidelines. Clear Protocol®
enhances validation – an essential step in modern clinical practice.
Clear Protocol® accepts any procedure used in health organizations and is
intended for any setting that provides direct care to patients and therefore needs
to comply with up-to-date clinical protocols. It can be the new, practical,
unobtrusive way to enable validation at the point of care - contemporaneously,
every time - all the time.
"The evidence base demonstrating the effectiveness of... [workflow support
approaches such as Clear Protocol®] is very strong." 2 (CDC, 2019)
3. Clear Protocol® Description
Clear Protocol® runs on electronic wearables. It will be used 24/7 by every nurse
and doctor working at a hospital, to validate treatment protocols
contemporaneously. It is hands-free, voice-operated. Users select a procedure on
the Clear Protocol® voice-activated platform, and then confirm the completed
steps in real time. Completed protocols are logged automatically. Figure 2 depicts
four elemental steps of any clinical intervention – 1 and 2 may at times be done from
memory, but 3 and 4 require interaction with the EHR.
Clear Protocol® uses voice recognition for the interaction between the system and
the user: Login, verification, etc. The voice recognition component is an
established healthcare-specific technology, already in use by 90% of hospitals
and embedded in the leading EMR systems (Nuance Communications, Inc.,
2019).
2 The statement was made in reference to Clinical Decision Support (CDS), the area of Healthcare IT for
Clear Protocol®.

Clear Protocol® is “hardware-agnostic”. Based on user preference, electronic
wearables will be programmed with our proprietary software. Clear Protocol®
can be “deviceless” (an over-the-ear microphone/speaker), or it can function via
smart glasses, a customized body cam, a wristband, or configured as a “badge-
style” device.
Figure 2 The process that Clear Protocol®
enhances.

4. Clear Protocol Enhances Validation of Clinical Practice
Table 1. Why Clear Protocol® is effective at validation and documentation,
compared to other systems.
Clear
Protocol
Conventional
validation
systems
Does not rely on external tablets/cellphone/ PCs X
Works hands-free in the background X
Keeps caregiver uninterrupted X
Validates practice contemporaneously X
Provides access to clinical protocols
Stores logs of validation & provides analytics *partially
All data, even verbal comments, are digitized
and structured
X

5. Clear Protocol® Features and Innovations
• Semi-automated clinical intervention validation and logging, potentially
saves clinicians hours per day.
• Interoperable with the major Electronic Medical Record systems
• HIPPAA compliant.
• Plug and play upgrades whenever new clinical guidelines are in place.
• The only computerized validation system we know of that meets the
Agency for Healthcare Research and Quality’s “Five Rights of CDS” 3 .
• The only data collected is of verification of the completed clinical
procedures, down to the “micro-step” level, as needed.
• Potential to add a module for voice-to-text comments to the patient’s EMR,
means that most charting/documentation can be completed
contemporaneously!
• Flexible workflows customized to the individual doctor and nurse.
• The user initiates the validation, so the user is in control of what items will
be logged.
• United States Utility Patent issued June, 2019, US 10,318,928B1; other
patents pending.
6. System Architecture
Displaying the right checklist or clinical pathway from the onboard library.
Initially, for a nurse or doctor at the start of their shift, there is a set of patients
with ongoing treatment plans – so there is already a predetermined set of tasks to
work on. These will be pre-loaded on the system, and displayed within the
situation context – for example, the nurse scans a barcode or verbally calls out
3 The Clinical Decision Support (CDS) Five Rights model states that we can achieve CDS-supported
improvements in desired healthcare outcomes if we communicate:
1. The right information: evidence-based, suitable to guide action, pertinent to the circumstance
2. To the right person: considering all members of the care team, including clinicians, patients, and their
caretakers
3. In the right CDS intervention format: such as an alert, order set, or reference information to answer a
clinical question
4. Through the right channel: for example, a clinical information system (CIS) such as an electronic
medical record (EMR), personal health record (PHR), or a more general channel such as the Internet or a
mobile device
5. At the right time in workflow: for example, at time of decision/action/need
Source: https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it-priorities/clinical-decision-support-
cds/chapter-1-approaching-clinical-decision/section-2-overview-cds-five-rights Accessed Nov. 13, 2019.

the ID no. on a patient’s wristband –then Clear Protocol® will automatically
display the clinical pathway/checklist for the specified procedure.
For any other procedure, the system stands by for operator input. The user can
prompt the system to retrieve from an onboard library of preexisting (and
hospital-practice specific) protocols/checklists.
Figure 4 below, illustrates how clinical procedures are “translated” into
computerized systems such as Clear Protocol®.
Figure 3. Translation from narrative form clinical therapies, to computer code.

7. Commercialization
We incorporated Clear Protocol, Inc., in California, in May 2016 to commercialize
the Clear Protocol® system. Our initial target market is hospitals in Southern
California. Our future market is all US hospitals, clinics, and private medical
practices. We plan to follow a Software-as-a-Service (SAAS) business model.
Revenue will come from initial setup and training fees, and “per bed” or “per
user” site license subscriptions.
We have an outstanding team, with expert advisors from leading universities, as
well as corporate and intellectual property legal representation:
• Dimitrios Zikos, PhD Health Informatics, BS Nursing, Professor, College of
the Health Professions, Central Michigan University;
• Matthew Turk, PhD, MS Electrical Engineering/Robotics, President, Toyota
Technological Institute at Chicago;
• Steven Werber, PhD. Psychology, Professor of Marketing, UCLA
Anderson School;
• Andrew Strachan, MSc, London Business School, Sloan Fellow. Business
Advisor at SBDC, Los Angeles, California
• Ryan Azlein, JD, Shareholder, Stradling Yocca Carlson & Rauth, P.C.,
Santa Monica, California. Emerging Company & Venture Capital Lawyer
• Otto Steinbusch, JD. Intellectual Property Attorney, Esplin & Associates,
PC, Carlsbad, California. IP planning and patent portfolio management

References
AHRQ. (2019). Health Information Technology, Clinical Decision Support. Retrieved
November 18, 2019, from Agency for Healthcare Research and Quality:
https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it-priorities/clinical-
decision-support-cds
CDC. (2019, November 18). Implementing Clinical Decision Support Systems.
Retrieved November 18, 2019, from CDC.gov:
www.cdc.gov/dhdsp/pubs/guides/best-practices/clinical-decision-support.htm
Nuance Communications, Inc. (2019, February 12). Healthcare AI Solutions & Services.
Retrieved February 12, 2019, from www.nuance.com:
www.nuance.com/healthcare.html
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