TelePack in Home Video and Med Dispenser

TelePack Pill Packet Dispenser for Personal Use – FDA funded

The outbreak of the COVID-19 has exposed shortages in capacity and capability in the healthcare system. Our award winning, patented Ai enabled TelePack Pill Packet Dispenser uses image and speech recognition to identify pill-packet contents and respond to spoken requests (Alexa). Our dispenser uses pre-packaged medications and vitamins from online pharmacies: Amazon PillPack, CVS, Walmart, Walgreens, Nurish, Persona. Our One-Touch Video call feature (zoom) is a dedicated Video conferencing device which allows people to received remote care and medication monitoring at lowest cost to under-serviced populations.

Our Web Portal admin dashboard provides quick real-time monitoring of 50+ remote dispensing units, with One-Touch Video Calling. Our conversational Avatar Assistant provides a friendly voice interactive conversation asking and answering questions while dispensing medications. Personalized Avatars can log spoken “key” words such as: headache, pain, nausea, anger, sadness, PTSD symptoms and suicide ideation.

All data is securely encrypted and compliant with HIPAA and the 2013 Drug Security Act. (Track/Trace/Authenticate). Insurance & Medicare coverage CPT codes 99453, 99454, 99457, 99458, 99473, 99474, 99607, 99490. Device for: Doctors, Nurse, Social Worker, Occupational Therapist, Physical Therapist, Physician Assistant, Psychologist, Dietitian, Public Health/Welfare Agency, Laboratory, Diagnostic Testing, Mammography, X-RAY, Voluntary Health/Charitable Agency Video demo of device

About David Prokop

NIH Food and Drug Admin - Principal Investigator - Lead Research Scientist
Grant #1R43FD006302-01
Development of TruMedicines Recognition Authentication Cloud Intelligence For Drug Product Surveillance (TRACI-4DPS) Software Solutions to Address FDA Post-Marketing Drug Surveillance Challenges
https://reporter.nih.gov/searc...

TeleHealth Medical Device TelePack uses Ai image recognition to identify pharmaceuticals within a pill packet dispenser 100% covered by Medicare Advantage Part D plans. David spent 15 years at Microsoft in R&D and several product groups, including XBOX Kinect computer vision device. Awarded 4 Patents in micro-image pattern recognition. US Patents 8,888,005; 9,477,810; 9,152,913 CA Patent 3,023,359 - Products, Systems and Methods for the Unique Identification of Individual Product Units (Ai Image Recognition), David has 30 Patents in 4 countries USA, Canada, UK, China. and has authored 1 book Making Pills Talk 2018.

Microsoft Surface Program Manager -managed admin internal website of 22 Surface project deliverable schedules. Created internal reference for worldwide power supply components

XBOX One Kinect Program Manager Development - Image recognition System
Manage sustaining product improvements, cost reductions, special builds for testing etc. New version of Kinect sensors: IR projector, camera, VGA camera and microphone array to detect and identify people and objects in 3D space.

Participated in development of several breakthrough products while 16 years at Microsoft product and R&D teams. Excel charting, Encarta Worldbook, Windows CE, Hardware - (Handheld PC, Pocket PC, eBook), Dynamic Layout, ClearType, DRM, ActiveSync, Hardware - XBOX Kinect.

Prokop Labs Founder of R&D of software and hardware platforms. Licensed Smart Glass keyboard design to Chinese keyboard maker King Leader Tech.Shenzhen China US and Chinese Patents issued. 

11 Licensees -Geleez Gel Mousepad Wristrests US Patent 5,566,913 product is recommended by US Dept of Labor OSHA

9 Patent Enforcement Cases Successfully Settled using 5 Law Firms
Perkins Coie, Seattle, Jerry A. Riedinger Senior Partner Litigator, Kevin Zeck Counsel
Bogle & Gates, Seattle, Steve Winters - Associate
Riddle Williams, Seattle, Steve Winters - Partner
Fellers Snider, Oklahoma, Dan Dooley - Partner
Hall Estill, Oklahoma, Dan Dooley - Partner
Successfully negotiated binding settlements in Patent rights cases. Litigation win rate 9 for 9

Patents owned: 27 patents (Canada, China, UK, USA) $1.2+ Million in royalties earned

We are looking to move the prototype TelePack dispenser out of the lab and into a real world beta test site. To improve the software and hardware features.

Successful HHS - FDA Phase I Grant Study – UW Global Health Pill Tracking Mobile App

TruMedicines of Seattle, WA funded by HHS-FDA grant# IR43FD006302 to create Medication tracking mobile app to log self-reported health measures and track drug adherence. Patient drug adherence is securely logged to a central database of patient history. Medical staff can quickly and easily check daily status of remote patients without risk of exposure. Healthcare staff can respond to all needs of the patient in real-time monitoring. Regulatory Classed Medical Device FDA Class I exempt CFR 21 § 890.5050-NXB 2799, GMP exempt (Daily activity assist device) https://doi-org.ezproxyberklee.flo.org/10.1177%2F1357...
US Patents# 8,888,005; 9,152,913; 9,477,810; CA Pat 2,858,923-Marked Pharmaceutical Tablets
HHS-FDA Study. “Pill Identification using a Mobile Phone App for Assessing Medication Adherence and Post-Market Drug Surveillance.” ArXiv abs/2004.11479 (2020): n. page.
TruMedicines Lab #218, UofWash., Fluke Hall, Box 354950, 4000 Mason Road, Seattle, WA 98195
https://comotion.uw.edu/meet-a...
PI - David@TruMedicines.com

Goals:

1) Build more prototype devices, to allow a 20 unit beta test

2) partner with a healthcare facility for real world testing

3) Build out the device network to larger and larger organizations

4) Be acquired by large healthcare org.

1) Build more prototype devices, to allow a 20 unit beta test

- working on getting demo features ready

2) partner with a healthcare facility for real world testing

- currently looking for dev partners

3) Build out the device network to larger and larger organizations

- tbd

4) Be acquired by large healthcare org.

Technical Brief

Number 26
Telehealth: Mapping the Evidence for Patient Outcomes From Systematic Reviews
Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
www.ahrq.gov

Telehealth: Mapping the Evidence for Patient Outcomes from Systematic Reviews
Structured Abstract
Background. Telehealth includes a wide range of technologies used to fulfill many functions in in health care for patients with a variety of clinical conditions. For this evidence map, telehealth is defined as the use of information and telecommunications technology in health care delivery for a specific patient involving a provider across distance or time. Various types of telehealth interventions have been evaluated in thousands of research studies and hundreds of systematic reviews. The vast size of the literature and the variations in how the literature has been collected, evaluated, and synthesized make it challenging to determine what is known about the effectiveness of telehealth for specific purposes and what questions remain unanswered.
Purpose. The purpose of this brief is to provide an overview of the large and disparate body of evidence about telehealth for use by decisionmakers. The approach used was to create an evidence map of systematic reviews published to date that assess the impact of telehealth on clinical outcomes. This evidence map describes a limited number of key characteristics of the systematic reviews currently available in order to evaluate the bodies of evidence available to inform practice, policy, and research decisions about telehealth.
Methods. An evidence map is a specific type of rapid or abbreviated review. While the creation of the evidence map is based on systematic review methodology, its goal is to describe rather than synthesize available research and to use graphics when possible to represent selected characteristics of the evidence. We included systematic reviews that synthesized the impact of telehealth interventions on clinical outcomes, utilization, or cost. We created bubble plots to separately examine the distribution of the evidence from systematic reviews in terms of volume (number of reviews, number of patients in the included studies), conclusions about benefit by clinical focus area, and telehealth function. We also determined how much evidence is available about combinations of clinical areas and telehealth functions reported in existing systematic reviews. We supplemented this by summarizing the topics covered in excluded reviews and the results of exploratory searches for primary studies on selected topics in order to assess the need for future systematic reviews or primary studies in key telehealth domains.
Findings. We identified 1,494 citations about telehealth, from which 58 systematic reviews met our inclusion criteria. A large volume of research reported that telehealth interventions produce positive outcomes when used for remote patient monitoring, broadly defined, for several chronic conditions and for psychotherapy as part of behavioral health. The most consistent benefit has been reported when telehealth is used for communication and counseling or remote monitoring in chronic conditions such as cardiovascular and respiratory disease, with improvements in outcomes such as mortality, quality of life, and reductions in hospital admissions. Given sufficient evidence of effectiveness for these topics, the focus of future research should shift to implementation and practice-based research. Topics with an evidence base that could be the focus of future systematic reviews include telehealth for consultation, uses in intensive care units, and applications in maternal and child health. We also identified topics with a limited
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evidence base such as telehealth for triage in urgent/primary care, management of serious pediatric conditions, patient outcomes for teledermatology, and the integration of behavioral and physical health that may be best addressed by additional primary research. Finally, telehealth research should be integrated into evaluation of new models of care and payment so that the potential of telehealth can be assessed across the continuum of care in organizations that are implementing these reforms.

Drugs Reinvented: A Transformation Into Data and Communication Devices
Critically, authentication enables two further functionalities: (1) the geo-position of the dosage form, and (2) advanced bi-directional communication tied to the dosage form. TruMedicines thus expands a dosage form beyond its therapeutic utility; TruMedicines turns drugs into real-time data collection and communication devices. A variety of real-time and historical data fields can be collected and transmitted between relevant parties (e.g. patient, physician, drug manufacturer, regulatory body, non-profit), including an individual tablet’s geoposition, its identity, strength, and manufacturing history (expiration date, impurity profile, etc.), and from an individual patient, real-time data on side-effects, adherence with therapy, and from the drug manufacturer or non-profit, communiques on disease awareness, summary data on adherence with therapy, and new drug availability.
A major public health objective of drug therapy is to prevent the spread of infection and the emergence of resistance; both of these are undermined by counterfeit medications and poor adherence with therapy. TruMedicines’ technology support these public health objectives by combatting counterfeit medications, and even more importantly, through real-time monitoring of data and outcomes that in turn can be used to influence outcomes remotely via advanced bidirectional communication. These capabilities are paradigm shifting.
Utilizing geospatial database tools like Excel Geoflow, powerful new analyses are possible, including the ability to visualize data temporally and in a 3D environment by integrating and correlating geo-location and time data.  For example, pill packets enabled with TruMedicines technology permit uptake and adherence with drug therapy to be correlated with geo-position and time. Data mining can identify geographic pockets that are outliers of poor adherence or that have newly emerged. Poor adherence that is either geographically concentrated and/or that has newly emerged would strongly signal a heightened risk of spread and/or the emergence of resistance. Real-time identification of such events can then be followed with timely focused interventions to increase adherence and rapidly squelch potential spread and emergence of resistant virus. In many cases, such focused interventions might be affected remotely by targeting communiques to the same smartphones associated with the non-adherence.

Data mining can provide visualization of other scenarios including transportation delay reflected by tablet ground velocity, hi-jacking of drug shipments, diversion of drug shipments to alternate locations, loss of drug shipment and where and when it happened, stock-piling of drug shipments reflected by long delays in authentications, and inefficient distribution of drugs as reflected by an imbalance between clinics in the distributions per clinic.
In developed countries, the technology in TruMedicines likewise enables a myriad of profound new capabilities both similar and different from those in resource-limited settings. For the purpose of understanding how Gates Foundation funding will be catalytic for TruMedicines, we discuss these in further detail below .
C.8 Manufacturing TruMedicines’ pill packets: Specific Activities, Costs and Decisions
This section describes the planned activities that constitute the research and development plan to manufacture TruMedicines’ pill packets, their costs, and the decisions that will be driven by each activity. Based on the totality of our analysis herein, we foresee no decision outcomes that will drive the project to a “no-go” conclusion, since regulatory, technical, IP and market paths all appear feasible. Appropriately resourced, implementation of TruMedicines is certain.

we are all inclusive start-up