The document reviews key advancements in digital health, focusing on remote monitoring, telemedicine, and digital intervention efficacy. It summarizes research findings from various studies, including those on diabetes management and wearable devices, while highlighting the ongoing need for more evidence in specific areas such as virtual reality and blockchain technology. Additionally, it discusses the FDA’s role in approving new technologies that could enhance adherence and monitoring in chronic care settings.

1. Society for Digital Medicine
Digital Medicine: Year in Review
John Sharp and Ashish Atreja
PCHAlliance/ HIMSS and Mount Sinai
@johnsharp @atreja

2. Our Approach
• Published in peer-reviewed journals
• Pilot and feasibility studies
• Validation Studies
• RCTs
• Literature reviews and meta-analysis

3. Digital Health Innovation Action Plan
• Launching an innovative
pilot precertification
program to work with our
customers to develop a
new approach to digital
health technology oversight
(FDA Pre-Cert for Software)
3

4. New CPT codes Approved for Remote
Patient Monitoring
11/5/17 CMS Expands
Telehealth
Reimbursement in
New Rule
covers remote
chronic care
management
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5. PCHAlliance
White Paper
Including
• review of 34 studies,
• latest evidence by condition
and
• call to action
5

6. Classic Studies

7. Problem: Diabetes- chronic disease management
Intervention: Remote Monitoring, connected glucometer with AI
Control: Usual Care, RCT over 12 months
Outcome: 1.9% vs 0.7% mean HbA1c decline in Bluestar arm vs.usual care
NODE Pearl: First App to get FDA approved based on evidence. Still not mainstream due to
transformation challenge
Quinn, C et al, Diabetes Care, 2011

8. From: Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart
Disease: A Randomized Clinical Trial
JAMA. 2015;314(12):1255-1263. doi:10.1001/jama.2015.10945
Enrollment of Participants in the TEXT-ME Randomized Clinical TrialLDL-C indicates low-density lipoprotein cholesterol.
Figure Legend:
At 6 months, levels of LDL-C were significantly
lower in intervention participants (mean
difference, −5 mg/dL with reductions in systolic
blood pressure (−7.6 mm Hg) and BMI (−1.3),,
and a significant reduction in smoking (26% vs
44%; relative risk, 0.61 [95% CI, 0.48 to
0.76]; P < .001).
The majority reported the text-message program
to be useful (91%), easy to understand (97%),
and appropriate in frequency (86%).

9. SnowWorld (VR)
SnowWorld,
developed at the
University of
Washington HITLab is
the first immersive
virtual world designed
for reducing pan and
anxiety. SnowWorld
was specifically
designed to help burn
patients. Published
RCT of 54 patients
show 15-44%
Schmitt YS et al, Burns
2011. PMID 20692769
https://www.youtube.com/watch?v=jNIqyyypojg

10. https://peerj.com/articles/1554/

11. HeadStrong Study in AMI survivors

13. Year 2017 Summary
Substantial evidence for
• Text messaging and Remote monitoring
• Telemedicine in right setting
Increasing Evidence for
• Wearable devices for right use case
• AI
Need more Evidence
• VR
• Blockchain

14. Text messaging
Text Messaging and Mobile Phone Apps as Interventions to
Improve Adherence in Adolescents With Chronic Health
Conditions –JMIR 5/17
Problem – Medication adherence is a major challenge in adolescents with chronic
conditions
Research design – meta-analysis of 15 studies, most from US
Outcome - Seven articles reported significant improvement in adherence
NODE Pearl - promising feasibility and acceptability, and there is modest
evidence to support the efficacy of these interventions
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15. Remote monitoring
Problem – Is the use of a Blue-tooth enabled inhaler sensor feasible in an elderly
population?
Intervention – use of Propeller Health inhaler sensor, data transmitted via a
wireless hub.
Research design – 198 with COPD, 38 with asthma followed for 12 months.
Outcome – SABA use decreased by 51%, Symptom-free days increased by 28%
NODE Pearl - management of remote monitoring feasible with elderly, COPD
management shows long term improvement.
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16. Telemedicine in right setting
Telehealth Interventions to Support Self-Management of
Long-Term Conditions – JMIR 5/17
Problem - Self-management support is one mechanism by which telehealth
interventions have been proposed to facilitate management of long-term
conditions
Research Design - Metareview of Diabetes, Heart Failure, Asthma, Chronic
Obstructive Pulmonary Disease, and Cancer. 53 systematic reviews,
comprising 232 unique RCTs
Outcome – Telehealth self monitoring not superior to usual care except in
heart failure and type 2 diabetes where the practice is more mature. No
reports of harm.
NODE Pearl – Studies to date encouraging but more theory based studies
needed. 16

17. Wearable devices for right use case
Cardiovascular Risk Stratification Using Off-the-Shelf Wearables and a Multi-
Task Deep Learning Algorithm – 2017 AHA Scientific Session - UCSF
Research Design - 6,115 active users of the Cardiogram app for Apple Watch
- Heart rate and step counts were collected for a period of 1 to 53 weeks
(mean=8.9).
Outcome - Deep Neural Network outperformed a baseline logistic regression
model incorporating age, sex, and beta blocker use, predicting prevalent
hypertension
NODE Pearl – wearables combined with AI demonstrating
usefulness in predicting disease events.
17

18. Wearables
Problem – Monitoring physical activity essential in Cardiac Rehab
Intervention - 40 patients wore Fitbit-Flex for four consecutive days x 8 wks
Research design – Measured changes with the Physical Activity Scale for the
Elderly (PASE) and 6 minute walk test (6MWT)
Outcome – significant increases in PASE score and 6MWT and average steps
NODE Pearl – Use of an activity monitor wearable a helpful adjuct to Cardiac Rehab18

19. Year 2017 Pick
PLEASE ADD PICO details for
1. Google AI Retinopathy
2. OMADA more
3. ALIVE Cor
4. FDA Digital pill approval
5. Telemedicine failure study

20. Google AI Retinopathy
-9963 images from 4997 patients
-Algorithm based on deep machine
learning had high sensitivity and
specificity for detecting referable
diabetic retinopathy
-NODE Pearl could lead to improved
care and outcomes compared with
current ophthalmologic assessment
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21. Virtual Coaching in Diabetes Prevention Programs
Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk
Reduction in a Medicare Population
Method: People at risk for diabetes enrolled in a program combining digital
health with human coaching (Omada Health)
Outcome: 501 patients, participants lost 7.5% (SD = 7.8%) of initial body
weight, glucose control improved (HbA1c change = −0.14%)
NODE Pearl: Virtual DPP is an
mature intervention which can
be applied to other chronic
conditions
21

22. Problem -integration of mHealth technology with self-management approaches to
improve the detection and management of atrial fibrillation
Intervention to determine if an FDA approved wireless ECG monitor designed for use with
smartphones (AliveCor™ ECG) could be utilized to detect and manage recurrent AF or other
atrial arrhythmias better than usual medical care
Research design Subjects with documented history of AF and were scheduled to undergo a
cardioversion, intervention group trained in device usage
Outcome no significant differences between groups with respect to the prevalence of coronary
artery disease, stroke/TIA, congestive heart failure, cardiovascular risk factors, or medication
usage.
NODE Pearl – Digital self monitoring of AF equally effective as current standard of care and with
better quality of life.
Journal of AFIB
11/29/17 FIRST APPLE WATCH GADGET CLEARED BY FDA:
AliveCor, the manufacturer of EKG gadgets, has expanded to the Apple Watch

23. FDA approves pill with sensor that digitally
tracks if patients have ingested their medication
11/13/17 - Abilify MyCite should not be used to track drug ingestion in “real-
time” or during an emergency because detection may be delayed or may not
occur. Proteus Digital Health.
For treatment of Schizophrenia and
Bipolar disorder
Sends a message from the pill’s sensor to a wearable
patch which transmits to a mobile application so that
patients can track the ingestion of the medication
on their smart phone.
NODE Pearl: Encouraging new use of digital in
medication adherence; new category - ingestibles
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24. Telemedicine Failure
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25. Conclusions (1)
• Evidence in several areas is growing and being featured in major journals:
telehealth and remote monitoring, text messaging, virtual coaching and
some wearables (CGMs, etc.)
• Increasing evidence for use of wearables including for research and AI
• More evidence needed for VR, Blockchain
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26. Conclusions (2)
Encouraging new developments with FDA approval of devices to monitor Atrial
Fibrillation, Artificial Pancreas for Type 1 Diabetes and an ingestible sensor.
More common use of connected devices an apps in research, rehabilitation,
post-discharge and procedure follow up
Emerging field of Digital Therapeutics which looks
to be an adjunct to traditional therapies or
to replace them with digital tools.
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