digital health & ophthalmology spotlight - ois...digital health & ophthalmology • digital...
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Linda A. Lam MD MBA
Vice Chair, Satellite Clinical Affairs
Associate Professor of Ophthalmology
USC Keck School of Medicine
Los Angeles, California
2019
Digital Health &
Ophthalmology Spotlight
Demographics
By 2030, over 72 million in United States will be 65 or older
The aging of the population brings with it a rise in chronic
ocular conditions such as
Age-related macular degeneration
Glaucoma
Diabetic retinopathy
Aging demographics and cost
Associated burdens of
frequent office visits + regular monitoring + ongoing treatment
= burgeoning health care costs
Technology advancements could help meet the challenge of
controlling costs - particularly in ophthalmology
Digital advances in ophthalmology are aimed at improving
diagnosis and treatment
Digital Health
Digital health - convergence of digital technologies with
health, healthcare, living, and society to enhance efficiency of
healthcare delivery and to be more personalized and precise
Digital health platform-
aim to improve health management fo patients and providers
Digital health provides the chance to facilitate personalized
medicine at lower cost
How Are Digital Health Products Used?
Providers and other stakeholders are using digital health
technologies in their efforts to:
• Reduce inefficiencies
• Improve access
• Reduce costs
• Increase quality
Make medicine more personalized for patients
FDA and Digital Health
• Ophthalmic digital health technology per FDA panel defined
to encompass (10/23/17)
• Software as a medical device
• Hardware devices with embedded software as a
principal component (software in a medical device)
• Diagnostic or decision support AI or other health data
analytics
• Ophthalmic telemedicine platforms
• FDA does not regulate the practice of telemedicine;
however, it does regulate ophthalmic cameras and other
devices that enable telemedicine
FDA and Digital Health
The broad scope of digital health includes categories such as
- Mobile health (mHealth)
- Health information technology (IT)
- Wearable devices
- Telehealth and telemedicine
- Artificial Intelligence
- Personalized medicine
Digital Health & Ophthalmology
• Digital health pubmed search 14,688 articles as of 10/5/19
• Annual Growth Rate for mobile health market 29%
• 77% Americans, 52% global population with smartphones
Smartphone devicesRemote Screening for Vision Loss
Peek Vision• Peek Acuity used to screen over
80,000 children and adults
• Peek Retina clip-on smartphone
adapter for retina images
Remote Retina Capture
D-Eye Portable Microscope• Image capture without slit lamp
ophthalmoscope or dilating drop
Peek Retina
D-Eye
VR Wearables- Virtual Reality
• Magnification
• OCR (text-to-
speech)
• Facial recognition
• Bar/QR/UPC
code readers
esightODG
Jordy OrcamIrisvision
Wearable Devices –
Augmented Reality
• Oculenz AR for AMD patients
with central vision loss• Eye tracking, customized
• Moves area of vision missing in
scotoma to adjacent retina
• ORlenz AR for surgery• <200 grams
• Wireless
• Beyeonics Clarity-• AR cataract, retina sx
• 1.5 lbs
• Tethered
Oculenz
Beyeonics
ORlenz
Software identifies patient’s non sighted area (circle) and buffers the streaming video
Pixels in circle are moved into adjacent areas of retina that can still see
Video from 4K cameras
Digital map of patient’s impairment stored in processor
The buffered video
creates a hybrid image
which is projected on
device and the brain
interprets as functional
vision
OculenzTM for AMD
OculenzTM Customization and key features-Resolution correlation, scotoma monitoring, SLAM
Resolution correlation
- Diagnostics mode
allows customized
pixel manipulation
- Enables resolution to
match changes for
advancing disease
stages
Scotoma monitoring
- Automatically alert
Physician when
patient’s scotoma has
changed
- May signal that patient
may potentially need
medical treatment
SLAM (simultaneous
localization and mapping)
- SLAM based object
identification software
to audibly alert a
wearer of obstacles
such as furniture,
doors, stairs, or curbs
- 7M objects database
Caution!
Step at
3 feet to
your
left…ALERT!
Telemedicine
Scottish EyeCare Integration Project
• Goals: expedite sight-saving tx & reduce global dz burden
• Use of EMR, digital imaging, redesigned care model
• Optometry referral to NHS email with digital imaging via VPN
• Benefits:
• Reduced wait times and triage
• Improved e-diagnosis in 20% without need for visit
• Rapid response to referrers
• Scotland 75% all referrals electronic from community to hospital
Implications for chronic disease: glaucoma, DR, ROP
Jeganathan VS, Hall HN, Sanders R. Electronic Referrals and Digital Imaging Systems in Ophthalmology: A Global Perspective. Asia Pac J Ophthalmol (Phila).
2017 Jan-Feb;6(1):3-7. doi: 10.22608/APO.2016110.
TelemedicineCloud-based referral in NHS
• 10 yr strategy to telemedicine to reduce unnecessary referrals
• Web-based pt review initially in referral path:
• 52% did not need specialist referral
• 14% needed urgent referral
• Post implementation >50% referrals avoided
AI in Diabetic RetinopathyOver 50% of patients with DM do not get an annual eye exam
• IDx: 1st AI diagnostic system with FDA clearance 4/18
• AI-powered, cloud-based system for use by PCP
• AI system achieved
• 87% sensitivity
• 90% specificity
• 96% imageability rate
• Under same tested standard
for sensitivity, for instance,
ophthalmologists perform
between 33-73%
Abràmoff MD, Lavin PT, Birch M, Shah N, Folk JC. Pivotal trial of an autonomous AI based diagnostic system for detection of
diabetic retinopathy in primary care offices. NPJ Digit Med. 2018; 1: 39.
Digital Healthcare & Big Data
• Connectivity of digital systems can feed into vast
databases, allowing for study of outcomes
• Outcomes study can generate AI platforms
• Potential to provide important information for physicians and
pharmaceutical researchers
•
Challenges for Digital HealthRegulatory and safety issues-
• Meet medical device standards regarding unmodified consumer hardware
platforms, e.g. smartphones and tablets, related to safety, interoperability,
and wireless coexistence
• Smartphone light source used as ophthalmic device illumination, FDA
regulatory issues such as optical radiation safety testing are considered
Compliance issues:
• HIPPA, data security, and encryption important when commercial digital
devices are adapted for medical purposes
Configuration safety and user interface design concerns:
• Software/hardwear changes can radically change user experience and may
have significant implications, especially if the intended users are patients
Summary:
Digital Health & Ophthalmology
• Digital health technology has the potential to augment
Telemedicine
Personalized health data collection
Home health care
Disease monitoring
Aiding with screening, diagnosis, and treatment
Digital health revolution provides a compelling
value proposition to all stakeholders in the
health care marketplace:
patients, physicians, payers, and pharma
to meet challenges of rising costs associated with
changing demographics