state of us telemedicine industry - etsi · us industry attributes consumerism of healthcare –...
TRANSCRIPT
State of US Telemedicine Industry
Prepared for ETSI
Sophia Antipolis, France
6 May 2014
ETSI eHealth Workshop
6 May 2014
Page 2
Agenda
Current State of Healthcare in the US Industry dynamics
Adoption of telemedicine/mHealth/digital health
Healthcare Legislation
FDA Regulation vs Guidance Mobile medical devices
Mobile medical apps
FCC Wireless Spectrum for healthcare
A Telemedicine success story US Veterans Administration
ETSI eHealth Workshop
6 May 2014
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US mirrors Rest of World on Healthcare
Healthcare costs growing rapidly (3x faster than inflation)
Aging population
Affordability of health insurance
Access to medical care
Prevalence of chronic disease increasing
Shortage of physicians on the horizon
Healthcare reform ongoing
ETSI eHealth Workshop
6 May 2014
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US Industry Attributes
Consumerism of healthcare – the public is ready for digital health
Technology is booming for health sector: sensors, mobile, digital
Access to capital is at an all time high: entrepreneurs and VCs
investing in mHealth, healthcare transformers
Paradigm shift to “health”- proactive prevention
Medical personnel reimbursed based on “value” and quality of care
Recognition that medicine be practiced at the individual level-
healthcare personalized based on a person’s DNA and health
markers
ETSI eHealth Workshop
6 May 2014
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Most exciting time in Health is here!
ETSI eHealth Workshop
6 May 2014
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US Healthcare Legislation
Federal government passed legislation (Affordable Care Act) in 2010 Prohibits insurers from denying coverage to individuals due to pre-
existing conditions
Requires insurers to offer the same premium price to all applicants of the
same age and geographical location without regard to gender or most
pre-existing conditions.
Federal legislation initiatives on telemedicine: Telehealth
Enhancement Act, National licensure
State governments passing legislation to mandate telemedicine be
reimbursed by insurance (both public and private insurances) 45 states passed law mandating Medicaid reimburse for telemedicine
21 states passed law mandating coverage by private insurers
ETSI eHealth Workshop
6 May 2014
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FDA Update (1/2)
U.S. Food and Drug Administration Protecting and Promoting US Public’s Health
“Incumbent to Adapt and Change”– Dr.
Margaret Hamburg, Dec 2013
Medical Devices FDA regulates a broad range of medical devices
New guidance on wireless medical devices issued 13 August 2013
Fewer than 50% of medical devices need to go through FDA approval Class 3= devices are generally the highest risk devices and are therefore subject
to the highest level of regulatory control. Class III devices must typically be
approved by FDA before they are marketed.
Exemptions= these medical devices are mostly low-risk, Class I devices and some
Class II devices that have been determined not to require FDA review before the
devices are marketed
FDA works with NIST to provide guidance for cybersecurity on mobile
medical devices
FDA promotes adherence to int’l standards and open device architectures
ETSI eHealth Workshop
6 May 2014
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FDA Update (2/2)
Mobile Medical Applications FDA regulates a medical application:
If an app transforms a mobile platform into a functional medical device
If the app is to be used as an accessory to a regulated medical device
FDA’s mobile medical apps policy does not consider mobile platform
manufacturers to be medical device manufacturers just because their
mobile platform could be used to run a mobile medical app regulated by
FDA.
Mobile Medical Applications Guidance for Industry issued 25 Sept 2013
Medical Device Software New guidance on software for medical devices expected in 2014
Any patches to fix security issues do not require FDA approval
ETSI eHealth Workshop
6 May 2014
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FCC Update (1/2)
Federal Communications Commission United States' primary authority for communications
law, regulation and technological innovation
Hired a mHealth Chief: “every American needs to
benefit from Digital Health”
Key areas of focus for wireless: Technical requirements to minimize interference
Equipment authorization/ certification (i.e. tests
mobile medical equipment before it can go into
hospitals)
MBANs spectrum allocation & 2014 effort to
harmonize internationally
ETSI eHealth Workshop
6 May 2014
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FCC Update (2/2)
Medical Body Area Networks (MBANs) Effective 11 October 2012, spectrum allocated for low-power networks
called MBANs
2360-2400 MHz band, the 2360-2390 MHz band for indoors only
2390-2400 MHz band for outdoors/ indoors
Devices on MBANs consist of wearable, low-powered sensors that send
non-voice data to nearby hubs that will then transmit the data to a
backend medical system
Patients, either in a clinical setting or at home, will wear the sensors
on their bodies, embedded in clothes, and/or on linens.
A patient will also wear wireless devices such as a wireless finger
pulse oximeter and wireless blood pressure cuff, drastically reducing
the number of wires connected to him.
ETSI eHealth Workshop
6 May 2014
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US Veteran’s Association
mCARE randomized control trial- US Army Veterans with Traumatic Brain Injuries (TBI)
Goal to get veterans out of hospital and back to their home communities
Still need to do 6-9 months of outpatient medical services
Still need to be connected to care team at Walter Reed Medical Center
Needed a remote patient monitoring tool
Created mCARE Platform alerts soldiers about medical appointment, personalized
health/wellness tips for their recovery, announcements from the VA, etc.
Encrypted SMS used to direct veteran to log on to his mCare app
Veteran required to respond to messages via mCare app- flagged as red,
yellow, green - trend analysis done on mood, sleep patterns, hygiene,
pain level, etc. and watched over time by the case managers/nurses
Success: Veterans using mCARE app 9+ months; not abandoning it
Success: Response rates 90%+; very engaged target audience
