State of US Telemedicine Industry

Transcription

1 State of US Telemedicine Industry Prepared for ETSI Sophia Antipolis, France 6 May 2014

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 6 May 2014 Page 2

3 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 6 May 2014 Page 3

4 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 levelhealthcare personalized based on a person s DNA and health markers 6 May 2014 Page 4

5 Most exciting time in Health is here! 6 May 2014 Page 5

6 US Healthcare Legislation Federal government passed legislation (Affordable Care Act) in 2010 Prohibits insurers from denying coverage to individuals due to preexisting 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 6 May 2014 Page 6

7 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 6 May 2014 Page 7

8 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 6 May 2014 Page 8

9 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 6 May 2014 Page 9

10 FCC Update (2/2) Medical Body Area Networks (MBANs) Effective 11 October 2012, spectrum allocated for low-power networks called MBANs MHz band, the MHz band for indoors only 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. 6 May 2014 Page 10

11 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 6 May 2014 Page 11

12 Thank you All rights reserved Giesecke & Devrient 2014