2. 원격의료
• 명시적으로 ‘금지’된 곳은 한국 밖에 없는 듯
• 해외에서는 새로운 서비스의 상당수가 원격의료 기능 포함
• 글로벌 100대 헬스케어 서비스 중 39개가 원격의료 포함
• 다른 모델과 결합하여 갈수록 새로운 모델이 만들어지는 중
• 스마트폰, 웨어러블, IoT, 인공지능, 챗봇 등과 결합
• 10년 뒤 한국 의료에서는?
3. 원격 의료
원격 진료
원격 환자 모니터링
화상 진료
전화 진료
2차 소견
용어 정리
데이터 판독
원격 수술
4. •원격 진료: 화상 진료
•원격 진료: 2차 소견
•원격 진료: 애플리케이션
•원격 환자 모니터링
원격 의료에도 종류가 많다.
5. •원격 진료: 화상 진료
•원격 진료: 2차 소견
•원격 진료: 애플리케이션
•원격 환자 모니터링
원격 의료에도 종류가 많다.
10. Average Time to Appointment (Familiy Medicine)
Boston
LA
Portland
Miami
Atlanta
Denver
Detroit
New York
Seattle
Houston
Philadelphia
Washington DC
San Diego
Dallas
Minneapolis
Total
0 30 60 90 120
20.3
10
8
24
30
9
17
8
24
14
14
9
7
8
59
63
19.5
10
5
7
14
21
19
23
26
16
16
24
12
13
20
66
29.3 days
8 days
12 days
13 days
17 days
17 days
21 days
26 days
26 days
27 days
27 days
27 days
28 days
39 days
42 days
109 days
2017
2014
2009
11. 0%
20%
40%
60%
80%
Canada USA UK France Netherlands Germany
76%
63%
57%
52%
48%
41%
0%
10.5%
21%
31.5%
42%
Germany Netherlands UK Switzerland France USA Ca
41%
39%
31%
28%27%
24%
22%
0%
20%
40%
60%
80%
Canada France GermanyNetherlands USA UK Switzerland
80%80%
76%75%
72%
51%
39%
http://economy.money.cnn.com/2013/11/14/america-healthcare/
Able to get same day/next-day appointment?
Used emergency room in past two years
Able to see specialist within four weeks
16. •원격 진료: 화상 진료
•원격 진료: 2차 소견
•원격 진료: 애플리케이션
•원격 환자 모니터링
원격 의료에도 종류가 많다.
17. •진단결과가 명확하지 않거나, 수술이나 치료법 결정시 2차 소견 권고
•수술 등의 경우 보험사가 2차 소견을 요구
•미국에서는 온라인으로 2차 소견을 제공하는 서비스의 증가
•2차 소견을 받음으로써 환자들이 새로운 치료 옵션을 갖게 될 수 있음
•만약 1, 2차 소견이 다르게 나온다면 추가적인 소견이 필요할 수 있음
•미국과 달리 국내에는 2차 소견을 받는 문화가 정착되어 있지 않음
•2가지 모델
•기존의 병원이 제공: 클리블랜드 클리닉, 메사츄세츠 종합 병원
•전문의들의 독립된 서비스: Best Doctors, SecondOpinionExpert etc
Second Opinion
한국에서는 불법
24. “왼쪽 귀에 대한 비디오를 보면 고막 뒤
에 액체가 보인다. 고막은 특별히 부어 있
거나 모양이 이상하지는 않다. 그러므로 심
한 염증이 있어보이지는 않는다.
네가 스쿠버 다이빙 하면서 압력평형에 어
려움을 느꼈다는 것을 감안한다면, 고막의
움직임을 테스트 할 수 있는 의사에게 직
접 진찰 받는 것도 좋겠다. ...”
한국에서는 불법
29. •원격 진료: 화상 진료
•원격 진료: 2차 소견
•원격 진료: 애플리케이션
•원격 환자 모니터링
원격 의료에도 종류가 많다.
30. Epic MyChart Epic EHR
Dexcom CGM
Patients/User
Devices
EH Hospit
Whitings
+
Apple Watch
Apps
HealthKit
한국에서는 불법한국에서는 불법
31. transfer from Share2 to HealthKit as mandated by Dexcom receiver
Food and Drug Administration device classification. Once the glucose
values reach HealthKit, they are passively shared with the Epic
MyChart app (https://www.epic.com/software-phr.php). The MyChart
patient portal is a component of the Epic EHR and uses the same data-
base, and the CGM values populate a standard glucose flowsheet in
the patient’s chart. This connection is initially established when a pro-
vider places an order in a patient’s electronic chart, resulting in a re-
quest to the patient within the MyChart app. Once the patient or
patient proxy (parent) accepts this connection request on the mobile
device, a communication bridge is established between HealthKit and
MyChart enabling population of CGM data as frequently as every 5
Participation required confirmation of Bluetooth pairing of the CGM re-
ceiver to a mobile device, updating the mobile device with the most recent
version of the operating system, Dexcom Share2 app, Epic MyChart app,
and confirming or establishing a username and password for all accounts,
including a parent’s/adolescent’s Epic MyChart account. Setup time aver-
aged 45–60 minutes in addition to the scheduled clinic visit. During this
time, there was specific verbal and written notification to the patients/par-
ents that the diabetes healthcare team would not be actively monitoring
or have real-time access to CGM data, which was out of scope for this pi-
lot. The patients/parents were advised that they should continue to contact
the diabetes care team by established means for any urgent questions/
concerns. Additionally, patients/parents were advised to maintain updates
Figure 1: Overview of the CGM data communication bridge architecture.
BRIEFCOMMUNICATION
Kumar R B, et al. J Am Med Inform Assoc 2016;0:1–6. doi:10.1093/jamia/ocv206, Brief Communication
byguestonApril7,2016http://jamia.oxfordjournals.org/Downloadedfrom
• Apple HealthKit, Dexcom CGM기기를 통해 지속적으로 혈당을 모니터링한 데이터를 EHR과 통합
• 당뇨환자의 혈당관리를 향상시켰다는 연구결과
• Stanford Children’s Health와 Stanford 의대에서 10명 type 1 당뇨 소아환자 대상으로 수행 (288 readings /day)
• EHR 기반 데이터분석과 시각화는 데이터 리뷰 및 환자커뮤니케이션을 향상
• 환자가 내원하여 진료하는 기존 방식에 비해 실시간 혈당변화에 환자가 대응
JAMIA 2016
Remote Patients Monitoring
via Dexcom-HealthKit-Epic-Stanford
한국에서는 불법한국에서는 불법
34. 미국의 원격 진료는 얼마나 정확한가?
Variation in Quality of Urgent Health Care
Provided During Commercial Virtual Visits
Adam J. Schoenfeld, MD; Jason M. Davies, MD, PhD; Ben J. Marafino, BS; Mitzi Dean, MS, MHA;
Colette DeJong, BA; Naomi S. Bardach, MD, MAS; Dhruv S. Kazi, MD, MS; W. John Boscardin, PhD;
Grace A. Lin, MD, MAS; Reena Duseja, MD; Y. John Mei, AB; Ateev Mehrotra, MD, MPH; R. Adams Dudley, MD, MBA
IMPORTANCE Commercial virtual visits are an increasingly popular model of health care for
the management of common acute illnesses. In commercial virtual visits, patients access a
website to be connected synchronously—via videoconference, telephone, or webchat—to a
physician with whom they have no prior relationship. To date, whether the care delivered
through those websites is similar or quality varies among the sites has not been assessed.
OBJECTIVE To assess the variation in the quality of urgent health care among virtual visit
companies.
DESIGN, SETTING, AND PARTICIPANTS This audit study used 67 trained standardized patients
who presented to commercial virtual visit companies with the following 6 common acute
illnesses: ankle pain, streptococcal pharyngitis, viral pharyngitis, acute rhinosinusitis, low
back pain, and recurrent female urinary tract infection. The 8 commercial virtual visit
websites with the highest web traffic were selected for audit, for a total of 599 visits. Data
were collected from May 1, 2013, to July 30, 2014, and analyzed from July 1, 2014, to
September 1, 2015.
MAIN OUTCOMES AND MEASURES Completeness of histories and physical examinations, the
correct diagnosis (vs an incorrect or no diagnosis), and adherence to guidelines of key
management decisions.
RESULTS Sixty-seven standardized patients completed 599 commercial virtual visits during
the study period. Histories and physical examinations were complete in 417 visits (69.6%;
95% CI, 67.7%-71.6%); diagnoses were correctly named in 458 visits (76.5%; 95% CI,
72.9%-79.9%), and key management decisions were adherent to guidelines in 325 visits
(54.3%; 95% CI, 50.2%-58.3%). Rates of guideline-adherent care ranged from 206 visits
(34.4%) to 396 visits (66.1%) across the 8 websites. Variation across websites was
significantly greater for viral pharyngitis and acute rhinosinusitis (adjusted rates, 12.8% to
82.1%) than for streptococcal pharyngitis and low back pain (adjusted rates, 74.6% to 96.5%)
or ankle pain and recurrent urinary tract infection (adjusted rates, 3.4% to 40.4%). No
statistically significant variation in guideline adherence by mode of communication
(videoconference vs telephone vs webchat) was found.
Invited Commentary
page 643
Supplemental content at
jamainternalmedicine.com
Research
Original Investigation
35. Variation in Quality of Urgent Health Care
Provided During Commercial Virtual Visits
•급성질환에 대한 미국의 원격진료 서비스들의 정확도와 진료의 퀄리티를 비교
•8개의 선도적인 원격 진료 서비스를 비교
•67명의 환자 역할을 하는 배우를 통해서 총 599번의 원격 진료를 진행
•대상 질병
•발목 통증
•연쇄상구균 인두염(streptococcal pharyngitis)
•바이러스성 인두염(viral pharyngitis)
•급성 부비동염(acute rhinosinusitis)
•허리 통증(low back pain)
•재발성 요도 감염(recurrent female urinary tract infection)
36. physical examinations ranged from 51.7% to 82.4%. The per-
centage of virtual visits with correct diagnoses named ranged
from 65.4% to 93.8%.
Adherence to Guidelines for Management Decisions
Across all conditions at all companies, key management de-
cisions were guideline adherent in 325 visits (54.3%; 95% CI,
50.2%-58.3%). We found substantial variation among condi-
tions and among companies (P < .001 and P = .009, respec-
tively; Figure 3). For example, physicians ordered urine cul-
its (adjusted for condition, 15.5%; 95% CI, 7.9%-23.2%),
whereasthey(appropriately)didnotorderaradiographforlow
back pain in 84 of 90 visits (adjusted for condition, 93.1%; 95%
CI, 87.7%-98.5%). Across virtual visit companies, adjusted ad-
herence of key management decisions to guidelines ranged
from 34.4% to 66.1%.
The pattern of variation in virtual visit companies’ perfor-
mance differed by condition (Figure 4). For the 2 conditions
(low back pain and streptococcal pharyngitis) with the high-
est overall adjusted rate of adherence to guidelines (ranging
Condition
Company No.
Rates of naming the correct diagnosis for each visit are based on whether the physician stated the correct diagnosis for each encounter. Each data point represents
the adjusted mean rate of naming the correct diagnosis by condition across all virtual visit companies (A) and by virtual visit company across all conditions (B). The
error bars indicate the 95% CIs; dotted line, the aggregate mean across conditions or virtual visit companies. Variations in naming the correct diagnosis by condition
and by virtual visit company were statistically significant (P < .001). UTI indicates urinary tract infection.
Figure 3. Adherence to Guidelines for Key Management Decisions by Condition and by Virtual Visit Company
100
90
80
10
20
30
40
50
60
70
0
GuidelineAdherenceRate
forKeyManagementDecision,%
Condition
By conditionA
Ankle
Pain
Streptococcal
Pharyngitis
Viral
Pharyngitis
RhinosinusitisRecurrent
Female UTI
Low
Back Pain
100
90
80
10
20
30
40
50
60
70
0
GuidelineAdherenceRate
forKeyManagementDecision,%
Company No.
By companyB
7 8654321
Each point represents the adjusted mean rate of adherence by condition across all virtual visit companies (A) and by virtual visit company across all conditions (B).
The error bars indicate 95% CIs; dotted line, the aggregate mean across conditions or virtual visit companies. Variation in guideline adherence was statistically
significant by condition (P < .001) and virtual visit company (P = .009). UTI indicates urinary tract infection.
질병별 / 회사별 진료 가이드라인의 준수 비율
(Adherence to Guidelines for Key Management Decisions by Condition and by Virtual Visit Company)
•질병별 진료 가이드라인의 준수 비중에 큰 차이가 있음
•허리 통증, 연쇄상구균 인두염 등에 대해서는 가이드라인이 잘 준수됨
•발목 통증, 요도 감염 등에 대해서는 가이드라인이 잘 준수되지 않음
•발목 통증 환자에 추가적인 영상 의학데이터를 요구하는 경우는 15.5%에 불과
•회사별 진료 가이드라인의 준수 비중에 큰 차이가 있음
•전반적으로 50% 내외에 지나지 않으며,
•30% 전후에 미치는 회사도 있음
37. 미국의 원격 진료는 얼마나 정확한가?
Choice, Transparency, Coordination, and Quality Among
Direct-to-Consumer Telemedicine Websites
and Apps Treating Skin Disease
Jack S. Resneck Jr, MD; Michael Abrouk; Meredith Steuer, MMS; Andrew Tam; Adam Yen; Ivy Lee, MD;
Carrie L. Kovarik, MD; Karen E. Edison, MD
IMPORTANCE Evidence supports use of teleconsultation for improving patient access to
dermatology. However, little is known about the quality of rapidly expanding
direct-to-consumer (DTC) telemedicine websites and smartphone apps diagnosing and
treating skin disease.
OBJECTIVE To assess the performance of DTC teledermatology services.
DESIGN AND PARTICIPANTS Simulated patients submitted a series of structured dermatologic
cases with photographs, including neoplastic, inflammatory, and infectious conditions, using
regional and national DTC telemedicine websites and smartphone apps offering services to
California residents.
MAIN OUTCOMES AND MEASURES Choice of clinician, transparency of credentials, clinician
location, demographic and medical data requested, diagnoses given, treatments
recommended or prescribed, adverse effects discussed, care coordination.
RESULTS We received responses for 62 clinical encounters from 16 DTC telemedicine
websites from February 4 to March 11, 2016. None asked for identification or raised concerns
about pseudonym use or falsified photographs. During most encounters (42 [68%]), patients
were assigned a clinician without any choice. Only 16 (26%) disclosed information about
clinician licensure, and some used internationally based physicians without California
licenses. Few collected the name of an existing primary care physician (14 [23%]) or offered
to send records (6 [10%]). A diagnosis or likely diagnosis was proffered in 48 encounters
(77%). Prescription medications were ordered in 31 of 48 diagnosed cases (65%), and
relevant adverse effects or pregnancy risks were disclosed in a minority (10 of 31 [32%] and
6 of 14 [43%], respectively). Websites made several correct diagnoses in clinical scenarios
where photographs alone were adequate, but when basic additional history elements (eg,
fever, hypertrichosis, oligomenorrhea) were important, they regularly failed to ask simple
relevant questions and diagnostic performance was poor. Major diagnoses were repeatedly
missed, including secondary syphilis, eczema herpeticum, gram-negative folliculitis, and
polycystic ovarian syndrome. Regardless of the diagnoses given, treatments prescribed were
sometimes at odds with existing guidelines.
CONCLUSIONS AND RELEVANCE Telemedicine has potential to expand access to high-value
health care. Our findings, however, raise concerns about the quality of skin disease diagnosis
Editor's Note
Author Affiliations: Department of
Dermatology, and Philip R. Lee
Institute for Health Policy Studies,
University of California, San Francisco
School of Medicine, San Francisco
(Resneck); University of California,
San Francisco School of Medicine,
Research
Original Investigation
39. Choice,Transparency, Coordination, and Quality Among
Direct-to-Consumer Telemedicine Websites
and Apps Treating Skin Disease
•68% 의 경우 환자가 의사에 대한 선택권 없음
•26% 의 경우에만 의사의 면허 관련 정보가 공개
•미국에는 환자가 속한 주의 면허를 가진 의사만 진료 가능
•하지만, 일부 서비스의 경우 인도나 스웨덴 등 외국 의사를 연결
•77% 의 경우에는 진단을 받음
•65% 의 경우 처방까지 받음
•하지만, 약의 부작용이나 임신 관련 위험에 대해 논의한 곳은 일부 (32%, 43%)
•사진만으로 진단을 내릴 수 있는 질병의 경우 상대적으로 정확
•추가 병력과 상세 정보가 필요한 경우에도 추가 정보를 요청하지 않는 경우 많음
40. •염증성 여드름이 있는 여성 다낭성 난소 증후군 환자
•다모증 (hypertrichosifs)이나 불규칙한 월경 주기 관련 질문을 하지 않은 경우
•모든 의사들이 여드름은 진단했지만, 다모증 (hirsutism), 남성 호르몬 과잉
(androgen excess), 혹은 다낭성 난소 증후군을 진단해내지는 못함
•12번의 진료 중에 대면 진료를 권고한 사례는 두 건 밖에 없었음
•항생제와 레티노이드를 처방해준 곳은 있지만, 호르몬 치료 옵션에 대한 언급은 없음
•제 2기 매독 (secondary syphilis) 환자
•최근 열이 난 적이 있는지 질문하지도 않았고, 급성 발진에 대해 의심 하는 의사 없음
•8명의 의사 중 7명은 건선으로 진단
•한 명의 의사는 진단을 내리지 못하고 로컬 피부과를 권고
•국부 스테로이드를 처방 받거나, 보습제를 쓰거나, 미지근한 물로 목욕을 권고
몇가지 케이스
44. Supervised autonomous robotic soft tissue surgery
Children’s National Health
System 소아외과에서 개발한
Smart Tissue Autonomous
Robot (STAR)
Azad Shademan et al. Sci Transl Med 2016
45. Azad Shademan et al. Sci Transl Med 2016
Supervised autonomous robotic soft tissue surgery
46. Azad Shademan et al. Sci Transl Med 2016
•Ex vivo 와 in vivo end-to-end 의 경우 모두 STAR 는 기존의 수술 방법들에 비해 대부분 더 나은 성과를 보임
•외과의사가 손으로 문합하는 것 (OPEN)
•복강경 수술 (laparoscopy, LAP)
•다빈치를 이용한 RAS
•비교 기준
•비교 기준은 봉합한 공간의 일관성 (spacing)
•얼마나 압력을 가했을 때 복강경이 새어 나오는가 (leak pressure)
•조직에서 바늘을 제거하는 것이 필요했던 실수의 횟수 (number of mistakes)
•총 수술 시간 (completion time)
•내강의 수축 여부 (lumen reduction)
suture placement compared to other techniques (table S1). Moreover,
leak pressure reflects the functional quality of suturing. The linear
closure from STAR was able to withstand a higher average leak pressure
than all other techniques (Fig. 2B).
suturing tool maneuvers before piercing. Using the NIRF markers as
reference points, the plan interpolated intermediate suture placements
on the bowel and adjusted placement of each suture, knot, and corner
slidetoaccommodatedeformationsandinducedscenerotations(Fig.1F).
Fig. 2. Ex vivo linear suturing under deformations. The experiment con-
sisted of closing a longitudinal cut along pig intestine, whereas the tissue
was deformed by pulling on stay sutures. Five samples were tested per tech-
nique (OPEN, LAP, RAS, and STAR). (A) Suture spacing. Central mark is the
median; box edges are the 25th and 75th percentiles, error bars are the range
excluding outliers, and red dots are outliers. The whiskers represent the range
not including outliers. There is a different N number for each boxplot because
eachsurgeonuseda different number of sutures [OPEN (n =174), LAP(n= 128),
RAS (n = 176), and STAR (n = 206)]. These data are presented numerically in
table S2, including the SDs. P values determined by ANOVA with post hoc
Games-Howell. (B and C) Leak pressures and number of mistakes (reposi-
tioned stitches or robot reboot). Data are from individual tissue samples
(n = 5) with averages marked by a horizontal line. P values determined by
independent samples t test. (D) Completion times separated into knot-tying
and suturing, and other time was spent restaging or changing sutures. Data
are averages (n = 5). P values determined by independent samples t test.
www.ScienceTranslationalMedicine.org 4 May 2016 Vol 8 Issue 337 337ra64 3
nMay7,2016
47. Azad Shademan et al. Sci Transl Med 2016
maining circumference (Fig. 3
ing that different levels of auto
be used effectively for differ
Overall, 57.8% of the procedu
fully autonomously with no a
Alternatively, in the current s
autonomous mode without an
teraction would require suture
in 42.2% of sutures placed, m
corners. The completion tim
also included supervisory ac
surgeon, which accounted f
the total time (7% for suture
justment, 3.3% for confirmati
location, and 2.6% for mistake
In vivo end-to-end anast
Finally, we performed in vivo
autonomous surgery in pig in
cessed through a laparotomy
(n = 4) and compared these a
an OPEN control (n = 1) (fig
used the same suture algorith
ex vivo trials (Fig. 1, G and
OPEN control, the surgeon us
surgical hand tools to open th
exposed the intestine, and sutu
a transverse incision. The av
STAR procedure time was 50.0
where 77.4% was anastomos
22.6% was restaging time be
and front walls, which inclu
2.16 min for marking the tis
B and E, and Table 1). Al
OPEN timewasonly 8min,th
was comparable to the averag
laparoscopic anastomoses that
30 min for vesicourethral (25
for aortic (26), to 90 min for
constructions (27).
No complications were obs
Fig. 3. End-to-end anastomosis ex vivo. The experiment
consisted of closing a transverse cut in pig intestine. Five
samples were tested per technique (OPEN, LAP, RAS, and STAR).
(A) Suture spacing. Central mark is the median; box edges are
the 25th and 75th percentiles; and red dots are outliers. The
whiskers represent the range not including outliers. There is a
different N number for each boxplot because each surgeon
used a different number of sutures [OPEN (n = 138), LAP (n =
98), RAS (n = 132), and STAR (n = 180)]. The average spacing
betweenconsecutive sutures was calculated and compared be-
tween STAR and other modalities. The variance of suture
spacing is presented numerically in table S2, including the SD.
P values determined by ANOVA with post hoc Games-Howell. (B) Exvivo end-to-end anastomosis leak pressures.
Dataareindividualtissuesamples,withmeansdisplayedashorizontallines(n=4to5).Onesample was sutured
closed and thus could not be tested for leak pressure. P values determined by independent samples t test.
(C) The leak pressure as a function of maximum suture spacing. Data are individual tissue samples that were fit
to a rational function (y = 0.854/x) (n = 4 to 5). (D) Number of mistakes (repositioned stitches or robot reboot).
Data are individual tissue samples with means displayed as horizontal lines (n = 5). P values determined by
independent samples t test. (E) Ex vivo end-to-end anastomosis completion times. Average times for n = 5
tissue samples per procedure are divided into subtasks of knots and running sutures. “Other” time was spent
restaging and changing sutures. Pvalues determined byindependent samplesttest.(F) Percentreductionin
•Ex vivo 와 in vivo end-to-end 의 경우 모두 STAR 는 기존의 수술 방법들에 비해 대부분 더 나은 성과를 보임
•외과의사가 손으로 문합하는 것 (OPEN)
•복강경 수술 (laparoscopy, LAP)
•다빈치를 이용한 RAS
•비교 기준
•비교 기준은 봉합한 공간의 일관성 (spacing)
•얼마나 압력을 가했을 때 복강경이 새어 나오는가 (leak pressure)
•조직에서 바늘을 제거하는 것이 필요했던 실수의 횟수 (number of mistakes)
•총 수술 시간 (completion time)
•내강의 수축 여부 (lumen reduction)
49. Augmented Reality
Augmented Reality is a technology enriching the real world with digital information and media,
such as 3D models and videos, overlaying in real-time the camera view
of your smartphone, tablet, PC or connected glasses.
50. 3D modeling and visualization of anatomical or pathological
structures in the medical image
51. 3D modeling and visualization of anatomical or pathological
structures in the medical image
52. • Surgical planning
• Training
• Share information with patient / other practitioners
• Intraoperative guidance
66. AnalysisTarget Discovery AnalysisLead Discovery Clinical Trial
Post Market
Surveillance
Digital Healthcare in Drug Development
•개인 유전 정보 분석
•블록체인 기반 유전체 분석
•딥러닝 기반 후보 물질
•인공지능+제약사
•환자 모집
•데이터 측정: 웨어러블
•디지털 표현형
•복약 순응도
•SNS 기반의 PMS
•블록체인 기반의 PMS
67. AnalysisTarget Discovery AnalysisLead Discovery Clinical Trial
Post Market
Surveillance
Digital Healthcare in Drug Development
•개인 유전 정보 분석
•블록체인 기반 유전체 분석
•딥러닝 기반 후보 물질
•인공지능+제약사
•환자 모집
•데이터 측정: 웨어러블
•디지털 표현형
•복약 순응도
•SNS 기반의 PMS
•블록체인 기반의 PMS
+
Digital Therapeutics
68. "The Birth of Prescription Digital Therapeutics,"
Pear Therapeutics and InCrowd, IIeX 2018”
69. Pear Therapeutics
•Pear Therapeutics의 reSET
•의사의 ‘처방’을 받아, 12주에 걸쳐 알콜, 코카인, 대마 등의 중독과 의존성을 치료
•스마트폰 앱 만으로 치료용 FDA 인허가 (De Novo)를 받은 것은 최초 (2017년 9월)
•업계에서는 digital therapeutics의 시초로 이 Pear Therapeutics를 꼽음
70. •reSET 의 Indication for Use
•18세 이상의, Substance Use Disorder(SUD)으로, 외래 진료를 받는 환자에게
•의사의 감독 하에, 기존의 contingency management system 에 더하여 (adjunctive to)
•CBT(Cognitive Behavioral Therapy)를 12주 동안 제공하여,
•SUD에 대한 abstinence와 치료 프로그램의 retention을 증가시키는 것이 목적
71. • Pear Therapeutics
• 2018년 11월 20일, 노바티스와 산도스를 통해서 reSET 을 시장 출시
• 현재, 인허가 및 시장 출시된 유일한 digital therapeutics
• 12-week (90-day) prescription digital therapeutic
to be used in conjunction with outpatient clinician-delivered care.
72. “치료 효과가 있는 ‘게임’이 아니라,
‘치료제’가 (어쩌다보니) 게임의 형식을 가진 것이다”
by Eddie Martucci, CEO of Akili Interactive, at DTxDM East 2018
73. •ADHD에 대해서는 대규모 RCT phase III 임상 시험 진행 중이며, FDA 의료기기 인허가 목표
•8-12살 환자(n=330), 치료 효과 없는 비디오게임을 control group으로
•primary endpoint: TOVA
•의사의 처방을 받는 ADHD 치료용 게임 + 보험사의 커버 목표
74. •2017년 12월, pivotal trial 의 임상 결과가 긍정적으로 나옴
•348 명의 소아 환자, 4주간의 사용
•ADHD와 집중력이 대조군 대비 유의미하게 개선됨 (Attention Performance Index)
•그러나, secondary outcome에 대해서는 대조군 대비 유의미한 개선을 보여주지 못함
•심각한 부작용은 없었음
75.
76. Weight loss efficacy of a novel mobile
Diabetes Prevention Program delivery
platform with human coaching
Andreas Michaelides, Christine Raby, Meghan Wood, Kit Farr, Tatiana Toro-Ramos
To cite: Michaelides A,
Raby C, Wood M, et al.
Weight loss efficacy of a
novel mobile Diabetes
Prevention Program delivery
platform with human
coaching. BMJ Open
Diabetes Research and Care
2016;4:e000264.
doi:10.1136/bmjdrc-2016-
000264
Received 4 May 2016
Revised 19 July 2016
Accepted 11 August 2016
Noom, Inc., New York,
New York, USA
Correspondence to
Dr Andreas Michaelides;
andreas@noom.com
ABSTRACT
Objective: To evaluate the weight loss efficacy of a
novel mobile platform delivering the Diabetes
Prevention Program.
Research Design and Methods: 43 overweight or
obese adult participants with a diagnosis of
prediabetes signed-up to receive a 24-week virtual
Diabetes Prevention Program with human coaching,
through a mobile platform. Weight loss and
engagement were the main outcomes, evaluated by
repeated measures analysis of variance, backward
regression, and mediation regression.
Results: Weight loss at 16 and 24 weeks was
significant, with 56% of starters and 64% of
completers losing over 5% body weight. Mean weight
loss at 24 weeks was 6.58% in starters and 7.5% in
completers. Participants were highly engaged, with
84% of the sample completing 9 lessons or more.
In-app actions related to self-monitoring significantly
predicted weight loss.
Conclusions: Our findings support the effectiveness
of a uniquely mobile prediabetes intervention,
producing weight loss comparable to studies with high
engagement, with potential for scalable population
health management.
INTRODUCTION
Lifestyle interventions,1
including the
National Diabetes Prevention Program
(NDPP) have proven effective in preventing
type 2 diabetes.2 3
Online delivery of an
adapted NDPP has resulted in high levels of
engagement, weight loss, and improvements
in glycated hemoglobin (HbA1c).4 5
Prechronic and chronic care efforts delivered
by other means (text and emails,6
nurse
support,7
DVDs,8
community care9
) have
also been successful in promoting behavior
change, weight loss, and glycemic control.
One study10
adapted the NDPP to deliver
the first part of the curriculum in-person
and the remaining sessions through a mobile
app, and found 6.8% weight loss at
5 months. Mobile health poses a promising
means of delivering prechronic and chronic
care,11 12
and provides a scalable,
convenient, and accessible method to deliver
the NDPP.
The weight loss efficacy of a completely
mobile delivery of a structured NDPP has not
been tested. The main aim of this pilot study
was to evaluate the weight loss efficacy of
Noom’s smartphone-based NDPP-based cur-
ricula with human coaching in a group of
overweight and obese hyperglycemic adults
receiving 16 weeks of core, plus postcore cur-
riculum. In this study, it was hypothesized
that the mobile DPP could produce trans-
formative weight loss over time.
RESEARCH DESIGN AND METHODS
A large Northeast-based insurance company
offered its employees free access to Noom
Health, a mobile-based application that deli-
vers structured curricula with human
coaches. An email or regular mail invitation
with information describing the study was
sent to potential participants based on an
elevated HbA1c status found in their medical
records, reflecting a diagnosis of prediabetes.
Interested participants were assigned to a
virtual Centers for Disease Control and
Prevention (CDC)-recognized NDPP master’s
level coach.
Key messages
▪ To the best of our knowledge, this study is the
first fully mobile translation of the Diabetes
Prevention Program.
▪ A National Diabetes Prevention Program (NDPP)
intervention delivered entirely through a smart-
phone platform showed high engagement and
6-month transformative weight loss, comparable
to the original NDPP and comparable to trad-
itional in-person programmes.
▪ This pilot shows that a novel mobile NDPP inter-
vention has the potential for scalability, and can
address the major barriers facing the widespread
translation of the NDPP into the community
setting, such as a high fixed overhead, fixed
locations, and lower levels of engagement and
weight loss.
BMJ Open Diabetes Research and Care 2016;4:e000264. doi:10.1136/bmjdrc-2016-000264 1
Open Access Research
group.bmj.comon April 27, 2017 - Published byhttp://drc.bmj.com/Downloaded from
•Noom Coach 앱이 체중 감량을 위해서 효과적임을 증명
•완전히 모바일로 이뤄진 최초의 당뇨병 예방 연구
•43명의 전당뇨단계에 있는 과체중이나 비만 환자를 대상
•24주간 Noom Coach의 앱과 모바일 코칭을 제공
•그 결과 64% 의 참가자들이 5-7% 의 체중 감량 효과
•84%에 달하는 사람들이 마지막까지 이 6개월 간의 프로그램에 참여
77. www.nature.com/scientificreports
Successful weight reduction
and maintenance by using a
smartphone application in those
with overweight and obesity
SangOukChin1,*
,Changwon Keum2,*
, JunghoonWoo3
, Jehwan Park2
, Hyung JinChoi4
,
Jeong-taekWoo5
& SangYoul Rhee5
A discrepancy exists with regard to the effect of smartphone applications (apps) on weight reduction
due to the several limitations of previous studies.This is a retrospective cohort study, aimed to
investigate the effectiveness of a smartphone app on weight reduction in obese or overweight
individuals, based on the complete enumeration study that utilized the clinical and logging data
entered by NoomCoach app users betweenOctober 2012 andApril 2014.A total of 35,921 participants
were included in the analysis, of whom 77.9% reported a decrease in body weight while they were using
the app (median 267 days; interquartile range=182). Dinner input frequency was the most important
factor for successful weight loss (OR=10.69; 95%CI=6.20–19.53; p<0.001), and more frequent
input of weight significantly decreased the possibility of experiencing the yo-yo effect (OR=0.59,
95%CI=0.39–0.89; p<0.001).This study demonstrated the clinical utility of an app for successful
weight reduction in the majority of the app users; the effects were more significant for individuals who
monitored their weight and diet more frequently.
Obesity is a global epidemic with a rapidly increasing prevalence worldwide1,2
. As obese individuals experience
significantly higher mortality when compared with the non-obese population3,4
, this phenomenon poses a sig-
nificant socioeconomic burden, necessitating strategies to manage overweight and prevent obesity5
. Although
numerous interventions such as life style modification including exercise6–10
, and pharmacotherapy11–13
have been
shown effective for both the prevention and treatment of obesity, some of these methods were found to have a
limitation which required substantial financial inputs and repeated time-consuming processes14,15
.
Recently, as the number of smartphone users is increasing dramatically, many investigators have attempted
to implement smartphone applications (app) for health promotion16–19
. Consequently, many smartphone apps
have demonstrated at least partial efficacy in promoting successful weight reduction according to the number
of previous studies20–24
. However, due to the limitations associated with study design such as small-scale studies
and short investigation periods, a discrepancy exists with regard to the effect of apps on weight reduction20,21,23
.
Even systemic reviews which investigated the efficacy of mobile apps for weight reduction reported more or less
inconsistent results; Flores Mateo et al. reported a significant weight loss by mobile phone app intervention when
compared with control groups25
whereas Semper et al. reported that four of the six studies included in the analysis
showed no significant difference of weight reduction between comparison groups26
. Thus, the aim of this study
was to investigate the effectiveness of a smartphone app on weight reduction in obese or overweight individuals
Recei e : 0 pri 016
Accepte : 15 eptem er 016
Pu is e : 0 o em er 016
OPEN
•스마트폰 앱이 체중 감량에 도움을 줄 수 있는가?
•2012년부터 2014년 까지 최소 6개월 이상 애플리케이션을 사용
•80여 국가(미국, 독일, 한국, 영국, 일본 등)에서 모집된 35,921명의 데이터
•애플리케이션 평균 사용기간은 267일
Chin et al. Sci Rep 2016
78. •미국 CDC의 당뇨병 예방 프로그램(DPP)으로 공식 인증
•CDC에서 fully recognised 된 첫번째 ‘virtual provider’
•2018년 1월부터 CMS(Centers for Medicare&Medicaid Services)의
보험 수가를 적용
•메디케어 1인당 2년에 성취도에 따라 $630 까지 지급
•B2B 사업으로도 확대 예정
"눔은 OEM(주문자상표부착생산) 업체로서 라이선스를 사간 기업에
모바일 플랫폼과 건강관리 코치들, 교육프로그램 등을 종합적으로 제공한다"
85. 임상-인허가-보험-의사 처방-RWE-환자 사용
• DTx에도 RCT가 필요한가
• 효용을 어떻게 증명할 것인가
• 의료기기 or 컨슈머BM
• 어떤 방식의 regulatory pathway로
• De Novo: 완전히 새로운
• 510(k): 기존 의료기기와 동등성
• Pre-Cert: 2021년은 되어야
• 보험사는 DTx를 어떻게 바라볼까
• 수가를 받을 수 있는가/받아야 하는가
• 기존 약 대신에 의사가 처방할까
• 기존 약 대비 강점을 가지는 분야는
• 의사들이 활용할 여건이 되는가
• EMR 속으로 어떻게 통합
• 진단/치료/관리 기준은
• 게임을 처방 받으면 환자는 어떻게 느낄까
• 지속사용성: 계속 사용할까
• 디지털 리터러시: 이해할 수 있을까
91. https://www.23andme.com/slideshow/research/
고객의 자발적인 참여에 의한 유전학 연구
깍지를 끼면 어느 쪽 엄지가 위로 오는가?
아침형 인간? 저녁형 인간?
빛에 노출되었을 때 재채기를 하는가?
근육의 퍼포먼스
쓴 맛 인식 능력
음주 후 얼굴이 붉어지나?
유당 분해 효소 결핍?
고객의 81%가 10개 이상의 질문에 자발적 답변
매주 1 million 개의 data point 축적
The More Data, The Higher Accuracy!
93. •신약 표적 발굴: 더 안전하고 효과적으로
•표적 치료에 효능을 보일 환자군의 선별에 도움
•임상시험 환자 리크루팅에 활용
•GSK의 파킨슨 신약: LRRK2 variant 환자군
•LRRK2 variant: 파킨슨 환자 100명 당 1명 보유
•23andMe는 이미 LRRK2 variant 250명 보유
GSK에 독점적 DB 접근권을 주고,
$300m의 투자 유치
94. 20만명의 GWAS 칩 데이터와 설문 데이터를 이용
MHC 특정 영역과 감염질환의 연관성 분석
23andme 데이터를 기반으로 성격과 관련된
유전자 loci 6군데를 발견
95.
96. • 아이폰의 센서로 측정한 자신의 의료/건강 데이터를 플랫폼에 공유 가능
• 가속도계, 마이크, 자이로스코프, GPS 센서 등을 이용
• 걸음, 운동량, 기억력, 목소리 떨림 등등
• 기존의 의학연구의 문제를 해결: 충분한 의료 데이터의 확보
• 연구 참여자 등록에 물리적, 시간적 장벽을 제거 (1번/3개월 ➞ 1번/1초)
• 대중의 의료 연구 참여 장려: 연구 참여자의 수 증가
• 발표 후 24시간 내에 수만명의 연구 참여자들이 지원
• 사용자 본인의 동의 하에 진행
ResearchKit
101. ‘Facebook for Patients’, PatientsLikeMe.com
Stephen Heywood
Benjamin Heywood
James Heywood
Jeff Cole
• In 2004, three MIT engineers established the service for their own brother
who was suffered from ALS.
• Until 2011, only patients of 22 chronic disease, including ALS, HIV, Parkinson’s.
104. Users can find and friends with patients like them,
based on disease, stage, age, sex ...
Finding Patients Like Me!
105. Patines can keep their medical journals in the ‘Wall’,
recording conditions, treatments, symptoms…
(They don’t have to lie, because it’s totally anonymous)
106. Medications he/she took
‘Real World’ Feedback from the Patients
• How long he/she took the medication
• Purpose for which he/she took the medication
• Dose of the medication
• Efficacy / side-effect of the medication
108. X 10,000
personal journal personal journal personal journal
personal journal personal journal personal journal
personal journal personal journal
Big Medical Data
114. The main side effect reported by PatientsLikeMe users on selective
serotonin reuptake inhibitor (SSRI) Lexapro (escitalopram) was
“Decreased sex drive (libido),” at 24% (n = 149),
whereas the clinical trial data on Lexapro report 3% (n = 715)
Nat Biotech 2009 Brownstein et al.
http://www.nature.com/nbt/journal/v27/n10/full/nbt1009-888.html#close
115.
116. “In the present study, we found that daily
doses of lithium, leading to plasma levels
ranging from 0.4 to 0.8 mEq/liter, delay
disease progression in human patients
affected by ALS.”
“Lithium Delays Progression of Amyotrophic Lateral Sclerosis (PNAS, 2007)”
117. “Accelerated clinical discovery using self-reported patient data collected
online and a patient-matching algorithm (Nat. Biotech., 2011)”
“Here we describe an analysis of data
reported on the website PatientsLikeMe by
patients with amyotrophic lateral sclerosis
(ALS) who experimented with lithium
carbonate treatment. ... At 12 months after
treatment, we found no effect of lithium on
disease progression.”
118. 44명의 환자들을 대상으로 (대조군 등으로 나눈 후)
16명의 환자들에게만 Lithium 을 투여
PatientsLikeMe에 등록된, 4,318 명의 ALS 환자들 중,
348명이 Lithium을 복용
그 중, 일정 기준을 충족하는 총 149명의 환자들을 분석
ALS는 매우 희귀하여 환자 수가 아주 적은 질환
온라인 SNS 서비스를 통해 자발적으로 데이터를 제공한 ALS 환자가,
전통적 임상 연구에 참여한 환자보다 9배 더 많았다!
119. 블록체인 기반의 탈중앙화된 환자 커뮤니티를 구축하는 휴먼스케이프
차별성 : 보상체계
정보 생산의 주체인 환자들과 검증의 주체인 의료 전문가들에게 보상이 분배되어 본인의 지적 생산물에 대한 합당한 가치를 인정받습니다.
커뮤니티에 작성한 정보는 다른 환자나 의료
전문가들의 투표를 통해 그 가치를 평가받고,
합당한 보상을 받게 됩니다.
환자가 작성한 개인건강기록은 비식별화되어
블록체인에 기록, 거래됩니다.
•PatientsLikeMe 등 기존의 환자 커뮤니티의 문제
•환자의 ‘자발적 참여’로 증상, 복약, 부작용 등의 데이터를 제공하므로 동기가 낮음
•플랫폼이 이 데이터를 제약사에 판매해도 환자는 정작 재정적 인센티브를 받지 못함
•블록체인 기반의 환자 커뮤니티: 데이터를 제공하고 커뮤니티에 기여하는 환자 및 의료진에게 인센티브 부여 가능
•글로벌 시장을 타겟으로, 연내 ICO 진행 예정 (Hum 토큰)
120. 관련 서비스의 한계
2004년 설립된 PatientsLikeMe는 주로 난치병 환자들이 자신의 증상에 관한 정보를
공유하는 온라인 커뮤니티이다. 현재까지 약 60만 명의 환자들이 이 커뮤니티에
가입되어 있다.
• 14년 간 가입자 수 60만 명
• 2018년 현재 활성 사용자 수 17,000여 명
• 자발적 참여의 한계
• 재주는 곰, 돈은 왕서방
환자들이 생산한 정보를 플랫폼사인 PLM이 보험사, 제약사 등에 판매, 수익을 얻는 구조.
중증 질환이 아닐수록 정보를 습득하거나 공유할 유인을 감소시켜 커뮤니티 참여율을
낮추게 되므로 다양한 범위의 건강 정보 수집에 어려움을 가져온다.
121. 차별성 : 보상체계
정보 생산의 주체인 환자들과 검증의 주체인 의료 전문가들에게 보상이 분배되어 본인의 지적 생산물에 대한 합당한 가치를 인정받습니다.
커뮤니티에 작성한 정보는 다른 환자나 의료
전문가들의 투표를 통해 그 가치를 평가받고,
합당한 보상을 받게 됩니다.
환자가 작성한 개인건강기록은 비식별화되어
블록체인에 기록, 거래됩니다.
122.
123.
124.
125. Night Scout Project
•연속 혈당계 기기를 해킹해서 클라우드에 혈당 수치를 전송할 수 있게
•언제 어디서든 스마트폰, 스마트 워치 등으로 자녀의 혈당 수치를 확인 가능
•소아 당뇨병 환자의 부모들이 자발적으로 개발 + 오픈소스로 무료 배포 + 본인이 자발적으로 설치
•상용 의료기기가 아니므로 FDA의 규제 없음
129. Hood Thabit et. al. Home Use of an Artificial Beta Cell in Type 1 Diabetes, NEJM (2015)
Home Use of an Artificial Beta Cell in Type 1 Diabetes
The proportion of time that the glycated hemoglobin level was in the target range
(primary end point) was significantly greater during the intervention period than during
the control period — by a mean of 11.0 percentage points (95% confidence interval [CI],
8.1 to 13.8; P<0.001).
130. Hood Thabit et. al. Home Use of an Artificial Beta Cell in Type 1 Diabetes, NEJM (2015)
The overnight mean glucose level was significantly lower with the closed-loop system
than with the control system (P<0.001), and the proportion of time that the glucose level
was within the overnight target range was greater with the closed-loop system (P<0.001)
Home Use of an Artificial Beta Cell in Type 1 Diabetes
132. • Self-reported data from a small group – 18 of the first 40 users
• The positive glucose and quality of life impact this system has had
• 0.9% improvement in A1c (from 7.1% to 6.2%)
• a strong time-in-range improvement from 58% to 81%
• near-unanimous improvements in sleep quality
OpenAPS DIY Automated Insulin Delivery Users Report 81%
Time in Range, Better Sleep, and a 0.9% A1c Improvement
https://openaps.org/2016/06/11/real-world-use-of-open-source-artificial-pancreas-systems-poster-presented-at-american-diabetes-association-scientific-sessions/
134. First FDA-approved Artificial Pancreas
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522974.htm
• 메드트로닉의 MiniMed 670G 가 최초로 제 1형 당뇨병 환자에 대해서 FDA 승인
• 14세 이상의 제 1형 당뇨병 환자 123명을 대상으로 진행된 임상
• 3개월의 추적 관찰 결과 당화혈색소(A1c) 수치가 7.4%에서 6.9%로 유의미하게 개선
• 당뇨병성 케톤산증, 저혈당증 등의 심각한 부작용이 이 기간 동안 발생 없음
• 메드트로닉은 향후 7-13세 환자들에 대해서 효과성과 안전성을 추가적으로 검증 계혹
(2016. 9. 28)
135. https://myglu.org/articles/a-pathway-to-an-artificial-pancreas-an-interview-with-jdrf-s-aaron-kowalski
•Step 1: 혈당 수치가 미리 정해놓은 기준까지 낮아지면, 인슐린 주입을 멈춤
•Step 2: 사용자의 혈당이 기준치까지 낮아질 것을 ‘예측’하여, 인슐린 주입을 미리 멈추거나 줄인다.
•Step 3: 혈당이 기준치 이하로 너무 낮아지는 것뿐만 아니라, 기준치 이상으로 너무 높아지는 것도 막는다.
•Step 4: 특정 범위 이내가 아니라, 특정 혈당 수치를 유지하는 것을 목표로 한다. (Hybrid closed-loop product)
•Step 5: Step 4 에서 더 나아가, 식전의 별도 인슐린 주입까지도 자동화한다.
•Step 6: 인슐린 뿐만 아니라, 글루카곤과 같은 추가적인 호르몬도 조절
Six Steps of Artificial Pancreas (JDRF)
136. https://myglu.org/articles/a-pathway-to-an-artificial-pancreas-an-interview-with-jdrf-s-aaron-kowalski
•Step 1: 혈당 수치가 미리 정해놓은 기준까지 낮아지면, 인슐린 주입을 멈춤
•Step 2: 사용자의 혈당이 기준치까지 낮아질 것을 ‘예측’하여, 인슐린 주입을 미리 멈추거나 줄인다.
•Step 3: 혈당이 기준치 이하로 너무 낮아지는 것뿐만 아니라, 기준치 이상으로 너무 높아지는 것도 막는다.
•Step 4: 특정 범위 이내가 아니라, 특정 혈당 수치를 유지하는 것을 목표로 한다. (Hybrid closed-loop product)
•Step 5: Step 4 에서 더 나아가, 식전의 별도 인슐린 주입까지도 자동화한다.
•Step 6: 인슐린 뿐만 아니라, 글루카곤과 같은 추가적인 호르몬도 조절
Six Steps of Artificial Pancreas (JDRF)
138. 딜레마
변화하지 않을 수 없는 의료
변화할 수 없는 한국 의료
• 한국의 의료전달체계: 의료기관별 역할 분담 안됨
• 문케어/단일보험: 새로운 혁신의 수용이 불가
• 저수가/3분 진료: 무엇을 새롭게 시도할 수 있을까
• 규제: 한국에서만 안 되는 것들이 너무 많음
• 의협: 변화를 이끌 것인가, 변화에 저항할 것인가
• 의료사고 무관용: 방어 진료, 보수적 진료
• 전공의특별법: 가용한 수련 시간의 감소
140. • 딴짓하는 의사도 있어야 하지만, 여전히 대부분의 의료인은 임상을 한다
• 인공지능은 과연 전공필수 과목이 되어야 하나
• 공감능력 / 커뮤니케이션 능력 / 넓은 시야: 교육으로 키울 수 있나
• 진료과를 가리지 않고 디지털 기술은 앞으로 점차 녹아들 것
• '디지털 의료'의 미래는 ‘의료'
• 우리는 ‘디지털 네러티브’ 세대를 교육할 준비가 되었는가?
• 이러한 변화에서 어떠한 역량이 더 필요하고, 덜 필요할 것인가
• adaptable practitioner
• life-long learner (from NEJM 2017)
• 플립 러닝이 도움이 될 수 있다. 다만,
• 평가 방식을 포함한 교육체계 전반이 바뀌어야
• 학생들의 불만: 로딩만 더 늘어난다
• 학생들의 목소리를 듣자. 교수의 생각과는 상당히 다를 수 있다.
141. 학생들은 이미 미래를 고민하고 있다.
(2017년 서울의대 예과 ‘의학 입문’ 수업 중)