1. 디지털 헬스케어 파트너스
대표파트너
최윤섭, PhD
한국에서 혁신적인 디지털 헬스케어 스타트업이 탄생하려면
2. 한국과 실리콘밸리의
디지털 헬스케어 스타트업
규제, 설립, 투자, 그리고 최신 마켓 트렌드
최윤섭 대표
디지털 헬스케어 파트너스
유지현 변호사
법무법인 광장
헬스케어 팀
김지현 변호사
Latham & Watkins
서울 사무소
김정은 변호사
Latham & Watkins
실리콘밸리 사무소
3. 최윤섭 대표 디지털 헬스케어 파트너스
한국에서 혁신적인 디지털 헬스케어 스타트업이 탄생하려면
법무법인 광장 헬스케어 팀유지현 변호사
한국의 디지털 헬스케어 스타트업 관련 규제
Latham & Watkins 서울 사무소김지현 변호사
미국 스타트업의 기본 법률 가이드: 회사 설립과 투자 유치
Latham & Watkins 실리콘밸리 사무소김정은 변호사
실리콘밸리 디지털 헬스케어 시장 동향과 가치 창출을 위한 법적 이슈
유지현, 김지현, 김정은 변호사 (모더레이터: 최윤섭 대표)
패널토의 및 질의응답
+
6. DHP의 목적 및 존재 이유
혁신적 헬스케어 스타트업
헬스케어 스타트업 생태계 구축
의료 혁신과 사회적 가치의 창출
7. 윤상철 MD
안과전문의
연세의료원 안과 교수
전) 에티오피아 국제협력의사
김우성 MD, MBA
소아청소년과 전문의
방배GF소아과 원장
카톨릭대학교 의료경영학 겸임교수
김현정 MD, PhD
피부과 전문의
차의과대학 피부과 교수
전)서울의료원 피부과 과장
김태호 MD
내분비내과 전문의
서울의료원 내분비내과 과장
전)명지병원 IT융합연구소 부소장
유규하 PhD
규제/인허가 전문가
성균관대 의료기기산업학과 교수
전)식약처 의료기기심사부장
신수용 PhD
의료-IT / 기계학습 전문가
성균관대학교 디지털헬스학과 교수
전)서울아산병원 의생명정보학과 교수
장진규 PhD
HCI / UX 아키텍처 전문가
연세대학교 인지과학연구소 교수
전) 융합기술원 컴패노이드랩스
허정윤
UX 전문가
국민대 자동차운송디자인학과 교수
국민대 디자인융합창조센터 소장
구태언
변호사
테크앤로 법률사무소 대표파트너
전)김앤장법률사무소
김신호
회계사
정현회계법인 이사
전)삼일회계법인
백승재 MD,PhD
이비인후과 전문의
전) 다국적제약사 의학부 상무
전)연세대학교 의과대학 교수
정지훈 MD, MPH, PhD
IT융합전문가/미래학자/의사
빅뱅엔젤스 파트너
전) 명지병원 IT융합연구소장
김치원 MD, MPH
디지털 헬스케어 전문가/내과전문의
서울와이즈요양병원장
전) 맥킨지 서울사무소 컨설턴트
DHP는 초기 헬스케어 스타트업에 직접적으로 도움을 드릴 수 있는
의료, 규제, 디자인 전문가들이 파트너로 참여하고 있습니다.
신재원 MD
가정의학과 전문의
에임메드 대표이사
전)모바일닥터 대표이사
명유진 MD
성형외과 전문의
아주대병원 성형외과 교수
전)분당서울대병원 성형외과 교수
주세경, PhD
의공학 전문가
서울아산병원 의공학과 부교수
울산의대 의공학교실 주임교수
정재호
임팩트 투자자
전) 카이스트청년창투 이사
전) SK텔레콤 신사업추진단
김준환 MD
내과 전문의
입원의학전문가
서울아산병원 내과 교수
8. 의료 헬스케어 및 스타트업
•내분비내과
•신장내과
•종양내과
•소아청소년과
•안과
•피부과
•가정의학과
•성형외과
•이비인후과
•규제/인허가
•의료정보학
•의공학
•인공지능
•UI/UX
•HCI
•법률/지재권
•회계/재무
•국제보건
•벤처캐피털
DHP 는 다양한 의료/헬스케어 분야 및 스타트업 전문가들이
초기 헬스케어 스타트업에 직접적으로 도움을 드립니다.
DHP 파트너 기준
9. DHP 는 다양한 의료/헬스케어 분야 및 스타트업 전문가들이
초기 헬스케어 스타트업에 직접적으로 도움을 드립니다.
의료
헬스케어 및 스타트업
•내분비내과
•신장내과
•종양내과
•소아청소년과
•안과
•피부과
•가정의학과
•성형외과
•이비인후과
•규제/인허가
•의료정보학
•의공학
•인공지능
•UI/UX
•HCI
•법률/지재권
•회계/재무
•국제보건
•벤처캐피털
•병원 경영
•소화기 내과
•순환기내과
•정신건강의학과
•진단검사의학과
•응급의학과
•마취통증의학과
•비뇨기과
•산부인과
•외과
•치의학과
DHP 파트너+자문가 기준
14. 헬스케어
넓은 의미의 건강 관리에는 해당되지만,
디지털 기술이 적용되지 않고, 전문 의료 영역도 아닌 것
예) 운동, 영양, 수면
디지털 헬스케어
건강 관리 중에 디지털 기술이 사용되는 것
예) 사물인터넷, 인공지능, 3D 프린터, VR/AR
모바일 헬스케어
디지털 헬스케어 중
모바일 기술이 사용되는 것
예) 스마트폰, 사물인터넷, SNS
개인 유전정보분석
암유전체, 질병위험도,
보인자, 약물 민감도
예) 웰니스, 조상 분석
헬스케어 관련 분야 구성도 (ver 0.6)
의료
질병 예방, 치료, 처방, 관리
등 전문 의료 영역
원격의료
원격 환자 모니터링
원격진료
전화, 화상, 판독
디지털 치료제
당뇨 예방 앱
중독 치료 앱
ADHD 치료게임
16. Global Digital Healthcare Industry Landscape
Data Measurement Data Integration Data Interpretation Treatment
Smartphone Gadget/Apps
DNA
Artificial Intelligence
2nd Opinion
Wearables / IoT
EMR/EHR 3D Printer
Counseling
Data Platform
Accelerator/early-VC
Telemedicine
Device
On Demand (O2O)
VR
21. •최근 3년 동안 Merck, J&J, GSK 등의 제약사들의 디지털 헬스케어 분야 투자 급증
•2015-2016년 총 22건의 deal (=2010-2014년의 5년간 투자 건수와 동일)
•Merck 가 가장 활발: 2009년부터 Global Health Innovation Fund 를 통해 24건 투자 ($5-7M)
•GSK 의 경우 2014년부터 6건 (via VC arm, SR One): including Propeller Health
34. 헬스케어 시장은 매우 세분화되어 있고
시장마다 니즈와 지불의사도 다르다.
• 건강인 / 환자
• 20대 / 30대 / 40대 / 50대 / 60대 / 70대 / 80대
• 남성 / 여성
• 저체중 / 정상 / 과체중
• 가족력
• 건강에 대한 관심
• 지불 능력
• 디지털 리터러시
35. •Divide and Conquer: 한 번에 하나씩 공략 하는 수밖에.
•그렇다면 어떤 고객을 골라야하나?
•가장 절박한 니즈를 가진 고객 세그먼트
•우리가 실제로 해결책을 제시할 수 있는 고객 세그먼트
•돈을 낼 수 있는 고객 세그먼트
•그런데…
그러면 어떻게 해야 하는가?
36. 헬스케어 마켓 패러독스
건강인 중증질환
급성질환
지불의사
높음
지불의사
낮음
대상 고객
많음
대상 고객
적음
중증도
46. 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
47. 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
49. 1SCIENTIFIC REPORTS | (2018) 8:3642 | DOI:10.1038/s41598-018-22034-0
www.nature.com/scientificreports
The effectiveness, reproducibility,
and durability of tailored mobile
coaching on diabetes management
in policyholders:A randomized,
controlled, open-label study
DaYoung Lee1,2
, Jeongwoon Park3
, DooahChoi3
, Hong-YupAhn4
, Sung-Woo Park1
&
Cheol-Young Park 1
This randomized, controlled, open-label study conducted in Kangbuk Samsung Hospital evaluated
the effectiveness, reproducibility, and durability of tailored mobile coaching (TMC) on diabetes
management.The participants included 148 Korean adult policyholders with type 2 diabetes divided
into the Intervention-Maintenance (I-M) group (n=74) andControl-Intervention (C-I) group (n=74).
Intervention was the addition ofTMC to typical diabetes care. In the 6-month phase 1, the I-M group
receivedTMC, and theC-I group received their usual diabetes care. During the second 6-month phase
2, theC-I group receivedTMC, and the I-M group received only regular information messages.After
the 6-month phase 1, a significant decrease (0.6%) in HbA1c levels compared with baseline values was
observed in only the I-M group (from 8.1±1.4% to 7.5±1.1%, P<0.001 based on a paired t-test).
At the end of phase 2, HbA1c levels in theC-I group decreased by 0.6% compared with the value at 6
months (from 7.9±1.5 to 7.3±1.0, P<0.001 based on a paired t-test). In the I-M group, no changes
were observed. Both groups showed significant improvements in frequency of blood-glucose testing
and exercise. In conclusion, addition ofTMC to conventional treatment for diabetes improved glycemic
control, and this effect was maintained without individualized message feedback.
The incidence and prevalence of type 2 diabetes are increasing rapidly worldwide, and the disease is expected
to affect 439 million adults by 20301
. Previous large clinical trials indicated that adequate glycemic control con-
tributed to a reduction in both microvascular and macrovascular complications as well as mortality rates due to
diabetes2,3
. Complications from diabetes result in greater expenditure and reduced productivity. Therefore, it is a
socioeconomic concern4,5
. Adequate glycemic control is important not only as an individual health problem, but
also as a challenge to healthcare systems worldwide.
However, approximately 40% of subjects with diabetes in the United States do not meet the recommended
target for glycemic control, low-density lipoprotein cholesterol (LDL-C) level, or blood pressure (BP)6
. In Korea,
glycated hemoglobin (HbA1c) levels for nearly half of diabetic patients were above 7.0%7
.
Although successful diabetes care requires therapeutic lifestyle modification in addition to proper medica-
tion8–10
, only 55% of individuals with type 2 diabetes receive diabetes education from healthcare professionals11
,
and 16% report adhering to recommended self-management activities9
. Multifaceted professional inter-
ventions are needed to support patient efforts for behavior change including healthy lifestyle choices, disease
self-management, and prevention of diabetes complications10
.
1
Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital,
SungkyunkwanUniversitySchool of Medicine,Seoul, Republic of Korea.2
Division of Endocrinology and Metabolism,
Department of Internal Medicine, KoreaUniversityCollege of Medicine,Seoul, Republic of Korea.3
Huraypositive Inc.
Sinsa-dong, Gangnam-gu, Seoul, Republic of Korea. 4
Department of Statistics, Dongguk University-Seoul, Seoul,
Republic of Korea. Correspondence and requests for materials should be addressed to C.-Y.P. (email: cydoctor@
chol.com)
Received: 29 November 2017
Accepted: 15 February 2018
Published: xx xx xxxx
OPEN
www.nature.com/scientificreports/
Figure 3. Changes in means and standard errors of glycated hemoglobin (HbA1c) levels ov
study period.
HbA1c levels of the C-I group who received TMC during phase 2 of the study
decreased by 0.6% compared to phase 1 levels. In the I-M group, initial
improvement in HbA1c levels at 3 months continued until 12 months.
Consequently, HbA1c levels in both the C-I and I-M groups decreased significantly
compared to baseline values over the 12-month study period.
52. OPEN
ORIGINAL ARTICLE
Characterizing cognitive control abilities in children with
16p11.2 deletion using adaptive ‘video game’ technology: a
pilot study
JA Anguera1,2
, AN Brandes-Aitken1
, CE Rolle1
, SN Skinner1
, SS Desai1
, JD Bower3
, WE Martucci3
, WK Chung4
, EH Sherr1,5
and
EJ Marco1,2,5
Assessing cognitive abilities in children is challenging for two primary reasons: lack of testing engagement can lead to low testing
sensitivity and inherent performance variability. Here we sought to explore whether an engaging, adaptive digital cognitive
platform built to look and feel like a video game would reliably measure attention-based abilities in children with and without
neurodevelopmental disabilities related to a known genetic condition, 16p11.2 deletion. We assessed 20 children with 16p11.2
deletion, a genetic variation implicated in attention deficit/hyperactivity disorder and autism, as well as 16 siblings without the
deletion and 75 neurotypical age-matched children. Deletion carriers showed significantly slower response times and greater
response variability when compared with all non-carriers; by comparison, traditional non-adaptive selective attention assessments
were unable to discriminate group differences. This phenotypic characterization highlights the potential power of administering
tools that integrate adaptive psychophysical mechanics into video-game-style mechanics to achieve robust, reliable measurements.
Translational Psychiatry (2016) 6, e893; doi:10.1038/tp.2016.178; published online 20 September 2016
INTRODUCTION
Cognition is typically associated with measures of intelligence
(for example, intellectual quotient (IQ)1
), and is a reflection of
one’s ability to perform higher-level processes by engaging
specific mechanisms associated with learning, memory and
reasoning. Such acts require the engagement of a specific subset
of cognitive resources called cognitive control abilities,2–5
which
engage the underlying neural mechanisms associated with atten-
tion, working memory and goal-management faculties.6
These
abilities are often assessed with validated pencil-and-paper
approaches or, now more commonly with these same paradigms
deployed on either desktop or laptop computers. These
approaches are often less than ideal when assessing pediatric
populations, as children have highly varied degree of testing
engagement, leading to low test sensitivity.7–9
This is especially
concerning when characterizing clinical populations, as increased
performance variability in these groups often exceeds the range of
testing sensitivity,7–9
limiting the ability to characterize cognitive
deficits in certain populations. A proper assessment of cognitive
control abilities in children is especially important, as these
abilities allow children to interact with their complex environment
in a goal-directed manner,10
are predictive of academic
performance11
and are correlated with overall quality of life.12
For pediatric clinical populations, this characterization is especially
critical as they are often assessed in an indirect fashion through
intelligence quotients, parent report questionnaires13
and/or
behavioral challenges,14
each of which fail to properly characterize
these abilities in a direct manner.
One approach to make testing more robust and user-friendly is
to present material in an optimally engaging manner, a strategy
particularly beneficial when assessing children. The rise of digital
health technologies facilitates the ability to administer these types
of tests on tablet-based technologies (that is, iPad) in a game-like
manner.15
For instance, Dundar and Akcayir16
assessed tablet-
based reading compared with book reading in school-aged
children, and discovered that students preferred tablet-based
reading, reporting it to be more enjoyable. Another approach
used to optimize the testing experience involves the integration of
adaptive staircase algorithms, as the incorporation of such appro-
aches lead to more reliable assessments that can be completed in
a timely manner. This approach, rooted in psychophysical
research,17
has been a powerful way to ensure that individuals
perform at their ability level on a given task, mitigating the possi-
bility of floor/ceiling effects. With respect to assessing individual
abilities, the incorporation of adaptive mechanics acts as a
normalizing agent for each individual in accordance with their
underlying cognitive abilities,18
facilitating fair comparisons between
groups (for example, neurotypical and study populations).
Adaptive mechanics in a consumer-style video game experi-
ence could potentially assist in the challenge of interrogating
cognitive abilities in a pediatric patient population. This synergistic
approach would seemingly raise one’s level of engagement by
making the testing experience more enjoyable and with greater
sensitivity to individual differences, a key aspect typically missing
in both clinical and research settings when testing these
populations. Video game approaches have previously been
utilized in clinical adult populations (for example, stroke,19,20
1
Department of Neurology, University of California, San Francisco, San Francisco, CA, USA; 2
Department of Psychiatry, University of California, San Francisco, San Francisco, CA,
USA; 3
Akili Interactive Labs, Boston, MA, USA; 4
Department of Pediatrics, Columbia University Medical Center, New York, NY, USA and 5
Department of Pediatrics, University of
California, San Francisco, San Francisco, CA, USA. Correspondence: JA Anguera or EJ Marco, University of California, San Francisco, Mission Bay – Sandler Neurosciences Center,
UCSF MC 0444, 675 Nelson Rising Lane, Room 502, San Francisco, CA 94158, USA.
E-mail: joaquin.anguera@ucsf.edu or elysa.marco@ucsf.edu
Received 6 March 2016; revised 13 July 2016; accepted 18 July 2016
Citation: Transl Psychiatry (2016) 6, e893; doi:10.1038/tp.2016.178
www.nature.com/tp
Figure 2. Project: EVO selective attention performance. (a) EVO single- and multi-tasking response time performance for each group (carriers,
non-affected siblings and non-affected control groups). (b) EVO multi-tasking RT. (c) Visual search task performance for the conjunction 12
Characterizing cognitive control abilities in children
JA Anguera et al
5
•Project EVO (게임)을 통해서,
•아동 집중력 장애(attention disorder) 관련 특정 유전형 carrier 를 골라낼 수 있음
•게임에서의 Response Time을 기준으로 carrier vs. non-carrier 간 유의미한 차이
54. •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
58. The Journal of Clinical Investigation C L I N I C A L M E D I C I N E
Introduction
Clinical laboratory testing plays a critical role in health care and
evidence-based medicine (1). Lab tests provide essential data
that support clinical decisions to screen, diagnose, and treat
health conditions (2). Most individuals encounter clinical testing
through their health care provider during a routine health assess-
ment or as a patient in a health care facility. However, individu-
als are increasingly playing more active roles in managing their
health, and some now seek direct access to laboratory testing for
self-guided assessment or monitoring (3–5).
IntheUSA,allclinicallaboratorytestingconductedonhumans
is regulated by Centers for Medicare & Medicaid Services (CMS)
based on guidelines outlined in Clinical Laboratory Improvement
Amendments (CLIA) (6). To ensure analytical quality of labora-
tory methods, certified laboratories are required to participate in
periodic proficiency testing using a homogeneous batch of sam-
ples that are distributed to each laboratory from a CMS-approved
proficiency testing program. These programs assess the total
allowable error (TEa) that combines method bias and total impre-
cision for each analyte. Acceptability criteria are determined by
CLIA and/or the appropriate accrediting agency (7).
Direct-to-consumer service models now provide means for
individuals to obtain laboratory testing outside traditional health
care settings (4, 5). One company implementing this new model is
Theranos, which offers a blood testing service that uses capillary
tube collection and promises several advantages over traditional
venipuncture: lower collection volumes (typically ≤150 μl versus
≥1.5 ml), convenience, and reduced cost — on average about 5-fold
less than the 2 largest testing laboratories in the USA (Quest and
LabCorp) (8). However, availability of these services varies by
state, where access to offerings may be more or less restrictive
BACKGROUND. Clinical laboratory tests are now being prescribed and made directly available to consumers through retail
outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these
venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through
these services.
METHODS. We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical
lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services
that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory
clinic and at retail outlets with point-of-care services.
RESULTS. Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the
22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent
lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times,
and subjects markedly influenced lab results.
CONCLUSION. While laboratory practice standards exist to control this variability, the disparities between testing services
we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of
testing technologies would increase their utility in personalized health management.
FUNDING. This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family
Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01
AG046170 and U01 AI111598, to E.E. Schadt).
Evaluation of direct-to-consumer low-volume lab tests
in healthy adults
Brian A. Kidd,1,2,3
Gabriel Hoffman,1,2
Noah Zimmerman,3
Li Li,1,2,3
Joseph W. Morgan,3
Patricia K. Glowe,1,2,3
Gregory J. Botwin,3
Samir Parekh,4
Nikolina Babic,5
Matthew W. Doust,6
Gregory B. Stock,1,2,3
Eric E. Schadt,1,2
and Joel T. Dudley1,2,3
1
Department of Genetics and Genomic Sciences, 2
Icahn Institute for Genomics and Multiscale Biology, 3
Harris Center for Precision Wellness, 4
Department of Hematology and Medical Oncology, and
5
Department of Pathology, Icahn School of Medicine at Mount Sinai, NewYork, NewYork, USA. 6
Hope Research Institute (HRI), Phoenix, Arizona, USA.
Conflict of interest: J.T. Dudley owns equity in NuMedii Inc. and has received consulting
fees or honoraria from Janssen Pharmaceuticals, GlaxoSmithKline, AstraZeneca, and
LAM Therapeutics.
Role of funding source: Study funding provided by the Icahn Institute for Genomics
and Multiscale Biology and the Harris Center for Precision Wellness at the Icahn
School of Medicine at Mount Sinai. Salaries of B.A. Kidd, J.T. Dudley, and E.E. Schadt
Downloaded from http://www.jci.org on March 28, 2016. http://dx.doi.org/10.1172/JCI86318
•Mt Sinai 에서 내어놓은 Theranos 의 정확도에 대한 논문
•2015년 7월 경에 60명의 건강한 환자들을 대상으로 5일 간에 걸쳐서
•22가지의 검사 항목을 테라노스와 또 다른 두 군데의 검사 기관에 맡겨서 결과를 비교
•결론적으로 Theranos의 결과가 많이 부정확
•콜레스테롤 등의 경우는 의사의 진단이 바뀔 정도로 크게 부정확
•전반적인 테스트들 결과 정상 범위가 아니라고 판단하는 경우가 테라노스가 1.6배 많음
•22개의 검사 항목 중에서 15개에서 유의미하게 결과의 차이가 있었습니다.
•논문에서는 알 수 없는 또 다른 문제
•Theranos가 자체적으로 개발했다고 '주장' 했던 에디슨 기기를 정말로 썼느냐...하는 것
•WSJ 에 나온 과거 직원의 증언에 따르면, 이미 2015년 7월경이라면,
•에디슨 기기를 쓰지 않고 지멘스 등 기존 다른 기기에 혈액을 희석해서 쓰고 있을 때
•역시나(?) 이번에도 테라노스는 conflict-of-interest 가 있는 잘못된 논문이라는 반응
68. 한국 의료 시스템의 특수성을 이해하라
•한국 의료 체계는 미국, 혹은 다른 국가와 크게 다르다.
•국내 의료 시스템의 특성을 명확히 파악할 필요가 있다.
•미국에서 대박났던 것이, 한국에서는 통하지 않거나 / 불법일 수 있다.
•반대로, 한국에서 안 통하던 것이, 미국 등에서는 통할 수 있다.
69. 의료 사고 부담
더 많은 데이터
부족한 시간
3분 진료저수가
EMR
전공의 특별법
인력 부족
과도한 업무
사회적 인식
의사의 삶은 고달프다
논문 실적
새로운 기술
진료 실적
삭감
진상 환자
70. 의료 사고 부담
더 많은 데이터
부족한 시간
3분 진료저수가
EMR
전공의 특별법
인력 부족
과도한 업무
사회적 인식
헬스케어 스타트업은?
논문 실적
새로운 기술
진료 실적
삭감
진상 환자
71. 신의료기술평가 문재인케어
의료전달체계 3분 진료전공의특별법
단일 건강 보험당연지정제
심평의학
저수가
당신의 사업에 어떤 영향을 미치나요?
이를 명확히 알지 못하면, 준비가 덜 되어도 한참 덜 된 것.
79. 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-
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-
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
JAMIA 2016
Remote Patients Monitoring
via Dexcom-HealthKit-Epic-Stanford
제1형 당뇨환자의 혈당을 연속혈당계로 측정하여,
아이폰, EMR을 거쳐
스탠퍼드 대학병원의 의료진이 모니터링한다.
89. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 시스템 밖으로 나간다. (해외진출)
90. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 시스템 밖으로 나간다. (해외진출)
91. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 시스템 밖으로 나간다. (해외진출)
92. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 시스템 밖으로 나간다. (해외진출)
93. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 다른 시스템으로 간다. (해외 진출)
94. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 다른 시스템으로 간다. (해외 진출)
95. 답이 없는 한국의 헬스케어 시스템,
스타트업에게는 어떤 옵션이 있나?
1. 시스템에 도전하여 변화를 이끈다. (23andMe)
2. 시스템 하에서 최선의 답을 찾는다. (현재 상장사들)
3. 시스템의 틈새를 공략한다. (타다)
4. 시스템을 회피한다. (웰니스)
5. 다른 시스템으로 간다. (해외 진출)
97. •기존 이해관계자를 mimic하면서 완전히 새로운 모델을 제시하는 야심있는 스타트업
•‘a new-age payer’ or ‘a new-age PBM(Pharmacy Benefit Management)’
•기존의 헬스케어 산업의 범주를 뭉개버리는 스타트업
•Oscar는 기존의 payer 역할에서 provider 까지 진출하고 있음
•23andMe 는 유전정보 분석회사에서 제약회사도 되고 있음
•Ginger.io 는 B2B 헬스케어 스타트업에서 provider도 되었음
어떠한 스타트업을 찾고 있는가?
Health 2.0 2017 Annual Conference
VC’s Talk New Trends in Investing
107. DHP는 정기적으로 DHP Office Hour 를 통해,
유망한 헬스케어 스타트업을 초청하여 자문, 네트워크, 투자를 지원합니다.
매달 세 팀을 초청하여 한 시간씩 무료로 자문을 제공
참여를 원하는 초기 헬스케어 스타트업은
dhp@dhpartners.io로 소개자료를 보내주세요
108. 수십 명의 의료/스타트업 전문가들이
오직 하나의 스타트업을 위해 자문
DHP Office Hour
123. •니즈가 있는 것을 만들어야 한다.
•헬스케어는 매우 세분화된 시장이며, 니즈와 지불의사도 다르다.
•헬스케어에서 사용자, 결정자, 지불자는 일치하지 않을 수 있다.
•근거가 중요하다. 타당성을 판단할 전문성도 필요하다.
혁신적인 디지털 헬스케어 스타트업이
정말 한국에서 나오려면
124. •‘답이 없는’ 한국 의료의 특수성을 이해해야 한다.
•스타트업의 옵션: 시스템에 도전 / 적응 / 회피 / 탈피
•더 도전적인 스타트업 + 더 많은 숫자의 스타트업
•결국은 생태계가 필요하다.
혁신적인 디지털 헬스케어 스타트업이
정말 한국에서 나오려면
125. 세상을 바꿀 혁신적인 디지털 헬스케어 스타트업의 시작, DHP 가 함께 하겠습니다.
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