12월4일에 대구 한국정보화진흥원 본관에서 진행되었던 대구 혁신도시 헬스케어 기업 세미나에서 발표했던 자료입니다. 의료 사물인터넷과 의료 인공지능 기술을 활용한 제품 및 서비스 개발시에 고려해야 할 사항들을 현재 동향 등과 함께 간략하게 정리해봤습니다. 관심 있는 분들께 도움이 되시길 바랍니다.

1. IoT 및 인공지능을 활용한
헬스케어 제품․서비스
개발 동향 및 주요 과제
Jonghong Jeon
ETRI, PEC
Email: hollobit@etri.re.kr
http://www.etri.re.kr

2. Simple Curriculum Vitae
• ISO/IEC JTC1 SC41 (Internet of Things)
– 국내 전문위원회 위원
• IEC TC124 (Wearable Electronics)
– 국내 전문위원회 위원
– 국제표준 제안 중
• IEC TC62D (Medical Electronic Equipment)
– 국내 전문위원회 위원
– KS 표준 작성 및 제정
• ITU-T SG20 (Internet of Things)
– Y.4117 공동 에디터
• OCF
– Healthcare 표준 에디터
• 식약처
– 스마트 헬스케어 자문위 총괄 코디네이터
• ISO/IEC JTC1 SC42 (Artificial Intelligence)
– 국내 전문위원회 위원
2

3. 변화들
3

4. Healthcare Paradigm Shift
4

5. 고령인구 증가 및 노령화
5

6. Healthcare 변화 동인
6
Source: http://www.splex.co.kr/wp-content/uploads/2015/05/smarthealth_002.jpg

7. 스마트 헬스케어 경제적 효과
7

8. Digital Innovation
8출처: 2018년 주요 디지털 기술 산업 이슈, LG경제연구원

9. The 4th Industrial Revolution
• 초연결, 빅데이터, 인공지능 등
디지털로 촉발되는 지능화 혁명
9출처: 정부의 4차 산업혁명 대응방안, 장병규
SW

10. Technical Challenges
10자료 : 관계부처 합동 ‘제4차 산업혁명에 대응한 지능정보사회 중장기 종합대책’(2016, 12)

11. BUT… 실제 현실은
11

12. 의료기기와 개인건강관리기기
• 의료기기와 개인용 건강관리제품 (웰니스 제품)의 차이
– 의료기기란 사람이나 동물에게 단독 또는 조합하여 사용하는 기구
기계 장치 재료 또는 이와 유사한 제품으로 다음에 해당
(의료기기법 제2조)
– 1) 질병을 진단·치료·경감·처치 또는 예방할 목적으로 사용하는
제품
– 2) 상해(傷害) 또는 장애를 진단·치료·경감 또는 보정할 목적으로
사용하는 제품
– 3) 신체 구조 또는 기능을 검사·대체 또는 변형할 목적으로
사용하는 제품
– 4) 임신을 조절할 목적으로 사용하는 제품
12
식품의약품안전처, “의료기기와 개인용 건강관리 (웰니스) 제품 판단기준” (2015)

13. 의료기기 등급 분류
• 사용목적과 사용시 인체에 미치는 잠재적 위해성 등의
차이에 따라 체계적·합리적 안전관리를 할 수 있도록
의료기기의 등급을 분류하여 지정(1~4 등급)
13
의료기기 품목 및 품목별 등급에 관한 규정 (식품의약품안전처고시)

14. 의료기기 신고·인증·허가 대상
14
출처: 식품의약품안전처

15. 의료기기산업의 특성
1. 의료기기는 다양한 제품군으로 구성되며, 기술발전에
따라 점차 복잡해지고 다양화되는 추세
2. 의료기기산업은 다품종 소량생산 산업
3. 의료기기산업은 정부의 의료정책 및 관리제도와
밀접한 관련성이 있음
– 인허가 측면에서 국가간 인증 허가제도가 상이하여 국제
교역에서 비관세 장벽으로 작용하고 있다. 미국 FDA의
인허가에 소요되는 기간이 평균 7.2개월, 중국 은
13개월이다. 이후 시장에 진입하는 소요 기간
4. 의료기기 시장은 수요가 한정된 특징이 있음
– 의료기기는 의료진단과 치료에 전문성을 가진 병원이 주요
수요처. 시장의 진입장벽이 높고 가격 탄력성은 낮다.
제품에 대한 인지도와 브랜드 파워가 매우 중요한 산업
5. 연구개발에 대한 지속적인 투자가 필요
15출처: 보건산업진흥원, 2017년도 의료기기 산업 분석 보고서

16. 국내 디지털 헬스케어 현황
16출처: 아산나눔재단 스타트업코리아 디지털 헬스케어 보고서 (2018.11)

17. 기업이 넘어야 할 현실 장벽들
17출처: 아산나눔재단 스타트업코리아 디지털 헬스케어 보고서 (2018.11)

18. 혁신의 제약 ­ 진입 규제
18출처: 아산나눔재단 스타트업코리아 디지털 헬스케어 보고서 (2018.11)

19. 혁신의 제약 ­ 진입 규제
19출처: 아산나눔재단 스타트업코리아 디지털 헬스케어 보고서 (2018.11)

20. 혁신의 제약 ­ 시장 진입
20출처: 아산나눔재단 스타트업코리아 디지털 헬스케어 보고서 (2018.11)

21. 시장환경 - 의료 산업 현황
• 의료 서비스 시장의 1/20 규모
21

22. 시장환경 - 의료기기 산업 현황
• 세부 유형으로 나누면 더 작은 규모 시장 현실
– 다른 IT 시장(또는 디지털 경제 영역) 규모와 비교하면 …
22
한국 모바일 광고
시장 : 4.4조 (’17)
한국 디지털 경제규
모 (’15)
(GDP 대비 17%)
중국 디지털 경제
규모 (‘18.4)
4641조
(GDP 대비 32%)

23. 그럼에도 희망은 …
23

24. K-FDA guideline (‘17.11)
24

25. K-FDA guideline (‘17.12)
25

26. K-FDA roadmap (‘18.8)
26

27. MEDICAL AI
May 5, 2016 Ope
n Connectivity Foun
27

28. AI ­ ML - DL
28

29. Deep Learning Timeline
29
Source: https://towardsdatascience.com/a-weird-introduction-to-deep-learning-7828803693b0

30. General Neural Network End-to-End Workflow
30
Source: Khronos group, 2018

31. General Neural Network End-to-End Workflow
31
Source: Khronos group, 2018
개발 전에 충분히 고민하고 고려해야 할 부분들

32. Disruptive tech in Healthcare
32

33. Emerging Healthcare AI
33

34. Emerging Healthcare AI
34

35. Emerging Healthcare AI
35
Source: https://techburst.io/ai-in-healthcare-industry-landscape-c433829b320c

36. 인허가된 인공지능 SW …
• ‘18.5
– 뷰노메드 본에이지 (2등급 의료기기)
• 의료영상 진단 지원 시스템
• ’18.8
– 루닛 인사이트(Lunit INSIGHT)
• 의료영상 검출 보조 소프트웨어
– 제이비에스-01케이(JBS-01K)
• 의료영상 진단 보조 소프트웨어
• 그러나… “허가만 완료된 것”
36

37. AI war ­ US vs. China
37

38. 고려사항 - Data is the key
38
Source: https://slideplayer.com/slide/6897901/

39. 고려사항 - Data is the New Source Code
39
Source: Nvidia, RSNA 2018

40. China’s benchmark dataset
40Shan Xu, CAICR, Chinese practice of benchmarking and algorithm evaluation

41. 대한의료인공지능학회 (‘18.10)
• http://www.kosaim.org/
• 비전
– 의료 인공지능 융합 기술을 이용한 지능형
의료기기 개발 및 임상적용
– 의료 인공지능 기술 연구개발을 위한
산/학/연/병/정 융합의 장
– 유용하고 안전한 의료인공지능 기술
임상시험 촉진
– 융합 교육을 통한 의료 인공지능 인재 육성
– 의료 인공지능 관련 산업 활성화
– 의료 인공지능 관련 국가 정책 개발/규제
조정을 위한 소통의 장
• 표준화 분과를 통한 협력/협력
41

42. TOWARD
CONNECTED HEALTHCARE
42

43. PCHA
(Personal Connected Health Alliance)
Continua Health
Alliance
[1] U-health에서 Connected Healthcare로
43
ISO/IEEE
11073

44. [2] U-health에서 Connected Healthcare로
• 유헬스케어 의료기기는 원격진료의 목적으로 의료진과 환자들이 사용하는
의료기기로, 의료기관 이외의 장소에서 환자의료정보 및 생체정보를 측정·
수집하고 의료기관에 전송·저장하여 의사의 진단을 도와준다
44출처: 유헬스케어 의료기기 시스템 허가심사 가이드라인, 식품의약품안전처

45. [3] U-health에서 Connected Healthcare로
45
Health
Record
Network
Interface
Personal Device
Weight Scale
Pulse Oximeter
Independent
Living Activity
Cardio / Strengt
h
Medication
Adherence
Glucose Meter
Pulse /
Blood Pressure
Thermometer
Physical Activity
Peak Flow
Aggregation
Manager
Device
Connectivity
Wide
Area
Network
(WAN)
Interface
Telehealth
Service
Center
Health
Records
EHR
PHR
HIE
NHIN
CCD
PCD 01
Continua BT
Profiles
Healthcare IoTHealthcare IoT
HealthcareIoTHealthcareIoT

46. [3] Connected Healthcare
46

47. [4] Connected Healthcare
47

48. [5] Connected Healthcare
48

49. STANDARDS FOR
CONNECTED HEALTHCARE

50. 50

51. OCF 2.0
- Core Framework
- Core Extension: OCF Cloud
- Core Extension: Wi-Fi Easy
Setup
- Security
- Bridging
- Resource Type
- OCF to AllJoyn Mapping
- Device Profile
51

52. OCF 2.0
52
Resource Type Use Case
3D Printer Device Control
Blood Pressure Personal Health
Body Mass Index Personal Health
Body Fat Personal Health
Body Fat Free Mass Personal Health
Body Location Personal Health
Body Location Temperature Personal Health
Body Soft Lean Mass Personal Health
Body Water Personal Health
Glucose Personal Health
Glucose Carbohydrates Personal Health
Glucose Exercise Personal Health
Glucose HbA1c Personal Health
Resource Types are Conditionally Mandatory. If an OCF Server hosts an OCF known resource then it
shall follow all normative requirements in the Resource Specification applicable to that Resource.
New Resource Types – OCF 2.0
Resource Type Use Case
Glucose Health Personal Health
Glucose Meal Personal Health
Glucose Medication Personal Health
Glucose Sample Location Personal Health
Glucose Tester Personal Health
ORFID Station Smart Factory
ORFID Tag Smart Factory
Power Source Energy Star
Print Queue Device Control
Pulse Rate Personal Health
Sensor Properties Generic Sensor Modeling
User ID Personal Health

53. OCF 2.0
53
• All OCF devices are grouped
into Device Categories
based on the Universal
Device Classification (UDC)
that was developed by LBNL.
• https://eta-
intranet.lbl.gov/sites/default
/files/lbnl-classification-
v1.pdf
Device Category
Name
Description
LBNL Categories
Space Conditioning Heating and cooling systems
Lighting
Appliance Also known as “white goods”; covers
major appliances only.
Electronics Personal electronics
Miscellaneous Small appliances, other
Infrastructure Physical building and infrastructure
Transportation Vehicles, fixed devices that provide
movement (e.g. Escalators)
Other
OCF Added Categories
Fitness Includes lifestyle
Medical
Personal Health

54. Why OCF ?
• IoT architecture & ecosystem
service #2
domain
service #1
domain
Local Control Remote Control Server to Server
IndustrialSmart Home Healthcare
SecurityDevice
management
Group
management
Protocol
Bridge/GW
Messaging StreamingDiscovery
ID &
Addressing
CRUDN
Common
Resource
Model
…
Wi-Fi BT/BLE Thread …
Vertical
Profiles
Baseline
Functionality
Connectivity
Controller
Controller
Cloud Servers Cloud Servers
Things
Controller App
Cloud Interface
Controller

55. Why OCF ?
• Core Framework for IoT
55
① Discovery: Common method for device
discovery (IETF CoRE)
② Messaging: Constrained device support as
default (IETF CoAP) as well as protocol translation
via bridges
③ Common Resource Model: Real world entities
defined as data models (resources)
④ CRUDN: Simple Request/Response mechanism
with Create, Retrieve, Update, Delete and Notify
commands
⑤ ID & Addressing: OCF IDs and addressing for OCF
entities (Devices, Clients, Servers, Resources)
⑥ Protocol Bridge/GW: Handled by the Bridging
Spec with some implications on the Core
TransportNetworkingL2 Connectivity
Vertical
Profiles
Smart
Home
OCF Core Framework
Security
Device
management
Protocol
Bridge/GW
MessagingDiscovery
ID & Addressing
CRUDN
Common
Resource
Model
Health
care
Auto-
motive
Industrial
Security is fundamental to the OCF ecosystem and applies to all elements

56. Example: Thermometer (oic.d.thermometer)
56
• Example overview
- Thermometer device with i) binary switch & ii) body temperature resource
• Device type: Thermometer device (oic.d.thermometer) [Defined by
the healthcare domain]
• Associated resources
- Core resources: ① oic/res, ② oic/d
- Device specific resources: ③ Binary switch (oic.r.switch.binary),
- Other optional resources can be exposed, in this example ④ Body
Temperature resource (oic.r.body.temperature)
Device
Title
Device
Type
Associated Resource Type M/O
Thermo
meter
oic.d.ther
mometer
oic/res (oic.wk.res) M
oic/d (oic.d.thermometer) M
Binary switch (oic.r.switch.binary) M
Body Temperature
(oic.r.body.temperature)
M
Example: Thermometer device with 4 resources
oic/res
oic/d
Binary switch
Body
Temperature
http://oneiota.org/revisions/971

57. Why OCF ?
Discovery
- Discover access policies, device info and resources on the devices
Operation
- Get device information by retrieving resources
- Control devices by changing resources
- Observe change on the properties of resources
Basic common services
- Device Monitoring
- Maintenance (e.g., reboot, factory reset, etc.)
Connectivity Networking SecurityTransportConnectivity Networking SecurityTransport
Discovery Operation

58. OCF’s Three Pillars
58
Relationships (Membership, Liaisons with other SDOs, Open Community…)
Openness (IPR policy, Open source)
Relationships (Membership, Liaisons with other SDOs, Open Community…)
Openness (IPR policy, Open source)

59. IPR Policy - Royalty Free* Licenses
59
Apache v2.0
Incoming:
Companies license their patent claims
covering their code
Outgoing:
All users (unless they sue another user for
patent infringement via IoTivity code)
RAND-Z
(By default – RAND under some circumstances*)
Incoming:
All members license their claims to IP
essential to implementing the
specification
Outgoing:
Compliant portion of certified products

60. OCF 표준 + IoTivity 오픈소스의 장점
원천기술을 빠르게
확보
확장 개발/개작/배포/유통
빠른 개발/적용
도입비용과 TCO 절감
신기술이 반영되는 소스
글로벌 경쟁력 확보
사물인터넷 생태계와 연계
60

61. International Standard
61
30118-x:2018

62. NEXT PHASE OF
OCF HEALTHCARE

63. Internet of Medical Things
16
• 10-15 Device per Bed
• ~50% Networked
Source: Markets and Markets, Oct 2015

64. IoMT & Digital Hospital
64

65. How many medical devices ?
• FDA has classified and described over 1,700 distinct types of devices
and organized them in the CFR into 16 medical specialty "panels"
such as Cardiovascular devices or Ear, Nose, and Throat devices.
17

66. Medical devices + IoT = IoMT
Internet
of
Things
18

67. Standards for Medical device
• IEC 60601 is a series of technical standards for the safety and
effectiveness of medical electrical equipment, published by
the International Electrotechnical Commission. First published
in 1977 and regularly updated and restructured, as of 2011 it
consists of a general standard, about 10 collateral standards,
and about 60 particular standards.
General requirements for basic safety and essential performance
Particular requirements for the basic safety and essential performance
19

68. Standards for Medical device
68

69. • IEC 60601-1-2 Part 1-2: Electromagnetic disturbances -
Requirements and tests
• IEC 60601-1-3 Part 1-3: Radiation protection in
diagnostic X-ray equipment
• IEC 60601-1-6 Part 1-6: Usability
• IEC 60601-1-8 Part 1-8: General requirements, tests
and guidance for alarm systems in medical electrical
equipment and medical electrical systems
• IEC 60601-1-9 Part 1-9: Requirements for
environmentally conscious design
• IEC 60601-1-10 Part 1-10: Requirements for the
development of physiologic closed-loop controllers
• IEC 60601-1-11 Part 1-11: Requirements for medical
electrical equipment and medical electrical systems used
in the home healthcare environment
• IEC 60601-1-12 Part 1-12: Requirements for medical
electrical equipment and medical electrical systems
intended for use in the emergency medical services
environment
• IEC 60601-2-1 Part 2-1: electron accelerators in the
range 1 MeV to 50 MeV
• IEC 60601-2-2 Part 2-2: high frequency surgical
equipment and high frequency surgical accessories
• IEC 60601-2-3 Part 2-3: short-wave therapy equipment
• IEC 60601-2-4 Part 2-4: cardiac defibrillators
• IEC 60601-2-5 Part 2-5: ultrasonic physiotherapy
equipment
• IEC 60601-2-6 Part 2-6: microwave therapy equipment
• IEC 60601-2-8 Part 2-8: Particular requirements for
basic safety and essential performance of therapeutic X-
ray equipment operating in the range 10 kV to 1 MV
• IEC 60601-2-10 Part 2-10: nerve and muscle stimulators
• IEC 60601-2-11 Part 2-11: gamma beam therapy
equipment
• IEC 60601-2-16 Part 2-16: Particular requirements for
basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
• IEC 60601-2-17 Part 2-17: automatically-controlled
brachytherapy afterloading equipment
• IEC 60601-2-18 Part 2-18: endoscopic equipment
• IEC 60601-2-19 Part 2-19: infant incubators
• IEC 60601-2-20 Part 2-20: infant transport incubators
• IEC 60601-2-21 Part 2-21: infant radiant warmers
• IEC 60601-2-22 Part 2-22: Particular requirements for
basic safety and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser equipment
• IEC 60601-2-23 Part 2-23: transcutaneous partial
pressure monitoring equipment
• IEC 60601-2-24 Part 2-24: infusion pumps and
controllers
• IEC 60601-2-25 Part 2-25: electrocardiographs
• IEC 60601-2-26 Part 2-26: electroencephalographs
Standards for Medical device (IEC 60601-x)
20

70. • IEC 60601-2-27 Part 2-27: electrocardiographic
monitoring equipment
• IEC 60601-2-28 Part 2-28: X-ray tube assemblies for
medical diagnosis
• IEC 60601-2-29 Part 2-29: radiotherapy simulators
• IEC 60601-2-31 Part 2-31: external cardiac pacemakers
with internal power source
• IEC 60601-2-33 Part 2-33: magnetic resonance
equipment for medical diagnosis
• IEC 60601-2-34 Part 2-34: invasive blood pressure
monitoring equipment
• IEC 60601-2-36 Part 2-36: equipment for
extracorporeally induced lithotripsy
• IEC 60601-2-37 Part 2-37: ultrasonic medical diagnostic
and monitoring equipment
• IEC 60601-2-39 Part 2-39: Particular requirements for
basic safety and essential performance of peritoneal
dialysis equipment
• IEC 60601-2-40 Part 2-40: electromyographs and
evoked response equipment
• IEC 60601-2-41 Part 2-41: surgical luminaires and
luminaires for diagnosis
• IEC 60601-2-43 Part 2-43: X-ray equipment for
interventional procedures
• IEC 60601-2-44 Part 2-44: X-ray equipment for
computed tomography
• IEC 60601-2-45 Part 2-45: Particular requirements for
basic safety and essential performance of
mammographic X-ray equipment and
mammomagraphic stereotactic devices
• IEC 60601-2-46 Part 2-46: operating tables
• IEC 60601-2-47 Part 2-47: ambulatory
electrocardiographic systems
• IEC 60601-2-49 Part 2-49: multifunction patient
monitoring equipment
• IEC 60601-2-50 Part 2-50: infant phototherapy
equipment
• IEC 60601-2-52 Part 2-52: medical beds
• IEC 60601-2-54 Part 2-54: X-ray equipment for
radiography and radioscopy
• IEC 60601-2-57 Part 2-57: non-laser light source
equipment intended for therapeutic, diagnostic,
monitoring and cosmetic/aesthetic use
• IEC 60601-2-62 Part 2-62: high intensity therapeutic
ultrasound (HITU) equipment
• IEC 60601-2-63 Part 2-63: dental extra-oral X-ray
equipment
• IEC 60601-2-64 Part 2-64: light ion beam medical
electrical equipment
• IEC 60601-2-65 Part 2-65: dental intra-oral X-ray
equipment
• IEC 60601-2-66 Part 2-66: hearing instruments and
hearing instrument systems
• IEC 60601-2-68 Part 2-68: X-ray-based image-guided
radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and
radionuclide beam therapy equipment
Standards for Medical device (IEC 60601-x)
21

71. Collaboration with IEC
71
Internet of
Things
Internet of
Medical
Things
IoT Framework & open source
(OCF)
Safety & Performance Requirements for
Medical Electrical equipment
(IEC)
Medical
Devices

72. Toward IoMT
72
• IEC 60601-2-25 (1993-03) 심전계
Electrocardiographs
• IEC 60601-2-27 (1994-04) 심전도 감시장치
Electrocardiographic monitoring equipment
• IEC 60601-2-38 (1996-10) 병원용 침대 Electrically
operated hospital beds
• IEC 60601-2-47 (2001-07) 휴대용 심전계
Ambulatory electrocardiographic systems
• IEC 80601-2-49 (2001-07) 다기능 환자 감시장치
Multifunction patient monitoring equipment
• IEC 60601-2-51 (2003-02) 단일 및 다중 채널
심전계 기록 및 분석 Recording and analyzing
single channel and multichannel
electrocardiographs
• IEC 60601-2-52 (2009+2015): 의료용 침대
medical beds
• Medical Refrigerators
• Smart bed – sleep monitor, patient monitoring
Activity Tracker
Airflow Sensor (Breathing)
Blood Pressure Monitor
Body composition analyzer
Continuous Glucose Monitoring
Cycling computer
Cycling Power Meter
Cycling Speed and Cadence
Electromyography Sensor
Galvanic Skin Response Sensor
Glucose Meter
Heart Rate Monitor
Height Scale
Muscle Oxygen Monitor
Patient Position Sensor
Peak flow
Pulse Oximeter
Respiration rate monitor
Scale
Sleep Monitor
Smart Watch
Strength fitness equipment
Thermometer

73. Use case of IoMT
• CGM(Continuous Glucose Monitor)
73
Server Client

74. Use case of IoMT
• CGM Calibration
– Automatically
• If you use a linking meter, when you test
your BG with a fingerstick, the value will
be automatically sent from the BGM to
your CGM device.
– Manually
• MAIN MENU > Sensor > Calibrate >
ENTER BG

75. Use case of IoMT
• CGM, Insulin pump, SAP(Sensor-
augmented pump)
75

76. Toward IoMT
76

77. 표준 및 가이드라인 개발 계획
• 표준 (안)
– 헬스케어 사물인터넷 ­ 제1부: 기본 안전 및 성능 요구사항
– 헬스케어 사물인터넷 ­ 제2-1부: 혈압계 ­ 개별 요구사항
– 헬스케어 사물인터넷 ­ 제2-2부: 체온계 ­ 개별 요구사항
– 헬스케어 사물인터넷 ­ 제2-3부: 체중계 ­ 개별 요구사항
– 헬스케어 사물인터넷 ­ 제2-4부: 혈당계 ­ 개별 요구사항
• 가이드라인 (안)
– 헬스케어 사물인터넷 의료기기 허가심사 가이드라인
– 헬스케어 사물인터넷 의료기기의 품목별 허가심사
가이드라인
77

78. 제2-X부 : 개별 요구사항
• 헬스케어 사물인터넷 (2018년 말)
– 제2-1부: 혈압계 ­ 개별 요구사항
– 제2-2부: 체온계 ­ 개별 요구사항
– 제2-3부: 체중계 ­ 개별 요구사항
– 제2-4부: 혈당계 ­ 개별 요구사항
• 헬스케어 사물인터넷 (2019년 말)
– 제2-X부: 심박계 ­ 개별 요구사항
– 제2-X부: 활동량계 ­ 개별 요구사항
– 제2-X부: 산소포화도계 ­ 개별 요구사항
– 제2-X부: CGM ­ 개별 요구사항
– 제2-X부: 체성분 분석계 ­ 개별 요구사항
– 제2-X부: 수면계 ­ 개별 요구사항
78

79. 기타 이슈들
• OCF 2.0 기능 지원
- Core Extension: OCF Cloud
- Core Extension: Wi-Fi Easy Setup
- Security
- Bridging
• 향후 고려가 필요한 사항
– UDI(Unique Device Identifier)
79

80. Timeplan
‘17.12 ‘18.5 ’18.12 ’19.5
ISO/IEC JTC1 PAS submited
(ISO/IEC 30118)
OCF 1.0
헬스케어 사물인터넷 KS 표준 및 가이드라인 (식약처)헬스케어 사물인터넷 KS 표준 및 가이드라인 (식약처)
OCF 2.0
(+Healthcare)Healthcare spec
(OCF Healthcare Phase 1)
OCF 2.5
(Cleveland)
OCF Healthcare Phase 2 (with IEC)
국문화 작업 KS 표준 제정
(KS ISO 30118)
초안 개발
OCF 3.0
(Dubai)
(for IoMT)

81. PoC ­ CES 2018
81

82. PoC ­ CES 2018
82

83. PoC ­ CES 2018
83

84. CONCLUSION
84

85. Connected Healthcare
• Connectivity support ­ LPWA, 4G/5G, BLE …
• OnBoarding Tool ­ WiFi Easy setup …
• Bridging ­ oneM2M, BLE, Zigbee, Z-wave …
• Cloud
• Security Profile & PKI
• Sleepy/Constrained Devices
• Device Management and Code Signing
• Privacy
• Group Services
• Data interoperability
85

86. Medical AI systems
86
Wojciech Samek: Transparent & Trustworthy AI for Medical Applications

87. Conclusion
• Connected Healthcare 성장
– Network, IoT, Security, SaMD …
• Healthcare AI 성장
– SaMD, CDSS, Data …
• 사업 시작 == “Winter is coming”
– 기술 보다 더 중요한 것은 Monetization
– 인허가 기간에 대한 대비 필요
– 명확한 제품 포지션, 시장 설정
– 국가별 인허가/진입 규제 파악 및 대응
– 수가 체계에 편입할 것인지 판단 필요
87

88. JongHong Jeon (hollobit@etri.re.kr)
+82-42-860-5333
https://www.linkedin.com/in/hollobit
http://twitter.com/hollobit