2018년 4월4일에 식품의약품안전처 주관으로 개최되었던 2018년도 의료제품 분야 국가표준 전문가 워크샵에서 발표했던 자료입니다. 의료 제품 분야에 ICT 기술이 결합되어야 하는 시대에, 어떤 표준화 이슈가 있고, 현재 국제표준화 기구에서의 대응이 어떻게 진행되고 있는지, 그리고 한국의 역할은 어떤지를 정리하였습니다. 나아가 4차산업혁명 시대에 의료기기 제품 개발을 위해 표준과 규제가 어떻게 함께 조화롭게 대응이 필요한지까지 언급 해보았습니다. 혹시 수정보완 등이 필요한 부분이 있으면 언제든 코멘트 남겨주시기 바랍니다.

1. ‫ރ(۔‬ Ӥ؋ॗύ չɓ ‫ͣڗ‬İİ इ‫܆‬७ ‫ڜ‬ժ
ᱥ᳦Ξ hollobit@etri.re.kr
ETRI ၙ௹ᱥఖᩑǍᗭ ƭᵡᩑǍᅙᇡ
֥ࠥ ᮹ഭᱽǙ ᇥ᧝ ǎaƭᵡ ᱥྙa ᬭⓍ᙮

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3. The 4th Industrial Revolution

4. $%+%$%$

6. ᷧ୸рⓀᒨᛴрⓀ⛀ ಬᒐ ✌ˉ۠∨/
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8. ኺ፛‫پ‬ ↚‫ݷ‬
X`]⎚
W⎚ ∊ӂ ᅎఇ

16. The 4th Industrial Revolution
ᜬနᷤ, ࡩ⒤ᆘ᭔, ᆜḩᏤ⏙ ☥ ♈Ꮴ᭜ʀ ᜭ‫⏈╌ـ‬ Ꮴ⏙⁸ ‥ҩ
ៀᚼaGሹ‫ޤ‬ᅼ [ᙌ ૔࿩‥ҩ ␴ᅵٍཬSGᇉ۵ἐ

17. https://www.societegenerale.com/en/digital-transformation
Zᔆ᱾ ࠆⅇኞ ย╖

18. Digital Transformation
DATADATA
Artificial IntelligenceArtificial Intelligence
InternetofThings

19. The 1st Wave
The 2nd Wave
The 3rd Wave
Big Waves in ICT worldBig Waves in ICT world
Digitalizing
Cyber Space
Hyper Connectivity
Super Intelligence
The ICT waves generated huge tsunami waves

20. The 2nd ICT Wave – “Cyber Space” withInternet,Broadband,WWW
Broadband Access
Internet
Now we are living in ”Cyber Space”

21. The 2nd ICT Wave – “Cyber Marketplace”
The value of intangible makes Money !
No Create Contents No Own Taxi
No Real HousesNo Inventory

22. Internet of ThingsInternet of Things
Hyper ConnectivityHyper Connectivity
The 3rd Wave

23. The 3rd ICT Wave – “Mobile BigBang”
Smart Mobile
Cloud Computing
IoT
Big Data
Connection to Physical Space and Cyber Space

24. Super IntelligenceSuper Intelligence
Artificial IntelligenceArtificial Intelligence Deep LearningDeep Learning
The 3rd Wave

25. The 3rd ICT Wave – “Hyper Connection Super Intelligence”
Smart Devices
Cloud Computing Big DATA
+
Expansion of Hyper Connection between
Physical space Cyber space
Adding the intelligence makes Big Impact !
Internet of Things Artificial Intelligence

26. DATADATA
Core of the 3rd Wave
Re-consideration of “DATA”
IoTAI
ἆῃ ◆ኺᱶṖ ᑗᇚ ˎ

27. Google'sGo-playingAIstillundefeated
withvictoryoverworldnumberone
Some thoughts for ArtificialIntelligence

28. Autonomous Vehicle - AI application
hpG₆൦ኺ Ṗያ ւፆ ፇᇯ♶ ฦ ௶ᄋ࣊ჂOfP
Some thoughts for ArtificialIntelligence

29. Elon Musk says:
Artificial Intelligence is like Summoning the Demon
ˈႋԎኞ ೒↞ˉ
Some thoughts for ArtificialIntelligence

32. Standards
ˈቪӲˉ
Some thoughts for ArtificialIntelligence

33. Misuse of technology brings DisasterMisuse of technology brings Disaster
Some thoughts for ArtificialIntelligence

34. How What Standardsneeds to be consider ?How What Standardsneeds to be consider ?
Internet of ThingsInternet of Things
SecuritySecurity
Hybrid CloudHybrid Cloud
Big DataBig Data
Artificial IntelligenceArtificial Intelligence
Smart X

35. IoT
Big
Data
Smart
Factory
Smart
Cities
AI
Smart
Car
Cloud
Computing
Smart
Home
AR/VR
IoT
Big
Data
Smart
Factory
Smart
Cities
AI
Smart
Car
Cloud
Computing
Smart
Home
AR/VR
??
??
??
??
??
??
Complexity of Standardization Activities – Convergence Competition Speed

36. Key Strategy
Convergence
Competition
Speed
Reality
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ٞΎ क़ս‫ڋ‬ Л‫ا‬ळ इ‫܆‬७ İ؋ ‫؛ވ‬ ७ ʴ
Њ̣ չ‫ڵ‬ӷࡨØΆ Ý̓ळ ‫ۋ̭ی‬ इ‫܆‬७ ɓ‫ڐ‬

37. Leading Status of KOREA in JTC 1 (2010-2017)
73%

38. Leading Status of KOREA in JTC 1 (2010-2017)

39. Some considerations for
the future STANDARDS in the era of
the forth Industrial Revolution
Some considerations for
the future STANDARDS in the era of
the forth Industrial Revolution

40. The era of 4th Industrial Revolution
Complex Conformance InteroperabilityComplex Conformance Interoperability
POINT #1

41. “System Integration Standards”
The era of 4th Industrial Revolution
POINT #2
Emerging for Human being more
BIO centric ICT with new disruption

42. The era of 4th Industrial RevolutionThe era of 4th Industrial Revolution
POINT #3
Open Source
Fast Prototyping Implementation

43. OPEN EnvironmentsOPEN Environments
The era of 4th Industrial Revolution
POINT #4
Collaborative ECOSYSTEM

44. POINT #5 Emerging Technology Convergence

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46. POINT #6 Connected Healthcare

47. POINT #6 Connected Healthcare

48. POINT #6 Connected Healthcare

49. POINT #6 Connected Healthcare
• IEC 60601-2-25 (1993-03) ഐረ᷸
Electrocardiographs
• IEC 60601-2-27 (1994-04) ഐረ⓸ ᵄഀᇉ᡼
Electrocardiographic monitoring equipment
• IEC 60601-2-38 (1996-10) ۵ჴჍ ᢌ␴
Electrically operated hospital beds
• IEC 60601-2-47 (2001-07) ⅘␴Ⴭ ഐረ᷸
Ambulatory electrocardiographic systems
• IEC 80601-2-49 (2001-07) ␘ὤ⏙ ⁼ᆴ ᵄഀᇉ᡼
Multifunction patient monitoring equipment
• IEC 60601-2-51 (2003-02) ␜ᆠ ‫س‬ ␘ጵ ᙨ≄
ഐረ᷸ ὤʁ ‫س‬ ިୁ Recording and analyzing
single channel and multichannel
electrocardiographs
• IEC 60601-2-52 (2009+2015): ᅼ˰Ⴭ ᢌ␴
medical beds
• Medical Refrigerators
• Smart bed – sleep monitor, patient monitoring

50. POINT #6 Connected Healthcare
Internet of Things
Internet of
Medical
Things
IoT Framework open source
(OCF)
Safety Performance Requirements for
Medical Electrical equipment
(IEC)
Medical
Devices
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51. POINT #6 Connected Verticals

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Security Privacy
Risk Management

53. POINT #7

54. POINT #8 Wearable Wellness

55. POINT #8 Wearable Wellness
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56. POINT #8 Wearable Wellness

57. POINT #8 Wearable Wellness
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58. POINT #9 Digital Innovation

59. ୹୊ -(҃ઁোҳਗ
઱ਃ ٣૑ణ ӝࣿh࢑স ੉गPOINT #9 Digital Innovation

60. POINT #9 Digital Innovation

62. Conclusion - The 4th Industrial Revolution
ᜬနᷤ, ࡩ⒤ᆘ᭔, ᆜḩᏤ⏙ ☥ ♈Ꮴ᭜ʀ ᜭ‫⏈╌ـ‬ Ꮴ⏙⁸ ‥ҩ
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Convergence
Connected Healthcare
System Integration
Standards
Security Privacy,
Risk Management
Complex Conformance Int
eroperability
OPEN Environment
Fast Prototyping
Implementation
Digital Innovation
Wearable
Wellness

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68. ର ࢑সഄ‫ݺ‬द‫੄؀‬
೾झாয ಴ળച ੹ۚ
Ӓ য‫ו‬ ‫׮ࠁٸ‬ ઺ਃೠ द੼ੑ‫׮פ‬

70. Washington Irving

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