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4차 산업혁명 시대, 의료기기 표준화 이슈

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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.

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4차 산업혁명 시대, 의료기기 표준화 이슈

  1. 1. ‫ރ(۔‬ Ӥ؋ॗύ չɓ ‫ͣڗ‬İİ इ‫܆‬७ ‫ڜ‬ժ ᱥ᳦Ξ hollobit@etri.re.kr ETRI ၙ௹ᱥఖᩑǍᗭ ƭᵡᩑǍᅙᇡ ֥ࠥ ᮹ഭᱽǙ ᇥ᧝ ǎaƭᵡ ᱥྙa ᬭⓍ᙮
  2. 2. 4*.1- $633*$6-6. 7*5 *565 4( *OUFSOFU PG 5IJOHT BOE 4NBSU $JUZ : ӣே ᶾംȎ *$ 5$ 8FBSBCMF MFDUSPOJDT BOE 5FDIOPMPHZ ՛ࢢ ῲጦỲẾ‫ݪ‬ ỲẾ *40*$ +5$ 4$ *OUFSOFU PG 5IJOHT ՛ࢢ ῲጦỲẾ‫ݪ‬ ỲẾ )( ቒᑲ *40*$ +5$ 4$ SUJGJDJBM *OUFMMJHFODF ՛ࢢ ῲጦỲẾ‫ݪ‬ ỲẾ 0$' 0QFO $POOFDUJWJUZ 'PVOEBUJPO )FBMUIDBSF EFWJDF TQFD DPFEJUPS 55 1( 1( ࠗ੄੢ Ỗᶢ࿚ᘂ ␦⁞ ኖ୦ ೟  ᓢʓᫎ૖⒢Ժ⃮ ՛ϮԺ⃮ ૒ᨆ    Ҵղ ಴ળച ನۢ ੄੢‫ױ‬ 0$' ,PSFB GPSVN ‫؞‬ᨎᕲӪ ᕮỲẾᾓ ೟ ૒ᨆ ὆ᾓ૖
  3. 3. The 4th Industrial Revolution
  4. 4. $%+%$%$
  5. 5. ᷧ୸рⓀᒨᛴрⓀ⛀ ಬᒐ ✌ˉ۠∨/ 7ቜ ۤ௹ᰵ¹൸ ಬᒌ
ᷨ ୭7⛲ ᭺₏঻ᕏ∊ ⋟Ȓ⋋ ⇪ृ⁾ₚ ᡒ߆ୡୡୡ#### ࣺÂ߆ओ₺࠶ ‫߆ێ‬च ⅺዮ୮ Ԋ *7૖ ♮ѳᒯ⁃*‫׮‬ ᐊጫѾ⛚ ‫׎‬ᙚᘶ ՂᴾᐎᐊB
  6. 6. ‫┊ܢ‬ ้ⓖ ᨚ᮪ ௢ଃ⍦ᝢ ┞ဪ 7ʮ Ṇ⍛ಇ᠛ (‫ރ‬ Ӥ؋ॗύؓ ΢ԅ ք٨‫׳‬ ऱȪ ‫ٿڜ‬ औ஍ඨ Ⅰ *7ቜۤ௹ᰵ¹*/#ఠ┰θ ȳࣩ‌ᮐB *7⛲ ᭺₏঻ᕏ*∾ቆ Ὰު *৲ྮۛ*∾ቆ ≇൞ථ ֢₉ ᔑᨦ͒໦ᯕ ᦥ‫ ܭ‬ ₉ ᔑᨦ͒໦ ᜽ʑᯕ֣݅
  7. 7. ኺ፛‫پ‬ ↚‫ݷ‬ X`]⎚ W⎚ ∊ӂ ᅎఇ
  8. 8. The 4th Industrial Revolution ᜬနᷤ, ࡩ⒤ᆘ᭔, ᆜḩᏤ⏙ ☥ ♈Ꮴ᭜ʀ ᜭ‫⏈╌ـ‬ Ꮴ⏙⁸ ‥ҩ ៀᚼaGሹ‫ޤ‬ᅼ [ᙌ ૔࿩‥ҩ ␴ᅵٍཬSGᇉ۵ἐ
  9. 9. https://www.societegenerale.com/en/digital-transformation Zᔆ᱾ ࠆⅇኞ ย╖
  10. 10. Digital Transformation DATADATA Artificial IntelligenceArtificial Intelligence InternetofThings
  11. 11. 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
  12. 12. The 2nd ICT Wave – “Cyber Space” withInternet,Broadband,WWW Broadband Access Internet Now we are living in ”Cyber Space”
  13. 13. The 2nd ICT Wave – “Cyber Marketplace” The value of intangible makes Money ! No Create Contents No Own Taxi No Real HousesNo Inventory
  14. 14. Internet of ThingsInternet of Things Hyper ConnectivityHyper Connectivity The 3rd Wave
  15. 15. The 3rd ICT Wave – “Mobile BigBang” Smart Mobile Cloud Computing IoT Big Data Connection to Physical Space and Cyber Space
  16. 16. Super IntelligenceSuper Intelligence Artificial IntelligenceArtificial Intelligence Deep LearningDeep Learning The 3rd Wave
  17. 17. 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
  18. 18. DATADATA Core of the 3rd Wave Re-consideration of “DATA” IoTAI ἆῃ ◆ኺᱶṖ ᑗᇚ ˎ
  19. 19. Google'sGo-playingAIstillundefeated withvictoryoverworldnumberone Some thoughts for ArtificialIntelligence
  20. 20. Autonomous Vehicle - AI application hpG₆൦ኺ Ṗያ ւፆ ፇᇯ♶ ฦ ௶ᄋ࣊ჂOfP Some thoughts for ArtificialIntelligence
  21. 21. Elon Musk says: Artificial Intelligence is like Summoning the Demon ˈႋԎኞ ೒↞ˉ Some thoughts for ArtificialIntelligence
  22. 22. Standards ˈቪӲˉ Some thoughts for ArtificialIntelligence
  23. 23. Misuse of technology brings DisasterMisuse of technology brings Disaster Some thoughts for ArtificialIntelligence
  24. 24. 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
  25. 25. 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
  26. 26. Key Strategy Convergence Competition Speed Reality İՒ“ ‫چ‬ѕष ࡞ Ӥ؋ ‫؞‬Ø ‘ԫ७Ά Ý̓ळ इ‫܆‬७ 5=͐ ‫ऺڞ‬ єɁ ‫܍“ڞ‬տ‫ڗ‬ =7HİՒ͐ Н‫ی‬ ‫ث‬ӭ इ‫܆‬७ İƓ Ö‫ڿ‬տ७ؓ ˁ΅ ॿ‫ۋڂ‬ इ‫܆‬७ ɓ‫ڐ‬ इ‫܆‬७ ۤİ ԉ‫ڋۏ‬ ࢑ळ İՒ Е չ‫ڵ‬ ԉɻ ‫ٖ܍‬ Ҙ΅ İՒ#չ‫ڵ‬ ы७ؓ ɓ‫ڐ‬ ‘ȱळ इ‫܆‬७ ‫ز‬तԪհ ‫؞‬Ø ɓ‫ڐ‬ ʴ ‫ۋަڤ‬ ɓ‫ڐ‬ ‫ڜ̭ی‬ बٖळ չ‫ۏ‬ ٞΎ क़ս‫ڋ‬ Л‫ا‬ळ इ‫܆‬७ İ؋ ‫؛ވ‬ ७ ʴ Њ̣ չ‫ڵ‬ӷࡨØΆ Ý̓ळ ‫ۋ̭ی‬ इ‫܆‬७ ɓ‫ڐ‬
  27. 27. Leading Status of KOREA in JTC 1 (2010-2017) 73%
  28. 28. Leading Status of KOREA in JTC 1 (2010-2017)
  29. 29. 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
  30. 30. The era of 4th Industrial Revolution Complex Conformance InteroperabilityComplex Conformance Interoperability POINT #1
  31. 31. “System Integration Standards” The era of 4th Industrial Revolution POINT #2 Emerging for Human being more BIO centric ICT with new disruption
  32. 32. The era of 4th Industrial RevolutionThe era of 4th Industrial Revolution POINT #3 Open Source Fast Prototyping Implementation
  33. 33. OPEN EnvironmentsOPEN Environments The era of 4th Industrial Revolution POINT #4 Collaborative ECOSYSTEM
  34. 34. POINT #5 Emerging Technology Convergence
  35. 35. • *40 5$ )FBMUI *OGPSNBUJDT • *40 5$ EEJUJWF NBOVGBDUVSJOH • *40 5$ #MPDLDIBJO BOE EJTUSJCVUFE MFEHFS UFDIOPMPHJFT • *$ 5$ 8FBSBCMF MFDUSPOJDT BOE 5FDIOPMPHZ • *$ 5$ FOFSHZ IBSWFTUJOH • *$ 5$ QSJOUFE FMFDUSPOJDT • *40*$ +5$ 4$ *OUFSOFU PG 5IJOHT • *40*$ +5$ 4$ SUJGJDJBM *OUFMMJHFODF • *40*$ +5$ 8( 4NBSU DJUJFT • *40*$ +5$ 8( % QSJOUJOH POINT #5 Emerging Technology Convergence
  36. 36. POINT #6 Connected Healthcare
  37. 37. POINT #6 Connected Healthcare
  38. 38. POINT #6 Connected Healthcare
  39. 39. 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
  40. 40. 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 *40*$ Y
  41. 41. POINT #6 Connected Verticals
  42. 42. • *40 3JTL NBOBHFNFOU • *40 2VBMJUZ .BOBHFNFOU 4ZTUFN • *$ m .% 3JTL .BOBHFNFOU • *$ m .% 4PGUXBSF -JGFDZDMF • *$ m .% 6TBCJMJUZ • *$ . TBGFUZ FTTFOUJBM QFSG • *$ 3. JO *5 OFUXPSLT JODPSQPSBUJOH .FEJDBM %FWJDFT • *40 *5 TFDVSJUZ 3. POINT #7 Security Privacy Risk Management
  43. 43. POINT #7
  44. 44. POINT #8 Wearable Wellness
  45. 45. POINT #8 Wearable Wellness *$ 5$ 8FBSBCMF MFDUSPOJDT 5FDIOPMPHZ
  46. 46. POINT #8 Wearable Wellness
  47. 47. POINT #8 Wearable Wellness *$ 5$ 8FBSBCMF MFDUSPOJDT 5FDIOPMPHZ • WBMVBUJPO NFUIPE PG UIF TUSFUDIBCMF SFTJTUJWF TUSBJO TFOTPS ᤊẦӪ‫؞‬૮ • 8BTIBCJMJUZ UFTU NFUIPE GPS MFJTVSF BOE TQPSUTXFBS FUFYUJMF TZTUFN ,05*5* • 5FTU BOE FWBMVBUJPO NFUIPET GPS XFBSBCMF HMPWF TFOTPST ,5* • -PX UFNQFSBUVSF TLJO CVSO TBGFUZ UFTU NFUIPET GPS CBOE UZQF POCPEZ XFBSBCMF FMFDUSPOJD EFWJDFT ,5* • 5FSNJOPMPHZ ᤟‫׎‬Ӯ૮ ,/#੄ /1 ઁউ ҅ദ • /8*1 5SBOTNJUUBODF DPOUSPMMBCMF XJOEPXT GPS XFBSBCMF EFWJDFT 53* • /8*1 4LJO QSFTTVSF TFOTPST 53*
  48. 48. POINT #9 Digital Innovation
  49. 49. ୹୊ -(҃ઁোҳਗ ઱ਃ ٣૑ణ ӝࣿh࢑স ੉गPOINT #9 Digital Innovation
  50. 50. POINT #9 Digital Innovation
  51. 51. Conclusion - The 4th Industrial Revolution ᜬနᷤ, ࡩ⒤ᆘ᭔, ᆜḩᏤ⏙ ☥ ♈Ꮴ᭜ʀ ᜭ‫⏈╌ـ‬ Ꮴ⏙⁸ ‥ҩ ៀᚼaGሹ‫ޤ‬ᅼ [ᙌ ૔࿩‥ҩ ␴ᅵٍཬSGᇉ۵ἐ
  52. 52. *40*$ +5$ 4$ (11 * *565
  53. 53. Emerging Technology Convergence Connected Healthcare System Integration Standards Security Privacy, Risk Management Complex Conformance Int eroperability OPEN Environment Fast Prototyping Implementation Digital Innovation Wearable Wellness
  54. 54. 5FDIOPMPHZ 1VTI1VMM 3FHVMBUPSZ 1VTI1VMM .BSLFU 1VTI1VMM *OOPWBUJPO 1SPEVDU RVBMJUZ YQFDUFE SFHVMBUJPO YTJUJOH MBX $PTUVNFS EFNBOE 3JTL NBOBHFNFOU .BSLFU TIBSF $PNQFUJUJPOT /FX .BSLFU 4UBOEBSEJ[BUJPO /FX 5FDI *13 -FBEFSTIJQ -FBEFSTIJQ
  55. 55. ର ࢑সഄ‫ݺ‬द‫੄؀‬ ೾झாয ಴ળച ੹ۚ Ӓ য‫ו‬ ‫׮ࠁٸ‬ ઺ਃೠ द੼ੑ‫׮פ‬
  56. 56. Washington Irving
  57. 57. JongHong Jeon (hollobit@etri.re.kr) +82-42-860-5333 https://www.linkedin.com/in/hollobit http://twitter.com/hollobit

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