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김 대 영
2019년 10월 17일
교수, 전산학부, KAIST
Director, Auto-ID Labs, KAIST
kimd@kaist.ac.kr, http://oliot.org, http://autoidlab.kaist.ac.kr, http://resl.kaist.ac.kr, http://autoidlabs.org, http://gs1.org
Internet of Medicine: GS1 국제표준기반의 헬스케어
디지털 트랜스포메이션
김 대 영
2020년 7월 28일
14:00 ~16:00 (Webinar)
교수, 전산학부, KAIST
Director, Auto-ID Labs, KAIST
Board member, GS1 Korea
kimd@kaist.ac.kr, http://oliot.org, http://autoidlab.kaist.ac.kr, http://resl.kaist.ac.kr, http://autoidlabs.org, http://gs1.org
© Auto-ID Lab Korea / KAIST
Slide 2
목차
Part I – 헬스케어 산업에서의 디지털 트랜스포메이션
Part II – GS1 Standards (GS1 국제표준, 산업표준)
Part III – GS1 헬스케어 표준
Part IV – GS1 관련 세계 헬스케어 산업 및 서비스 동향
Part V – 디지털트윈, 디지털인프라, 디지털 SoC 인프라
Part I – 헬스케어 산업에서의
디지털 트랜스포메이션
© Auto-ID Lab Korea / KAIST
Slide 4
© GS1 2019
https://www.theguardian.com/society/2019/feb/12/fake-cancer-drug-made-from-paracetamol-world-health-organization
WHO warns of fake cancer drug made from paracetamol
Pills that resemble Leukaemia drug Iclusig sold in Europe and Americas for
£5,000 a pack
© GS1 2019
This year’s investigations revealed that the trafficking not only
covered opioid medicines, but also pharmaceutical products used
for the treatment of major illnesses such as cancer and heart
conditions, as well as performance and image enhancing drugs.
© GS1 2019
This investigation is
creating huge media
activities – have a look at
the video on their page
also!
https://www.icij.org/investigations/impl
ant-files/
Global issues with implants
https://www.icij.org/blog/2018/11/icij-publishes
-new-investigation-the-implant-files/
https://youtu.be/tZUzmA32Lbo
© Auto-ID Lab Korea / KAIST
Slide 9
불법 사용 - Point-of-Care Scanning
© GS1 2019
(병원) Hospital Leaders, Providers Stress Over
Supply Chain Management (1/2)
• 74% of frontline providers report looking for supplies that should be at hand has
the most negative impact on their workplace productivity, and 84% of supply
chain managers say the same (약품과 의료기기의 요구되는 장소에 적시 공급)
• 49% of frontline providers say they manually count and track supplies, and
almost half (46%) state the manual process has a “very” or “somewhat”
negative effect on their workforce productivity (자동화된 공급 체계)
• 70% of supply chain managers and clinicians cite wasting and overutilization of
supplies as a significant or somewhat significant problem (낭비 또는 과잉이용)
Supply chain management is an integral part of cutting costs and
advancing care quality, meaning all stakeholders need to be on board
to streamline and optimize supply chain processes for healthcare
success.
From the fourth annual Cardinal Health Hospital Supply Chain Survey (https://cardinalhealth.mediaroom.com/2019-05-08-
Cardinal-Health-Fourth-Annual-Survey-Finds-Supply-Chain-Tasks-Causing-Stress-for-Clinicians-and-Impacting-Patient-Care)
© Auto-ID Lab Korea / KAIST
Slide 11
Humanitarian
Logistics
다양한 산업 분야에서
데이터를 표준화하고
공유하는 글로벌
프레임웍을 제공함
“데이터 기반의 사물인터넷"
4차 산업혁명의 중심은 “데이터 산업”
사람과 사물이 공존하는
사물인터넷 세상
© Auto-ID Lab Korea / KAIST
Slide 12
patient safety
(환자안전)
Traceability
(이력추적)
product data
(의약품 및 의료기기 데이터)
medical data
(의료 데이터)
supply chain
security & efficiency
(의약품, 의료기기 공급망 보안 및 효율 향상)
GS1 Healthcare 비전
© Auto-ID Lab Korea / KAIST
Slide 13
GS1 Healthcare
헬스케어 분야 국제기구와의 협력
© Auto-ID Lab Korea / KAIST
Slide 14
병원이 맞닥뜨리고 있는 도전 과제
Excess clinical time spent
ordering and managing
stock (스탁관리 시간)
Lack of traceability due to
absence of product
identification and patient
ID (글로벌 식별자)
Wastage and costs
associated with disposal
and reordering (낭비와
비용)
Risk of medication errors
Errors due to manual
processes (의료 실수)
Ineffective
and inefficient product
recalls (리콜)
Lack of inventory visibility
and stock control (재고
관리)
In a hospital clinical and supply chain processes can be improved by
automation(자동화) and accurate data (정확한 데이터)
© Auto-ID Lab Korea / KAIST
Slide 15
Safer, more efficient care starts with a simple scan.
© Auto-ID Lab Korea / KAIST
Slide 16
GS1 Project Imagine
© Auto-ID Lab Korea / KAIST
Slide 17
GS1 Project Imagine
© Auto-ID Lab Korea / KAIST
Slide 18
FDA DSCSA(Drug Supply Chain Security Act)
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
© Auto-ID Lab Korea / KAIST
Slide 19
DSCSA 타임라인
The Falsified
Medicines
Directive will be
rolled out in
Europe from
February 2019 to
address the
threat of fake
medicines and
will impact the
entire supply
chain
Citation: The Pharmaceutical Journal,
February 2018, Vol 300, No 7910,
online | DOI:
10.1211/PJ.2018.20204433
https://www.pharmamanufacturing.com/articles/2016/dscsa-support-the-benefits-of-leveraging-epcis
1. EPCIS works with standards many pharma companies are
already using.
2. EPCIS is versatile.
3. Successful pilot programs are being reported.
4. EPCIS helps a company collaborate long term with different
supply chain partners.
© Auto-ID Lab Korea / KAIST
Slide 22
제약회사당 데이터 요구량 (빅데이터)
© Auto-ID Lab Korea / KAIST
Slide 23
UDI (Unique Device Identification) System
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
© Auto-ID Lab Korea / KAIST
Slide 24
• 미국 FDA는 2013년 9월 모든 의료 기기에 글로벌하게 식별이 가능한 GS1 코드 시스템
체계를 적용한다고 발표하였다.
• 이에 따라, GS1/FDA Unique Device Identifier (UDI) 식별자가 의료기기 생산자로부터
모든 버전의 기기 모델에 적용되어야 하며, 사람이 판독 가능하면서 동시에 AutoID
포맷이어야 한다.
Unique Device Idetifier (UDI)
© Auto-ID Lab Korea / KAIST
Slide 25
GS1 Healthcare - FDA
의료기기표준코드(UDI)는 바코드와 같은 자동인식(AIDC)기술을 통해 정확
하고 간편하게 FDA DB에서 해당 의료기기정보를 access 할 수 있도록 구성
표준
코드체계
표준
DB
표준
자동인식
기술
• UDI/UDID 시스템 구조
• 현재 500,000개 이상의 의료 기기 정보가 GS1/FDA의 Global UDI Database (GUDID)에 저장
되어있습니다.
© Auto-ID Lab Korea / KAIST
Slide 26
UDI (Unique Device Identification) 생태계
https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd
The term Software as a Medical Device is defined by the International Medical Device Regulators Forum
(IMDRF) as "software intended to be used for one or more medical purposes that perform
these purposes without being part of a hardware medical device."
https://www.fda.gov/media/122535/download
https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd
Software as a Medical Device ranges from software
that allows a smartphone to view images obtained
from a magnetic resonance imaging (MRI) medical
device for diagnostic purposes to Computer-Aided
Detection (CAD) software that performs image
post-processing to help detect breast cancer.
https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd
http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-udi-system-n48-180712.pdf
© Auto-ID Lab Korea / KAIST
Slide 30
UNICEF와 세계백신면역연합인 GAVI가 GS1 국제표준기반 백신 이력추적을 요구
하기 시작했습니다. 중국도 백신 이력추적제도의 전면도입 준비를 시작했습니다.
"유니세프와 가비, 백신에 GS1 표준 요구
2021 년 12 월 31 일까지 개발 도상국 의 백신 동맹국 인 Gavi가 자금을 지원하는
모든 유니세프가 후원하는 예방 접종 캠페인 경연 대회 는 이차 백신 패키지에 GS1
바코드를 사용하여 추적 성을 개선하여 환자 안전" - 구글번역
https://www.newsfarma.pt/noticias/8517-unicef-e-gavi-exigem-standards-gs1-nas-vacinas.html
https://www.gs1.o
rg/industries/heal
thcare/clinical-
trials
© Auto-ID Lab Korea / KAIST
Slide 32
GS1 Standard
New standard for investigational products answers clinical trial
industry’s need for consistency
https://www.gs1.org/industries/healthcare/clinical-trials
© GS1 2019
IP kit type
Investigational
product type
Bringing the concepts together
Kit assembly
batch/lot
IP label
IP kit label
AI (01) GTIN
AI (01) GTIN or
AI(8006) ITIP
Clinical trial
management system
IP kit
instance
Investigational
product
instance
AI (10) batch/lot
AI (21) serial ID
AI (01) GTIN (kit)
Protocol
AI (7240) protocol ID
Treatment
treatment ID
AI (10) batch/lot
AI (7240) protocol ID
Investigational
product instance
IP kit instance
kit ID
AI (21) serial ID
AI (01) GTIN or
AI(8006) ITIP (material)
AI (10) batch/lot
AI (7240) Protocol ID
Part II – GS1 Standards
(GS1 국제표준)
© Auto-ID Lab Korea / KAIST
Slide 36
GS1 (Global Standards 1) 국제표준기구
(데이터, 비즈니스, 산업, 사물인터넷)
산업 분야에서
데이터를 표준화하고
공유하는 글로벌
플랫폼 제공
114개국 국가-MO (Member Organizations), 170개 국가 공식 활용
2백만 이상의 기업 멤버로 구성된 비영리 국제표준기구
한국은 대한상공회의소 산하의 GS1 Korea (유통물류진흥원) 와
Auto-ID Labs, KAIST GS1 사물인터넷 국제표준공동연구소 운영
(KAIST, MIT, Cambridge, ETH Zurich, Keio, Fudan University)
© Auto-ID Lab Korea / KAIST
Slide 37
여권으로 보는 국제표준 데이터 구성
데이터 DATA
식별자 (Identifier)
예) 여권 번호, 여권 발급 장소, 공항 출입국 심사대, 출입국 기기 식별자 등
어휘 (Vocabulary)
예) 사람 이름, 성별, 주민등록번호, 국적, 여권발급, 비자발급, 출입국 기록등
마스터 데이터 (Master Data)
변하지 않는 데이터
예) 이름, 성별, 국적, 사진
트랜잭션 데이터 (Transaction Data)
비즈니스 관련 데이터
예) 여권 발급, 수수료 납부, 비자 발급
이벤트 데이터 (Event Data)
발생 이벤트 관련 데이터
예) 출국 및 입국 이벤트, 출입국 특이 사항 이벤트
이미지 출처: 외교부 www.mofa.go.kr
© Auto-ID Lab Korea / KAIST
Slide 38
GS1 Company Prefix (식별자의 시작)
• GS1 국제 생태계에 진입하기 위해, 각 기업이나 기관은 국가코드와 기업/기관 코드로 이루어진 GS1
Company Prefix (GCP) 를 확보해야 함
• GS1 Company Prefix 를 기반으로 13종류이상의 다양한 글로벌 GS1 식별자를 사용할 수 있음 (GTIN, GRAI,
GIAI, GLN, GSRN, ….)
© Auto-ID Lab Korea / KAIST
Slide 39
의약품, 의료기기 (GTIN, 8809045540005) 24시간 혈압측정기 병원자산 (GRAI) MRI 병원자산 (GIAI)
병원, 병실, 수술실 (GLN) 처방전 (GDTI)환자, 의사, 간호사 (GSRN)
글로벌 식별체계
부품 코드 (CPID, Components and
Parts IDentifier)
책 및 잡지 (ISBN, ISSN)
할인 쿠폰 (GCN, Global Coupon Number)
운송 코드 (GSIN, Global Shipment Identification Number)
탁송코드 (GINC, Global Identification
Number for Consignment)
배송 박스 코드 (SSCC, Serialized Shipping
Container Code)
* 모델번호 (GMN, Global Model Number)
© Auto-ID Lab Korea / KAIST
Slide 41
GS1 Application Identifiers
(응용 식별자)
~~~~
http://www.health.kr/searchDrug/result_drug.asp?drug_c
d=2017013100003
https://www.hospitalhealth.com.au/content/technology/article/traceability-a-digitalised-healthcare-supply-chain-for-the-new-decade-225143814#axzz6SXAc0EAm
© Auto-ID Lab Korea / KAIST
Slide 46
GS1 GDSN, Global Registry Attributes [마스터 데이터]
B2B 상품(의약품, 의료기기) 데이터 (+GS1 Source, GS1 Registry
Platform)
- 표준화된 상품(사물) 데이터를 글로벌 하게 공유하기 위한 표준과 분산
데이터풀 (데이터베이스) 시스템
- 2020년 5월 1일 현재 전세계 43개 Data Pool 운영
• B2C의 상세 상품 데이터를 제공하기 위한 노력이 GDSN,
GS1 Source, GS1 Registry Platform 를 통해 상호 보완으로
진행되고 있음. (예. 식품의 성분, 인증, 앨러지 정보등)
© GS1 2015
Managing data at global and local level
1. Find a standards based solution which can scale as more
countries release UDI regulation
2. Find a technology partner that can connect you globally
3. Define ALL regulatory and commercial attributes (Super Spec)
47
FDA
Submission
Acknowledgement
UDI Data
Submission
Future UDI
Databases
Global
Providers
GPOs
US Providers
Data PoolLableler
Super
Spec
Source: Margot Drees, GHX
© Auto-ID Lab Korea / KAIST
Slide 48
EPC Information Service (EPCIS)
GS1의 데이터공유 6하원칙
GS1의 6하원칙
WHO Pfizer Korea
GS1 GLN
WHAT 약
GS1 SGTIN
WHERE Pfizer 라벨링 시설
GS1 GLN/SGLN + geo
WHEN 방금 / 어제
UTC
HOW GS1에는 없습니다. 어떻게 그
럴수가 있니?
WHY 출하했다
GS1 CBV Vocabulary/Data
Dictionary / Comissioning
© Auto-ID Lab Korea / KAIST
Slide 49
Common Business
Vocabulary (CBV)
동사, 형용사, 부사
urn:epcglobal:cbv:
bizstep:assembling
bizstep:retail_selling
bizstep:inspecting
bizstep:repairing
© Auto-ID Lab Korea / KAIST
Slide 50
GS1 국제 표준 – Lifetime 프로세스
모델링 기술
• ObjectEvent – 상품의 생성/관찰/제거
• AggregationEvent – 상품의 포장/적재
• TransactionEvent – 상품의 판매 상황
• TransformationEvent – 상품의 가공 상황
• Association Event – Coming soon
생성부터 판매까지 상품(사물)의 lifetime을
기록할 수 있는 데이터 모델을 통해서 상품
을 효율적으로 관리
What, Where, When, Why 를 통한 상세한 이벤트 정보 입력
© GS1 2019
Party at beginning of
the supply chain (e.g.,
manufacturer)
• Commissioning
• Packing
• Shipping
EPCIS events captured and shared by . . .
Intermediate parties
(e.g., distributor)
• Receiving
• Unpacking
• Packing
• Shipping
Party at end of chain
(e.g., pharmacy)
• Receiving
• Unpacking
• Dispensing
• Decommissioning
© Auto-ID Lab Korea / KAIST
Slide 52
• EPC Information Service (EPCIS)
• Current Version 1.2, Oct. 2016
• Also adopted by ISO/IEC
ISO/IEC 19987:2015 standard
사물인터넷 이벤트를 저장하는 분산 연합 데이터 베이스
/ 왼쪽 그림 처럼 EPCIS 가 중앙에 하나 있는 게 아니라,
백신후보물질(원료), 물류 회사, 백신제조회사, 유통회사, 병원
등이 제각기 운영하고,가상으로는 단일의 데이터 저장소로 보임
- 기존 시스템 대체가 아니라, 별개 시스템 설치 후 쉽게 연결함
➢ RFID를 위한 EPCglobal 표준은 지난 5년간
확장되어, 사물인터넷의 인프라 프레임웍으로 발전중임
EPC Information Service (EPCIS)
트랜잭션 데이터와 이벤트 데이터 공유 (+EDI)
© Auto-ID Lab Korea / KAIST
Slide 53
글로벌 이력추적 추진 동력
Regulations emerge worldwide (규정)
Supply Chain costs increase (유통물류비용)
Electronic Health Records (환자 데이터)
Medication errors (투약실수)
Counterfeiting (위조 약품)
Brand Protection (브랜드 보호)
BUT
• Traceability is complex, multi-sectorial and cross border, but it is not always recognized
as such
• Traceability is becoming a necessity, but one that is addressed by an endless number of
isolated solutions
• GS1 Standards can help…
© GS1 2019
Why use EPCIS-based traceability systems?
Com-
mission
Pack Ship Rcv Unpack Pack
Dispense
Destroy
Decommission
Rcv Unpack <<Ship <<<<<<<
Manufacturer Distributor(s) Dispenser
Possibly Repeated
Local regulatory data Local regulatory data
EPCIS allows querying of information
1
2
3
All events for Item
“00312345325671”?
• Commissioning Event
• Packing Event
• Shipping Event
EPCIS is global !4
EPCIS is Flexible
EPCIS is Extensible
© Auto-ID Lab Korea / KAIST
Slide 55
GTSH “One up, One down”
Flow of goods Flow of goods Flow of goods
Physical
Flow
Information
Flow
Flow of Info Flow of Info Flow of Info
Traceability Partner Traceability Partner Traceability Partner Traceability Partner
Implementing a traceability system within a supply chain requires
all parties involved to systematically link the physical flow of materials
and products with the flow of information about them.
© Auto-ID Lab Korea / KAIST
Slide 56
GS1-Traceability (이력추적표준) Factory
▪ GS1 Global Traceability Standard에서는
▪ 상품(사물)의 생산-유통-소비 라이프사이클에 따른 이력 추적 관리 (TRACK)
▪ 최종 상품의 원산지 확인을 위한 역 이력 관리 (TRACE)
▪ 시스템 구축 가이드라인을 제시
© Auto-ID Lab Korea / KAIST
Slide 58
GS1 Digital Link + ONS
(QR 표준: 서비스 표준접근)
국제표준QR
(국가, 기업, 상품, 로트, 일련번호, 생
산연월일, 유통기한등)
© Auto-ID Lab Korea / KAIST
Slide 59
ONS (Object Naming Service)
GS1 사물인터넷 서비스 검색 표준
Object Name Service
(ONS)
manual
html
epcis
…
의료기기 및 자산 (GIAI)
수술실, 병실 (SGLN)
환자 (GSRN)
© Auto-ID Lab Korea / KAIST
Slide 60
GS1 헬스케어와 블록체인과의 만남
Refer:https://www2.deloitte.com/content/dam/Deloitte/us/Documents/strategy/u
s-cons-supply-chain-meets-blockchain.pdf
© Auto-ID Lab Korea / KAIST
Slide 61
블록체인 (식품, 의약품, Identifier
GS1 표준 데이터로 상호 운용성 확보)
© Auto-ID Lab Korea / KAIST
Slide 62
GS1 Project Imagine
© Auto-ID Lab Korea / KAIST
Slide 64
• Oliot Open Source Project
• http://oliot.org
GS1 EPCglobal 데이터 및 서비스 공유 국제표준 구현
• GS1 Source
• Pedigree
• Traceability & Recall
• ONS
• DS
• EPCIS
• F&C
• IoT connectivity Layer, etc.
Oliot Open Source Project (KAIST)
Apache License
© Auto-ID Lab Korea / KAIST
Slide 65
6 Continents, 103 countries, 1147 Cities
13618 Organizations/Companies/Individuals
2020.05.26.
2014년 6월25일 (Oliot 1.0)
2016년 (Oliot 1.2)
2020년 하반기 예정 (Oliot 2.0))
Part III – GS1 Healthcare Standards
© Auto-ID Lab Korea / KAIST
Slide 67
GS1 Healthcare Standards (Selected)
• Healthcare specific standards already ratified
• Healthcare GTIN Allocation Rules
• Global Traceability Standard for healthcare
• Application Standard for Products in Clinical Trials
• GS1 Pharmaceutical Clinical Trial Electronic Messaging Standard Implementation Guideline
• Implementation Guidelines
• GS1 AIDC Healthcare Implementation Guideline, providing guidance for using GS1 keys in a healthcare
environment along with; procedures for recognising if additional data is required for types of products,
needs for traceability, and marking requirements.
• GLN in Healthcare Implementation Guide, a general guide for the implementation of GLNs in healthcare and
as a guide this document: assists the reader in understanding; what is a GLN, how are GLNs applied/used,
the GLN data structure, and steps for implementing GLNs.
• Barcoding Plasma Derivatives Implementation Guide, to enable a safe and efficient delivery control process
for plasma derivatives and traceability ‘from vein to vein’.
• GS1 EDI Healthcare Guidelines outline a model for harmonised and streamlined business processes as well
as EDI processes to be used by the participants in the healthcare supply chain.
• GS1 Global Traceability Standard for Healthcare (GTSH) Implementation Guideline provides guidance to all
healthcare supply chain stakeholders on implementing the Global Traceability Standard for Healthcare (GTSH).
• GS1 Pharmaceutical Image Implementation Guideline provides a method of image naming; associated data,
and transport methods needed to increase efficiencies and minimise costs.
© Auto-ID Lab Korea / KAIST
Slide 69
Identify (식별체계)
© Auto-ID Lab Korea / KAIST
Slide 70
Capture (바코드, Data Matrix, RFID)
© Auto-ID Lab Korea / KAIST
Slide 71
Share (EPCIS Critical Tracking Event)
© Auto-ID Lab Korea / KAIST
Slide 72
Share
(EPCIS 데이터)
© Auto-ID Lab Korea / KAIST
Slide 73
Share - Serialized Item-Level Traceability Concepts
DSCSA Item-Level Data Elements
© Auto-ID Lab Korea / KAIST
Slide 74
Share - Serialized Item-Level Traceability Concepts
Commissioning event
© Auto-ID Lab Korea / KAIST
Slide 75
Share - Serialized Item-Level Traceability Concepts
(예) Commissioning event – XML example
© Auto-ID Lab Korea / KAIST
Slide 76
https://www.cardinalhealth.com/content/dam/corp/web/documents/Policy/cardinal-health-epcis-
onboarding-guide-for-dscsa.pdf
The purpose of this document is to provide
simplified, self-help instructions to enable Trading
Partners to successfully adhere to Cardinal
Health requirements for serialized EPCIS data
exchange for the purposes of November 2019
saleable returns verifications and future DSCSA
interoperability requirements in November 2023.
Verification Router
Service
As an outgrowth of the Healthcare Distribution Alliance's 2019
saleable returns pilot work, the group has been exploring a VRS
as an option for compliance to support DSCSA verification
requirements.
https://www.healthcarepackaging.com/issues/traceability-serialization/article/13294390/verification-
router-service-update
https://www.tracelink.com/insights/case-study-tracelink-verification-router-service-tracelink-dscsa-
saleable-returns-verification
Part IV – GS1 관련 세계 헬스케어 산업 동향
The U.S. Food and Drug Administration’s (FDA)
2013 Drug Supply Chain Security Act (DSCSA)
requires that the pharmaceutical industry
implement end-to-end traceability by 2023. As
trading partners, Johnson & Johnson Supply
Chain (JJSC) and AmerisourceBergen
(ABC) chose to implement and test GS1
standards-based solutions in a real-world pilot
to meet the deadline for interoperability.
While GS1 standards have created a hierarchy
that reaches down to the product level for
serialisation, several industry entities have
voluntarily chosen to use GS1 EPCIS (Electronic
Product Code Information Services) to fully
meet the intent of the regulation. EPCIS allows
trading partners to exchange data in concert
with products as they move through the
supply chain. The industry pilot between JJSC
and ABC did just that, with actionable and
repeatable results.
https://www.scan4safety.nhs.uk/
GS1 standards have been included in NHS policies for some years,
although their wide scale adoption has been patchy. In 2014, the
NHS eProcurement strategy received endorsement from the
Parliamentary Under Secretary of State for Health, Dr Daniel
Poulter MP.
© Auto-ID Lab Korea / KAIST
Slide 85
인도
https://www.expresshealthcare.in/interviews/implementing-gln-for-hospitals-needs-a-mind-set-change-ravi-mathur-ceo-gs1-india/414426/
인도 사립 의료기관의 반인 33,000개의 병원이 GS1의 GLN 코
드를 가지고 있습니다. GS1 코드는 병원의 유일한 글로벌 식별
자로의 역할 뿐만 아니라, 의약품, 의료기기, 환자, EHR등의 식
별자로 사용될수 있습니다. 불법 의약품, 의료보험 사기등에 대
한 대응책도 될 수 있습니다.
© Auto-ID Lab Korea / KAIST
Slide 101
처방전의 약품코드
http://www.kpbma.or.kr/api_board/download/notice/235027
© Auto-ID Lab Korea / KAIST
Slide 102
바코드에 유효기간 정보 담기
http://www.yakup.com/news/index.html?mode=view&cat=12&nid=238220
Part V – 디지털 트윈, 디지털 인프라,
디지털 SOC 인프라
(GS1 + 웹 + 공간정보)
디지털 인프라
© Auto-ID Lab Korea / KAIST
Slide 106
WEB Silos (웹상 Covid-19 검체 채취소?)
© Auto-ID Lab Korea / KAIST
Slide 107
WEB Silos
https://schema.org/docs/search_results.html?q=midical
https://schema.org/MedicalClinic
https://schema.org/CovidTestingFacility
© Auto-ID Lab Korea / KAIST
Slide 113
공간정보 상호호환성 (Interoperability)
© Auto-ID Lab Korea / KAIST
Slide 114
GS1 과 BIM 표준의 협력
© Auto-ID Lab Korea / KAIST
Slide 115
건설 및 건축분야의 디지털 미래
© Auto-ID Lab Korea / KAIST
Slide 116
BIM 오브젝트 데이터 (GS1 GTIN, GLN,
SSCC , GIAI)
© Auto-ID Lab Korea / KAIST
Slide 119
디지털 인프라, SoC의 디지털화? 국제 표준이 기본입니다.
[schema.org + GS1 + BIM/3D GIS]
• Medical Clinic (병원, 의대) - schema.org - https://schema.org/MedicalClinic
• (웹 데이터 국제 고속도로)
• Healthcare Standards | GS1 - https://www.gs1.org/industries/healthcare
(산업 데이터 국제 고속도로)
• Hospital BIM Open 2020, 28-29 October 2020, Virtual Conference- buildingSMART
International - https://www.buildingsmart.org/
(공간 데이터 국제고속도로)
Schema.org, GS1, BIM 모두 병원은 GS1의 GLN(Global Location Number) 식별자를 가집니다
© Auto-ID Lab Korea / KAIST
Slide 120
관련 슬라이드 및 동영상 자료
[0] GS1 튜토리얼 세미나 자료
https://www.slideshare.net/gatordkim/gs1-tutorial-korean-by-daeyoung-kim-autoid-labs-kaist
[1] GS1 튜토리얼 세미나 발표동영상 (1/3)
https://youtu.be/rNaUpbO0fqY
[2] GS1 튜토리얼 세미나 발표동영상 (2/3)
https://youtu.be/4I0HNSM_Veg
[3] GS1 튜토리얼 세미나 발표동영상 (3/3)
https://youtu.be/cvC3B6vFqPg
[4] Smart City Position Paper - GS1 Standards Perspective
https://www.slideshare.net/gatordkim/smart-city-position-paper-gs1-standards-perspective
[5] GS1 EPCIS, CBV 세미자자료
https://www.slideshare.net/gatordkim/gs1-epcis-and-cbv-tutorial-autoid-labs-kaist-apr-28-2020
[6] GS1 EPCIS, CBV 세미나 발표동영상
https://www.youtube.com/watch?v=d-ubhyXyT3A
[7] GS1 ONS, Digital Link 세미나자료
https://www.slideshare.net/gatordkim/gs1-ons-and-digital-link-tutorial-autoid-labs-kaist-apr-28-2020
[8] GS1 ONS, Digital Link 세미나 발표동영상
https://www.youtube.com/watch?v=bs3OjSpyH60
[9] GS1발 데이터혁명시리즈 1 - 안전한 수산물 확보와 해양생물 보존을 위한 글로벌 수산물 이력 추적 시스템 구축 동향과 기술 – 세미나 자료
https://www.slideshare.net/gatordkim/digital-revolution-series-1seafood-industry
[10] GS1발 데이터혁명시리즈 1 - 안전한 수산물 확보와 해양생물 보존을 위한 글로벌 수산물 이력 추적 시스템 구축 동향과 기술 – 발표 동영상 자료
https://www.youtube.com/watch?v=ohuQyBsE8fQ&feature=youtu.be
[11] GS1발 데이터혁명시리즈 2 - Internet of Trains: GS1 국제표준기반의 철도산업 디지털 트랜스포메이션 전략과 구축 기술 – 세미나 자료
https://www.slideshare.net/gatordkim/gs1-data-revolution-series-2-internet-of-trains
[12] GS1발 데이터혁명시리즈 2 - Internet of Trains: GS1 국제표준기반의 철도산업 디지털 트랜스포메이션 전략과 구축 기술 – 발표 동영상 자료
https://www.youtube.com/watch?v=Mb8qKqGUsuY
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Use,
and Imagine
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GS1 Data Revolution Series #3 Healthcare

  • 1. 김 대 영 2019년 10월 17일 교수, 전산학부, KAIST Director, Auto-ID Labs, KAIST kimd@kaist.ac.kr, http://oliot.org, http://autoidlab.kaist.ac.kr, http://resl.kaist.ac.kr, http://autoidlabs.org, http://gs1.org Internet of Medicine: GS1 국제표준기반의 헬스케어 디지털 트랜스포메이션 김 대 영 2020년 7월 28일 14:00 ~16:00 (Webinar) 교수, 전산학부, KAIST Director, Auto-ID Labs, KAIST Board member, GS1 Korea kimd@kaist.ac.kr, http://oliot.org, http://autoidlab.kaist.ac.kr, http://resl.kaist.ac.kr, http://autoidlabs.org, http://gs1.org
  • 2. © Auto-ID Lab Korea / KAIST Slide 2 목차 Part I – 헬스케어 산업에서의 디지털 트랜스포메이션 Part II – GS1 Standards (GS1 국제표준, 산업표준) Part III – GS1 헬스케어 표준 Part IV – GS1 관련 세계 헬스케어 산업 및 서비스 동향 Part V – 디지털트윈, 디지털인프라, 디지털 SoC 인프라
  • 3. Part I – 헬스케어 산업에서의 디지털 트랜스포메이션
  • 4. © Auto-ID Lab Korea / KAIST Slide 4
  • 5. © GS1 2019 https://www.theguardian.com/society/2019/feb/12/fake-cancer-drug-made-from-paracetamol-world-health-organization WHO warns of fake cancer drug made from paracetamol Pills that resemble Leukaemia drug Iclusig sold in Europe and Americas for £5,000 a pack
  • 6. © GS1 2019 This year’s investigations revealed that the trafficking not only covered opioid medicines, but also pharmaceutical products used for the treatment of major illnesses such as cancer and heart conditions, as well as performance and image enhancing drugs.
  • 7. © GS1 2019 This investigation is creating huge media activities – have a look at the video on their page also! https://www.icij.org/investigations/impl ant-files/ Global issues with implants https://www.icij.org/blog/2018/11/icij-publishes -new-investigation-the-implant-files/ https://youtu.be/tZUzmA32Lbo
  • 8.
  • 9. © Auto-ID Lab Korea / KAIST Slide 9 불법 사용 - Point-of-Care Scanning
  • 10. © GS1 2019 (병원) Hospital Leaders, Providers Stress Over Supply Chain Management (1/2) • 74% of frontline providers report looking for supplies that should be at hand has the most negative impact on their workplace productivity, and 84% of supply chain managers say the same (약품과 의료기기의 요구되는 장소에 적시 공급) • 49% of frontline providers say they manually count and track supplies, and almost half (46%) state the manual process has a “very” or “somewhat” negative effect on their workforce productivity (자동화된 공급 체계) • 70% of supply chain managers and clinicians cite wasting and overutilization of supplies as a significant or somewhat significant problem (낭비 또는 과잉이용) Supply chain management is an integral part of cutting costs and advancing care quality, meaning all stakeholders need to be on board to streamline and optimize supply chain processes for healthcare success. From the fourth annual Cardinal Health Hospital Supply Chain Survey (https://cardinalhealth.mediaroom.com/2019-05-08- Cardinal-Health-Fourth-Annual-Survey-Finds-Supply-Chain-Tasks-Causing-Stress-for-Clinicians-and-Impacting-Patient-Care)
  • 11. © Auto-ID Lab Korea / KAIST Slide 11 Humanitarian Logistics 다양한 산업 분야에서 데이터를 표준화하고 공유하는 글로벌 프레임웍을 제공함 “데이터 기반의 사물인터넷" 4차 산업혁명의 중심은 “데이터 산업” 사람과 사물이 공존하는 사물인터넷 세상
  • 12. © Auto-ID Lab Korea / KAIST Slide 12 patient safety (환자안전) Traceability (이력추적) product data (의약품 및 의료기기 데이터) medical data (의료 데이터) supply chain security & efficiency (의약품, 의료기기 공급망 보안 및 효율 향상) GS1 Healthcare 비전
  • 13. © Auto-ID Lab Korea / KAIST Slide 13 GS1 Healthcare 헬스케어 분야 국제기구와의 협력
  • 14. © Auto-ID Lab Korea / KAIST Slide 14 병원이 맞닥뜨리고 있는 도전 과제 Excess clinical time spent ordering and managing stock (스탁관리 시간) Lack of traceability due to absence of product identification and patient ID (글로벌 식별자) Wastage and costs associated with disposal and reordering (낭비와 비용) Risk of medication errors Errors due to manual processes (의료 실수) Ineffective and inefficient product recalls (리콜) Lack of inventory visibility and stock control (재고 관리) In a hospital clinical and supply chain processes can be improved by automation(자동화) and accurate data (정확한 데이터)
  • 15. © Auto-ID Lab Korea / KAIST Slide 15 Safer, more efficient care starts with a simple scan.
  • 16. © Auto-ID Lab Korea / KAIST Slide 16 GS1 Project Imagine
  • 17. © Auto-ID Lab Korea / KAIST Slide 17 GS1 Project Imagine
  • 18. © Auto-ID Lab Korea / KAIST Slide 18 FDA DSCSA(Drug Supply Chain Security Act) https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
  • 19. © Auto-ID Lab Korea / KAIST Slide 19 DSCSA 타임라인
  • 20. The Falsified Medicines Directive will be rolled out in Europe from February 2019 to address the threat of fake medicines and will impact the entire supply chain Citation: The Pharmaceutical Journal, February 2018, Vol 300, No 7910, online | DOI: 10.1211/PJ.2018.20204433
  • 21. https://www.pharmamanufacturing.com/articles/2016/dscsa-support-the-benefits-of-leveraging-epcis 1. EPCIS works with standards many pharma companies are already using. 2. EPCIS is versatile. 3. Successful pilot programs are being reported. 4. EPCIS helps a company collaborate long term with different supply chain partners.
  • 22. © Auto-ID Lab Korea / KAIST Slide 22 제약회사당 데이터 요구량 (빅데이터)
  • 23. © Auto-ID Lab Korea / KAIST Slide 23 UDI (Unique Device Identification) System https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
  • 24. © Auto-ID Lab Korea / KAIST Slide 24 • 미국 FDA는 2013년 9월 모든 의료 기기에 글로벌하게 식별이 가능한 GS1 코드 시스템 체계를 적용한다고 발표하였다. • 이에 따라, GS1/FDA Unique Device Identifier (UDI) 식별자가 의료기기 생산자로부터 모든 버전의 기기 모델에 적용되어야 하며, 사람이 판독 가능하면서 동시에 AutoID 포맷이어야 한다. Unique Device Idetifier (UDI)
  • 25. © Auto-ID Lab Korea / KAIST Slide 25 GS1 Healthcare - FDA 의료기기표준코드(UDI)는 바코드와 같은 자동인식(AIDC)기술을 통해 정확 하고 간편하게 FDA DB에서 해당 의료기기정보를 access 할 수 있도록 구성 표준 코드체계 표준 DB 표준 자동인식 기술 • UDI/UDID 시스템 구조 • 현재 500,000개 이상의 의료 기기 정보가 GS1/FDA의 Global UDI Database (GUDID)에 저장 되어있습니다.
  • 26. © Auto-ID Lab Korea / KAIST Slide 26 UDI (Unique Device Identification) 생태계
  • 27. https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." https://www.fda.gov/media/122535/download
  • 28. https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd Software as a Medical Device ranges from software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.
  • 30. © Auto-ID Lab Korea / KAIST Slide 30 UNICEF와 세계백신면역연합인 GAVI가 GS1 국제표준기반 백신 이력추적을 요구 하기 시작했습니다. 중국도 백신 이력추적제도의 전면도입 준비를 시작했습니다. "유니세프와 가비, 백신에 GS1 표준 요구 2021 년 12 월 31 일까지 개발 도상국 의 백신 동맹국 인 Gavi가 자금을 지원하는 모든 유니세프가 후원하는 예방 접종 캠페인 경연 대회 는 이차 백신 패키지에 GS1 바코드를 사용하여 추적 성을 개선하여 환자 안전" - 구글번역 https://www.newsfarma.pt/noticias/8517-unicef-e-gavi-exigem-standards-gs1-nas-vacinas.html
  • 32. © Auto-ID Lab Korea / KAIST Slide 32 GS1 Standard New standard for investigational products answers clinical trial industry’s need for consistency https://www.gs1.org/industries/healthcare/clinical-trials
  • 33. © GS1 2019 IP kit type Investigational product type Bringing the concepts together Kit assembly batch/lot IP label IP kit label AI (01) GTIN AI (01) GTIN or AI(8006) ITIP Clinical trial management system IP kit instance Investigational product instance AI (10) batch/lot AI (21) serial ID AI (01) GTIN (kit) Protocol AI (7240) protocol ID Treatment treatment ID AI (10) batch/lot AI (7240) protocol ID Investigational product instance IP kit instance kit ID AI (21) serial ID AI (01) GTIN or AI(8006) ITIP (material) AI (10) batch/lot AI (7240) Protocol ID
  • 34.
  • 35. Part II – GS1 Standards (GS1 국제표준)
  • 36. © Auto-ID Lab Korea / KAIST Slide 36 GS1 (Global Standards 1) 국제표준기구 (데이터, 비즈니스, 산업, 사물인터넷) 산업 분야에서 데이터를 표준화하고 공유하는 글로벌 플랫폼 제공 114개국 국가-MO (Member Organizations), 170개 국가 공식 활용 2백만 이상의 기업 멤버로 구성된 비영리 국제표준기구 한국은 대한상공회의소 산하의 GS1 Korea (유통물류진흥원) 와 Auto-ID Labs, KAIST GS1 사물인터넷 국제표준공동연구소 운영 (KAIST, MIT, Cambridge, ETH Zurich, Keio, Fudan University)
  • 37. © Auto-ID Lab Korea / KAIST Slide 37 여권으로 보는 국제표준 데이터 구성 데이터 DATA 식별자 (Identifier) 예) 여권 번호, 여권 발급 장소, 공항 출입국 심사대, 출입국 기기 식별자 등 어휘 (Vocabulary) 예) 사람 이름, 성별, 주민등록번호, 국적, 여권발급, 비자발급, 출입국 기록등 마스터 데이터 (Master Data) 변하지 않는 데이터 예) 이름, 성별, 국적, 사진 트랜잭션 데이터 (Transaction Data) 비즈니스 관련 데이터 예) 여권 발급, 수수료 납부, 비자 발급 이벤트 데이터 (Event Data) 발생 이벤트 관련 데이터 예) 출국 및 입국 이벤트, 출입국 특이 사항 이벤트 이미지 출처: 외교부 www.mofa.go.kr
  • 38. © Auto-ID Lab Korea / KAIST Slide 38 GS1 Company Prefix (식별자의 시작) • GS1 국제 생태계에 진입하기 위해, 각 기업이나 기관은 국가코드와 기업/기관 코드로 이루어진 GS1 Company Prefix (GCP) 를 확보해야 함 • GS1 Company Prefix 를 기반으로 13종류이상의 다양한 글로벌 GS1 식별자를 사용할 수 있음 (GTIN, GRAI, GIAI, GLN, GSRN, ….)
  • 39. © Auto-ID Lab Korea / KAIST Slide 39 의약품, 의료기기 (GTIN, 8809045540005) 24시간 혈압측정기 병원자산 (GRAI) MRI 병원자산 (GIAI) 병원, 병실, 수술실 (GLN) 처방전 (GDTI)환자, 의사, 간호사 (GSRN) 글로벌 식별체계
  • 40. 부품 코드 (CPID, Components and Parts IDentifier) 책 및 잡지 (ISBN, ISSN) 할인 쿠폰 (GCN, Global Coupon Number) 운송 코드 (GSIN, Global Shipment Identification Number) 탁송코드 (GINC, Global Identification Number for Consignment) 배송 박스 코드 (SSCC, Serialized Shipping Container Code) * 모델번호 (GMN, Global Model Number)
  • 41. © Auto-ID Lab Korea / KAIST Slide 41 GS1 Application Identifiers (응용 식별자) ~~~~
  • 42.
  • 44.
  • 46. © Auto-ID Lab Korea / KAIST Slide 46 GS1 GDSN, Global Registry Attributes [마스터 데이터] B2B 상품(의약품, 의료기기) 데이터 (+GS1 Source, GS1 Registry Platform) - 표준화된 상품(사물) 데이터를 글로벌 하게 공유하기 위한 표준과 분산 데이터풀 (데이터베이스) 시스템 - 2020년 5월 1일 현재 전세계 43개 Data Pool 운영 • B2C의 상세 상품 데이터를 제공하기 위한 노력이 GDSN, GS1 Source, GS1 Registry Platform 를 통해 상호 보완으로 진행되고 있음. (예. 식품의 성분, 인증, 앨러지 정보등)
  • 47. © GS1 2015 Managing data at global and local level 1. Find a standards based solution which can scale as more countries release UDI regulation 2. Find a technology partner that can connect you globally 3. Define ALL regulatory and commercial attributes (Super Spec) 47 FDA Submission Acknowledgement UDI Data Submission Future UDI Databases Global Providers GPOs US Providers Data PoolLableler Super Spec Source: Margot Drees, GHX
  • 48. © Auto-ID Lab Korea / KAIST Slide 48 EPC Information Service (EPCIS) GS1의 데이터공유 6하원칙 GS1의 6하원칙 WHO Pfizer Korea GS1 GLN WHAT 약 GS1 SGTIN WHERE Pfizer 라벨링 시설 GS1 GLN/SGLN + geo WHEN 방금 / 어제 UTC HOW GS1에는 없습니다. 어떻게 그 럴수가 있니? WHY 출하했다 GS1 CBV Vocabulary/Data Dictionary / Comissioning
  • 49. © Auto-ID Lab Korea / KAIST Slide 49 Common Business Vocabulary (CBV) 동사, 형용사, 부사 urn:epcglobal:cbv: bizstep:assembling bizstep:retail_selling bizstep:inspecting bizstep:repairing
  • 50. © Auto-ID Lab Korea / KAIST Slide 50 GS1 국제 표준 – Lifetime 프로세스 모델링 기술 • ObjectEvent – 상품의 생성/관찰/제거 • AggregationEvent – 상품의 포장/적재 • TransactionEvent – 상품의 판매 상황 • TransformationEvent – 상품의 가공 상황 • Association Event – Coming soon 생성부터 판매까지 상품(사물)의 lifetime을 기록할 수 있는 데이터 모델을 통해서 상품 을 효율적으로 관리 What, Where, When, Why 를 통한 상세한 이벤트 정보 입력
  • 51. © GS1 2019 Party at beginning of the supply chain (e.g., manufacturer) • Commissioning • Packing • Shipping EPCIS events captured and shared by . . . Intermediate parties (e.g., distributor) • Receiving • Unpacking • Packing • Shipping Party at end of chain (e.g., pharmacy) • Receiving • Unpacking • Dispensing • Decommissioning
  • 52. © Auto-ID Lab Korea / KAIST Slide 52 • EPC Information Service (EPCIS) • Current Version 1.2, Oct. 2016 • Also adopted by ISO/IEC ISO/IEC 19987:2015 standard 사물인터넷 이벤트를 저장하는 분산 연합 데이터 베이스 / 왼쪽 그림 처럼 EPCIS 가 중앙에 하나 있는 게 아니라, 백신후보물질(원료), 물류 회사, 백신제조회사, 유통회사, 병원 등이 제각기 운영하고,가상으로는 단일의 데이터 저장소로 보임 - 기존 시스템 대체가 아니라, 별개 시스템 설치 후 쉽게 연결함 ➢ RFID를 위한 EPCglobal 표준은 지난 5년간 확장되어, 사물인터넷의 인프라 프레임웍으로 발전중임 EPC Information Service (EPCIS) 트랜잭션 데이터와 이벤트 데이터 공유 (+EDI)
  • 53. © Auto-ID Lab Korea / KAIST Slide 53 글로벌 이력추적 추진 동력 Regulations emerge worldwide (규정) Supply Chain costs increase (유통물류비용) Electronic Health Records (환자 데이터) Medication errors (투약실수) Counterfeiting (위조 약품) Brand Protection (브랜드 보호) BUT • Traceability is complex, multi-sectorial and cross border, but it is not always recognized as such • Traceability is becoming a necessity, but one that is addressed by an endless number of isolated solutions • GS1 Standards can help…
  • 54. © GS1 2019 Why use EPCIS-based traceability systems? Com- mission Pack Ship Rcv Unpack Pack Dispense Destroy Decommission Rcv Unpack <<Ship <<<<<<< Manufacturer Distributor(s) Dispenser Possibly Repeated Local regulatory data Local regulatory data EPCIS allows querying of information 1 2 3 All events for Item “00312345325671”? • Commissioning Event • Packing Event • Shipping Event EPCIS is global !4 EPCIS is Flexible EPCIS is Extensible
  • 55. © Auto-ID Lab Korea / KAIST Slide 55 GTSH “One up, One down” Flow of goods Flow of goods Flow of goods Physical Flow Information Flow Flow of Info Flow of Info Flow of Info Traceability Partner Traceability Partner Traceability Partner Traceability Partner Implementing a traceability system within a supply chain requires all parties involved to systematically link the physical flow of materials and products with the flow of information about them.
  • 56. © Auto-ID Lab Korea / KAIST Slide 56 GS1-Traceability (이력추적표준) Factory ▪ GS1 Global Traceability Standard에서는 ▪ 상품(사물)의 생산-유통-소비 라이프사이클에 따른 이력 추적 관리 (TRACK) ▪ 최종 상품의 원산지 확인을 위한 역 이력 관리 (TRACE) ▪ 시스템 구축 가이드라인을 제시
  • 57.
  • 58. © Auto-ID Lab Korea / KAIST Slide 58 GS1 Digital Link + ONS (QR 표준: 서비스 표준접근) 국제표준QR (국가, 기업, 상품, 로트, 일련번호, 생 산연월일, 유통기한등)
  • 59. © Auto-ID Lab Korea / KAIST Slide 59 ONS (Object Naming Service) GS1 사물인터넷 서비스 검색 표준 Object Name Service (ONS) manual html epcis … 의료기기 및 자산 (GIAI) 수술실, 병실 (SGLN) 환자 (GSRN)
  • 60. © Auto-ID Lab Korea / KAIST Slide 60 GS1 헬스케어와 블록체인과의 만남 Refer:https://www2.deloitte.com/content/dam/Deloitte/us/Documents/strategy/u s-cons-supply-chain-meets-blockchain.pdf
  • 61. © Auto-ID Lab Korea / KAIST Slide 61 블록체인 (식품, 의약품, Identifier GS1 표준 데이터로 상호 운용성 확보)
  • 62. © Auto-ID Lab Korea / KAIST Slide 62 GS1 Project Imagine
  • 63.
  • 64. © Auto-ID Lab Korea / KAIST Slide 64 • Oliot Open Source Project • http://oliot.org GS1 EPCglobal 데이터 및 서비스 공유 국제표준 구현 • GS1 Source • Pedigree • Traceability & Recall • ONS • DS • EPCIS • F&C • IoT connectivity Layer, etc. Oliot Open Source Project (KAIST) Apache License
  • 65. © Auto-ID Lab Korea / KAIST Slide 65 6 Continents, 103 countries, 1147 Cities 13618 Organizations/Companies/Individuals 2020.05.26. 2014년 6월25일 (Oliot 1.0) 2016년 (Oliot 1.2) 2020년 하반기 예정 (Oliot 2.0))
  • 66. Part III – GS1 Healthcare Standards
  • 67. © Auto-ID Lab Korea / KAIST Slide 67 GS1 Healthcare Standards (Selected) • Healthcare specific standards already ratified • Healthcare GTIN Allocation Rules • Global Traceability Standard for healthcare • Application Standard for Products in Clinical Trials • GS1 Pharmaceutical Clinical Trial Electronic Messaging Standard Implementation Guideline • Implementation Guidelines • GS1 AIDC Healthcare Implementation Guideline, providing guidance for using GS1 keys in a healthcare environment along with; procedures for recognising if additional data is required for types of products, needs for traceability, and marking requirements. • GLN in Healthcare Implementation Guide, a general guide for the implementation of GLNs in healthcare and as a guide this document: assists the reader in understanding; what is a GLN, how are GLNs applied/used, the GLN data structure, and steps for implementing GLNs. • Barcoding Plasma Derivatives Implementation Guide, to enable a safe and efficient delivery control process for plasma derivatives and traceability ‘from vein to vein’. • GS1 EDI Healthcare Guidelines outline a model for harmonised and streamlined business processes as well as EDI processes to be used by the participants in the healthcare supply chain. • GS1 Global Traceability Standard for Healthcare (GTSH) Implementation Guideline provides guidance to all healthcare supply chain stakeholders on implementing the Global Traceability Standard for Healthcare (GTSH). • GS1 Pharmaceutical Image Implementation Guideline provides a method of image naming; associated data, and transport methods needed to increase efficiencies and minimise costs.
  • 68.
  • 69. © Auto-ID Lab Korea / KAIST Slide 69 Identify (식별체계)
  • 70. © Auto-ID Lab Korea / KAIST Slide 70 Capture (바코드, Data Matrix, RFID)
  • 71. © Auto-ID Lab Korea / KAIST Slide 71 Share (EPCIS Critical Tracking Event)
  • 72. © Auto-ID Lab Korea / KAIST Slide 72 Share (EPCIS 데이터)
  • 73. © Auto-ID Lab Korea / KAIST Slide 73 Share - Serialized Item-Level Traceability Concepts DSCSA Item-Level Data Elements
  • 74. © Auto-ID Lab Korea / KAIST Slide 74 Share - Serialized Item-Level Traceability Concepts Commissioning event
  • 75. © Auto-ID Lab Korea / KAIST Slide 75 Share - Serialized Item-Level Traceability Concepts (예) Commissioning event – XML example
  • 76. © Auto-ID Lab Korea / KAIST Slide 76 https://www.cardinalhealth.com/content/dam/corp/web/documents/Policy/cardinal-health-epcis- onboarding-guide-for-dscsa.pdf The purpose of this document is to provide simplified, self-help instructions to enable Trading Partners to successfully adhere to Cardinal Health requirements for serialized EPCIS data exchange for the purposes of November 2019 saleable returns verifications and future DSCSA interoperability requirements in November 2023.
  • 77.
  • 78. Verification Router Service As an outgrowth of the Healthcare Distribution Alliance's 2019 saleable returns pilot work, the group has been exploring a VRS as an option for compliance to support DSCSA verification requirements. https://www.healthcarepackaging.com/issues/traceability-serialization/article/13294390/verification- router-service-update https://www.tracelink.com/insights/case-study-tracelink-verification-router-service-tracelink-dscsa- saleable-returns-verification
  • 79. Part IV – GS1 관련 세계 헬스케어 산업 동향
  • 80. The U.S. Food and Drug Administration’s (FDA) 2013 Drug Supply Chain Security Act (DSCSA) requires that the pharmaceutical industry implement end-to-end traceability by 2023. As trading partners, Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen (ABC) chose to implement and test GS1 standards-based solutions in a real-world pilot to meet the deadline for interoperability. While GS1 standards have created a hierarchy that reaches down to the product level for serialisation, several industry entities have voluntarily chosen to use GS1 EPCIS (Electronic Product Code Information Services) to fully meet the intent of the regulation. EPCIS allows trading partners to exchange data in concert with products as they move through the supply chain. The industry pilot between JJSC and ABC did just that, with actionable and repeatable results.
  • 81.
  • 82.
  • 83.
  • 84. https://www.scan4safety.nhs.uk/ GS1 standards have been included in NHS policies for some years, although their wide scale adoption has been patchy. In 2014, the NHS eProcurement strategy received endorsement from the Parliamentary Under Secretary of State for Health, Dr Daniel Poulter MP.
  • 85. © Auto-ID Lab Korea / KAIST Slide 85 인도 https://www.expresshealthcare.in/interviews/implementing-gln-for-hospitals-needs-a-mind-set-change-ravi-mathur-ceo-gs1-india/414426/ 인도 사립 의료기관의 반인 33,000개의 병원이 GS1의 GLN 코 드를 가지고 있습니다. GS1 코드는 병원의 유일한 글로벌 식별 자로의 역할 뿐만 아니라, 의약품, 의료기기, 환자, EHR등의 식 별자로 사용될수 있습니다. 불법 의약품, 의료보험 사기등에 대 한 대응책도 될 수 있습니다.
  • 86.
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  • 100.
  • 101. © Auto-ID Lab Korea / KAIST Slide 101 처방전의 약품코드 http://www.kpbma.or.kr/api_board/download/notice/235027
  • 102. © Auto-ID Lab Korea / KAIST Slide 102 바코드에 유효기간 정보 담기 http://www.yakup.com/news/index.html?mode=view&cat=12&nid=238220
  • 103.
  • 104. Part V – 디지털 트윈, 디지털 인프라, 디지털 SOC 인프라 (GS1 + 웹 + 공간정보)
  • 106. © Auto-ID Lab Korea / KAIST Slide 106 WEB Silos (웹상 Covid-19 검체 채취소?)
  • 107. © Auto-ID Lab Korea / KAIST Slide 107 WEB Silos
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  • 113. © Auto-ID Lab Korea / KAIST Slide 113 공간정보 상호호환성 (Interoperability)
  • 114. © Auto-ID Lab Korea / KAIST Slide 114 GS1 과 BIM 표준의 협력
  • 115. © Auto-ID Lab Korea / KAIST Slide 115 건설 및 건축분야의 디지털 미래
  • 116. © Auto-ID Lab Korea / KAIST Slide 116 BIM 오브젝트 데이터 (GS1 GTIN, GLN, SSCC , GIAI)
  • 117.
  • 118.
  • 119. © Auto-ID Lab Korea / KAIST Slide 119 디지털 인프라, SoC의 디지털화? 국제 표준이 기본입니다. [schema.org + GS1 + BIM/3D GIS] • Medical Clinic (병원, 의대) - schema.org - https://schema.org/MedicalClinic • (웹 데이터 국제 고속도로) • Healthcare Standards | GS1 - https://www.gs1.org/industries/healthcare (산업 데이터 국제 고속도로) • Hospital BIM Open 2020, 28-29 October 2020, Virtual Conference- buildingSMART International - https://www.buildingsmart.org/ (공간 데이터 국제고속도로) Schema.org, GS1, BIM 모두 병원은 GS1의 GLN(Global Location Number) 식별자를 가집니다
  • 120. © Auto-ID Lab Korea / KAIST Slide 120 관련 슬라이드 및 동영상 자료 [0] GS1 튜토리얼 세미나 자료 https://www.slideshare.net/gatordkim/gs1-tutorial-korean-by-daeyoung-kim-autoid-labs-kaist [1] GS1 튜토리얼 세미나 발표동영상 (1/3) https://youtu.be/rNaUpbO0fqY [2] GS1 튜토리얼 세미나 발표동영상 (2/3) https://youtu.be/4I0HNSM_Veg [3] GS1 튜토리얼 세미나 발표동영상 (3/3) https://youtu.be/cvC3B6vFqPg [4] Smart City Position Paper - GS1 Standards Perspective https://www.slideshare.net/gatordkim/smart-city-position-paper-gs1-standards-perspective [5] GS1 EPCIS, CBV 세미자자료 https://www.slideshare.net/gatordkim/gs1-epcis-and-cbv-tutorial-autoid-labs-kaist-apr-28-2020 [6] GS1 EPCIS, CBV 세미나 발표동영상 https://www.youtube.com/watch?v=d-ubhyXyT3A [7] GS1 ONS, Digital Link 세미나자료 https://www.slideshare.net/gatordkim/gs1-ons-and-digital-link-tutorial-autoid-labs-kaist-apr-28-2020 [8] GS1 ONS, Digital Link 세미나 발표동영상 https://www.youtube.com/watch?v=bs3OjSpyH60 [9] GS1발 데이터혁명시리즈 1 - 안전한 수산물 확보와 해양생물 보존을 위한 글로벌 수산물 이력 추적 시스템 구축 동향과 기술 – 세미나 자료 https://www.slideshare.net/gatordkim/digital-revolution-series-1seafood-industry [10] GS1발 데이터혁명시리즈 1 - 안전한 수산물 확보와 해양생물 보존을 위한 글로벌 수산물 이력 추적 시스템 구축 동향과 기술 – 발표 동영상 자료 https://www.youtube.com/watch?v=ohuQyBsE8fQ&feature=youtu.be [11] GS1발 데이터혁명시리즈 2 - Internet of Trains: GS1 국제표준기반의 철도산업 디지털 트랜스포메이션 전략과 구축 기술 – 세미나 자료 https://www.slideshare.net/gatordkim/gs1-data-revolution-series-2-internet-of-trains [12] GS1발 데이터혁명시리즈 2 - Internet of Trains: GS1 국제표준기반의 철도산업 디지털 트랜스포메이션 전략과 구축 기술 – 발표 동영상 자료 https://www.youtube.com/watch?v=Mb8qKqGUsuY