미래건강/의료기기 상호운용성&허가 심포지움

 

스마트헬스표준포럼에서 ‘미래건강/의료기기 상호운용성&허가 심포지움’을 개최히오니

관심 있는 분들의 많은 참석 바랍니다.

 

건강관련기기, 의료기기의 발전은 눈부시다고 할 수 있습니다. 새로운 기기들이 아주 빠르게 개발되고 있기 때문에, 이렇게 빨리 개발한 건강 관련기기와 의료기기들의 사용허가 또한 신속하고도 정확하게 이루어져야 합니다.

 

본 심포지움에서는 미국에서 다년간 IEEE 11073, AAMI Medical Devices 표준 개발에 힘써온 Todd Copper와 함께 차세대 현장진료 의료기기(Next Generation Point-of-Care Medical Devices)를 사용 허가 받을 수 있기에 꼭 필요한 상호운용성 인증 (Interoperability Certification) 세미나를 준비하였습니다. 또한 한국의 식약처에서 준비한 융합의료기기에서의 인공지능 활용에 관한 허가, 심사 유의사항, 이슈들에 관한 내용들로 더위를 식힐 수 있기를 희망합니다.

-(사)스마트헬스표준포럼 회장 임효근 (성균관대학교 삼성융합의과학원장)-

 

*일시: 2019. 8. 23.(금) 13:30 -17:30

*장소: 신촌세브란스병원 본관 6층 제2세미나실 (선착순 40명)

 

프로그램:

- 13:30-14:00 등록

- 14:00 – 16:00 “Interoperability Certification to Address Regulatory Requirements for Next Generation Point-of-Care Medical Devices” (Todd Cooper, CEO)

- 16:00 – 16:20 Break (휴식)

- 16:20 – 17:30 “인공지능 기반 의료기기 허가심사 정책” (손승호 주무관, 식약처)

 

참가비: 사전등록 50,000원 (8월20일까지) 온오프믹스를 통한결제

 

스마트헬스표준포럼으로 직접 계좌이체를 원하실 경우는

신한은행: 100-032-213331으로 입금해주시기 바랍니다. (계산서 발급가능)

 

현장등록 70,000원

* 참가등록사이트: https://onoffmix.com/event/189394

 

Synopsis:

Technical approaches for achieving open seamless interoperability of medical devices - “from the device interface” - in high acuity healthcare contexts such as OR and ICU, has been repeatedly standardized over the last 40 years; however, business and regulatory challenges have undermined all efforts to implement interoperable medical devices in these high acuity environments. The emerging ISO-IEEE Service-oriented Device Connectivity (SDC) family of standards along with the IHE Service-oriented Device Point-of-care Interoperability (SDPi) technical framework specifications, all directly address regulatory needs related to the safety, effectiveness and security of connected medical technology, from the earliest stages of product concept and development, to interoperability testing and certification, and ultimately to regulatory market “clearance” and product implementation and use. This includes addressing the challenges emerging from medical “apps” and the integration of knowledge-based technology including real-time analytics and artificial intelligence / machine learning. This presentation builds on the SDC overview presented earlier in the day to review the regulatory approach taken by the ISO-IEEE 11073 SDC family of standards, identifying the key purposes for which a medical device implements an interoperable interface, and laying out how SDC-enabled devices can be certified as components of a larger high acuity system-of-systems. The roadmap for realizing interoperability-certified medical products will be reviewed, starting in 2020 and beyond.

 

Audience:Regulatory professionals

Product developers, from technical marketing to R&D to testing and production, including regulatory managers

Innovators who have been hindered by the challenges of addressing regulatory hurdles for interoperable technologies

App - health software / software as a medical device (SAMD) - developers integrating next generation knowledge-based analytics and artificial intelligence technologies consuming real-time medical device data and enabling autonomous therapeutic medical / clinical algorithms

Interoperability testing & certification organizations

Healthcare technology managers / clinical engineers / clinical technology managers

Clinical staff who want to ensure that their needs are heard, understood and supported

Students preparing for technology development and use in future healthcare contexts

Topics include:

Overview of the ISO-IEEE 11073 SDC standards (brief version of the morning session)

Overview of regulatory challenges for interoperable high acuity medical technologies

Approach of SDC standards / IHE SDPi technical specifications to address regulatory needs

Interoperability conformity assessment (CA testing) and certification supporting product regulatory “clearance” submissions

Roadmap for implementation of IHE SDPi profiles, including CA, regulatory agency submissions and implementation & use of interoperable medical devices

Background:

Complete information about the SDC@IHE initiative can be accessed at: wiki.ihe.net/index.php/SDC@IHE

A public comment version of the IHE SDPi White Paper should be available for review in early August.