박실비아 ․ 박은자 ․ 채수미 ․ 이예슬

목 차

Abstract············································1

요 약 ···················································3

제1장 서론 ·································································21

제1절 연구 배경과 필요성 ··············································21

제2절 연구 목적 ··························································23

제3절 연구 범위 ····················································································24

제4절 연구 내용 및 방법 ·············································25

제2장 이론적 고찰 ······························································29

제1절 신의료기술의 정의 ·······················································29

제2절 혁신과 기술의 확산 ···························································34

제3절 의료기술의 도입과 확산 ··········································39

제2장 이론적 고찰 ····························································29

제1절 신의료기술의 정의 ··········································29

제2절 혁신과 기술의 확산 ·····················································34

제3절 의료기술의 도입과 확산 ·······································39

제3장 신의료기술 도입 및 확산에 관한 국내 정책 현황 ······················47

제1절 신의료기술의 시장 진입 및 관련 정책 ····································47

제2절 신의료기술의 건강보험 도입 관련 정책 ······································56

제3절 신의료기술의 도입 이후 확산 및 재평가 정책 ·······························61

제4장 신의료기술 도입 및 확산에 관한 외국의 정책 현황 ··················71

제1절 영국 ·········································································71

제2절 미국 ···········································································82

제3절 호주 ··················································································96

제4절 캐나다 ··············································································117

제5장 신의료기술의 도입과 확산에 관한 정책의 국제 동향과 고찰 ··137

제1절 시장 진입 의사결정의 신속화 ···································137

제2절 시장 진입 결정과 급여 결정의 연계 ···································154

제3절 위험분담을 통한 관리된 급여계약 ·········································164

제4절 신의료기술의 시장 도입 이후 재평가 ···································172

제6장 결론 ·······················································183

참고문헌 ················································································191

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요 약

1. 서론 가. 연구 배경 및 목적

⧠ 의료기술이 의료서비스의 제공 과정과 의료비용에 미치는 영향이 커지면서 의료기술이 시장에 진입하고 확산, 사용되는 과정은 세계 적으로 보건의료정책의 주요 대상이 되어왔음.

⧠ 우리나라에서도 최근 의료기술에 대한 보건의료정책 영역이 크게 확대되었고, 의료기술이 보건의료정책에서 차지하는 비중은 계속 커질 것으로 예상됨.

⧠ 지금까지 국내에서의 의료기술에 대한 정책 연구는 의료행위를 중 심으로 하는 의료기술평가제도에 집중해왔으며 기술의 전주기에 걸 친 폭넓은 정책 이슈를 다루지 못한 한계가 있음.

⧠ 의약품, 의료기기, 의료행위를 포함하여 의료기술 전반을 대상으로 그것의 시장 진입과 확산을 결정하고 관리하기 위한 보건의료정책 의 연구를 통해 우리나라의 의료기술에 대한 정책의 현주소를 파악 하고 향후의 발전방향에 대한 모색이 필요함.

⧠ 이 연구는 우리나라 및 외국의 신의료기술 도입과 확산에 관한 정책 현황을 고찰하고 신의료기술에 관한 세계적인 정책의 흐름을비판적으로 조망하여 향후 의료기술의 발전을 통해 의료의 질 향상 과 자원 이용의 효율화에 기여할 수 있도록 하기 위한 의료기술 관련 정책 방향을 모색하는 데 기여하는 것을 목적으로 함.

나. 연구의 범위

⧠ 이 연구에서 신의료기술의 범위는 임상에 적용할 수 있는 수준으로 개발되어 시장에 도입되기 직전 또는 도입되기 시작한 의약품, 의료 기기, 의료행위로 한정하여 논의함.

⧠ 이 연구에서는 보건의료체계 내에서 신의료기술의 도입을 결정 하는 정책 및 도입 후 합리적 사용을 위한 정책으로서 의료기술 자 체를 대상으로 하는 정책에 초점을 맞추어 다루고자 함.