목 차

국문요약·····················································································1
제1장최민영
서론·····························································································3
제1절 논의의 범위·····················································································5
제2절 연구의 방법과 내용··········································································6
제2장남승민
디지털치료의 개념과 현황··························································7
제1절 디지털치료의 개념···········································································9
제2절 디지털치료의 종류·········································································12
1. 디지털치료의 구분···············································································12
2. 디지털치료의 임상연구 현황································································14
제3장최은경․남승민
주요국가 법제 비교검토···························································21
제1절 미국·······························································································23
1. 연혁·····································································································23
가. IMDRF의 시작과 FDASIA의 제정··················································23
나. FDASIA 건강 IT 보고서 발간과 규제 대상 소프트웨어 분류···········26
iv 첨단의료기술 임상연구 규제 합리화 방안 연구-디지털치료를 중심으로
다. 21세기 치료법(21st Century Cures Act)의 발효와 새로운 규제
패러다임의 도입············································································· 28
2. 근래 의료기기와 의료기기로서의 소프트웨어의 핵심정의 및 분류·······29
가. 의료기기 정의················································································· 29
나. 의료기기로서의 소프트웨어(SaMD) 정의 및 규제·························· 32
제2절 유럽연합(EU) ················································································ 42
1. 연혁 ····································································································· 42
가. 새로운 의료기기 규정(MDR, IVDR)의 도입···································· 42
나. MDR과 MDD의 내용····································································· 42
다. IVDR과 IVDD의 내용 ····································································· 43
2. 근래 의료기기와 의료기기로서의 소프트웨어의 핵심정의 및 분류·······44
가. 의료기기 정의················································································· 44
나. 의료기기로서의 소프트웨어(SaMD) 정의 및 규제·························· 47
다. 영국의 디지털 헬스 테크놀로지의 근거 기반 프레임워크
(Evidence standards framework (ESF) for digital health
technologies) ················································································ 51
3. 소프트웨어 의료기기에 관한 미국, 유럽 법 규제 함의·························· 55
가. 의료기기로서의 소프트웨어 기준의 정립········································ 55
나. 의료기기로서의 소프트웨어의 안전성 등급 판단···························· 56
제3절 일본······························································································· 57
1. 정책 ····································································································· 57
가. 보건 의료 분야 AI 개발 가속 컨소시엄··········································· 58
나. 의료DX추진···················································································· 58
다. 의약품 산업 강화 종합 전략···························································· 59
라. 건강･의료전략 계획(健康･医療戦略) ············································· 60
2. 규제 ····································································································· 61
가. 규제당국························································································· 61
나. 법령································································································ 63
다. 기타 제도 및 가이드라인································································66
3. 사례 ····································································································· 69
가. 현황································································································ 69
나. 최초의 디지털치료 도입 – 니코틴 의존증 치료 어플리케이션
(ニコチン依存症治療アプリ)························································· 71
목차v
다. 디지털 치료 승인–고혈압 치료 어플리케이션(高血圧治療アプリ)··73
4. 함의·····································································································75
제4장최민영
국내법제 검토···········································································77
제1절 의료기기 정의와 판단기준·····························································79
1. 의료기기 정의와 등급분류····································································79
2. 의료기기와 개인용 웰니스 제품의 구별················································80
3. 의료기기로서 혁신의료기기·································································81
제2절 의료기기 사용 절차와 기준····························································81
1. 의료기기 사용 절차··············································································81
가. 의료기기 제조허가··········································································81
나. 기존기술 여부 확인········································································83
다. 신의료기술평가··············································································83
라. 건강보험 급여여부 결정··································································85
2. 의료기기 및 의료기술 평가기준 및 기간···············································86
제3절 혁신의료기기 지정절차 및 기준·····················································88
1. 혁신의료기기 지정절차········································································88
가. 혁신의료기기군 지정······································································88
나. 혁신의료기기 지정 신청·································································89
다. 혁신의료기기 지정 후, 허가심사 특례·············································89
라. 혁신의료기기소프트웨어 특례 ·······················································90
2. 혁신의료기기 지정 통합심사································································91
가. 관련 규정의 개정············································································91
나. 관련 공고 내용···············································································92
3. 시판후 조사 및 임상시험 지원······························································94
4. 소결·····································································································94
제4절 디지털치료 관련 법제 검토····························································95
1. 혁신의료기기소프트웨어로서 디지털치료의 정의·································95
2. 관련 가이드라인···················································································96
가. 디지털치료 관련 가이드라인··························································96
vi첨단의료기술 임상연구 규제 합리화 방안 연구-디지털치료를 중심으로
나. 디지털치료기기 안전성･성능 평가 및 임상시험계획서 작성
가이드라인·····················································································99
3. 실제 사례 소개···················································································100
4. 소결···································································································101
제5장최민영
결론·························································································103
제1절 외국법제 비교분석의 착안점························································105
1. 미국의 혁신의료기기 규제 법정책······················································105
가. 21세기 치료법 제정 후의 변화·····················································105
나. 소프트웨어 의료기기 정의 규정과 관련 법정책의 변화·················107
2. 유럽의 소프트웨어 규제 법정책·························································107
3. 착안점································································································108
가. 소프트웨어 의료기기 정의규정·····················································108
나. 소프트웨어 의료기기의 안전성 및 임상적 유효성 판단기준··········109
다. 규제의 유연성과 일관성·······························································109
제2절 디지털치료 (임상연구) 규제를 위한 법정책적 기본방향···············110
1. 현행법의 개정방향·············································································110
2. 관련 제도의 개선···············································································110
참고문헌·················································································113
Abstract··················································································121