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醫療法中改正法律案
(金聖順의원 대표발의)
發議年月日 : 2001. 5. .
發 議 者 : 金聖順·金洪信 議員
贊 成 者 : 人
제안이유 및 주요골자
1. 改正理由
良質의 의료서비스를 제공할 수 있는 토대를 마련하기 위해 필요한 사항을 반영하는 한편, 醫療機關의 集團休·廢業 등 國民醫療를 沮害하는 行爲를 禁止하여 國民健康權을 보장하고, 醫療人의 虛僞 또는 不當한 診療費 請求行爲에 대해 免許를 取消하거나 資格을 停止시킬 수 있는 行政處分 根據를 마련하여 醫療人의 職業倫理를 확립하고 國民健康保險財政을 건전하게 운영하는데 필요한 사항을 정하여 國民便宜中心의 醫療制度를 확립하려는 것임.
2. 主要骨子
가. 綜合病院에 전속전문의를 두어야 하는 필수 診療科目 중 5개 과목(정신과, 치과는 필수 진료과목에서 삭제)만 法에서 정하고 4개이상 과목은 醫療機關이 選擇하여 운영할 수 있도록 하고, 필수 診療科目이외의 기타 診療科目에는 계약에 의한 전문의를 둘 수 있도록 함(案 第3條第3項第2號 및 第3號)
나. 刑法第347條(虛僞로 診療費를 청구하여 환자나 국민건강보험공단을 기망한 경우에 한한다), 藥事法을 위반하여 禁錮이상의 刑을 받는 경우를 醫療人의 缺格事由로 정함(案 第8條第1項第5號)
다. 醫療機關 開設者 또는 醫療人의 정당한 이유없는 診療中斷과 集團休業 또는 集團廢業 등 集團的 診療拒否를 금지하고(案 第16條第3項), 醫療人團體(중앙회와 지부)와 醫療人의 醫療機關 休·廢業 誘導등 團體行動을 금지함.(案 第16條의2)
라. 知識情報化社會 기반구축을 위한 電子醫務記錄, 醫療機關間 遠隔診療 등 도입(案 第21條의2 및 案 第30條의2)
마. 醫療機關 또는 醫療人이 營利를 목적으로 患者를 紹介·알선·誘引하거나 이를 使嗾하는 行爲를 法에 구체적으로 規定함(案 第25條第3項)
바. 藥局의 시설내 또는 구내인 경우 등 醫療機關의 開設을 制限할 수 있는 요건을 정함(案 第30條第8項)
사. 醫療의 질향상을 위한 醫療機關評價 및 病院感染管理의 法的 根據를 마련함(案 第4條의2, 第37條의3, 第47條의2, 第71條第1項第3號)
아. 醫療廣告의 規制를 완화하여 동일 診療科目內 醫療人의 숙련정도를 알려주는 經歷廣告 허용(案 第46條第3項)하는한편, 學歷·經歷의 虛僞廣告에 대한 벌칙규정마련(案 第67條)
자. 市·道知事 또는 市長·郡守·區廳長이 醫療機關의 集團休業時 발하던 業務開始命令의 범위에 정당한 이유없는 診療中斷이나 集團廢業을 포함하고, 保健福祉部長官이 직접 業務開始命令이 可能하도록 根據를 마련함.(案 第48條第2項)
차. 醫療機關 開設者는 病院經營의 透明性確保를 위해 노력하도록 하고 保健福祉部令이 정하는 일정규모이상 醫療機關에 대해서는 醫療機關會計指針을 준수토록 하는 등 醫療機關透明性確保方案 마련(第49條의2)
카. 醫療機關 개설자가 虛僞 또는 不當한 方法으로 診療費를 청구하여 禁錮 이상의 刑의 宣告나 100萬원이상의 罰金刑을 宣告받은 때는 醫療業을 停止 또는 開設許可를 取消할 수 있도록 함(案 第51條第1項第7號)
타. 醫療人이 虛僞 또는 不當한 방법으로 診療費를 청구하여 禁錮 이상의 刑의 宣告나 100萬원이상의 罰金刑을 宣告받은 때 免許를 取消하고 이 경우의 면허를 10년이내에는 재교부하지 못하도록 함(案 第52條第1項第7號)
파. 醫療人이 虛僞 또는 不當한 방법으로 診療費를 청구한 때에는 3년의 범위내에서 免許資格을 停止시킬 수 있도록 하고, 이 경우 醫療機關 開設者가 免許資格停止處分을 받은 때에는 당해 醫療機關은 醫療業을 할 수 없도록 함(案 第53條第1項第7號, 第4項)
하. 醫療機關의 醫療業停止處分에 갈음하여 賦課하는 課徵金의 한도액을 2億원으로 상향조정함(案 第53條의2)
新·舊條文對比表 別添
法律 第 號
醫療法中改正法律案
醫療法中 다음과 같이 改正한다.
第3條第3項第2號 및 第3號를 각각 다음과 같이 한다.
2. "內科·一般外科·小兒科·産婦人科·診斷放射線科·痲醉科, 臨床病理科 또는 解剖病理科, 精神科(大統領令이 정하는 규모이상의 病床을 가진 경우에 한한다) 및 齒科를 포함한 9개이상의 診療科目"을 "內科·一般外科·小兒科·産婦人科 중 2개 科目과 診斷放射線科·痲醉科, 臨床病理科 또는 解剖病理科을 포함한 9개이상의 필수 診療科目(綜合病院의 필수진료과목운영에 관하여 필요한 사항은 保健福祉部令으로 정한다)과 그외의 기타 診療科目"으로 한다.
3. “第2號의 規定에 의한 각 診療科目마다 필요한 專門醫”를 “第2號의 規定에 의한 필수 診療科目마다 전속 專門醫, 기타 診療科目은 전속 專門醫 또는 契約에 의한 專門醫”로 한다.
第4條의2를 다음과 같이 新設한다.
第4條의2 (醫療人 및 醫療機關長의 義務) 醫療人과 醫療機關의 長은 患者에게 최선의 의료서비스를 제공하고 病院感染을 예방하며, 의료서비스의 질 향상을 도모하여야 한다.
第8條第1項第5號중 “刑法第31條第1項, 保健犯罪團束에관한特別措置法”을 “刑法第317條第1項, 刑法第347條(虛僞로 診療費를 청구하여 환자나 국민건강보험공단을 기망한 경우에 한한다), 保健犯罪團束에관한特別措置法”으로 하고 “麻藥法·向精神性醫藥品管理法·大麻管理法·母子保健法”을 “麻藥類管理에관한法律·母子保健法·藥事法”으로 한다.
第16條第3項을 다음과 같이 신설한다.
③醫療機關의 開設者 또는 醫療人은 정당한 이유없이 患者의 診療를 中斷하거나 集團的으로 休業 또는 廢業을 하여서는 아니된다.
第16條의2를 다음과 같이 新設한다.
第16條의2(集團休·廢業 誘導禁止 등) 第26條의 規定에 의하여 設立된 中央會와 그 支部(“分會”를 포함한다) 및 醫療人은 이 法 또는 다른 法令에 특별히 規定된 경우를 제외하고는 醫療機關의 集團的인 休業 또는 廢業을 誘導하거나 診療拒否등과 관련된 團體行動을 하여서는 아니된다.
第18條의2第1項을 “醫療業에 從事하고 자신이 診察한 醫師 또는 齒科醫師는 患者에게 醫藥品을 투여할 필요가 있다고 인정하는 때에는 藥事法에 의하여 자신이 직접 醫藥品을 조제할 수 있는 경우를 제외하고는 保健福祉部令이 정하는 바에 의하여 종이 處方箋을 작성하여 患者에게 교부하거나 電子文書 형태의 處方箋을 患者 또는 患者가 원하는 약국으로 전송할 수 있다.”라고 하고, 제3항 또는 제4항을 다음과 같이 新設한다.
③ 第1項의 規定에 의한 電子文書 형태의 處方箋에 저장된 個人情報를 저장·취급하거나 취급하였던 자는 이를 통해 알게된 환자의 비밀을 漏泄하여서는 안되며 電子文書 형태의 處方箋을 閱覽시키거나 그 記錄 探知에 응하여서는 안된다.
④ 第1項의 規定에 의한 電子文書 형태의 處方箋을 취급하는 醫療機關, 醫療人, 醫療機關從事者 등은 個人情報가 紛失·盜難·漏出·變造 또는 毁損되지 아니하도록 安全性確保에 필요한 措置 등을 강구하여야 한다.
第21條의2를 다음과 같이 新設한다.
第21條의2 (電磁醫務記錄) ①醫療人은 第21條의 規定에 의한 診療記錄簿 등을 컴퓨터 등 전산기록장치에 의하여 작성한 醫務記錄(이하 “電子醫務記錄”이라 한다)을 보관할 수 있다.
②電子醫務記錄에는 電子署名法에 의한 電子署名이 기재되어 있어야 한다.
③醫療機關은 電子醫務記錄을 안전하게 관리 및 보관할 수 있도록 하기 위하여 필요한 시설을 설치하여야 한다.
④電子醫務記錄의 표준형식 및 電子醫務記錄 저장시스템의 안전관리 등 필요한 사항은 大統領令으로 정한다.
⑤醫療機關은 電子醫務記錄에 저장된 個人情報가 紛失·盜難·漏出·變造 또는 毁損되지 않도록 안전성확보에 필요한 보호조치 등을 강구하여야 한다.
⑥누구든지 부당한 방법으로 第5項의 規定에 의한 보호조치를 侵害하거나 毁損하여서는 아니된다.
第25條第3項을 "누구든지 營利를 目的으로 患者를 誘因하거나 이를 使嗾하기 위하여 다음 各號의 1에 해당하는 行爲를 하여서는 안된다. 다만 患者의 經濟的 事情 등 특정한 사정이 있어 관할 市長·郡守·區廳長의 事前承認을 득한 경우에는 그러하지 아니하다."로 하고, 各 號를 다음과 같이 新設한다.
1. 不特定多數人을 對象으로 本人負擔金을 免除 또는 割引하는 行爲
2. 不特定多數人을 運送하기 위한 交通便宜를 제공하는 行爲
3. 患者를 유치할 목적으로 金品 등을 제공하는 行爲
4. 無料診療를 媒介로 患者를 醫療機關에 내원하도록 誘導하는 行爲
5. 기타 營利를 目的으로 患者를 斡旋·紹介·誘引 또는 이를 使嗾하는 行爲로서 大統領令이 정하는 行爲
第30條第8項을 다음과 같이 新設한다.
⑧다음 各號의 1에 해당하는 경우에는 醫療機關을 開設할 수 없다.
1. 藥局의 시설내 또는 구내인 경우
2. 藥局의 施設 또는 부지의 일부를 分割·변경 또는 改修하여 醫療機關을 開設하는 경우
3. 醫療機關과 藥局간의 專用의 복도·계단·승강기 또는 구름다리 등의 통로가 설치되어 있거나 이를 설치하는 경우
第30條의2를 다음과 같이 新設한다.
第30條의2 (遠隔醫療) ①서로 떨어져있는 참여자 사이에서 情報通信技術을 활용하여 醫療를 제공하거나 支援(이하 “遠隔醫療”라 한다)하기 위해 필요한 施設과 裝備를 갖춘 醫療機關에 한하여 다음 各號의 1에 해당하는 경우에 遠隔醫療를 행할 수 있다. 遠隔醫療를 위해 필요한 施設과 裝備에 관한 사항은 保健福祉部令으로 정한다.
1. 醫療機關간 및 醫療人간(醫療業에 종사하는 醫師, 齒科醫師, 韓醫師에 한한다)의 遠隔諮問
2. 醫療人이 特定疾患 患者에 대해 1회이상 對面診療를 실시한 경우로서 初診을 한 醫療人에 한하여 일정기일이내에 동일 상병에 대해 遠隔醫療가 患者의 利益에 부합한다고 인정할 만한 상당한 이유가 있는 경우
②第1項第2號의 規定에 의한 遠隔診療시 특정질환의 범위 및 진료기일 등에 관한 사항은 保健福祉部令으로 정한다.
③第1項第2號의 規定에 의한 遠隔醫療를 실시하는 경우 醫療人은 電磁書名法에 따라 전자서명이 기재된 전자문서형태의 處方箋(이하 "電磁處方箋"이라 한다)을 患者의 요구가 있는 경우에 患者가 지정하는 藥局으로 전송할 수 있다.
④第3項의 規定에 의한 電子處方箋에 의해 醫藥品을 조제할 경우 약국개설자는 患者, 그 配偶者, 그 直系尊卑屬 또는 配偶者의 直系尊屬(配偶者·直系尊卑屬 및 配偶者의 直系尊屬이 없는 경우에는 患者가 지정하는 代理人) 여부를 확인하여야 한다.
⑤遠隔醫療를 시행하는 者는 患者에 대하여 對面醫療에서 발생하는 책임과 동일한 책임을 진다.
⑥患者를 직접 대면하여 診療하는 醫師(이하 "現地醫師"라 한다)가 遠隔諮問에 의해 醫療行爲를 한 경우 遠隔地 醫師의 과실을 인정할 만한 명백한 근거가 없는 한 患者에 대한 責任은 現地醫師에게 있다.
第32條의2第1項·第2項·第3項중 “診斷用放射線發生裝置”를 “醫療用放射線裝置”로 한다.
第32條의3第3項을 다음과 같이 新設한다.
③醫療人이 다른 醫療機關의 施設·裝備 및 人力 등을 이용하여 診療한 경우 그 醫療機關의 施設·裝備 및 人力 등의 과실을 인정할 만한 명백한 근거가 없는 한 患者에 대한 責任은 診療한 醫療人에게 있다.
第37條의3를 다음과 같이 新設한다.
第37條의3 (病院感染의 豫防) ①保健福祉部令이 정하는 일정규모 이상의 醫療機關의 長은 病院感染業務 擔當部署의 設置, 感染豫防擔當要員의 指定, 醫療機關內의 感染對策委員會의 設置·運營 등 病院感染豫防을 위하여 필요한 措置를 하여야 한다.
②第1項의 規定에 의한 病院感染業務 擔當部署 設置, 擔當要員의 資格 및 業務內容, 感染對策委員會의 構成·運營 등 필요한 사항은 保健福祉部令으로 정한다.
第46條第3項중 "누구든지 特定醫療機關이나 特定醫療人의 技能·診療方法·助産方法이나 經歷 또는 藥效등에 關하여"를 "누구든지 特定醫療機關이나 特定醫療人의 技能·診療方法·助産方法이나 藥效등에 關하여"로 한다.
第47條의2를 다음과 같이 新設한다.
第47條의2 (醫療機關評價) ①保健福祉部長官은 醫療의 질향상을 촉진하기 위하여 大統領令이 정하는 바에 따라 醫療機關에 대한 評價(이하 “醫療機關評價”라 한다)를 실시하여야 한다.
②保健福祉部長官은 第1項의 規定에 의한 醫療機關評價를 大統領令으로 정하는 關係專門機關 또는 團體로 하여금 실시하게 할 수 있다.
③保健福祉部長官은 第2項의 規定에 의하여 關係專門機關 또는 團體로 하여금 醫療機關評價를 실시하게 한때에는 필요한 豫算을 支援할 수 있다.
④保健福祉部長官은 第1項의 規定에 의한 醫療機關評價의 結果를 公表하여야 한다.
⑤保健福祉部長官은 第1項의 規定에 의한 醫療機關評價의 結果가 우수한 醫療機關에 대하여 行政的·財政的 支援을 할 수 있다.
⑥評價對象 醫療機關의 長은 특별한 사유가 있는 경우를 제외하고는 第1項의 規定에 의한 醫療機關評價에 응하여야 한다.
⑦第1項의 規定에 의한 醫療機關評價의 時期, 範圍 및 節次와 第4項의 規定에 의한 公表 등에 관하여 필요한 사항은 保健福祉部令으로 정한다.
第48條第2項을 다음과 같이 한다.
②保健福祉部長官, 市·道知事 또는 市長·郡守·區廳長은 醫療機關의 開設者 또는 醫療人이 정당한 이유없이 診療를 中斷하거나 集團休業 또는 集團廢業으로 患者診療에 막대한 지장이 발생하거나 발생할 우려가 있다고 인정할 만한 상당한 이유가 있는 때에는 당해 醫療機關의 開設者 또는 醫療人에 대하여 業務開始命令을 할 수 있다.
第49條의2를 다음과 같이 新設한다.
第49條의2 (醫療機關의 運營등) ①醫療機關의 開設者는 醫療機關의 운영에 있어 經營의 透明性을 확보하도록 노력하여야 한다.
②保健福祉部令으로 정하는 일정규모이상의 醫療機關은 第1項의 規定에 의한 經營의 透明性 確保를 위하여 醫療機關會計指針을 遵守하여야 한다.
③第2項의 醫療機關會計指針은 保健福祉部令으로 정한다.
第50條중 “第34條 내지 第37條의2의 規定”을 “第34條 내지 第37條의2, 第49條의2第2項의 規定”으로 한다.
第51條第1項第7號를 다음과 같이 新設한다.
7. 醫療機關 開設者가 虛僞 또는 不當한 방법으로 診療費를 청구하여 禁錮 이상의 刑의 宣告나 100萬원이상의 罰金刑을 宣告받은 때
第52條第1項 단서조항 중 “다만, 第1號의 경우”를 “다만, 第1號 또는 第7號의 경우”로 하고 第7號를 다음과 같이 新設한다.
7. 虛僞 또는 不當한 방법으로 診療費를 청구하여 禁錮 이상의 刑의 宣告나 100萬원이상의 罰金刑을 宣告받은 때
第52條第2項중 “1年이내, 第1項第3號 또는 第5號의 規定에 의하여 免許가 取消된 경우와 第8條第1項第5號의 規定에 의한 사유로 免許가 取消된 경우에는 그 取消된 날부터 2年이내에는 再交付하지 못한다.”를 “3年이내, 第1項第3號 또는 第5號의 規定에 의하여 免許가 取消된 경우와 第8條第1項第5號의 規定에 의한 사유로 免許가 取消된 경우에는 그 取消된 날부터 5年이내에는 再交付하지 못하고, 第7號의 規定에 의하여 免許가 取消된 경우에는 10년이내에는 再交付하지 못한다.”로 한다.
第53條第1項중 “1年의 범위내에서”를 “3年의 범위내에서”로 하고, 第1項第7號 및 第4項을 다음과 같이 新設한다.
7. 虛僞 또는 不當한 방법으로 診療費를 청구한 때
④ 醫療機關 開設者가 第1項第7號의 規定에 의한 資格停止處分을 받은 때에는 그 資格停止期間중 당해 醫療機關은 醫療業을 할 수 없다.
第53條의2중 “醫療業停止處分에 갈음하여 2千萬원이하의 課徵金을 賦課할 수 있다. 이 경우 課徵金의 賦課는 醫療業停止處分이 國民保健에 큰 危害를 가져오거나 가져올 우려가 있는 때에 한하며, 3回를 초과하여 賦課할 수 없다.”를 “醫療業停止處分에 갈음하여 2億원이하의 課徵金을 賦課할 수 있다. 이 경우 課徵金은 3回를 초과하여 賦課할 수 없다.”로 한다.
第63條의3第1項중 “診斷用放射線發生裝置”를 “醫療用放射線裝置”로 한다.
第66條第3號중 “第12條第2項, 第25條第1項, 第30條第2項(第61條第3項에서 準用하는 경우를 포함한다)의 規定”을 “第12條第2項, 第18條의2第3項·第4項, 第21條의2第5項·第6項, 第25條第1項, 第30條第2項(第61條第3項에서 準用하는 경우를 포함한다)의 規定”으로 한다.
第67條중 “第19條, 第19條의2, 第20條第1項, 第25條第3項, 第30條第4項, 第31條第1項 但書, 第48條第3項, 第54條第3項의 規定”을 “第16條第3項, 第16條의2, 第19條, 第19條의2, 第20條第1項, 第25條第3項, 第30條第4項, 第31條第1項 但書, 第46條, 第47條, 第48條第3項, 第54條第3項의 規定”으로 한다.
第68條중 “第16條第1項, 第18條第1項·第2項(第1項 但書 後段 및 第2項 但書의 規定을 제외한다)의 規定”을 “第16條第1項, 第18條第1項·第2項(第1項 但書 後段 및 第2項 但書의 規定을 제외한다), 제18조의2第1項의 規定”으로 한다.
第69條중 “第41條第3項·第4項, 第46條, 第47條, 第51條第2項”을 “第41條第3項·第4項, 第51條第2項”으로 한다.
第71條第1項第1號중 “診斷用放射線發生裝置”를 “醫療用放射線裝置”로 하고, 第3號, 第4號, 第5號를 각각 다음과 같이 新設한다.
3. 第37條의3의 規定에 違反하여 病院感染豫防에 필요한 措置를 취하지 아니한 者
4. 第47條의2第6項의 規定에 違反하여 醫療機關評價에 응하지 아니한 者
5. 第49條의2第2項의 規定에 違反하여 醫療機關會計指針을 遵守하지 않은 醫療機關 開設者
附 則
第1條 (施行日) 이 法은 公布후 6月이 경과한 날부터 施行한다. 다만, 第51條第1項第7號, 第52條第1項第7號 및 第2項, 第53條第1項第7號 및 第4項의 改正規定은 公布한 날부터 施行하고, 第21條의2, 第30條의2 改正規定은 公布후 2年이 경과한 날부터 施行한다.
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