医療分野の研究開発に資するための匿名加工医療情報に関する法律施行令
Order for Enforcement of the Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field
平成三十年五月七日政令第百六十三号
Cabinet Order No. 163 of May 7, 2018
内閣は、医療分野の研究開発に資するための匿名加工医療情報に関する法律(平成二十九年法律第二十八号)第二条第一項、第四項及び第五項、第八条第三項第一号イ及びハ(3)(これらの規定を同法第二十九条において準用する場合を含む。)、第十六条第三項(同法第二十九条において準用する場合を含む。)並びに第三十条第一項の規定に基づき、この政令を制定する。
The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraphs (1), (4), and (5), Article 8, paragraph (3), item (i), (a) and (c), 3. (including as these provisions are applied mutatis mutandis pursuant to Article 29), Article 16, paragraph (3) (including as applied mutatis mutandis pursuant to Article 29), and Article 30, paragraph (1) of the Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (Act No. 28 of 2017).
(医療情報)
(Medical Information)
第一条 医療分野の研究開発に資するための匿名加工医療情報に関する法律(以下「法」という。)第二条第一項の政令で定める記述等は、次に掲げるものとする。
Article 1 The descriptions and accounts specified by Cabinet Order that are referred to in Article 2, paragraph (1) of the Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (hereinafter referred to as the "Act") mean the following:
一 特定の個人の病歴
(i) the medical history of a specific individual;
二 次に掲げる事項のいずれかを内容とする記述等(前号に該当するものを除く。)
(ii) a description or account containing any of the following information (other than a description or account also falling under the preceding item):
イ 身体障害、知的障害、精神障害(発達障害を含む。)その他の主務省令で定める心身の機能の障害があること。
(a) the fact that the person in question has a physical disability, intellectual disability, mental disability (inclusive of developmental disabilities), or other impairment of physical or mental function specified by Order of the competent ministries;
ロ 特定の個人に対して医師その他医療に関連する職務に従事する者(ハにおいて「医師等」という。)により行われた疾病の予防及び早期発見のための健康診断その他の検査(ハにおいて「健康診断等」という。)の結果
(b) the results of a medical check-up or other examination (referred to as a "medical check-up or examination" in (c)) for the prevention and early detection of diseases that has been conducted on a specific individual by a medical doctor or other person engaged in duties relevant to medicine (referred to as a "doctor or other medical professional" in (c)); and
ハ 健康診断等の結果に基づき、又は疾病、負傷その他の心身の変化を理由として、特定の個人に対して医師等により心身の状態の改善のための指導又は診療若しくは調剤が行われたこと。
(c) the fact that, based on the results of a medical check-up or examination or due to a disease, injury, or other mental or physical change, a specific individual has been provided with guidance that is meant to improve the individual's mental or physical condition, or with medical care or a prescription, by a doctor or other medical professional.
(匿名加工医療情報データベース等)
(Databases and Similar Collections of Anonymized Medical Data)
第二条 法第二条第四項の政令で定めるものは、これに含まれる匿名加工医療情報を一定の規則に従って整理することにより特定の匿名加工医療情報を容易に検索することができるように体系的に構成した情報の集合物であって、目次、索引その他検索を容易にするためのものを有するものをいう。
Article 2 That which is specified by Cabinet Order as referred to in Article 2, paragraph (4) of the Act means a collection of information that has been systematically organized by arranging anonymized medical data contained in that collection according to established rules that enable a person to readily search for specific anonymized medical data, and that has a table of contents, index, or the like to facilitate searches.
(医療情報データベース等)
(Databases and Similar Collections of Medical Information)
第三条 法第二条第五項の政令で定めるものは、これに含まれる医療情報を一定の規則に従って整理することにより特定の医療情報を容易に検索することができるように体系的に構成した情報の集合物であって、目次、索引その他検索を容易にするためのものを有するものをいう。
Article 3 (1) That which is specified by Cabinet Order as referred to in Article 2, paragraph (5) of the Act means a collection of information that has been systematically organized by arranging medical information contained in that collection according to established rules that enable a person to readily search for specific medical information, and that has a table of contents, index, or the like to facilitate searches.
(法第八条第三項第一号イ及びハ(3)の政令で定める法律)
(Acts Specified by Cabinet Order That Are Referred to in Article 8, Paragraph (3), Item (i), (a) and (c), 3. of the Act)
第四条 法第八条第三項第一号イ及びハ(3)(これらの規定を法第二十九条において準用する場合を含む。)の政令で定める法律は、次のとおりとする。
Article 4 The Acts specified by Cabinet Order that are referred to in Article 8, paragraph (3), item (i), (a) and (c), 3. of the Act (including as applied mutatis mutandis pursuant to Article 29 of the Act) are as follows:
一 個人情報の保護に関する法律(平成十五年法律第五十七号)
(i) the Act on the Protection of Personal Information (Act No. 57 of 2003);
(iii) the Act on the Protection of Personal Information Held by Incorporated Administrative Agencies (Act No. 59 of 2003); and
(外国取扱者の事務所等における検査に要する費用の負担)
(Bearing of Costs Required to Undertake Inspections at the Offices of Foreign Handlers)
第五条 法第十六条第三項(法第二十九条において準用する場合を含む。)の政令で定める費用は、法第十六条第一項第三号(法第二十九条において準用する場合を含む。)の規定による検査のため同号の職員がその検査に係る事務所その他の事業所(外国にあるものに限る。)の所在地に出張をするのに要する旅費の額に相当するものとする。この場合において、その旅費の額の計算に関し必要な細目は、主務省令で定める。
Article 5 The costs specified by Cabinet Order that are referred to in Article 16, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to Article 29 of the Act) are those constituting the amount of travel expenses needed in order for the officials referred to in Article 16, paragraph (1), item (iii) of the Act (including as applied mutatis mutandis pursuant to Article 29 of the Act) to take a business trip to the locality of an office or other place of business subject to inspection under that item (limited to one that is located in a foreign state) for the purpose of that inspection. In such a case, Order of the competent ministries provides for the necessary details regarding the calculation of the amount of those travel expenses.
(遺族の範囲)
(Scope of Surviving Family)
第六条 法第三十条第一項の政令で定める者は、死亡した本人の配偶者(婚姻の届出をしていないが、事実上婚姻関係と同様の事情にあった者を含む。)、子、父母、孫、祖父母及び兄弟姉妹とする。
Article 6 The persons specified by Cabinet Order that are referred to in Article 30, paragraph (1) of the Act mean the deceased principal's spouse (inclusive of a person whose involvement with the deceased principal was the same as a marital relationship for all practical purposes, even though no marriage had been registered), children, parents, grandchildren, grandparents, and siblings.