Medical Law - Iryohho

This law, Act No. 205 of 1948, stipulates the establishment and management of hospitals, clinics, and midwifery clinics, the maintenance and management systems of these medical facilities, medical plans established by prefectures, regulations regarding medical corporations, the provision of medical information, penalties, etc., and forms the core of Japan's medical system.

After the Medical Care Act was enacted in 1948, its operation and development had been left to the voluntary actions of the Japan Medical Association and other organizations, but the issue of amending the Medical Care Act, including strengthening the supervision of medical corporations, became an issue following incidents such as the indiscriminate diagnosis and treatment incident at a maternity hospital in Saitama Prefecture in 1980. The Medical Care Act was amended in 1985 to establish guidance and supervision regulations for medical corporations, and to respond to changes in disease patterns and rising medical costs due to the aging of the population, regional medical plans were formulated by prefectures.

The second amendment to the Medical Care Act was made in 1992 (Heisei 4), and in order to clarify the functional classification of medical facilities, it created designated function hospitals (hospitals that provide advanced medical care. These hospitals meet the requirements such as the number of hospital beds, the contents of the facilities, the qualifications of doctors, the number of doctors and nurses, etc., and medical fees are set higher than at general hospitals) and long-term care bed groups (medical facilities for long-term medical patients, where emphasis is placed on living conditions and the quality of care. In the fourth amendment, they were renamed long-term care beds. They are classified into medical insurance type and long-term care insurance type), and advertising regulations were relaxed. In the third amendment in 1997, from the viewpoint of securing and promoting cooperation in regional medical care, the long-term care bed group was expanded to include clinics, and regional medical support hospitals were created. In the fourth amendment in 2000 (Heisei 12), in order to provide appropriate medical care that corresponds to the advancement of medical technology and the needs of the people, the classification of general hospital beds and long-term care beds was made, the medical safety management system was made mandatory for clinics with beds, and clinical training for doctors was made compulsory. The fifth amendment in 2006 was a comprehensive review from the patient's perspective, and in order to ensure a high-quality medical system in response to the declining birthrate and aging population, it promoted the provision of medical information to patients, provided seamless medical care by promoting differentiation of medical functions and mutual cooperation, ensured quality of life (QOL), ensured medical safety, and revised regulations for clinics with beds. In addition, the establishment of new medical corporations was limited to "medical corporations without equity" only, and a transitional plan certification system was established for existing "medical corporations with equity" as a transitional measure, with a deadline of the end of September 2017. Equity is the right of employees who are investors to receive distributions from the corporation's assets in proportion to their share of the equity.

The sixth revision in 2014 aimed to realize comprehensive community care, and a transition from a hospital-based model to a community-based model led by prefectures was planned. Specifically, the pillars of the reform include formulating a regional medical vision by introducing a bed function reporting system by medical institutions to classify the functions of hospital beds and promote mutual cooperation, promoting home medical care, promoting the division of roles among medical professionals and team medical care, securing doctors and nurses and improving their working environment, establishing a medical accident investigation system, promoting clinical research, and reviewing the medical corporation system.

The seventh amendment in 2016 created the Regional Medical Cooperation Promotion Corporation System and revised the medical corporation system. The former stipulates a policy (Medical Cooperation Promotion Policy) to promote collaboration among multiple hospitals (medical corporations, etc.) that provide medical care in the region, creates general incorporated associations (Regional Medical Cooperation Promotion Corporations) with the purpose of training medical professionals, supplying pharmaceuticals, lending funds, and carrying out other operations (Medical Cooperation Promotion Operations), and adjusts the number of hospital beds to meet medical demand in the regional medical plan. With regard to the latter, measures were implemented to ensure the transparency of medical corporation management and strengthen governance, establish rules regarding the division of medical corporations (excluding social medical corporations, specified medical corporations, and medical corporations with equity interests), and regulate the certification of social medical corporations (in the case of a medical corporation that has opened hospitals and clinics in two or more prefectures and provides medical care in an integrated manner, certification can be obtained only from the governor of the prefecture where the main office of the said medical corporation is located, rather than from the governors of all of the prefectures. Medical corporations that have had their certification as social medical corporations revoked and meet certain requirements can continue their revenue-generating operations if they create a continuation implementation plan for projects related to ensuring emergency medical care, etc., and receive approval from the prefectural governor).

The eighth amendment in 2017 strengthened regulations on medical advertising (see "Medical Advertising" for details), relaxed the requirements for the transition plan certification system to non-equity medical corporations, established supervision regulations for medical institution operators, and created regulations for quality and accuracy control of specimen testing. The fifth amendment did not promote the transition from equity medical corporations to equity-free medical corporations, and nearly 80% have not made the transition. One of the reasons for the lack of progress in transition is the risk of high inheritance and gift taxes being imposed if they transition to equity-free medical corporations. Therefore, the eighth amendment transferred the tax standards that were previously determined by the tax office to the Ministry of Health, Labor and Welfare, and medical corporations that received this certification were exempt from the application of Article 66, Paragraph 4 of the Inheritance Tax Act. In addition, the certification requirements were relaxed, the non-family standard requirement was abolished, and the deadline for the transition plan certification system was extended by three years. Regarding supervision regulations, the current law has provisions for on-site inspections and revocation of opening licenses for medical institutions established by medical corporations, but these regulations do not extend to the operation of medical institutions other than medical corporations, and supervision has been inadequate. Therefore, the revised law will establish supervision regulations similar to those for medical corporations for hospital operators other than medical corporations, such as general incorporated associations and general incorporated foundations. Regarding specimen testing, the law provides the basis for the establishment of standards for quality and accuracy testing for specimen testing conducted by medical institutions themselves.

[Takeshi Tsuchida February 18, 2019]

"Key Points of the Sixth Amendment to the Medical Care Act and 60 Response Strategies" by Koichi Kawabuchi (2014, Japan Medical Planning)" ▽ "Basic Medical Care Six Laws Compilation Committee, ed., "Basic Medical Care Six Laws," Annual Edition (Chuohoki Publishing)"

Source: Shogakukan Encyclopedia Nipponica About Encyclopedia Nipponica Information | Legend

病院・診療所・助産所の開設および管理、それらの医療施設の整備や管理体制、都道府県の定める医療計画、医療法人に関する規定、医療に関する情報提供、罰則などについて定めた法律で、日本の医事制度の中核をなしている。昭和23年法律第205号。

　医療法は、1948年（昭和23）に制定された後、その運用・整備は日本医師会等による自発的な対応にゆだねられてきたが、1980年におきた埼玉県の産婦人科病院での乱診乱療事件等を契機に医療法人の監督強化などの医療法改正が課題となった。1985年に医療法が改正され、医療法人の指導監督規定の整備に加えて、人口高齢化に伴う疾病構造の変化や医療費の増大に対応して、都道府県による地域医療計画の策定が行われた。

　1992年（平成4）に第二次医療法改正が行われ、医療施設の機能区分を明確化するために、特定機能病院（高度の医療を提供する病院。病床数、施設内容、医師の資格、医師・看護師等の配置数などの要件を満たした病院で、診療報酬が一般病院よりも高く設定されている）と療養型病床群（長期療養者を対象とする医療施設で、居住性と介護の質が重視される。第四次改正で療養病床と改称。医療保険型と介護保険型に区分されている）の創設、広告規制の緩和等が図られた。1997年の第三次改正では、地域医療の確保と連携を進める観点から、療養型病床群の診療所への拡大、地域医療支援病院の創設などが行われた。2000年（平成12）の第四次改正では、医療技術の進歩と国民のニーズに対応した適切な医療を提供するため、一般病床と療養病床の区分、有床診療所等への医療安全管理体制の義務化、医師の臨床研修必修化などが行われた。2006年の第五次改正では、患者の視点から全体的見直しが図られ、少子高齢化に対応した質の高い医療体制を確保するために、患者への医療情報提供の推進、医療機能の分化と相互の連携の推進による切れ目のない医療提供、クオリティ・オブ・ライフ（QOL）の確保、医療安全の確保、有床診療所への規制の見直しが行われた。また新規医療法人の設立を「出資持分なし医療法人」のみに限定し、既存の「出資持分あり医療法人」については経過措置として2017年9月末を期限とする移行計画認定制度が設けられた。出資持分とは、出資者たる社員が法人財産から持分割合に応じた分配を受けられる権利のことである。

　2014年の第六次改正では、地域包括ケアの実現に向けて都道府県主導による病院完結型から地域完結型への移行が図られることになった。具体的には、病床の機能区分と相互の連携に向けて医療機関による病床機能報告制度を導入して地域医療構想を策定することを柱に、在宅医療の推進、医療従事者間の役割分担とチーム医療の推進、医師・看護職員の確保と勤務環境の改善、医療事故調査制度の整備、臨床研究の推進、医療法人制度の見直しを行うことなどがあげられる。

　2016年の第七次改正では、地域医療連携推進法人制度の創設と、医療法人制度の見直しが行われた。前者は、地域の医療を提供する複数の病院（医療法人等）に係る業務の連携を推進するための方針（医療連携推進方針）を定め、医療従事者の研修、医薬品等の供給、資金の貸付その他の業務（医療連携推進業務）を行うことを目的とする一般社団法人（地域医療連携推進法人）を創設し、地域医療構想における医療需要に適合する病床数等を調整することとしたものである。また後者については、医療法人の経営の透明化の確保とガバナンスの強化、医療法人（社会医療法人、特定医療法人、出資持分あり医療法人を除く）の分割に関する規定の整備、社会医療法人の認定に関する規制（2か所以上の都道府県で病院および診療所を開設し、医療の提供を一体的に行っている場合には、すべての都道府県知事ではなく当該医療法人の主たる事務所の所在地の都道府県知事だけで認定可能とする。社会医療法人の認定を取り消された医療法人で一定要件に該当するものは、救急医療確保事業に係る事業等の継続的な実施計画を作成し、都道府県知事の認可を受けたときは収益業務の継続を可能とする）が行われた。

　2017年の第八次改正では、医療に関する広告規制の強化（詳細は「医療広告」参照）、出資持分なし医療法人への移行計画認定制度の要件緩和、医療機関開設者に関する監督規定の整備、検体検査の品質・精度管理に関する規定の創設が行われた。第五次改正による出資持分あり医療法人から出資持分なし医療法人への移行促進は進展せず、8割近くが移行していない。移行が進まない原因として、出資持分なし医療法人に移行した場合に高額な相続税および贈与税が課せられるおそれのあることがあげられる。そこで第八次改正では、税務署が判断していた課税基準を厚生労働省に移管し、その認定を受けた医療法人については相続税法第66条第4項の適用を排除することとした。また認定要件が緩和され、非同族基準要件なども撤廃され、移行計画認定制度の期限も3年延長された。監督規定については、現行法では医療法人が開設している医療機関には立入検査や開設許可取消などに関する規定はあるが、医療法人以外の医療機関の運営に対しては規制が及ばず、監督が行き届かないことがあった。そこで改正法では一般社団法人、一般財団法人など医療法人以外の病院開設者に対しても、医療法人と同様の監督規定を設けることにしたものである。検体検査については、医療機関が自ら行う検体検査について、品質・精度検査に係る基準を定めるために必要な根拠規定を行ったものである。

［土田武史　2019年2月18日］

『川渕孝一著『第六次医療法改正のポイントと対応戦略60』（2014・日本医療企画）』▽『基本医療六法編纂委員会編『基本医療六法』各年版（中央法規出版）』

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