Experience and laws related to medical corporations, nursing homes, pharmacies, etc.
当事務所に所属する弁護士は、顧問弁護士として、東京、大阪、名古屋、横浜、福岡、北海道等の医療法人、病院、薬局、ドラッグストア、介護施設等の支援経験を有しており、実務や現場の課題にも精通しております。医療・介護分野では多くの法律や規制があり、それぞれの施設運営や事業実施に関して遵守すべき法的枠組みが存在します。以下では、医療法人、介護施設、薬局等に関連する主要な法律についても研鑽を積んており主な法律分野は以下の通りです。また、普段の業務に限らず、デジタルサービスとこれら医療系事業者の連携にも経験値を有しており、医療分野のDXの対応も可能です。また、これらヘルスケア産業の企業の事業承継やM＆A等にも実績を有しております。
1. laws concerning medical corporations
1.1 Medical Law
The Medical Care Act is the basic law concerning medical facilities, and it stipulates the establishment of hospitals and clinics, facility standards, and the medical corporation system.
Main Regulations:
- Regulations concerning permission to establish a hospital or clinic
- Regulations concerning the establishment and operation of medical corporations
- Ensure medical care delivery system
- Medical Advertisement Regulations
- Provisions of the non-profit principle (medical corporations must not operate for profit)
A medical corporation is established based on the authorization principle (a system whereby a medical corporation is authorized by the competent authorities after fulfilling the requirements stipulated by law). The establishment and operation of a medical institution requires the permission of the prefectural governor or other competent authorities. Ministry of Health, Labor and Welfare
1.2 Medical, Dental, and Other Qualification Laws
The law regulates the qualifications and scope of work regarding health care providers.
Main Content:
- Qualification requirements for physicians, dentists, nurses, etc.
- Scope of Services
- Obligations of physicians, etc. (obligation to respond to invitations, obligation to examine and treat patients, etc.)
- Regulations on Medical Practice
これらの法律は医療従事者の質を確保し、適切な医療サービスの提供を目的としています。また、当事務所では、多くのヘルスケアITｽﾀｰﾄｱｯﾌﾟの支援をしているため、逆に医療法人がこのようなサービスとどう向き合うかについて経験値を有しております。デジタルヘルスのサービスを医療情報システムの安全管理に関するガイドラインにも準拠する形でどのように対応するかについてもごそうだだけま
す。
2. laws concerning long-term care facilities
2.1 Long-Term Care Insurance Law
The law is the foundation of the long-term care insurance system and regulates the system related to long-term care services for the elderly.
Main Content:
- Structure of the long-term care insurance system (insured persons, premiums, benefits, etc.)
- Designation and supervision of care service providers
- Provisions for long-term care facilities (long-term care welfare facilities for the elderly, long-term care health facilities for the elderly, etc.)
- Types and Contents of Services
Article 94, paragraph 1 of the Long-Term Care Insurance Act stipulates that "a person who intends to open a long-term care health facility for the elderly must obtain a license from the prefectural governor pursuant to an Ordinance of the Ministry of Health, Labor and Welfare. In order to operate a long-term care facility, a license from the local government is mandatory. Long-Term Care Insurance Law
2.2 Welfare Law for the Elderly
It is a basic law concerning the welfare of the elderly and is closely related to the Long-Term Care Insurance Law.
Main Content:
- Provisions for welfare facilities for the elderly (e.g., special nursing homes for the elderly)
- Regulations regarding fee-based nursing homes
- Elder Abuse Prevention
- (Provisions Concerning In-Home Living Assistance Services for the Elderly)
The Elderly Welfare Law stipulates that the establisher of a fee-based home for the elderly must not receive "rights money or other money or goods" from residents. In addition, notification to the prefectural governor is required for the commencement, change, discontinuation, or suspension of the business. Welfare Law for the Elderly
3. laws concerning pharmacies
3.1 Law Concerning Assurance of Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Law)
Renamed from the former Pharmaceutical Affairs Law, this law regulates the manufacture, sale, and use of pharmaceuticals and medical devices.
Main Content:
- Permit system for opening a pharmacy
- Manufacturing and marketing approval system for pharmaceuticals, etc.
- Classification and Regulation of Sales of Drugs, etc.
- advertising regulations
- Legal compliance system for pharmacy operators, etc.
薬局を開設するためには、その所在地の都道府県知事の許可を受けなければなりません（薬機法第4条第1項）。また、薬局開設者は薬局の管理に関する業務を適正に遂行し、薬事に関する法令の規定遵守を確保するための体制整備が義務付けられています。厚生労働省。こういった規制を配慮した上でドラッグストアや薬局の新しい戦略立案や、サービスの創出のための法的問題の課題についても対応しております。
3.2 Pharmacy Law
The law defines the qualifications and scope of work of pharmacists.
Main Content:
- Licensure of pharmacists
- Duties and obligations of dispensing
- Code of Ethics for Pharmacists
- Duties of pharmacists (e.g., guidance based on pharmacological knowledge)
In accordance with the Pharmacists Act, pharmacists are obligated to dispense drugs according to prescriptions and provide medication guidance based on pharmacological knowledge.
4. laws concerning rehabilitation facilities
4.1 Physical and Occupational Therapist Act
It defines the qualifications and scope of practice of physical and occupational therapists in the rehabilitation profession.
Main Content:
- Definition of Physical and Occupational Therapist
- Qualification Requirements and Licenses
- Scope of Services
- Restrictions on the use of names
The purpose of this law is to contribute to the dissemination and improvement of medical care by establishing qualifications for physical therapists and occupational therapists and disciplining them to ensure that their work is properly administered. Physical Therapist and Occupational Therapist Act
4.2 Standards for Outpatient Rehabilitation Facilities
These are facility standards related to day rehabilitation (day care) based on the Long-Term Care Insurance Law.
Main requirements:
- Dedicated functional training rooms (30 square meters or more for hospitals and 20 square meters or more for clinics)
- Installation of specialized equipment and instruments
- Staffing with qualified personnel
- Establishment of operational management system
In order to provide daytime rehabilitation services, it is necessary to meet the standards for personnel, facilities, and operation stipulated by prefectural or other government ordinances, and to receive designation as a business facility from the prefectural or other government. Ministry of Health, Labour and Welfare
5. laws concerning diagnostic imaging equipment
5.1 Law Concerning Assurance of Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Law)
The purpose of this law is to ensure the quality, effectiveness and safety of medical devices (including diagnostic imaging devices).
Main Content:
- Marketing Authorization System for Medical Devices
- Classification and Regulation of Medical Devices
- Manufacturing and marketing license system
- Post-market safety measures
This law defines "medical device" as "a machine, appliance, etc. intended to be used for the diagnosis, treatment or prevention of human or animal diseases, or to affect the structure or function of the human or animal body. Pharmaceuticals and Medical Devices Act
5.2 Radiologic Technologist Law
This is a professional qualification law for the handling of diagnostic equipment using radiation.
Main Content:
- Definition and Scope of Work of Radiologic Technologists
- license system
- Obligations and Prohibitions
- Restrictions on the use of names
The purpose of this law is to establish the qualifications of medical radiology technologists, to discipline them so that their work is properly operated, and to contribute to the promotion and improvement of medical care and public health. Act on Medical Radiation Technologists
6. laws related to the medical insurance system
6.1 Health Insurance Law
The law, which is the basis of employee insurance, regulates the medical insurance system for salaried workers and their families.
Main Content:
- insured status
- Insurance Benefits
- Designation of insurance medical institutions and insurance pharmacies
- payment (system) for medical services
6.2 National Health Insurance Law
The law, which is the cornerstone of community insurance, regulates the medical insurance system for the self-employed and unemployed.
Main Content:
- insured status
- Insurance Benefits
- Operation of National Health Insurance
- fiscal adjustment monies
7. other related laws and regulations
7.1 Livelihood Protection Law
The law includes provisions for medical assistance to the economically needy.
7.2 Infectious Diseases Control Law (Law Concerning Prevention of Infectious Diseases and Medical Care for Patients with Infections)
The law on infectious disease control also defines the role of medical institutions.
7.3 Personal Data Protection Law
医療・介護分野の個人情報管理に関する規定を含む法律です。医療分関連事業者の取り扱うデータに関し、その１時利用と2次利用の側面は分けて考えなければなりません。どのような目的でどのような利活用をするのか。そして要配慮個人情報である以上、非常に慎重な取り扱いと患者さんにも理解される取り扱いを心掛けなければいけません。
summary
A wide variety of laws and regulations are involved in the operation of medical corporations, nursing homes, pharmacies, etc. These legal frameworks are designed to
- Ensuring the health and safety of the public: Ensuring the provision of appropriate medical and nursing care services
- Ensure quality of professionals: clarify qualifications and responsibilities of physicians, pharmacists, etc.
- Ensure safety of facilities and equipment: Set appropriate facility standards and equipment requirements
- Guaranteeing equitable access: Ensuring equitable access to medical and long-term care services
- Ensuring proper operations: Ensuring proper operations that are not profit-oriented
Understanding and complying with these laws is a fundamental social responsibility for medical and long-term care providers and the foundation for sustainable business operations. In addition, laws are frequently revised, so it is important to always collect and respond to the latest information on laws and regulations.