Navigate Japan’s Regulations. Accelerate Healthcare.

Okuizumi Administrative Legal Office supports a broad range of matters arising at the intersection of healthcare and public systems—from regulatory strategy and commercialization support for healthcare businesses to operational and administrative issues faced by healthcare providers and professionals, as well as ongoing support for individuals and families dealing with illness or disability.

Our work is grounded in the combined perspectives of a physician and an Administrative Procedures Legal Specialist, together with experience in clinical medicine, pharmaceutical Medical Affairs, medical research, regulatory analysis, and professional documentation.

Our principal areas of support are:

Regulatory analysis, commercialization, and implementation support for medical AI, SaMD, HealthTech, RWD, medical devices, and related healthcare businesses
Operational, administrative, factual, and documentation support for healthcare institutions, pharmacies, long-term care providers, physicians, and other healthcare professionals
Ongoing medical, long-term care, and administrative support for individuals and families facing illness or disability

Support for Healthcare and Life Sciences Businesses

We support domestic and international medical device manufacturers, SaMD and HealthTech companies, medical AI and healthcare data businesses, venture capital and corporate venture capital firms, portfolio companies, research institutions, university spinouts, and overseas healthcare companies seeking to enter the Japanese market.

Our services include early-stage regulatory analysis, preparation for consultations with the Pharmaceuticals and Medical Devices Agency and other public authorities, licensing and notification procedures, and the preparation of contracts, explanatory materials, regulatory documents, and other professional documentation.

Drawing on backgrounds in medicine and molecular genetics, we examine how a product or service will actually be used in clinical practice, how it may affect patient safety and physician decision-making, and how it fits within the healthcare delivery system.

We then break down the business concept into relevant issues under the Pharmaceuticals and Medical Devices Act, the Medical Practitioners’ Act, SaMD regulation, medical advertising rules, data protection requirements, telemedicine rules, and the allocation of responsibilities among the parties involved. Based on this analysis, we help design the procedures, consultations, and documentation required for responsible implementation.

We place particular emphasis on areas requiring both medical and scientific understanding and regulatory or administrative analysis, including:

Medical AI, SaMD, and medical device software
Genomic medicine and genetic testing
Healthcare data and real-world data
Regenerative medicine and telemedicine
Japanese market entry by overseas medical device and HealthTech companies
Medical and regulatory due diligence for venture capital and corporate venture capital investment
University spinouts and industry–academia collaboration

Support for Healthcare Providers and Healthcare Professionals

We assist healthcare institutions, pharmacies, long-term care facilities, home-care providers, and related organizations with matters including establishment, modification, closure, succession, licensing and notification management, administrative communications, contracts and explanatory documents, patient safety, internal governance, multidisciplinary coordination, and systems for communicating with patients and families.

We also support employed physicians, part-time physicians, medical directors, pharmacists, and other healthcare professionals who encounter concerns involving:

Use of a physician’s name or professional credentials
Medical records and electronic health records
Prescriptions and pharmacy inquiries
Patient and family communications
Working hours, compensation, and contractual arrangements
Contract renewal or termination
Communications with administrative authorities, the police, or other public bodies

Our support may include organizing the factual chronology, reviewing available records, identifying unresolved questions, determining appropriate consultation routes, and preparing consultation materials or documents for submission to public authorities.

Support for Individuals and Families

For individuals and families facing illness or disability, we provide support not only after a matter develops into a legal dispute, but also while medical treatment, hospitalization, discharge planning, medication management, home-based care, long-term care, disability welfare services, and administrative procedures are still in progress.

As a general rule, this service is not limited by age, diagnosis, disability, or medical specialty.

We help organize information such as:

The course of symptoms and illness
Medical consultations, examinations, treatment, and medication
Explanations received from healthcare providers
Long-term care and welfare services currently being used
Changes in the individual’s daily life and functional status
Communication among family members, healthcare providers, care providers, and public authorities

Based on that information, we help identify potentially appropriate medical specialties, types of healthcare institutions, public authorities, long-term care or welfare organizations, and other professionals to consult.

Where appropriate, we also prepare:

Chronologies
Question lists and confirmation checklists
Written information summaries
Consultation letters
Factual background statements
Requests for clarification
Documents for submission to public authorities or other relevant institutions

The purpose is to help individuals and families communicate the situation accurately, understand the available routes, and connect with the support they need while the matter is still developing.

Translating Medical Facts into Systems, Documents, and Action

Healthcare matters often involve a complex combination of medical facts, laws and regulations, administrative procedures, contractual relationships, organizational governance, and practical concerns affecting daily life.

Our office does more than explain rules in the abstract. We help clarify:

Which medical or scientific facts are materially important
Which laws, public systems, or authorities may be relevant
Who should be contacted, what should be asked, and in what order
What records and documents should be prepared or preserved
At what point another professional should become involved

We then translate those issues into a practical structure that enables the client to take the next appropriate step.

Collaboration with Other Professionals

Where a matter requires advanced or highly specialized expertise—such as medical device marketing authorization, quality management systems, certification or approval applications, reimbursement, overseas regulation, specialist medical evaluation, contentious legal representation, registration, taxation, labor matters, or social insurance—we work in coordination with appropriate professionals.

Depending on the nature and stage of the matter, this may include physicians in relevant specialties, medical device regulatory professionals, attorneys, patent attorneys, judicial scriveners, tax accountants, labor and social security attorneys, engineers, data scientists, and other specialists.

We also welcome inquiries regarding matters not specifically listed on this website, including cases where the issues have not yet been clearly identified.

After reviewing the nature of the matter, the stage of the business or medical situation, the organizational structure, the circumstances of the individual or family, and the involvement of other institutions, we will explain:

The scope of support our office may provide
The proposed approach
The estimated fees
Whether collaboration with other professionals may be required

Important notice: Okuizumi Administrative Legal Office is not a medical institution and does not provide diagnosis, prescribe medication, determine treatment, provide emergency medical care, or deliver continuing clinical care. Where urgent symptoms or a risk to life or physical safety is suspected, please contact emergency services or an appropriate healthcare institution without waiting for a consultation with our office.

1. For Corporate Clients

Commercialization Support for Medical AI, SaMD, HealthTech, RWD, and Medical Device Companies

– Supporting the translation of healthcare ideas into regulated, document-ready, and implementation-ready business models

We support companies developing medical AI, software as a medical device (SaMD), medical device software, HealthTech services, real-world data (RWD) and healthcare data platforms, genomic medicine, regenerative medicine, gene therapy, telemedicine platforms, and healthcare SaaS solutions.

From the early concept stage, we help identify and organize key regulatory, medical, and administrative issues, including medical device applicability, the Pharmaceuticals and Medical Devices Act, the Medical Practitioners’ Act, medical advertising regulations, personal data protection, online medical consultation, allocation of responsibility, and the need for consultation with administrative authorities.

Even when the business concept is still at an early or unstructured stage, we can listen to the current idea and help clarify the main issues, required confirmations, and possible next steps, including whether consultation with PMDA or other administrative authorities, or collaboration with other specialists, may be necessary.

Main Target Clients

Medical device manufacturers
SaMD and medical device software companies
Medical AI companies
HealthTech companies
RWD and healthcare data platform companies
Telemedicine and online medical consultation companies
Genomic analysis and genetic testing companies
Regenerative medicine and gene therapy companies
Foreign medical device and HealthTech companies
Overseas companies considering market entry into Japan
Venture capital and corporate venture capital firms and their portfolio companies
University spinouts and R&D-based startups
Universities, research institutions, technology licensing organizations, and industry-academia collaboration departments
Business corporations considering new healthcare-related businesses

Business Formation, Licensing, and Japan Market Entry Support

Support for applications and procedures required to start healthcare-related businesses, including highly controlled medical device sales licenses, medical institution-related procedures, and long-term care service designations
Establishment or restructuring of Japanese entities for foreign companies
Re-design of business structures for companies facing unexpected regulatory or operational issues in Japan
Preparation and review of articles of incorporation and business purposes for healthcare-related businesses
Support for business manager visa and other status of residence applications
Support for foreign medical device and SaMD companies in establishing DMAH/MAH-related structures in Japan
Support for domestic marketing authorization holder structures, designated marketing authorization holder arrangements, in-country caretaker structures, sales and distribution frameworks, PMDA consultation preparation, administrative procedures, and contractual documentation
Coordination with attorneys, patent attorneys, regulatory affairs specialists, technical experts, data science experts, and other professionals as needed

Regulatory Issue Mapping and Administrative Consultation Support for Business Models

Issue mapping for new services, applications, SaaS products, medical AI, SaMD, genomic analysis services, and related businesses under the Medical Practitioners’ Act, Pharmaceuticals and Medical Devices Act, AI-related guidelines, and other applicable frameworks
Initial analysis of legal and regulatory issues affecting business models
Preparation and support for prior consultation or inquiries with administrative authorities
Support for use of the no-action letter system and related procedures
Preparation of questions, explanatory materials, factual assumptions, and business scheme descriptions before consultation with PMDA or other authorities

Healthcare Data, RWD, and Health Data Utilization Support

For businesses utilizing medical AI, SaMD, RWD, healthcare data platforms, electronic medical record data, claims data, laboratory data, and related datasets, we support cross-functional issue mapping and documentation from medical, legal, and business perspectives.

Key areas include personal information protection, the Next Generation Medical Infrastructure Act, consent design, anonymized and pseudonymized data, research use and commercial use, and preparation for PMDA or other administrative consultation.

Where appropriate, we support the preparation of explanatory documents, informed consent documents, terms of use, privacy policies, materials for medical institutions, materials for pharmaceutical companies, and documents related to research use.

If specific legal opinions are required, we coordinate with attorneys and other professionals as appropriate.

Genomic Medicine and Genetic Testing Business Support

We support issue mapping for DTC genetic testing, genomic analysis services, companion diagnostics, gene therapy, and genetic testing in rare disease areas.

Areas covered include medical and scientific validity, the Pharmaceuticals and Medical Devices Act, the Medical Practitioners’ Act, advertising regulations, informed consent documents, genetic counseling structures, administrative procedures, and related documentation.

This service does not replace genetic counseling itself. Where necessary, we coordinate with clinical geneticists, certified genetic counselors, attorneys, and other professionals.

Regenerative Medicine and Gene Therapy Business Support

Support for certified or notified regenerative medicine provision plans in connection with the introduction of gene therapy, cancer immunotherapy, and related services
Issue mapping for Class I and Class II regenerative medicine provision plans
Organization of scientific rationale, molecular mechanisms, and implementation structures for provision plans
Support for applications and notifications related to cell processing facilities
Documentation and operational support for clinical research and regenerative medicine-related committees
Support for regulations, SOPs, conflict-of-interest management, committee composition, annual reports, and administrative filings related to certified clinical research review boards, certified regenerative medicine committees, and related bodies
Coordination with attorneys, physicians, research ethics specialists, clinical research experts, and other professionals as needed

Regulatory and Medical Due Diligence / Hands-on Support

For VC/CVC Firms and Portfolio Startups

We support investment evaluation and post-investment value creation in the biotechnology and healthcare sectors from both medical/scientific and legal/regulatory perspectives.

Regulatory and medical due diligence
Fact-finding, issue mapping, and documentation related to medical and regulatory matters for investment evaluation
Upstream regulatory and legal strategy for product development
Preparation and legal review of target product profiles
Support for prior consultation or inquiries with administrative authorities
Preparation of PMDA consultation materials, draft questions, and factual assumptions
Issue mapping regarding the boundary between healthcare AI, medical device software, and medical practice
Issue mapping regarding scientific validity in regenerative medicine provision plans
Literature review and preparation of fact-certification documents to support medical issues
Preparation and review of contracts and legal documents for portfolio companies, including joint research agreements, non-disclosure agreements, and service agreements

We do not provide advice or representation regarding investment decisions, valuation, investment terms, or expected financial returns.

Public Funding Application Support for Healthcare and R&D Startups

Support for business plans and application documents for R&D grants from AMED, NEDO, and similar organizations
Organization of materials to demonstrate scientific validity and innovation
Evidence-building to clarify medical and technical validity
Support for descriptions of medical background, research and development plans, social implementation potential, and literature-based rationale

University Spinout and Academia-Industry Collaboration Support

We support universities, research institutions, technology licensing organizations, industry-academia collaboration departments, medical researchers, and university spinouts with documentation and procedural design related to joint research, material transfer agreements, outside activities, conflict-of-interest management, AMED/NEDO and other R&D support, early-stage regulatory issue mapping, and external specialist collaboration.

For licensing agreements, intellectual property strategy, dispute-related legal issues, and similar matters, we coordinate with attorneys, patent attorneys, and other professionals as needed.

Business Design Support for Next-Generation Pharmacies and Healthcare Access Points

We support business models that use pharmacies as healthcare access points, including pharmacy-based medical DX, healthcare services, patient engagement, medical institution collaboration, data utilization, and app-based services.

We help organize issues related to the Pharmaceuticals and Medical Devices Act, personal information protection, medical advertising, online medication guidance, specimen measurement rooms, involvement of physicians and pharmacists, and allocation of responsibility.

Legal and regulatory issue mapping and notification support for online medication guidance
Legal and regulatory issue mapping and notification support for specimen measurement rooms
Risk assessment under the Pharmaceuticals and Medical Devices Act and personal information protection laws for pharmacy DX, delivery collaboration, and app-based services
Initial issue mapping for medical institution collaboration, patient guidance, patient explanation, and data utilization using pharmacies as healthcare access points

For major dispensing pharmacy chains that are current or potential collaborative research partners, we may decline engagement from the perspective of conflict-of-interest management. Please contact us and we will confirm whether we can assist.

2. For Medical Institutions, Pharmacies, and Long-Term Care Facilities

– Supporting stable healthcare operations and smooth business succession

We support hospitals, clinics, pharmacies, long-term care facilities, home medical care providers, medical corporations, and long-term care service operators with opening, change, closure, succession, M&A, licensing management, administrative procedures, contracts, explanatory documents, advertising, medical safety, institutional governance, interprofessional collaboration, and patient/family-facing documentation.

We assist with day-to-day operational procedures for existing medical institutions, pharmacies, and long-term care facilities, including notifications, administrative responses, contract documentation, explanatory materials, and documentation of internal operations.

We also support the design of licensing and administrative schemes for M&A and business succession, risk identification before and after succession, and post-merger integration procedures.

Main Target Clients

Hospitals
Clinics
Medical corporations
Pharmacies
Long-term care facilities
Home medical care providers
Long-term care service operators
Businesses considering M&A in the medical, long-term care, or pharmacy sectors
Corporations acquiring or succeeding to medical institutions, pharmacies, or long-term care facilities
Executives and administrators considering operational improvement of medical institutions, pharmacies, or long-term care facilities

Legal, Administrative, and Licensing Due Diligence for Medical, Long-Term Care, and Pharmacy M&A

Structuring of succession schemes
Development of administrative procedure logic for closure and opening procedures with public health centers and regional health bureaus in connection with changes in operator, incorporation, business transfers, or management succession
Support for prior consultation with administrative authorities to avoid operational gaps
Administrative legal due diligence on the regulatory compliance status of target facilities
Risk assessment regarding staffing requirements, structural and equipment requirements, advertising regulations, administrators, and notification status
Organization of corrective action plans before and after succession
Support for post-merger integration procedures, including administrator change notifications, hospital bed-related notifications, service designations, public expense-related procedures, workers’ compensation-related procedures, and related amendments

Contract Preparation and Documentation Support

Japanese and English

Service agreement preparation support
System use agreement preparation support
Non-disclosure agreement preparation support
Joint research agreement preparation support
Terms of use for telemedicine and online medical consultation applications
Terms of use, privacy policies, and patient-facing informed consent documents for HealthTech services
Legal check of employment agreements, work rules, and related documents for medical institutions and long-term care facilities
For work rules and other labor-related documents, we coordinate with affiliated certified social insurance and labor consultants as needed

Government Procedures and Licensing Management

Preparation and submission support for periodic reports to administrative authorities
Preparation and submission support for change notifications and business reports
Change notifications and amendment applications related to officer changes
Change notifications and amendment applications related to relocation of business offices
Change notifications and amendment applications related to administrator changes
Administrative procedure support in connection with the opening, change, closure, or succession of medical institutions, pharmacies, and long-term care facilities

Operational Documentation Support in Neurology and General Internal Medicine

Based on clinical experience in neurology, dementia, stroke, and general internal medicine, we support the preparation of operational documents for medical institutions, including clinical service structures, internal operations for the introduction of advanced treatments, patient and family explanation documents, informed consent documents, outpatient management systems, materials for relevant stakeholders, and administrative and operational documentation.

Operational documentation for dementia care systems
Documentation for outpatient management systems in stroke, neurological diseases, and general internal medicine
Internal operational documents for the introduction of advanced treatments and related services
Patient and family explanation documents and informed consent documents
Materials for relevant stakeholders
Administrative procedure and operational documentation support

We do not provide advice based on confidential information of any specific pharmaceutical product, pharmaceutical company, or medical institution. We confirm whether we can assist on a case-by-case basis, taking into account conflicts of interest, confidentiality obligations, and applicable rules of affiliated organizations.

Advertising and Promotional Materials Review

Requirement mapping for website, landing page, brochure, and other display materials
Risk assessment from the perspective of the Medical Care Act, medical advertising guidelines, the Pharmaceuticals and Medical Devices Act, the Act against Unjustifiable Premiums and Misleading Representations, and related rules
Organization of revision policies for advertising displays, explanatory materials, and patient-facing guidance
Support for review of display content related to medical institutions, pharmacies, long-term care facilities, and healthcare services

Medical Institution Governance and Compliance Support

We identify and organize risks related to patient explanations, medical records and electronic medical record operations, interprofessional collaboration, physician responsibilities, involvement of non-physician staff, and the allocation of responsibilities among corporations, administrators, and medical professionals.

From the dual perspectives of a physician and a certified administrative procedures legal specialist, we help visualize inappropriate or overlooked operational practices at an early stage and, where necessary, support improvement planning, documentation, and coordination with external professionals.

We translate “early signs of concern” in medical institutions into legal, administrative, and governance issues before they escalate into disputes or incidents.

Operational and Documentation Support for Pharmacies and Long-Term Care Facilities

We support pharmacies and long-term care facilities with day-to-day operations, collaboration with medical institutions, patient and resident explanations, personal information management, advertising, online medication guidance, specimen measurement rooms, pharmacy DX, medical collaboration documents for long-term care facilities, and related administrative and documentation matters.

Issue mapping for online medication guidance, specimen measurement rooms, delivery collaboration, and app-based services in pharmacies
Risk assessment under the Pharmaceuticals and Medical Devices Act and personal information protection laws for pharmacy DX
Documentation for medical institution collaboration, family explanations, records, and information sharing in long-term care facilities
Organization of role allocation, responsibility boundaries, and explanatory documents among medical institutions, pharmacies, and long-term care facilities

3. Strategic Medical Advisory for Professionals

Collaborating with lawyers, patent attorneys, M&A advisors, strategic consulting firms, medical device regulatory specialists, RA/QA professionals, regulatory consultants, and other professionals involved in medical device licensing, certification, approval, QMS, or PMDA-related work to maximize project certainty and execution quality by integrating advanced medical and regulatory insights

For matters requiring advanced medical knowledge or the interpretation of molecular genetics and pharmaceutical regulatory frameworks, we provide specialized expertise and document preparation support from the perspective of both a certified administrative scrivener and a physician to professionals such as law firms, patent firms, M&A advisory firms, consulting firms, medical device regulatory specialists, RA/QA professionals, regulatory consultants, and other professional service providers involved in medical device and SaMD regulatory operations.

We also provide spot support or joint support to medical device regulatory professionals, RA/QA specialists, and regulatory consultants who need medical or clinical input for upstream issue-spotting, PMDA consultation preparation, client-facing explanatory materials, or expert review.

Medical Opinion, Literature Review, and Evidence Support for Lawyers and Other Professionals
For matters involving neurology, general internal medicine, molecular genetics, pharmaceuticals, medical devices, and related healthcare issues, we support lawyers and other professionals by preparing medical literature reviews, scientific evidence summaries, medical issue analyses, factual proof documents, investigation reports, and medical opinion documents.
Note: We do not act as legal counsel, represent clients in litigation, negotiate disputes, or formulate legal claims in a manner restricted to lawyers under the Attorneys Act.
Expert Issue-Spotting in Genomic Medicine and Neurological Diseases
- For matters involving genomic medicine, genetic testing, neurodegenerative diseases, dementia, rare neurological diseases, and related areas, we support professionals, Certified Administrative Procedures Legal Specialists, law firms, consulting firms, and other professional service providers with medical and scientific validity review, literature reviews, regulatory issue-spotting for R&D and commercialization, and the preparation of patient explanation materials and informed consent documents.
Preparation of Fact-Finding Documents and Investigation Reports on Legality & Safety of New Businesses
- Organization of factual relationships concerning medical safety and compliance with Article 20 of the Medical Practitioners’ Act (prohibition of treatment without examination) for Telemedicine/Online Medical schemes.
- Literature research and fact-finding to substantiate the boundary between “Medical Practice” and “Health Consultation” in Healthcare AI and SaMD.
- Clinical and factual organization of intended use, actual use settings, intended users, patient safety considerations, and potential impact on physician judgment for medical devices, Healthcare AI, and potential SaMD products.
- Medical and clinical issue-spotting to support medical device applicability analysis, risk classification discussions, PMDA consultation preparation, expert review, and client-facing explanatory materials.
- Extraction of medical evidence and factual organization based on administrative interpretations concerning the safety of unapproved devices used in beauty/wellness businesses and potential conflicts with the Medical Practitioners’ Act.
- Preparation of investigation reports (documents certifying facts) on risk classification of processed cells and scientific validity of provision plans under the Act on the Safety of Regenerative Medicine.

Joint Acceptance & Spot Support for Advanced Medicine
- Joint acceptance of license applications requiring high-level scientific knowledge, such as gene therapy and clinical research using viral vectors.
- Scientific validity checks of protocols and informed consent documents from the perspective of a Molecular Geneticist.
- Advisory and training on advanced medical law for other professional firms.
- Joint engagement or spot support for medical device regulatory specialists and authorization professionals in medical AI, SaMD, and HealthTech matters, particularly in organizing clinical use cases, patient safety issues, physician judgment, medical validity, and responsibility allocation before proceeding to regulatory operations, PMDA consultation, or expert review.
Evidence Construction & Fact-Finding
- Product Liability (PL) Defense & Corporate Legal Support: Comprehensive systematic reviews of medical literature regarding causality between pharmaceuticals/medical devices and health damage. Preparation of investigation reports demonstrating medical validity.
Healthcare Delivery System and Operational Documentation Support in Neurology, Including Dementia and Stroke, and General Internal Medicine
- Drawing on clinical experience in neurology, including dementia and stroke, as well as general internal medicine, we support medical institutions in developing dementia care systems, internal operational procedures for the introduction of advanced therapies, patient and family explanation materials, informed consent documents, outpatient management frameworks, stakeholder briefing materials, administrative procedures, and operational documentation.
  Note: We do not provide advice based on non-public information concerning any specific pharmaceutical product, pharmaceutical company, or medical institution. We assess each matter individually in light of conflicts of interest, confidentiality obligations, internal rules of affiliated organizations, and applicable professional responsibilities.
Support for M&A Professionals
- Investigation and reporting on compliance status with the Medical Care Act and PMD Act during business succession (M&A) considerations.
- Analysis of license transferability, administrative sanction risks, and legal organization of remediation schemes.

4. Support for Employed Physicians and Healthcare Professionals

– Fact Organization and Preparation for Consultations with Public Authorities

When employed physicians, part-time physicians, medical directors, pharmacists, or other healthcare professionals experience concern or discomfort regarding the use of a physician’s name, medical records, prescriptions, explanation records, actual working hours, employment conditions, payment of wages, contract renewal, regulatory or administrative matters, or whether consultation with the police or other authorities may be necessary, our office assists them in organizing the relevant facts, parties involved, supporting evidence, matters requiring confirmation, and appropriate consultation channels.

Within healthcare settings, difficulties may arise not only between patients and medical institutions, but also internally between individual healthcare professionals and the organizations for which they work. Such issues may involve the use of a physician’s name, the management of electronic medical records and other clinical documentation, proxy data entry, prescription issuance, responses to pharmacy inquiries, protection of staff in connection with patient-related incidents, actual working hours, employment conditions, wage payments, and contract renewal.

Where so-called “normalization of deviance” has occurred—making discrepancies between established practices and applicable laws, authority, procedures, or record-keeping difficult to recognize under the assumption that “this is how things have always been done”—we help make the relevant facts visible and organize them into a form that can be clearly explained to government authorities or relevant professionals.

Drawing on the perspectives of both a physician and an Administrative Procedures Legal Specialist, our office assists employed physicians and healthcare professionals in clarifying their position, organizing the relevant chronology, identifying matters requiring confirmation, and determining appropriate consultation channels. We also assist in preparing chronologies, evidence indexes, lists of questions and confirmation points, factual statements, and other materials for consultations with medical institutions, public health centers, Regional Bureaus of Health and Welfare, Prefectural Labour Bureaus, Labour Standards Inspection Offices, the police, Prefectural Public Safety Commissions, attorneys, labour and social security attorneys, and other relevant authorities and professionals.

With respect to employment-related matters, including employment conditions, contract renewal, non-renewal, reassignment, changes in working days or duties, wage reductions, harassment, and adverse treatment, we assist clients in organizing the relevant facts, documents, questions, and consultation points in preparation for contacting a General Labour Consultation Corner or another office of a Prefectural Labour Bureau, or for considering the use of advice, guidance, mediation, or other available procedures.

Depending on the circumstances, we also assist in organizing the chronology, supporting evidence, and consultation materials necessary to consider reporting a matter to the police, making a statement of victimization, or filing a criminal complaint or criminal accusation. To the extent permitted within our professional scope, we may also assist in preparing criminal complaints, criminal accusations, and other documents to be submitted to police stations or other public authorities, based on the relevant facts and supporting evidence.

Where there are matters requiring clarification concerning the police response to a consultation or other conduct by police personnel in the performance of their duties, we assist in organizing the history of the consultation, the information provided to the police, the police response, the matters to be raised, and the relevant supporting materials. We may also assist in preparing a written complaint and related submission materials for filing with the relevant Prefectural Public Safety Commission under Article 79 of the Police Act.

Main Areas of Support

Organizing the facts and chronology concerning the use and management of physicians’ names, prescriptions, medical records, electronic medical records, proxy data entry, physician IDs, and related systems
Preparing consultation materials concerning patient-related incidents, internal workplace problems, interference with medical practice, safety concerns, and similar matters
Organizing facts concerning part-time work, holiday work, overnight or on-call duties, actual working hours, employment conditions, wage payments, contract renewal, and related matters
Organizing facts, documents, and lists of questions for consultations with a General Labour Consultation Corner or another office of a Prefectural Labour Bureau concerning dismissal, non-renewal, contract renewal, reassignment, changes in working days or employment conditions, wage reductions, harassment, adverse treatment, and related matters
Organizing the chronology, relevant materials, consultation issues, and confirmation points in preparation for considering advice or guidance by a Prefectural Labour Bureau, mediation by a Dispute Adjustment Commission, or other available procedures
Preparing chronologies, evidence indexes, lists of questions and confirmation points, and factual statements for use by clients when consulting public health centers, Regional Bureaus of Health and Welfare, Prefectural Labour Bureaus, Labour Standards Inspection Offices, the police, or other relevant authorities
Organizing the relevant chronology, supporting evidence, and consultation materials in preparation for consultation with the police, reporting victimization, or considering a criminal complaint or criminal accusation
Assisting, to the extent permitted within our professional scope, in preparing criminal complaints, criminal accusations, and other documents to be submitted to police stations or other public authorities
Organizing the facts, consultation history, police response, and supporting materials in preparation for submitting a complaint to a Prefectural Public Safety Commission concerning the performance of duties by police personnel
Assisting, to the extent permitted within our professional scope, in preparing written complaints and other related documents for submission to a Prefectural Public Safety Commission
Organizing issues and supporting materials before consultation with attorneys, labour and social security attorneys, other professionals, medical institutions, or administrative authorities
Organizing explanations provided by medical institutions, internal records, emails, medical records, prescriptions, pharmacy inquiry records, and other relevant materials

Scope of This Service

This service does not include representing employed physicians or healthcare professionals in contentious negotiations or disputes with medical institutions, corporate entities, patients, administrative authorities, investigative authorities, or other third parties.

With respect to criminal complaints and criminal accusations, our services principally consist of organizing the relevant chronology and evidence, preparing consultation materials, and, where permitted within our professional scope, assisting with the preparation of documents to be submitted to public authorities.

Determining whether a matter should be treated as a criminal case, negotiating the acceptance of a criminal complaint or criminal accusation, communicating or negotiating with investigative authorities, conducting settlement negotiations, responding to the subject of a complaint or accusation or other opposing parties, and handling criminal or civil litigation or other contentious proceedings fall outside the scope of this service. Where necessary, we will coordinate with an attorney.

With respect to complaints submitted to a Prefectural Public Safety Commission, our services principally consist of organizing the history of the police consultation, the conduct of the police personnel involved, the matters to be raised, and the relevant supporting materials, as well as assisting in preparing documents to be submitted in the client’s own name. We do not guarantee that the police will commence an investigation, treat the matter as a criminal case, accept a criminal complaint or accusation, take action against any police personnel, or reach any particular outcome.

With respect to employment-related matters, our services principally consist of organizing the relevant facts, actual working records, employment agreements, work rules, wage statements, emails, and other materials, and assisting clients in preparing for consultations conducted in their own name.

Where the matter requires the preparation or submission of applications or other documents, or representation in advice, guidance, mediation, or other dispute-resolution procedures before a Prefectural Labour Bureau; the preparation or submission of applications, records, or other documents under labour and social security legislation; the legal determination of unpaid wages or other claimed amounts; negotiations with an employer; labour tribunal proceedings; litigation; or other contentious representation, we will clarify the applicable professional boundaries and, where appropriate, coordinate with an attorney, a specially certified labour and social security attorney, a labour and social security attorney, or another qualified professional.

This service does not provide diagnosis, determine treatment plans, issue prescriptions, provide continuing medical care, make emergency medical decisions, or otherwise provide medical treatment. Where there is an immediate risk to life or physical safety, clients should contact the police, emergency medical services, or another appropriate emergency service without waiting to consult our office.

Where internal information of a medical institution, patient information, clinical information, personal data, or other confidential information is involved, we will determine whether we can accept the matter and what materials may be handled only after considering professional confidentiality obligations, personal information protection requirements, conflicts of interest, workplace rules, information management policies, and other applicable requirements.

5. Support for Individuals and Families

Ongoing Medical, Long-Term Care, and Administrative Support When Facing Illness or Disability

— Organizing ongoing medical and long-term care issues and creating a pathway to more appropriate care and support

When an individual or family member faces illness or disability, many issues may arise simultaneously, including diagnosis and treatment, hospitalization and discharge, transfer to another healthcare institution, medication management, rehabilitation, home-based care, long-term care services, disability support services, administrative procedures, and communication among family members.

In such circumstances, individuals and families may be required to respond without clearly understanding:

what medical and practical issues are currently arising;
which medical specialty or healthcare institution they should consult;
what they should ask or confirm with the attending physician or healthcare institution;
which public authority, long-term care or welfare organization, or professional they should contact; and
what records and documents should be organized and preserved.

While medical treatment and long-term care are still in progress, medical issues, practical concerns affecting daily life, long-term care and welfare systems, administrative procedures, and family coordination are often closely interconnected. However, the relevant sources of support are divided among healthcare, long-term care, welfare, public administration, and legal services. As a result, it may be difficult to find a professional who can review the overall situation across these fields and help connect the individual or family with appropriate care and support.

If necessary confirmation and information sharing are delayed, difficulties may arise in relation to treatment and care choices, hospital discharge or transfer, medication management, home-based care, or admission to a residential facility. Differences in understanding among the individual, family members, healthcare institutions, and other relevant parties may also become more significant over time.

As a general rule, our office does not limit this service by age, illness, disability, or medical specialty. From the combined perspectives of a physician and an Administrative Procedures Legal Specialist, we help organize relevant information, including the course of the medical condition, consultation history, examinations, treatment and medication, explanations provided by healthcare institutions, the use of long-term care and welfare services, changes in daily life, and communication among family members and relevant institutions.

Based on this review, we help individuals and families identify an appropriate pathway to medical specialties, healthcare institutions, public authorities, long-term care and welfare organizations, and other professionals. We also assist in preparing chronologies, question lists, confirmation checklists, written information summaries, consultation materials, and other necessary documents.

Where highly specialized medical consideration is required, we may, with the consent of the individual or family, coordinate with physicians in the relevant specialty or other appropriate professionals.

Main Areas of Support

Preparing a chronological summary of symptoms, medical conditions, consultations, examinations, diagnoses, treatment, and medication
Organizing explanations received from healthcare institutions, unresolved matters, and issues requiring further confirmation
Identifying potentially appropriate medical specialties, types of healthcare institutions, specific consultation options, and routes of access
Preparing question lists and confirmation checklists for medical consultations, hospitalization, discharge, transfer, discharge-planning meetings, and care conferences
Organizing medical records, referral letters, test results, prescription information, long-term care records, administrative documents, emails, and other relevant materials
Organizing matters to be confirmed with the attending physician regarding medication changes, suspected adverse effects, or changes following treatment
Identifying appropriate consultation routes and matters requiring confirmation in relation to home-based care, long-term care services, residential facilities, and disability support services
Preparing for consultations with public health centers, prefectural and municipal authorities, Regional Bureaus of Health and Welfare, Medical Safety Support Centers, Community General Support Centers, and offices responsible for long-term care insurance and disability welfare
Preparing written information summaries, factual chronologies, consultation letters, requests for clarification, and other documents for submission to healthcare institutions, long-term care or welfare organizations, and public authorities
Organizing information and matters requiring confirmation among the individual, family members, healthcare institutions, long-term care providers, and other relevant parties
Updating factual chronologies, questions, confirmation items, and consultation materials as circumstances change
Coordinating, where appropriate, with physicians in relevant specialties, attorneys, judicial scriveners, social welfare professionals, long-term care and welfare professionals, and other specialists

Scope and Purpose of This Service

This service is not intended to pursue liability against healthcare institutions or other parties.

Its purpose is to organize ongoing medical and long-term care circumstances and to ensure that necessary information sharing, confirmation, and consultation take place at an appropriate stage, so that individuals and families can connect with more appropriate healthcare, long-term care, welfare services, and public support.

Early organization and action may help prevent misunderstandings, delays in necessary responses, and the escalation of problems, and may consequently also help prevent disputes.

Our office provides factual organization, review and organization of relevant materials, document preparation, consultation planning, and coordination with other professionals. It does not replace an attending physician or healthcare institution and does not provide diagnosis, determine treatment, prescribe medication, provide continuing clinical care, or deliver emergency medical services. Nor does it guarantee any particular treatment outcome at a healthcare institution.

Where urgent symptoms or a risk to life or physical safety is suspected, emergency services or an appropriate healthcare institution should be contacted without waiting for a consultation with our office.

If, during the course of this service, it becomes apparent that a conflict of interests between the parties has already become manifest, or that a claim for damages, negotiation with another party, assessment of alleged medical malpractice, or determination of legal liability is required, we will clarify the scope of our services and, where appropriate, coordinate with an attorney or other relevant professional.

Applications for adult guardianship, registration matters, taxation, labor and social insurance matters, and other specialist services will likewise be handled in cooperation with the relevant professionals.matters, tax matters, labor and social insurance matters, and other specialist services will likewise be handled in cooperation with the relevant professionals.

Collaboration with Other Professionals

Our office seeks to provide the most appropriate support depending on the nature of each matter. For issues that fall outside the scope of gyoseishoshi services, such as contentious legal matters, tax filings, registration applications, or labor and employment management, we introduce trusted attorneys-at-law, certified tax accountants, judicial scriveners, labor and social security attorneys, and other professionals, and work with them as necessary.

For large-scale matters or matters involving specific areas of expertise, we are also working to develop a collaborative framework with gyoseishoshi professionals, physicians in relevant clinical specialties, medical device regulatory and licensing professionals, patent attorneys, healthcare management and business development professionals, AI and data science experts, and other specialists, depending on the nature of the case.

Professional Collaboration to Keep Business Moving
Our office places the representative’s expertise in medicine, pharmaceutical/regulatory affairs, and administrative procedures at the core of each matter, while identifying the required expertise at an early stage and seeking appropriate role-sharing with relevant professionals. When accepting a matter, we confirm the scope of work, deliverables, expected timeline, and collaboration structure, and accept matters only to the extent that quality and response speed can be maintained. For medical issues outside the representative’s own areas of expertise, we seek to incorporate the knowledge of appropriate specialists as necessary, in order to help ensure the quality and safety of our services.

In matters involving SaMD, Medical AI, HealthTech, and related fields, technical understanding is also important. Accordingly, we are working to develop collaborative relationships with technical experts, including software developers, AI and data science professionals, and cybersecurity specialists, as necessary.

For matters involving genomic medicine, genetic testing, medical data and RWD, dementia and neurological fields, regenerative medicine, clinical research, and related areas, we are also working to develop a framework for collaboration, as necessary, with clinical geneticists, certified genetic counselors, physicians in relevant specialties, attorneys-at-law, patent attorneys, and specialists in research ethics and clinical research.

⚠ Important Notice (Compliance & Conflict of Interest)

The principal is currently employed by a pharmaceutical company. From the perspectives of compliance and conflict-of-interest management, we assess on a case-by-case basis whether we are able to accept the following matters.

Matters involving the principal’s current employer, affiliated companies, clients, or other related parties that may present conflicts of interest, non-compete concerns, or other compliance issues:
*We will determine whether we can accept the matter after reviewing the details of the request.
We do not provide advice based on non-public information, internal materials, individual business opportunities, product strategies, sales or marketing activities, or any other confidential information concerning the principal’s current or former employers, affiliated medical institutions, joint research partners, clients, or other related parties. We assess each request individually in light of conflicts of interest, confidentiality obligations, non-compete obligations, professional ethics, and applicable laws and regulations.
Duties restricted to Lawyers under the Attorneys Act:
- E.g., Acting as an agent in litigation, negotiation of disputes. We will coordinate with lawyers as necessary.

Client information is strictly managed based on the confidentiality obligations of the Certified Administrative Procedures Legal Specialist Act and will not be disclosed to third parties unless required by law.

We will assess whether we can handle your request based on the details provided. Please feel free to contact us via the inquiry form for an initial overview.

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