Healthcare, Pharma and Medical LegalFrom whether a function qualifies as a medical device program to medical advertising, health data and contracts with medical institutions, our attorneys sort out the issues.
- Response time
- 1 business day*
- First consultation
- 30 min free
- Scope
- Applicability · Medical advertising · Health data · Contracts
* As a rule, for contract reviews and routine legal questions. For complex or urgent matters we propose a schedule that fits the matter.
Client companies served*
150+Selected clients shown, in no particular order. * Clients and partners. Not limited to Healthcare, Pharma and Medical Legal matters.
Checking how health services are regulated, function by function
For services such as health management apps, online consultations and wearable device integration, we check whether each function qualifies as a medical device program or medical practice, expressions under the Pharmaceuticals and Medical Devices Act (PMD Act) and medical advertising rules, the handling of special care-required personal information and contracts with medical institutions, in line with how the function is designed. Where an inquiry to the competent authority is needed, we also prepare the draft inquiry.
- You cannot tell whether a new feature qualifies as a medical device program
- You are unsure whether the efficacy claims in an agency's landing page draft can be published
- Your privacy policy has not kept up with the health data you collect
- Partnership terms with a medical institution have not been put into a contract
Why LegalAgent
With LegalAgent, you can sort out regulatory issues from the planning stage
We support your service planning in three ways: fast answers, upfront fee estimates and deliverables that include proposed revisions to your documents and contracts.
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01Speed
Typical law firms
3–5 business daysLegalAgent1 business day, as a rule
Issues identified before the specifications are fixed
For contract reviews and routine legal questions, we respond within one business day as a rule. We can start sorting out the issues from a rough picture of the functions or the data items you plan to collect.
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02Fees
Hourly billing
Total unknown at the startLegalAgentScope and fee set before we start
Fees estimated from the number of functions and contracts
We ask about the number of functions to assess, the number of advertising expressions to check, the number of contracts and whether an inquiry to the competent authority is needed, and give you an estimate before we start. Matter-based work is generally on a fixed fee.
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03Deliverables
- Applicability memo
- Advertising revisions
- Privacy policy revisions
- Medical institution contract draft
Findings built into documents and contracts
We deliver a memo setting out our approach to applicability, together with separate proposed revisions to the policy, the advertising and the contracts, divided into units that are easy to check internally.
* Response times are for contract reviews and routine legal questions; they vary by matter.
How it works
The AI Agent organizes the specifications; attorneys judge regulatory applicability
The AI Agent extracts issues from specifications and screen images and drafts proposed revisions; attorneys judge whether a function qualifies as a medical device program or medical practice and whether advertising expressions are permissible.
AI Agentdoes the work
- Organizes functions and data items from specifications and screen images
- Extracts efficacy and effect claims from advertising drafts
- Drafts revisions to policies and contracts and the wording of inquiries
Attorneysmake the judgment
- Assess medical device and medical practice applicability and whether to make an inquiry
- Judge the permissible range of expressions under the PMD Act and medical advertising rules
- Take responsibility for the final revisions and contracts
- STEP 01Understanding the service and the data
We confirm what is provided, the target users, whether healthcare professionals are involved and the types of data collected
List of issues to review
- STEP 02Assessing regulatory applicability
We assess medical device program applicability, medical practice applicability and the permissibility of expressions under the Pharmaceuticals and Medical Devices Act and medical advertising rules, and consider whether an inquiry to the competent authority is needed
Applicability memo and assessment of whether an inquiry is needed
- STEP 03Organizing the policy for reflecting results in data handling and contracts
We review the legal basis for collecting special care-required personal information, contractor management and the allocation of responsibility with medical institutions, and organize the policy for reflecting them
List of revision policies
- STEP 04Building results into documents and contracts
We prepare drafts reflecting the results in the privacy policy, advertising expressions, outsourcing contracts and medical institution collaboration contracts
Full set of draft revisions (privacy policy, advertising expressions, draft contracts and the like)
- Attorneys make the final callAn attorney checks every deliverable and takes responsibility for it.
- Your inputs are not used to train AIOn top of attorneys' statutory duty of confidentiality, we work in an environment where your inputs are not used to train AI.
- An AI Agent built in-houseOur own engineers develop it. Information Security Policy
Use cases
Common requests and what you receive
In healthcare businesses, the applicability of functions, the permissibility of advertising expressions, the legal basis for data collection and contracts with medical institutions may look like separate issues, but they can arise in a chain from a single function design.
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01
You are about to add a new feature to a health management app that assesses physical condition from values such as heart rate or blood glucose and gives advice
If left aloneReleasing a function that may qualify as a medical device program or medical practice without confirming its applicability forces you to respond to administrative guidance or suspend the function
What we doWe review the purpose of the function, the assessment logic and how results are presented to users, and organize the approach to medical device program and medical practice applicability, including considering an inquiry to the competent authority where necessary
What you receive- Memo on function applicability
- Assessment of whether to make an inquiry to the competent authority, and a draft inquiry
- Issue list for revising function specifications
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02
You want to check advertising expressions for healthcare products and services (landing pages, social media and videos) before publication
If left aloneExpressions that appear to guarantee efficacy or the use of testimonials become problematic under the Pharmaceuticals and Medical Devices Act or the Medical Advertising Guidelines, leading to advertising revisions or administrative guidance
What we doFor each expression, we confirm the scope of application of the Pharmaceuticals and Medical Devices Act and the Medical Advertising Guidelines, and organize the range of permissible expressions, necessary notes and whether supporting materials are needed
What you receive- Draft revisions to advertising expressions
- Draft note wording
- Supporting materials checklist
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03
You have decided to add a new feature that links with wearable devices and collects health and medical data
If left aloneCollecting special care-required personal information with inadequate consent and contractor management leaves you behind in reporting and explaining to users in the event of a leak
What we doWe review the types of data collected, the purposes of collection, the consent flow and whether data is entrusted or provided to third parties, and organize the legal basis for collecting it as special care-required personal information
What you receive- Draft privacy policy revisions
- Issue summary for consent screens
- Outsourcing contract checklist
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04
You will enter into a contract to provide services such as online consultations in collaboration with medical institutions and physicians
If left aloneContracting while the division of work and data management obligations are unclear leads to disputes over the scope of responsibility of the medical institution and the service provider when an incident occurs
What we doWe review the collaboration, the division of work, the flow of data and the allocation of responsibility in the event of an incident, and build them into the contract
What you receive- Draft medical institution collaboration contract
- Issue list on the allocation of responsibility
- Internal explanatory materials
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05
Each time a feature is added or advertising is updated, there is no settled internal process for whom to ask and how to confirm regulatory applicability
If left aloneEach check is left to individual staff judgment, causing gaps in checks and inconsistent judgments
What we doBased on past review results, we organize the perspectives to be checked internally and the consultation route
What you receive- Internal check criteria
- Organized consultation route
- Issue list template
Scope of our healthcare, pharma and medical legal support
We show our work on regulatory applicability, data design and contracts, divided into points to review and the documents and contracts in which they are reflected.
- Confirming the regulatory applicability of services and products
- Based on the content of each function, we assess applicability as a medical device program or medical practice and the permissibility of expressions under the Pharmaceuticals and Medical Devices Act and medical advertising rules.
- Assessing medical device program applicability
- Assessing medical practice applicability
- Checking expressions under the Pharmaceuticals and Medical Devices Act and medical advertising rules
- Designing the collection and use of health and medical data
- For health and medical data that may constitute special care-required personal information, we review everything from the legal basis for collection to contractor management.
- Designing the collection of and consent for special care-required personal information
- Organizing outsourcing and provision to third parties
- Collaboration contracts with medical institutions and professionals
- For services in collaboration with medical institutions, physicians and other professionals, we build the division of work and allocation of responsibility into the contract.
- Developing collaboration contracts with medical institutions and physicians
- Organizing an internal check framework
Our approach
What we focus on in Healthcare, Pharma and Medical Legal
In healthcare matters, we focus on the following perspectives.
- 01
Determining regulatory applicability from what each function actually does
Rather than judging uniformly by field, as in "because it is a healthcare app" or "because it is a medical-related service", we review the purpose, assessment logic and method of presentation to users of each individual function, and then organize the approach to medical device and medical practice applicability. Where a definitive conclusion cannot be reached, we present options including an inquiry to the competent authority.
- 02
Reviewing advertising expressions and data design separately
Checking expressions from the perspective of the Pharmaceuticals and Medical Devices Act and medical advertising rules and designing the collection and use of special care-required personal information involve different regulations and different perspectives. We do not treat them as one, but separate the issues of expression from the issues of data flow.
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Contract design reflecting the practices of medical institutions
In contracts with medical institutions and physicians, using a general service agreement template as is may not be acceptable in practice. We consider terms that both sides can readily agree to, taking into account the medical institution's decision-making process and customary remuneration structures.
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Building a framework for rechecking each time a feature is added
Rather than ending with a single review, we organize what should be checked each time a feature is added or advertising is updated and put it in a form that can be reused internally, reducing the burden of each check.
Pricing
Healthcare, pharma and medical legal fees
Because the scope of work varies with the number of functions, data items and contracts to be reviewed, we provide an estimate after hearing the details.
How fees are set
Scope and fee agreed before we startMatter-based work is generally on a fixed fee. For complex or urgent matters, we propose a schedule and an estimate that fit the matter.
First consultation
A free 30-minute online meeting.You can come to us before your documents are in order. Tell us what you know so far.
Free consultationWhat we check before quoting
- The number of functions requiring an applicability assessment (medical device program or medical practice)
- The number of advertising expressions to be checked and the types of media
- The number of health and medical data items collected and the number of contractors
- The number of contracts with medical institutions and professionals and whether negotiation is needed
- Whether an inquiry to the competent authority is involved
Because the volume of work varies with the scope of review and whether an inquiry to the competent authority is needed, we present the final estimate separately after hearing about your matter.
Team & Record
Attorneys who know business practice handle your matters
- Contract reviews and drafts
- 2,000+
- Client companies
- 150+
- Startup legal matters
- 200+
- Legal and investment DD
- 20+
* Approximate figures based on matters handled by our firm; actual figures vary by matter.
Founders · M&A · FundraisingNoriaki AsatoRepresentative Attorney / Founder & CEO / Dai-ichi Tokyo Bar Association
Startup legal · Contract operations DX · Business development experienceTakashi SugaiAttorney / Corporate Legal Practice / Daini Tokyo Bar Association
Intellectual property · Patent disputes · Japan Patent Office secondmentKosuke HirukawaAttorney / Intellectual Property Practice / Tokyo Bar Association
Engineers
Shinya Makita and Sota Miya build our product on the same team as the attorneys.
Practical guides to healthcare and data law
FAQ
Frequently asked questions
Can we also consult you on whether something qualifies as a medical device program or medical practice?
Yes. We review the purpose of the function, the assessment logic and how results are presented to users, and organize the approach to whether it may qualify as a medical device program or medical practice. Where a final determination is needed, we also consider an inquiry to the competent authority.
Can we consult you at the planning stage before specifications are settled?
We can begin the consultation at the planning stage. Even with a bullet-point image of the functions or envisaged data items, we can organize the issues of regulatory applicability and data design at an early stage.
Can we engage you only to check advertising expressions?
We also accept engagements limited to checking advertising expressions. General review of advertising expressions regardless of industry is handled on the Advertising Review page, while consultations centered on issues specific to the Pharmaceuticals and Medical Devices Act and the Medical Advertising Guidelines are handled on this page.
Can we consult you on Act on the Protection of Personal Information compliance in general through this page?
Healthcare-specific design of data collection and use involving special care-required personal information is handled on this page. For consultations on Act on the Protection of Personal Information compliance in general, please also see the Data Privacy page.
Are health foods and food labeling checks also covered?
Labeling checks for food and health foods are handled on the Food Labeling and Advertising Regulation page. Please consult us on this page about issues specific to medical device applicability, medical practice applicability and medical advertising.
Can R&D-driven biotech ventures consult you on intellectual property?
Joint research contracts and intellectual property issues at the R&D stage are handled on the Deep Tech page. This page focuses on assessing the regulatory applicability of services and products, the handling of health data and collaboration contracts with medical institutions.
Do you handle both one-off and ongoing consultations?
We handle everything from one-off consultations on individual functions or advertising expressions to building an ongoing framework for checks each time a feature is added or advertising is updated.
Can we engage you to draft or review contracts with medical institutions and physicians?
Yes. After reviewing the collaboration, the division of work and the flow of data, we build them into the contract, including the allocation of responsibility in the event of an incident.
Contact
Talk to us about regulation of your healthcare service
Please let us know the functions and data items you know of at this point. We can start reviewing even with information at the planning stage.
- A free 30-minute online first meeting
- You can also ask us to draft or review contracts with medical institutions
- You can ask us only to check advertising expressions