In the healthcare sector, rapid advances in digital technology and the growing use of diverse data are driving the creation of innovative services and business models across a wide range of fields, including wellness, medical care, and nursing care. These developments include healthcare applications that utilize personal data, online platforms for medical consultations and medication guidance, and AI-powered medical devices.
These emerging areas are often collectively referred to as Healthtech. However, launching and operating new Healthtech services requires navigating a complex regulatory landscape. In addition to healthcare-specific laws and guidelines, such as the Pharmaceuticals and Medical Devices Act (PMD Act), the Medical Care Act, and the Medical Practitioners Act, businesses must also address legal issues spanning IT, data protection, and intellectual property. Moreover, the volume of applicable regulations, combined with frequent legal amendments and guideline updates, makes it challenging for companies to continuously identify risks and stay up to date.
ZeLo has extensive experience supporting clients in the Healthtech sector, from new business launches and business model design to practical implementation and day-to-day operations. In highly regulated areas or fields where legal frameworks are still evolving, ZeLo’s strength lies in providing end-to-end legal support—going beyond compliance and structuring to include regulatory engagement, rulemaking, and the development of new legal frameworks that enable innovation.
Practice Areas
- Healthcare data use, sharing, and utilization
- AI-driven medical and healthcare services (development and operations)
- Software as a Medical Device (SaMD) development and regulatory support
- Online medical consultation and remote medication guidance platforms
- Online medical institution and pharmacy operations (including online pharmaceutical sales)
- Healthcare-related applications and information websites
- Health management and health promotion applications
- DX and operational efficiency services for medical institutions, pharmacies, and related entities
- Consumer-facing testing and diagnostic services
- Establishment and operation of medical corporations and MS (Management Service) companies
- Advertising and promotional material review (healthcare and medical-related)
Experience
Data Utilization
- Advising on the use of medical and clinical data, including personal information handling, anonymization, and statistical processing
Online Medical Consultation / Remote Medication Guidance
- Launch and operational support for online medical consultation and remote medication guidance services
- Regulatory and operational support for online pharmacy businesses, including OTC pharmaceutical sales
- Feasibility analysis of mobile clinic business models
AI in Healthcare
- Compliance analysis and operational support for AI-powered medical interview services
- Compliance analysis and operational support for AI-assisted medical record creation services
- Legal advisory services for the development and provision of AI-based medical devices
Healthcare Applications and Platforms
- Regulatory and operational support for online medical consultation platforms
- Legal support for exercise guidance and nutritional guidance services
- Medical device classification and regulatory advice for health management and health promotion applications
- Legal and operational support for medical institution reservation and review platforms
Consumer-Facing Testing Services
- Regulatory and operational support for consumer-facing cancer testing services
- Regulatory and operational support for genetic testing businesses
Advertising, IP, and Other Matters
- Review of advertising and representations under the Medical Care Act, PMD Act, Act against Unjustifiable Premiums and Misleading Representations, and related laws
- Legal support for CBD product distribution businesses
- Advisory services for industry–academia collaboration between startups and universities
- Development of guidelines for online veterinary medical consultations and support for related legislative lobbying activities
- IP strategy design and implementation for pharmaceutical and medical device startups, including IPO-focused IP strategies
- Registered Supporter Organization of the Ministry of Economy, Trade and Industry’s Healthcare Innovation Hub, providing legal consultations to healthcare and life science startups
- Recognized as a “Key Private Company Engaged in Medical–Engineering Collaboration” by MEDIC
- Finalist for Healthcare and Life Sciences Law Firm of the Year at the ALB Japan Law Awards 2022
- Speaking engagement by Attorney Akihiro Saotome at Healthcare Marketing Day (hosted by M3, Inc.)
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