At this breakfast meeting, Mr. Takafumi Ochiai (lawyer), gave a lecture entitled “Medical ICT and related regulations: Case examples from foreign countries and the desired future debate in Japan”

Summary of the Event

■Regulations relating to the use of telemedicine
The promotion of telemedicine is part of the national Government’s Growth Strategy, which is being advanced by the Headquarters for Healthcare Policy and other agencies. The August 2015 administrative circular on the proper use of telemedicine from the chief of the Health Policy Bureau was issued in line with this strategy. The issuance of the circular led to the emergence of doctors and businesses willing to offer telemedicine-based services for patients with chronic diseases being treated in urban areas. Up to now, telemedicine has been regulated under article 20 of the Medical Practitioners’ Act. Physicians have previously made use of only a select few telemedicine models related to matters such as diagnostic imaging. However, owing to the aforementioned circular and the impression it conveyed that it was not necessary for a patient’s first consultation to be done in a face-to-face setting, trends toward the promotion of telemedicine are gaining momentum even in places other than remote localities and outlying islands. In terms of related regulations, there are some cases in which problems are arising pertaining to the Medical Service Act and other regulations, in addition to the Medical Practitioners’ Act.

■ Reimbursements relating to the use of telemedicine
With regard to reimbursements for medical services that make use of telemedicine, in cases where doctors are working with other doctors through teleconferencing, the assisting doctors only receive reimbursements for their services in limited instances, such as when they perform diagnostic imaging. However, in doctor-to-patient cases, telemedicine reimbursements are provided in line with what they would be for face-to-face consultations. In cases where a patient’s first ever consultation with a doctor is performed via telemedicine, patients are not charged any special “first consultation” fees. Moving forward, the Central Social Insurance Medical Council will be examining ways to account for lost “first consultation” fees when calculating the amount of reimbursement in instances where telemedicine is used.

■ Important matters with regard to laws and regulations related to medical services
Medical devices are regulated by the Pharmaceuticals and Medical Devices Act. The extant of this law’s purview is large however, and the actual scope of its applicability may lead to problems when put into practice. It is therefore all the more important to pay heed to the Pharmacist Act, the Pharmaceuticals and Medical Devices Act, and other relevant regulations when prescribing and forwarding medical and pharmaceutical products.

■Regarding the utilization of medical information, data portability, etc.
The revision of the Personal Information Protection Act has clarified the definition of personal information, and has added provisions giving considerable consideration to personal information. Much discussions is now underway regarding the utilization of Big Data and anonymous data information processing in the medical field. The most recent revision of the Act included the formulation of guidelines for the medical field from the perspective of reinforcing the protection of personal information without creating impediments to the practice of medicine. Lawmakers are now working to formulate new research ethics guidelines, lay the foundation for the next generation of medical law separate from the Personal Information Protection Act, and promote the further use of information. Furthermore, we are entering the era in which consumers will be managing and utilizing their own personal information (as can be seen in the discussions people are having related to data portability rights in relation to the European General Data Protection Regulation). Personal Data Stores (PDS), information banks, data transaction markets and other issues are being investigated by the Cabinet Secretariat. 

In addition to the above, Mr. Ochiai also provided explanations on data circulation and utilization, and on the revision of existing laws related to data and the course of action for the improvement of future systems. The lecture was followed by a lively Q&A session.

Exhibition date：2017-03-24