A number of ophthalmologists across the country provided surgical videos to medical device manufacturers without the consent of patients and received cash. Administrative guidance was given all at once on the 2nd as there was a problem.
It is unusual for the Protection Committee to give guidance to multiple businesses at once, and it is likely to affect the debate over the handling of personal information in medical settings.
In order to solve this problem, several ophthalmologists working at general hospitals across the country, without the permission of patients and hospitals, sent Star Japan, a medical device manufacturer headquartered in Chiba Prefecture, to undergo cataract surgery using this company's lenses. provided videos and received cash.
The Fair Trade Council, which is created by the medical device manufacturer industry, said in July this year that Star Japan paid a total of more than 21 million yen to 75 doctors in the name of providing cash to doctors. In addition to publishing the results of the investigation, the government's Personal Information Protection Commission was also investigating the facts, as videos of surgeries could lead to the identification of patients.
According to the Protection Committee, as a result, all 60 medical institutions nationwide that were the subject of the investigation were
found to have provided videos to manufacturers without the patient's consent, and
▽ medical institutions were aware of the provision of videos. There were problems such as there being no such thing, so
we gave administrative guidance such as calling attention all at once on the 2nd.
Of these, 11 medical institutions were given guidance based on the Personal Information Protection Law together with Star Japan, saying that the risk of identifying individuals was relatively high.
In addition, we alerted all medical institutions in Japan about the video management system through our website.
It is unusual for the Protection Committee to give administrative guidance to multiple businesses all at once, and it is likely to have an impact on the debate over the handling of personal information in medical settings.
Star Japan "Thorough measures to prevent recurrence"
Star Japan said, "We deeply apologize for the concern and inconvenience caused to all medical personnel, patients, and families. We regret the incident and will continue to thoroughly implement compliance and preventive measures to ensure the proper handling of personal information.”
Personal Information Protection Commission "Deepen discussion in the entire medical industry to prevent recurrence"
In response to NHK's interview, the Personal Information Protection Commission said, ``I have to say that this problem was a case of low awareness about the handling of personal information. I would like you to deepen the discussion about this and strive to prevent recurrence.”
On top of that, he said, ``This administrative guidance does not restrict the use of personal information, but rather protects the rights of individuals, and I hope that it will lead to the development of medical care in an appropriate manner.''
What is the Personal Information Protection Law?
The Act on the Protection of Personal Information defines “personal information” as information that can identify a specific individual, such as name, date of birth, and driver's license number.
In principle, the business operator must obtain the consent of the person when providing the acquired "personal information" to a third party.
In particular, medical records of medical institutions are required to be handled with particular strictness as "personal information requiring special care."
Surgical videos may contain information that can identify patients from video and audio, etc. According to the National Personal Information Protection Commission, medical institutions should take appropriate measures based on this law to prevent leaks. Management and employee supervision are required.
The Personal Information Protection Commission has the authority to conduct on-site inspections of business operators, and to issue guidance, recommendations, and orders according to the actual situation.
Furthermore, if the order is violated,
individuals will
be subject to imprisonment with work for up to one year or fines of up to 1 million yen, and corporations will be fined up to 100 million yen.
The Act on the Protection of Personal Information is a law aimed at balancing
the effective use of personal information and the protection of individual rights and interests
as the use of big data advances
. It contains provisions for reviewing content.
There is also a movement to use "surgical videos" for the development of medical care
While complying with the rules of the Personal Information Protection Law, there is also a movement to use surgical videos for the development of medical care.
The National Cancer Center Hospital East, located in Kashiwa City, Chiba Prefecture, has created a database of approximately 3,000 surgical videos using endoscopes with the cooperation of approximately 70 universities and academic societies nationwide
. We are working on
a diagnostic imaging system using artificial intelligence, and
a business that utilizes it as a teaching material for surgeons' operations.
When the endoscope is inserted and removed from the body, the camera of the endoscope may capture information that can identify the patient, such as the doctor's face and electronic medical record data.
For this reason, all of the collected videos are edited to eliminate such reflections, which is called ``anonymous processing'', and the patient's name and hospital name are also deleted from the data.
In addition, all patients have been individually informed of the purpose of this project, and their consent has been obtained in advance to use the obtained data for the company's product development.
Masaaki Ito, deputy director of the National Cancer Center Hospital East, who is the representative of the project, said, "The history of surgical videos is still short, and I think the reality is that discussions on how to handle them are not mature. Efforts are being made not only in surgery but also in other fields at the same time, so I think the government should follow the same direction to develop rules to some extent."
Medical information Efforts to utilize big data Lowest level in Japan
It has been pointed out that Japan lags behind other countries in efforts to utilize medical information such as patient medical records as big data for the development of medical technology.
According to the market research firm Global Information, the global market for medical IT, such as electronic medical records and telemedicine, is expected to reach 18 trillion yen in 2027, and is expected to expand by nearly 50% over the next five years. .
On the other hand, according to a report compiled by the OECD = Organization for Economic Cooperation and Development in 2017, Japan is the subject of a survey in an evaluation that analyzes the penetration rate of electronic medical records and the utilization status of medical information for research and development. It was the lowest level among the 28 countries.
One of the reasons why the utilization of medical information is not progressing is the difficulty of understanding the Personal Information Protection Law.
When providing personal information such as medical records to a third party for the purpose of research and development, etc., it is necessary to clarify to what extent the patient must be informed and obtain consent, and to
delineate the cases in which it is possible to provide the information without consent. It has also been pointed out that there is no proper definition, which is causing medical institutions and companies to shrink their utilization.
Under these circumstances, the Ministry of Health, Labor and Welfare and other organizations have launched a study group aimed at promoting the use of personal information as big data in the medical field, and are proceeding with discussions on reviewing rules and ensuring transparency when providing external information. I'm here.
Expert "Make rules and operate with transparency"
Professor Kaori Ishii of Chuo University, who is familiar with the Personal Information Protection Act, commented on the administrative guidance this time: "There was an ethical problem. If the hospital where I work was not aware of the external provision of doctors, there would also be a problem with safety management on the hospital side."
On top of that, regarding the fact that the Personal Information Protection Commission has alerted all medical institutions in Japan, he said, ``The committee decided that it was necessary to change the mindset of the entire industry, and it was a very important measure. I think it will have some impact," he said.
In addition, regarding the ongoing discussion of reviewing the system to promote the use of medical information as big data, he said, "The Personal Information Protection Law seeks to balance the protection of individual rights and interests and the utilization of information, but it has been decided that In order to improve the quality of medical care, it is necessary to have a framework that allows people to use information with peace of mind, and if medical institutions and other users do not have sufficient awareness, the public will not trust them. It is necessary to create a system and operate it with transparency."