NHK's interview revealed that five ophthalmologists working at general hospitals nationwide repeatedly provided videos of cataract surgery to medical device manufacturers without permission from patients and their workplaces, and received cash. rice field.
The videos of surgery are required to be properly managed by hospitals based on the Personal Information Protection Law, and each hospital, after instructing doctors, said, "The management was inappropriate. I would like to try to prevent recurrence. "And so on.
According to interviews with related parties, five ophthalmologists nationwide have posted a video of cataract surgery using lenses manufactured by this company with "Star Japan", a Japanese subsidiary of an American medical equipment manufacturer. After signing a contract to create it, he repeatedly provided the video and received cash of 400,000 to 1.05 million yen in the three years until last year.
Video of surgery may lead to identification of patients from video and audio, and according to the National Personal Information Protection Commission, medical institutions should properly manage and employees based on the Personal Information Protection Law to prevent leakage. You are required to supervise the personnel.
However, five doctors work at ▽ Obihiro Association Hospital in Hokkaido, ▽ Saishukan Hospital in Aichi Prefecture, ▽ JA Hiroshima General Hospital in Hiroshima Prefecture, ▽ Fukui Red Cross Hospital in Fukui City, ▽ Fuchu Hospital in Osaka Prefecture. The doctor provided the video and didn't know he was receiving the cash.
In response to NHK's interview, the five hospitals instructed doctors and commented, "The management was inappropriate. I would like to try to prevent recurrence."
Five doctors did not agree with the patient, and one of them said, "The video did not contain any personally identifiable data, but I received guidance and attention from the hospital and was very remorseful. I'm doing it. "
Star Japan responded to NHK's interview by e-mail, stating that "we had a program to create teaching materials for surgical techniques using intraocular lenses" and "problems with compliance. We report this to the relevant authorities and outsource the investigation to an external law firm. We take the situation seriously and cause concern and inconvenience to medical staff, patients and their families. We apologize for the inconvenience. We are canceling the program because it is under investigation. "
Expert "Data handling Needs to make visible rules"
Professor Kaori Ishii of Chuo University, who is familiar with the Personal Information Protection Law, said, "The discretion of doctors should not be allowed for the act of providing videos without the consent of the patient. However, in order to prevent the recurrence of cases like this one, I think it will be necessary for each hospital to create visible rules regarding the handling of hospital data, including personal information. "
On top of that, he said that the doctor had received cash from the manufacturer, saying, "Even if the patient agrees to take a video of the surgery, it is expected that the doctor will provide it to a third party for money. It is quite possible that the patient's consent cannot be obtained outside. It is not only a privacy issue but also a doctor's ethics issue. "
Comments from each hospital
Obihiro Association Hospital (Hokkaido)
"There is a possibility of violating the work rules that prohibit the removal of personal information without permission, so we paid close attention to doctors and instructed them in writing. Personal information is included in the video provided to the manufacturer. Even if it wasn't, the medical information of the patients had to be managed appropriately, and the management and supervision of the hospital was not perfect. I think it is necessary to thoroughly prevent recurrence
.
" We decided that it was not appropriate to provide the video to the outside without the consent of the patient, and we paid close attention to the doctor verbally in accordance with the work regulations. The video provided did not contain any personally identifiable information. However, I think that it was necessary to explain to the patient properly and obtain consent, as in the case of using it at academic societies, etc. When providing personal information to the outside, be sure to apply to the hospital and consent to the patient. JA
Hiroshima General Hospital (Hiroshima Prefecture)
"We are considering disposal in light of work regulations. We are responsible for properly managing the personal information of patients, and only the consent of the patient when providing it to the outside." However, approval in the hospital was also required, but the guidance and dissemination to the staff were not thoroughly done. It is not concluded whether the video provided to the manufacturer contained personal information, As a hospital, I would like to consider creating rules regarding the handling of videos of surgery. "
Fukui Red Cross Hospital (Fukui City)
" The work rules prohibit side jobs without permission, and I warned doctors verbally. I take this case seriously. The video provided to the manufacturer did not include the patient's name or ID, but the date and time it was recorded was left behind. The video could be verified by a hospital official searching for it in an electronic charter. , There is a possibility that it may be personal information. I would like to consider what kind of organization is necessary for the storage and management of surgical videos in the future. "
Fuchu Hospital (Osaka Prefecture)
"It was inappropriate for the doctor to provide it to the outside without permission. I believe that the video provided did not contain any personally identifiable information and did not require the consent of the patient. However, it is necessary for the hospital to judge whether the video of the surgery contains personal information, and all hospitals should report it to the hospital when the manufacturer requests it. It is necessary to consider making some rules regarding the handling of surgical videos. "
Manufacturer's comment
"Star Japan GK is entrusting surgeons with a program to create teaching materials for sharing best practices and surgical techniques using intraocular lenses (IOLs) that we sell in Japan. We have come to realize that there may be compliance issues with this program. We report to the Japan Medical Equipment Industry Fair Trade Council and relevant authorities and outsource it to an external law firm. We are investigating this issue. This matter does not affect the health and safety of patients or the treatment by medical personnel. We take this situation seriously and Japanese medical personnel, We apologize for any inconvenience caused to the patient and his / her family. This program has been discontinued due to investigation. "
Video of surgery There is also a movement to follow the rules of the Personal Information Protection Law and utilize it.
There is also a movement to use surgical videos for the development of medical care after complying with the rules of the Personal Information Protection Law.
The National Cancer Center Hospital East in Kashiwa City, Chiba Prefecture, with the cooperation of about 70 universities and academic societies nationwide, collects a large amount of videos of endoscopic surgery to improve medical technology. I am working on a project to build a database to help.
In surgery such as cancer using an endoscope, it is inevitable that information that can identify the patient, such as the doctor's face and electronic medical record data, will be reflected when the endoscope is taken in and out of the body.
For this reason, all the videos collected are edited by what is called "anonymous processing" to eliminate such reflections, and the patient's name and hospital name are also deleted from the data.
In addition, all patients are individually explained to the purpose of the project and have prior consent.
Since the number of videos collected so far exceeds 3,000, ▽ Efforts to make AI learn a large amount of video data and use it for the development of systems that support surgery, ▽ for the production of educational videos Is progressing.
Masaaki Ito, Deputy Director of the National Cancer Center Hospital East, said, "Since the endoscopic surgery video does not show the patient's face or name, it may not be strictly personal information. During discussions with the Center's Institutional Review Board and lawyers, we decided that it was necessary to carefully explain and obtain consent from each patient in order to utilize it in research and industry. "
On top of that, "I think the reality is that the video of surgery is still young and the discussion about how to handle it is not mature. Since the efforts to create a medical database are progressing not only in surgery but also in other fields at the same time. , Shouldn't the country proceed with the development of rules in the same direction to some extent? "
What is the Personal Information Protection Law?
The Personal Information Protection Law stipulates information that can identify a specific individual, such as name, date of birth, and driver's license number, as "personal information".
As a general rule, the business operator needs the consent of the person when providing the acquired "personal information" to a third party.
Above all, medical records of medical institutions are required to be treated with strict strictness as "personal information requiring consideration".
The video of the surgery may contain information that can identify the patient from video and audio, and according to the National Personal Information Protection Commission, medical institutions are appropriate based on this law to prevent leakage etc. It is required to manage and supervise employees.
The Personal Information Protection Commission has the authority to conduct on-site inspections of businesses and issue guidance, recommendations, and orders according to the actual situation.
Furthermore, if you violate the order, you will be punished by imprisonment with work for not more than 1 year or a fine of not more than 1 million yen, and a fine of not more than 100 million yen for corporations.
The Personal Information Protection Law is a law to balance the effective use of personal information and the protection of personal rights and interests while the utilization of big data is progressing. It includes provisions for reviewing.