Last month a bill aimed at facilitating medical research through the use of patient records stored at medical institutions cleared the Diet.

The law, commonly called Jisedai Iryo-kiban Ho — roughly translated as the next-generation medical infrastructure law — will allow medical big data to be pooled anonymously so it can be utilized for research into diseases and the development of new drugs.

Here are some basic questions and answers on the new law, which is set to come into effect by next May.

Why is this law needed?

Despite the nation being ranked the world’s No. 1 for longevity, many people in Japan spend the last 10 years or so of their lives mobility-impaired or bedridden.

The administration of Prime Minister Shinzo Abe is keen to prolong people’s healthy life expectancy and also make the nation’s health care sector a “growth industry.”

Medical records of people who receive care at hospitals and clinics have remained largely untapped due to privacy concerns and the difficulty of handling sensitive data. But the government believes they can be put to better use if they are made anonymous, with the goal of spurring drug development and other medical innovations.

Do researchers have access to medical records now?

Researchers have always studied individual patients, looking at areas such as the effects of drugs and disease conditions, with their consent.

Moreover, all medical fee records, which refer to requests for fee reimbursements filed by hospitals and clinics for procedures performed under the nation’s universal health care system, have been available for research.

But such records, known as reseputo, only provide information on medical procedures that were performed and drugs prescribed, and not on the outcome of the treatment.

“The analysis of ‘input’ information, such as shots, surgeries and prescriptions, has been possible, but data on their outcomes have not been utilized,” said Toshihisa Okamoto, a counselor at the office of health care policy at the Cabinet Secretariat. “The outcome data should be made available for analysis, so each patient can get the best care they need.”

Revisions to the Law on the Protection of Personal Information that came into effect this month have, in fact, enabled the use of clinical records for research without asking for a patient’s consent. But to use such data, each hospital and clinic is responsible for making its data anonymous by deleting patients’ names and other privacy information, which is seen as cumbersome when their primary job is providing health care.

Okamoto said examples of research to be made possible under the new law include a more comprehensive review of the side effects of drugs. Currently, hospitals and drugmakers are required by law to report to authorities severe incidents following the prescription of a drug. But such reports are not comprehensive, as it is ultimately up to each facility to decide which cases to report.

Okamoto said if raw data on a drug’s side effects are made available, it would be possible to better grasp the effect of different drugs, and to compare the harmful data of one drug against other drugs within the same patient group, for example.

How will the framework work?

The new law will allow hospitals and clinics to provide patient data to private-sector companies to be accredited by the state. Such companies will be responsible for making the data anonymous and searchable.

The system is not mandatory, meaning that only hospitals that want to provide such data to companies can. The accredited data companies will store and make patient information anonymous, and will provide them to academic researchers, drug companies or government agencies for a fee, Okamoto said.

Hospitals and clinics that want to provide such information can do so by informing patients beforehand. Patients can opt out if they do not wish to participate, he added.

“The point is that the system is voluntary, and it is not aiming to collect the personal data of 130 million people in Japan,” he said. “Even if it’s a tiny portion of all medical data available, it could be used for research if the amount of information provided is statistically significant enough.”

What type of information will be covered by the law?

All clinical records, including a summary of conditions, prescriptions written by doctors and visual data such as MRI scans, will be included.

One thing to note is that the data must be electronic. Handwritten memos by doctors or health data currently kept on paper — such as the results of health checkups held at schools — cannot be used.

As of 2014, only 34.2 percent of all hospitals and 35 percent of all clinics in Japan kept clinical records electronically, according to the health ministry.

Are there any dangers of personal data leaks?

Privacy protection is key, especially with medical data, which are highly sensitive. Okamoto said the government will start the project small, accrediting only a small number of trustworthy operators.

The Cabinet Office, the science ministry, the health ministry and the industry ministry will jointly screen each of the applications for accreditation, and the accredited data businesses will be required to take numerous measures to prevent data leaks, both through cyberattacks and through thefts of information by employees.

Specifically, the accredited data companies will need to safeguard themselves from possible data theft by employees by having them sign confidentiality agreements and rigidly recording their entry into data rooms, including through security cameras. Employees who violate the regulations will be criminally punished.

To avoid the kind of cyberattacks that led to the leak of 1.25 million cases of personal data at the Japan Pension Service in 2015, the core system that contains a personal information database will also need to be completely separated from the internet, Okamoto said.

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