How Should Hospitals Return Medical Data to Patients? Insights from Dr. Duan Tao

The ownership of medical data has always been a sensitive and controversial issue.

So, who actually owns medical data?

From the patient’s perspective, medical records generated during hospital visits are not automatically produced; rather, they result from patients’ participation and actions, and thus belong to the patients themselves. Hospitals and physicians, however, argue that although these medical data are not automatically generated, they are obtained through the professional labor of healthcare providers and therefore carry the intellectual property (IP) rights of the hospitals and physicians. Without the involvement of hospitals and physicians, such data would not exist; hence, the data should belong to them. Meanwhile, health insurance payers, as the entities covering costs for both hospitals and patients, contend that ownership of medical data should rest with them.

Synthesizing the perspectives of the three parties, medical data theoretically belongs to the public. However, the current reality is that patients cannot obtain their own medical records unless hospitals voluntarily provide them. The only remaining, albeit extreme, recourse is to file a lawsuit against the hospital to compel the release of such data, in accordance with the legal documents issued by the National Health and Family Planning Commission.

Thus, how hospitals can return medical data to patients has become a widely discussed topic. In response, Dr. Duan Tao, Director of Shanghai First Maternity and Infant Hospital and a prominent figure among hospital administrators, shared his insights and proposed solutions at the “Open Healthcare and Health” special session of the Yunqi Conference, hosted by OMAHA.

In this era, everyone is talking about opening up medical data and returning it to patients. But why are hospitals unwilling to return medical data to patients?

First, although medical data resides within hospital systems, extracting and returning it to patients is a technically cumbersome task, with the entire process being highly complex;

Second, returning medical data to patients carries potential risks. In most cases, if the data is not returned, patients’ subsequent conditions remain unchanged. However, if the data is returned, any emergence of health issues may subject patients to psychological distress driven by health-related anxiety.

Third, misdiagnosis is an unavoidable issue throughout the entire medical care process. Given the current level of healthcare in the United States, misdiagnoses result in at least 100,000 patient deaths annually. If medical data were made accessible to patients, any instance of misdiagnosis could lead to lawsuits, with hospitals typically losing such cases. Courts tend to view hospitals as being in a dominant position—perceiving them as well-funded public entities—while considering patients as individuals. Consequently, awarding compensation of several hundred thousand yuan to patients is often seen as routine and manageable. In more extreme cases, some rulings have granted patients 500,000 yuan to maintain social stability, with 200,000 yuan drawn from a special stability maintenance fund and the remaining 300,000 yuan borne by the hospital. As a result, public hospitals are perpetually placed in a disadvantaged position. Under these circumstances, returning medical data to patients poses significant risks.

From the hospital’s perspective, returning medical data to patients would be cumbersome and pose significant risks and challenges. Moreover, some argue that individual patient data lacks meaningful value and is therefore useless to return. However, this is not the case.

Although discussions on medical big data no longer focus on single data points, such data remain meaningful to patients. Patients have the right to be informed and to access all their medical data, as these constitute their personal information. While individual personal information may seem insignificant in the context of overall big data, it represents “big data” from the patient’s perspective, as they seek comprehensive insights into all health- and disease-related information concerning themselves. The accumulation of health and medical data throughout an individual’s life, starting from birth, forms a personal medical big data repository, which is of considerable importance.

Secondly, once patients have access to their medical data, redundancy and waste can be reduced, facilitating consultations across different healthcare institutions. Shanghai is a pioneer in this field: medical records from all major public hospitals are interconnected, allowing past medical data to be retrieved using only the patient’s visit card when seeking care at any one hospital. However, this openness is limited to exchanges among healthcare institutions—an internal form of sharing—and has not been extended to patients themselves. True openness will only be achieved when patients are able to take their medical data out of healthcare institutions.

However, when returning medical data to patients, the method of return must be carefully considered. The first approach involves providing patients with only the data they need, while de-identified data is shared with third-party platforms. The second approach entails returning all data to the patient first and then sharing it with third-party platforms only after obtaining the patient’s consent. Clearly, the second approach is more cumbersome., butWithout the involvement of third-party platforms, vast amounts of patient data cannot be integrated, causing the data to lose its value.

Currently, the approach adopted in China is collective decision-making, whereby data are shared without consulting patients. The rationale behind this is that if individual informed consent were required for each dataset, the process would be too slow to achieve effective outcomes. Therefore, how best to handle this matter remains open to discussion.

From a practical standpoint, how can hospitals return data to patients? Many may oversimplify the issue, assuming that medical data generated by hospitals is readily usable. In reality, it is far more complex. At times, the accuracy of certain data falls below 50%, and significant portions of patients’ medical histories are missing, rendering such data unreliable for clinical use.

Conclusions drawn from such “dirty big data” are inevitably flawed. However, performing data cleaning to obtain structured, accurate, and scientifically rigorous medical data is no easy task for any hospital. Therefore, under real-world conditions, we must first understand the current situation before making decisions, proceeding step by step.

First, it is essential to understand the composition of a patient’s medical data:

Part 1: Laboratory Results and Reports, Imaging Reports, Urinalysis Reports;

Part II: Objective Medical Records, including the patient's chief complaints and the findings from the physician's examination;

Part III: Subjective medical records; results following physician discussion;

Part IV: Outpatient and Inpatient Medical Records, a series of medical records generated separately for outpatient and inpatient care;

Part 5: Partially Structured, Partially Unstructured Data.

Returning such diverse data to patients in a manner that is comprehensive, systematic, and accurate is not as straightforward as one might imagine. A significant challenge lies in the fact that, within most healthcare institutions in China, objective and subjective medical records are not well segregated; they are typically generated as Word documents, which complicates the process of providing them to patients.

According to Dean Duan Tao, Shanghai First Maternity and Infant Hospital will launch the “Returning Data to Patients” initiative in late October, providing a series of methodologies for this effort.

Step 1: First, return the laboratory and imaging test results and reports. Patients can access all their laboratory and imaging reports via Alipay or WeChat.

Step 2: Return of Outpatient Medical Records. The information contained in outpatient medical records largely consists of personal data provided by patients. Since a significant portion of this content is not fully structured data, the initial approach will be to return the data in PDF document format, transmitted via mobile devices.

Step 3: Gradually convert laboratory and imaging reports, outpatient medical records, and inpatient medical records into structured data, and return all of them to patients via cloud-based implementation.

1. Structuring of patient medical data. China’s electronic medical systems should adopt a standardized Hospital Information System (HIS), similar to the Microsoft Windows operating system; customizing HIS solutions hinders the achievement of data structuring.

2. Data is made accessible via the cloud, but considerations must be given to the extent of access, whether patient consent is required, how cloud-based access should be priced, who will collect the fees, rules governing big data usage, and protection of patient privacy.；

3. Hospitals, particularly hospital administrators, must have the mindset and willingness to enable comprehensive, structured sharing of medical data via the cloud.

Regarding the idea of returning medical data to patients, Dr. Duan Tao also candidly acknowledged that there is resistance, much confusion, and considerable concern. However, as a physician and hospital administrator, one must remain true to the original aspiration, think from the patient’s perspective, and act in a patient-centered manner. Through continuous communication, it becomes evident that the majority of people are understanding and supportive, and that is sufficient.