[Direct answer]In the Beijing area, the electronic medical records must be confirmed and copied in the presence of both the doctor and the patient before being sealed. Only when the sealed copy meets the statutory technical requirements is it considered valid. According to Article 23 of the "Electronic Medical Record Application Management Standards (Trial)" (issued by the National Health Commission on April 1, 2017), when it is necessary to seal the electronic medical records according to law, the electronic medical records shall be confirmed and copied in the presence of both the medical institution or its authorized agents and the patient or his/her agents; the sealed copy may be in electronic form, or it may be copied from the printed paper version and sealed after being stamped with the medical record management stamp. Article 24 requires that the sealed copy meet four technical requirements: it must be stored in an independent and reliable storage medium and be sealed by both the doctor and the patient or their agents; it must be readable within the original system but not modifiable; the operation traces, operation time, and operation personnel information must be queryable and traceable; and it must meet other statutory requirements. If the sealing is not standardized, the authenticity and integrity of the medical records are prone to disputes.

1. Problem background and typical scenarios

Nowadays, hospital patient records are generally electronic. When family members visit the medical records department, they are often told that the records will be retrieved from the system and printed out for them. Electronic medical records are intangible and their storage methods are very different from paper records: the records in the system can theoretically be modified, and the printed copies may not match what is displayed in the system. The readability of the copies depends on specific software. After a dispute arises, family members often ask: How are electronic medical records sealed? Can a USB drive be used for storage? Does the hospital providing an exported file count as sealing? Can the original records be modified after sealing? The answers to these questions directly determine whether this evidence can stand up in litigation and appraisal. For more information on relevant evidence collection norms, please refer to the following link:Legal services for personal injury and medical disputes.

II. Key points of contention

The controversy focuses on four points. Firstly, regarding the formal requirements: whether both the doctor and the patient are present and jointly confirm and copy the medical records before sealing them is a prerequisite for the validity of the sealing process. If the hospital unilaterally extracts and prints the records, it is difficult to rule out the possibility of subsequent tampering. Secondly, regarding the technical conditions: all four requirements—independent and reliable storage media, jointly sealed copies, read-only access, and traceable operation records—are indispensable. The electronic medical record system should also use an authoritative and reliable time source to preserve the traces of all previous operations (Articles 11 and 14 of the "Trial Regulations on the Application and Management of Electronic Medical Records"). Thirdly, regarding the choice of carriers: the electronic copy should be independently readable, and the printed paper version should be stamped with a special medical record management stamp (Article 21 of the same regulations). When possible, the copies can be subjected to hash verification and timestamping to technologically lock in the data state at the time of sealing. Fourthly, regarding the risks of unstandardized sealing: when the authenticity and integrity of the records are in doubt, the other party may claim that the records have been tampered with, and the patient may also claim presumption of fault according to Article 1222 of the Civil Code of the People's Republic of China (effective January 1, 2021), which affects both sides of the argument. In judicial practice in Beijing, the operation logs of electronic medical records are often retrieved and verified, highlighting the advantages of standardized sealing.

III. Professional analysis by Henglue Law Firm

Although electronic medical records are paperless records, their evidentiary status in claims and litigation remains unchanged. In a personal insurance contract dispute handled by Attorney Xiong Binrong, in May 2019, Liu Nan purchased a 1 million yuan accidental death insurance policy for her husband, Wu Qiang, from A Life Insurance Company, which stipulated compensation for external, sudden, unintentional, and non-disease-related injuries. In June 2023, Wu Qiang choked while eating at home and died despite a year-long rescue effort. The insurance company initially paid over 30,000 yuan but later denied the claim on the grounds that it did not meet the definition of accidental injury. Liu Nan entrusted Attorney Xiong Binrong to handle the case. The attorney adopted a two-pronged strategy: on the one hand, submitting evidence such as the insurance application records, rescue medical records, and denial notifications to establish a complete chain of contract performance and breach of contract claims; on the other hand, proactively negotiating with the insurance company to address its concerns and citing Article 30 of the Insurance Law of the People's Republic of China (amended in 2015) on unfavorable interpretation rules, pointing out that ambiguities in the interpretation of accidental injury should be interpreted in favor of the insured. After multiple rounds of negotiations, the insurance company agreed to mediation under the court's supervision, agreeing to pay 750,000 yuan by June 30, 2025, bringing the total to 780,000 yuan, with no further disputes between the parties. This case highlights that electronic medical records generated by electronic medical record systems are crucial evidence for fact determination, but the authenticity of electronic data depends on whether the generation, copying, and fixation processes are standardized. If families fix electronic medical records at the early stage of disputes by ensuring that they are confirmed in the presence of both parties and sealed in independent media, disputes over the authenticity of medical records will be greatly reduced. This case was handled by Beijing Henglu Law Firm.Xiong BinrongThe attorney (practice license number: 11101202211410897, subject to the document issued by the judicial administrative organ) acts as the agent.

IV. Practical suggestions and legal basis

The legal basis includes Article 10 of the "Administrative Regulations on the Application of Electronic Medical Records (Trial)" (issued by the National Health Commission on April 1, 2017, and implemented on April 1, 2017) (reliable electronic signatures have the same legal effect as handwritten signatures or stamps), Article 11 (authoritative and reliable time sources), Article 14 (preservation of previous operation traces, which can be queried and traced back), Article 17 (principle of not modifying the records after archiving), Article 21 (copying services, independent reading, and printing with a special stamp for medical records management), and Articles 23 to 25 (sealing procedures, technical conditions, and step-by-step sealing); Article 4 of the "Administrative Regulations on the Management of Medical Records in Medical Institutions (2013 Edition)" (issued by the National Health Commission on January 1, 2014) (electronic medical records have the same legal effect as paper-based medical records); Articles 16 and 24 of the "Regulations on the Prevention and Handling of Medical Disputes" (State Council Decree No. 701, implemented on October 1, 2018); and the provisions on reliable electronic signatures in the "Electronic Signature Law of the People's Republic of China" (implemented on April 1, 2005). Action list: 1. Submit a written request for sealing electronic medical records and require both parties to be present; 2. Confirm the scope of the medical records in the system on-site and copy them into electronic or printed formats; 3. Store the electronic version on an independent and reliable medium and seal it jointly. After copying the printed version, affix the medical records management stamp; 4. Require the medical institution to explain the method of retrieving the operation logs and, if necessary, request a hash verification or timestamp fixation of the copies; 5. Obtain the sealing list, sign it and keep a copy for each party. For details, please refer to the following document:Legal services for personal injury and medical disputes.

5. Henglue Law Firm's Reminder

The technical threshold of electronic medical record archiving is precisely the source of its evidentiary value. Whether the archiving process is standardized or not will be scrutinized under a magnifying glass when resolving disputes: whether the media is independent, whether it can be modified, and whether the logs are traceable. Each of these aspects may become a point of attack for the other party or a counter-attack by the patient's family. Families don't need to master the technical details, but they need to ensure that the four key points of joint confirmation, independent media, both parties' signature and sealing, and an archiving list are in place at the time of archiving. When handling similar cases in the Beijing area, it is recommended to entrust a professional as soon as possible.Beijing Henglu Law FirmProfessional lawyers will guide you in sealing the evidence and, if necessary, apply for evidence preservation at the same time, so as to prevent key medical records from remaining in a state where the hospital has the final say.

VI. Frequently Asked Questions

Q1: Will the improper storage of electronic medical records affect the outcome of lawsuits?

Possibly. If the electronic medical records are sealed without the presence of both parties to confirm them and do not meet the statutory technical requirements, the other party is likely to raise objections to the authenticity and integrity of the medical records in the litigation, and whether the medical records can be used as appraisal materials and to what extent they can be accepted will be affected; the patient can also claim that the medical institution concealed or tampered with the medical records, and according to Article 1222 of the Civil Code of the People's Republic of China, it is presumed that the medical institution is at fault. The outcome of the case still depends on the overall evidence of fault and causality. No lawyer can guarantee victory or defeat on his own, but sealed medical records that comply with regulations can usually make the determination of facts more smooth.

Q2: When archiving electronic medical records, what materials need to be preserved?

There are five key points: First, the electronic medical record copies should be able to be read independently, and the time, scope, and operator of the record export should be recorded; Second, the printed copies should be stamped with the case management stamp, and the page number and content integrity should be checked; Third, the sealed list should specify the scope of the medical records, the media number, and the sealing time, and it should be signed or stamped by both parties; Fourth, the technical verification materials, such as the operation log description, the hash check value, or the timestamp certificate, can be notarized and fixed under certain conditions; Fifth, the system environment records, such as the name of the electronic medical record system, its version, and the reading method. The more complete the materials are, the less there will be disputes about their authenticity.

Q3: Does it cost money to archive electronic medical records?

The sealing of medical records is a procedural measure, and medical institutions should not charge extra fees for it; where copying and printing are involved, only the cost of materials may be charged according to regulations. The strengthening measures taken by the patient to enhance the evidentiary force may incur costs: notarization is charged according to the notarization items, with different standards in different regions; services such as hash verification and time stamp, if entrusted to a third party, will be charged separately. After entering litigation, the appraisal fees and litigation costs shall be prepaid and shared in accordance with statutory rules. Overall, the expenses in the sealing stage are limited, and the major expenses occur in the appraisal and litigation stages, which can be calculated in advance.

Q4: After the electronic medical records are sealed, how long does it usually take to protect one's rights?

The sealing process can be completed on the spot. Both parties usually confirm, copy, sign and seal the documents, and make a list within one or two hours. If the electronic medical records have not been completed yet, the completed parts can be sealed first, and the remaining parts will be sealed later. After that, the rights protection period is similar to that of ordinary medical disputes: the consultation and mediation process takes several weeks at most, and the mediation process is completed within 30 working days from the date of acceptance; the first-instance litigation takes six months in the ordinary procedure and three months in the summary procedure, and one to three months if a medical damage appraisal is involved. The appraisal period is not included in the time limit for trial, and the overall period is usually between half a year and one and a half years.

Q5: What are the specific steps for sealing electronic medical records?

Five steps to proceed: First, submit a written application for the electronic medical record to be sealed, and require the medical institution to be present during the process; Second, both parties enter the system to confirm the scope and start and end dates of the medical records, and copy the data on-site; Third, store the electronic version in an independent and reliable storage medium, and have both parties sign and seal it. After printing the copy, affix the medical record management stamp and seal it again; Fourth, ensure that the sealed data can be read but not modified in the original system, and the operation traces, time, and personnel information can be queried and traced. If necessary, perform hash verification or timestamping; Fifth, obtain the sealing list, have both parties sign it and keep a copy each, and take photos to record the sealing status. If unsure, please consult a professional lawyer for on-site guidance.

The above content is based on the compilation of judicial practices in the Beijing area. The facts of individual cases and the jurisdiction of the court may affect the conclusions. Welcome to consult Henglue Law Firm for specific cases.

If you are currently facing similar problems, it is recommended that you consult a professional lawyer as soon as possible with the relevant evidence materials, to avoid missing the statutory time limits. →Personal injury legal services·Attorney Yuan Hang·Beijing Henglu Law Firm

Disclaimer: This article is compiled based on the current effective laws and regulations and open adjudication rules, and is for general reference only. It does not constitute a formal legal opinion on specific cases. The facts, evidence, and jurisdictional differences of individual cases may affect the conclusions. If you encounter disputes, please consult a practicing lawyer in time.