Taking the informational shuttle bus as the most important medical document, the medical record is rapidly becoming electronic. However, the legal risks of electronic medical records are still seriously ignored. Recently, the Beijing Health Law Society Patient Safety Professional Committee and the Peking Union Medical College School of Humanities, China University of Political Science and Law Medical Law and Ethics Research Center, China Hospital Association, Chinese Medical Association Medical Risk Management Committee, Beijing Law Society Medical and Health Law Professional Committee, etc. Conducted research and academic research on the legal evidence qualification and evidence preservation methods of electronic medical records. In view of the legal risks faced in the process of medical record informationization, how to use the necessary technical means to ensure the legal qualifications of electronic medical records, and the results of the research and interviews, the author combed and summarized the opinions of the experts. --editor
The legal status of electronic medical records needs to be clear
As a professional term, electronic medical records are not clear or even confusing. According to the information level of medical records, medical records can be divided into several categories:
1. Writing medical records: refers to the medical records completed by hand, which is the most primitive medical record form.
2. Traditional printed medical records: refers to the medical record form printed on the medical record paper and handwritten and signed according to Article 31 of the Basic Rules for Medical Record Writing, using Word, WPS and other software.
3. Information system printing medical records: refers to medical institutions to establish a dedicated medical record information system and use the system to create, save and manage medical records of medical records, but the system does not have the "electronic signature law" and "electronic medical records basic norms (Trial) and other documents on the qualification requirements of electronic medical records. Such medical records may be very high in the level of information management, and may have all the functional requirements of electronic medical records, but they do not have legal requirements and are still essentially “print medical recordsâ€. According to the requirements of Article 31 of the Basic Rules for the Writing of Medical Records, the information system prints the medical records in time, that is, they are printed and signed immediately after the handwritten medical records are written. However, at present, in most medical institutions, the most common situation is that a complete medical record will be printed when the patient is discharged or died. There is almost no timely printing, and thus there may be legal doubts such as forgery, falsification or no provision. Therefore, some experts also unknowingly call it "pseudo-electronic medical records."
4. Electronic medical record: refers to medical personnel using digital information generated by medical institution information system in the process of medical activities, such as words, symbols, charts, graphics, data, images, etc., and can realize medical records stored, managed, transmitted and reproduced. It fully complies with the legal requirements of electronic data in the Electronic Signature Law and the Basic Norms of Electronic Medical Records (Trial). The electronic version is the medical record of the original legal evidence. The true electronic medical record does not have printing difficulty, and it can be completely paperless because the electronic information itself is the original medical record.
Although medical institutions have invested heavily in electronic medical record systems in recent years, they generally only pay attention to the functions of electronic medical records. Some medical institutions have extremely powerful electronic medical record system functions, but the "reliable electronic signature" and "trusted time stamp" that constitute their legal identity are completely absent. Many hospitals have begun to boldly implement medical paperless programs, but they do not care whether electronic medical records have the original medical records that can be used as legal evidence. As a result, the paper medical records are missing or incomplete, and the electronic data is invalid.
Once in the real era of electronic medical records, certain issues need to be fully valued and standardized. For example, the electronic medical record is the same as the paper medical record. According to the "Basic Specification for Medical Record Writing", it must be printed or sealed for the patient under certain circumstances. The "Electronic Medical Record Basic Specification (Trial)" also has provisions for copying and locking it. However, how the electronic medical records are printed, copied, locked or sealed, the current legal provisions are not clear, and standardized and refined answers are needed, and they are tested in practice to make up for the current laws but not to be detailed at the operational level. The embarrassing situation.
The reason why the Chaoyang District People's Court of Beijing submitted a judicial suggestion letter to the National Health Planning Commission was because the hospital replied in the face of the patient's lock-up request: "We have no lock-up. We don't think we need to lock it. We don't know how to lock it. "This answer is obviously contradictory to the provisions of Article 32 of the Basic Rules for Electronic Medical Records (Trial)", "There should be an electronic medical record in the presence of both doctors and patients in the event of a medical accident dispute," but the hospital also has Hard-working because they have never been told how to lock.
Electronic medical record identification should be "cautious and careful"
The family of Mr. Wang mentioned in the previous article sued the two hospitals in Beijing for medical disputes. The judicial appraisal fee for the authenticity of the electronic medical record was as high as 49,800 yuan. Previously, the unit had requested a price of 500,000 yuan. Based on the high cost of identification, the original and defendant's cross-examination of the electronic medical record in the trial is naturally "cautious and cautious."
Which conditions are suitable for the identification of electronic medical records
First, the parties have prima facie evidence that there is a logical flaw in the paper medical records printed according to the electronic medical records, and there is a possibility of tampering.
Second, the time indicated by the electronic medical record is inconsistent with the completion of the actual medical record or the preservation time.
Third, electronic medical records that have been completed or saved cannot provide traces of modification.
Fourth, the electronic signatures of the medical record input, different levels of signers, and reviewers are not in line with routine medical practice. However, for issues such as inconsistencies, errors, embarrassment, and irregularities in electronic medical records, the people's courts should first solve them through cross-examination, consultation with medical records, and clinical experts and technical experts.
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