When it comes to the identity of electronic medical records, there are two key times that cannot be avoided-2002 and 2005. In April 2002, the new "Regulations on Handling Medical Accidents" was promulgated, and there was no mention of electronic medical records. It is clearly stipulated that China implements "inversion of burden of proof" in civil litigation of medical disputes, that is, if a medical dispute occurs, the hospital must produce evidence to prove its innocence.
Medical records are the most critical evidence in medical disputes, so hospitals are more cautious about medical records. At the same time, the Ministry of Health has issued seven regulations that are compatible with the Regulations. Among them, the Basic Specification for Medical Record Writing has made extremely strict and meticulous requirements for medical records, and explained in detail what kind of ink should be used to write medical records, but it has not mentioned anything about electronic medical records. It is a departmental regulation that is completely aimed at traditional paper medical records.
Electronic medical record belongs to the scope of adjustment of Electronic Signature Law. Without this law, the promotion of electronic medical records is unimaginable. But it can't solve all the problems, because there are no laws and regulations specifically for electronic medical records, and it is not easy to operate when it comes to some specific problems.
Since then, there has been no law explicitly written into "electronic medical records" in China, and the legal status of electronic medical records has been pending. Although hospitals all over the country began to use electronic medical records, the lack of "name" ultimately affected the promotion and implementation of electronic medical records.
According to the principle of inversion of burden of proof, in case of dispute, if patients doubt the authenticity of electronic medical records, hospitals should produce enough evidence to prove the authenticity and integrity of electronic medical records.
Nowadays, the electronic medical record system of many hospitals can technically record the traces of modification. Through the system log, the system can accurately record the content and time of modification and who modified it. However, many hospital leaders still have such concerns. The users of the electronic medical record system are hospitals, and both the software and hardware are hospitals. In addition, the burden of proof is reversed. In case something goes wrong, the hospital will be very passive.
At present, electronic medical records have not been legally recognized and guaranteed in China, and there is no unified regulation on their security, especially the inverted burden of proof system. Patients' awareness of law is increasing, which will lead to more medical disputes around the authenticity and integrity of medical records.