Great moves from Shanghai! Video monitoring "unified party"

Source: Cypress blue, Dec 13, 2017, medical network: after the three strikes of "drug registration", "drug registration" and face recognition, Shanghai has made great moves for "Tongfang"! Shanghai Health and Family Planning Commission requires that video monitoring be configured for the posts of the parties involved, and the monitoring data shall be kept for at least one month! Yesterday (December 12), the Shanghai Health and Family Planning Commission issued a policy interpretation of the provisions on strengthening the standardized management of drug use information system in Shanghai (hereinafter referred to as the administrative provisions) (note that the "drugs" mentioned in this regulation of Shanghai include consumables For details, see the original regulation at the end of the article.) The management regulations require that the statistical posts of the drug-related information system should be equipped with video monitoring, and the monitoring data should be kept for at least one month for future reference, and a confidentiality agreement should be signed for the development and operation and maintenance personnel of the system, so as to meet the needs of "double sequencing, double publicity" and "interview" for the dosage and drug amount Drug control agency: since CCTV exposed the "kickback gate" of six large hospitals in Shanghai and Hunan in December last year, Shanghai has vigorously rectified the irregularities of medical representatives On August 24, Shanghai food and Drug Administration issued the Trial Measures for the registration and management of medical representatives in Shanghai (Draft for comments), which clearly proposed to implement the record system management of medical representatives, which is also the first special policy document for medical representatives in China Prior to this, Shanghai Health and Family Planning Commission also issued the opinions on strengthening the construction of kickback management system for pharmaceutical products (hereinafter referred to as the opinions), which proposed to standardize the reception of pharmaceutical representatives, implement the registration and filing management of pharmaceutical representatives, and implement the provisions of "three fixed and one have" (fixed time, location, personnel, and records) In addition to policy supervision, hospitals also take strict precautions against medical representatives In March this year, the 10th people's Hospital of Shanghai informed all kinds of staff and sales representatives of the supplier to take photos and file them, and cooperate with the facial recognition system behind to monitor and manage them In June, the 10th people's Hospital officially launched a trial face recognition system to "catch" medical representatives! Subsequently, Shanghai First People's Hospital, Shanghai Huashan Hospital and other hospitals carried out similar operations Generally speaking, the illegal "unified party" is either committed by the insiders of the hospital or attacked by hackers The management regulations issued by Shanghai put forward corresponding measures against both means For "internal ghost", the management regulations put forward video monitoring; for external hacker attacks, the management regulations put forward that medical and health institutions should strengthen the network (wired, wireless) access management of drug-related information system, establish a white list of allowed access equipment, record the terminal access log, and take effective measures to prevent and prompt illegal access In fact, not long ago, several drug agents bought "Tongfang" through hackers, and at least 50 drug representatives were involved According to the information of China judicial document network, since 2009, there have been 128 criminal cases related to the unified party, involving 15 provinces and autonomous regions Among them, 43 cases were heard in 2014 alone, and 44 in 2016 It can be seen that the collection of "unified" data has once become a potential industry rule In addition to the management regulations issued in Shanghai, on May 11, the State Food and Drug Administration issued the relevant policies on encouraging the innovation of pharmaceutical medical devices to implement the full life cycle management of pharmaceutical medical devices (Draft for comments) (hereinafter referred to as the draft for comments) One of the "three prohibitions" in the draft is to prohibit the "unified party" After the drug agency was strictly guarded, the illegal acquisition of "Tongfang" was also strictly controlled Under the pressure of the policy, the compliance transformation is the top priority of the medical personnel Attachment: the medical and health institutions shall establish and improve the use system of the information system for the specific management measures of the drug use information system (I) the medical and health institutions shall determine the key positions and staff for the statistics and batch query of drugs (consumables), and strengthen the supervision and management （2） Medical and health institutions shall strictly manage the authority of statistics and batch query of information system drugs (consumables), authorize and register according to the principle of minimum sufficiency; review the authority configuration of information system users, and close the operation authority limit necessary for non work positions of staff (3) the medical and health institutions shall review the operation authority of the operation and maintenance personnel set up by the information system according to the principle of minimum sufficiency, and the operation authority shall be bound with the specific operation and maintenance personnel; the two factor authentication shall be used to manage the operation and maintenance personnel to log in to the system (4) medical and health institutions shall continuously improve the functions of the software by applying the "Fang Tong Fang" software (including self-development) The traces of drug (consumables) statistics and batch query operations, and the traces of information system operation and maintenance operations shall be kept The operation log shall be established and kept for at least one year The log analysis shall be carried out regularly to discover and dispose of abnormalities in a timely manner (5) medical and health institutions shall strengthen the network (wired and wireless) access management of drug-related information system, establish a white list of allowed access equipment, record the terminal access log, and take effective measures to prevent and prompt illegal access (6) medical and health institutions shall configure video monitoring equipment for key positions such as drug-related information system statistics (batch query), and keep the monitoring data for at least one month (7) medical and health institutions shall sign confidentiality agreements with the staff of drug (consumable) statistics and bulk inquiry posts, the development of information system and the operation and maintenance units and their operation and maintenance personnel (8) medical and health institutions shall establish systems for statistics of drugs (consumables), data transfer for batch query, data storage and data destruction (9) medical and health institutions shall improve the function of information system, and the operation and Management Department of information system shall organize and carry out data sampling and data extraction services according to the needs of carrying out prescription review, carrying out "double sorting, double publicity" of drug dosage and amount, carrying out "interview" and other work (10) medical and health institutions shall use the information system to establish a monitoring mechanism for the unreasonable increase of medical expenses, focusing on the monitoring of antibiotics, auxiliary drugs, nutritional drugs and high priced drugs at their own expense The operation and Management Department of the information system shall provide data support for strengthening the management of drug use.