Pharmaceutical Network December 13, following the drug on behalf of the record, 'drug on behalf of the record', face recognition strike three strokes, Shanghai, 'unification party' also out a big trick!
Shanghai Wei Planning Commission requested the deployment of video surveillance related to the position of the party, monitoring data at least for a month!
Yesterday (December 12), Shanghai Municipal Health Planning Commission issued a policy interpretation on "Shanghai Municipality, Regulating the Regulation on Regulatory Information on Drug Use Information System" (hereinafter referred to as the "Regulations").
(Note that this requirement in Shanghai, the proposed 'drug' is included supplies, the exact text can be found at the end of the original text)
Management regulations require that the information monitoring system be set up with video monitoring and monitoring data for at least one month for future reference, and a confidentiality agreement shall be signed for system development and operation and maintenance personnel. The double-disclosure and dual publicity shall be made on the dosage and medication amount, To carry out 'interviews' and other needs of the work.
Control on behalf of the drug
Since last December, CCTV exposure Shanghai, Hunan, six large hospital 'Kickbacks door', Shanghai vigorously remediation medicine Representative of the non-standard behavior.
On August 24, Shanghai Food and Drug Administration issued the Trial Measures for the Registration of Pharmaceutical Representatives in Shanghai (draft for soliciting opinions), which clearly states that it is necessary to administer the filing system for medical representatives. This is also the first special policy document for the pharmaceutical representatives in China.
Prior to this, Shanghai Health Planning Commission also promulgated the "Opinions on Strengthening the Construction of Rebate Governance System for Pharmaceutical Products" (hereinafter referred to as Opinions). The Opinion proposes to regulate the reception of medical representatives, implement the registration and administration of medical representatives, and follow the guidelines of ' There are '(time, place, personnel, records) provisions of the implementation.
In addition to policy supervision, hospitals also have strict precautions against medical representatives.
In March this year, Shanghai Tenth People's Hospital informed suppliers of various types of staff and sales representatives photo archiving, with the back of the face recognition system for monitoring and management.June, the Tenth People's Hospital officially launched trial face recognition system to ' Grab 'medical representatives! Subsequently, the Shanghai First People's Hospital, Shanghai Huashan Hospital and several other hospitals also conducted a similar operation.
Management system side
In general, the illegal "unification" is not a crime committed by insiders in the hospital, or an external attack by a hacker. The regulations promulgated by Shanghai put forward corresponding measures for cracking down on these two measures.
In view of the "inner ghosts", the video surveillance is put forward according to the regulations of management. In view of the hacker's external attack and management regulations, the medical and health institutions should strengthen the network (wired and wireless) access management of the information system involved in medicine, establish the whitelist of access equipment, Access logs, to take effective measures to prevent and prompt illegal access.
In fact, not long ago, more than a generation of drug agents purchased by the hacker 'unilateral' incident, at least 50Famous doctor Drug representatives involved.
According to the information provided by the China Judgment Paper, since December 2009, there have been 128 criminal cases involving the Tongfang involving 15 provinces in China, of which 43 cases were heard in 2014 and 44 in 2016. Visible It was the unspoken rules of the industry to collect the data of 'unification'.
In addition to the introduction of the Shanghai regulations, May 11, the State Food and Drug Administration released "on encouraging drugs medical instruments Innovative Implementation of Drug-related Medical Device Life Cycle Management Policy (Draft for Comment) "(hereinafter referred to as the draft), one of the" three prohibitions "in the draft is the prohibition of" unification. "
Subsequent to the generation of drugs being strictly controlled, illegal access to the 'unification party' has also been strictly controlled. Under policy coercion, compliance restructuring is a priority for medical professionals.
Attachment: medical and health institutions for drug use information system specific management measures
(1) Medical and health institutions shall establish and improve the system of using information systems, determine the statistics of drugs (consumables), make inquiries about the key posts and staff in batches and strengthen supervision and administration;
(2) The medical and health institutions shall strictly manage the examination and approval of the information system medicines (consumables) according to the principle of the minimum quantity and shall authorize and register them according to the principle of the minimum quantity; the configuration of the authority of the information system users shall be examined and the non-working staff of the information system shall be closed Required operating authority.
(3) Medical and health institutions shall review the operation rights of operation and maintenance personnel set up by the information system according to the principle of minimum strength, and the operation rights shall be bound with the operation and maintenance staffs. Two-factor authentication operation and maintenance personnel shall log in to the system.
(4) Medical and health institutions shall continue to improve the functions of software by using 'anti-unification prescription' software (including self-development), keep traces of statistical and batch inquiry operation of drugs (consumables), traces of operation and maintenance of information systems and establish operation log Keep it for at least one year, carry out log analysis on a regular basis, and find out and handle the anomalies in time.
(5) The medical and health institutions shall strengthen the network (wired and wireless) access management of the information system involved in the drug establishment, establish a whitelist for allowing access to equipment, record the access logs of terminals, and take effective measures to prevent and prompt illegal access.
(6) Medical and health institutions shall set up video surveillance equipment for the work points of key posts such as statistical information concerning the drug-related information system (batch inquiry), and keep the monitoring data for at least one month.
(7) The medical and health institutions shall sign a confidentiality agreement with the staff of the pharmaceutical (consumables) statistics and bulk inquiry posts, the development and operation and maintenance departments of the information system and their operation and maintenance personnel.
(8) The medical and health institutions shall establish such systems as the data transfer, data storage and data destruction of drugs (consumables) statistics and batch inquiries.
(I) Medical and health institutions shall improve the functions of information systems. Information system operation and management departments shall, according to the prescriptions of prescriptions, carry out the needs of "double ordering and double publicity" on the amount of medication and the amount of medications to carry out 'interviews' and organize the development of data Sampling and data extraction services.
(10) Medical and health institutions should use information systems to establish a monitoring mechanism for unreasonable increases in medical expenses, with a focus on monitoring of antibiotics, adjuvant drugs and nutrition drug , Expensive drugs at their own expense, information system operation and management departments should provide data to strengthen the management of drug use.
