14 Mar Private medical prescription, competitive advantages and news 2023
In these days as the main external auditor of private electronic medical prescriptions I help the main computer solutions of medical clinics, podiatrists and dentists to adapt their software to the requirements posedby the collegiate medical organization regarding security and compliance measures that are required for the digital management of private prescriptions among other issues. In this post I want to talk about the main new features introduced for version 1.1. of the requirements as well as the competitive advantages of obtaining this approval.
Private medical prescription, competitive advantages and news 2023
Recently it has been issued from the General Councils of Official Colleges of Physicians, Dentists, Podiatrists and Pharmacists derived from the provisions of article 14 of Royal Decree 1718/2010, a series of novelties that every electronic private prescription solution must meet, changing the main requirements of version 1.0 of the homologation.
Changes in requirements:
FT05: Control measures in relation to the prescription of narcotic and psychotropic medicinal products
This control is modified to clarify that, in each prescription of narcotics, only a single medication can be prescribed and may cover a maximum of the medication required for three months of treatment and without exceeding a total of four containers, in accordance with RD 1675/2012.
This control is also modified to indicate that only a container of psychotropic medicinal substances and preparations may be prescribed and dispensed by prescription and may not be made in the same prescription together with other medicines, in accordance with RD 2829/1977.
Aspects are added to be taken into account in the technical review to be carried out by the auditor in his audit report on these two indications.
FT11: Printing the patient information sheet
This control is modified in its documentary aspect to indicate the obligation to add in the HIP the logo or denomination of the holder of the certification granted by the SREP and issued by the CGCOM.
FD01: Minimum contents of the electronic prescription
This control is modified indicating the obligation to indicate the identification of the patient in accordance with sections 3.2 and 8.2 of RD 1718/2010.
FD02: Electronic signature
This control is modified to clarify the existing electronic signature options to be used in prescribing prescriptions, which are the qualified e-signature, the advanced e-signature based on qualified certificate and the non-cryptographic e-signature.
In addition, technical aspects are added to be verified by the auditor in his audit report, regarding the various types of e-signature that can be used, mainly, in the case of the non-cryptographic e-signature.
SC01: Physician Access to the Electronic Prescription System
This control is modified so that the auditor evidences in his report that technically it is verified in the log of the prescription system the moment and the response of the Central Registry of professionals of the corresponding General Council of the validation of the qualification of the prescriber.
SC01bis: Registration of professional prescribers
This control is created to clarify all aspects related to the registration of the prescriber before the prescription system, which can be (1) in person, (2) telematically by certificate, or (3) remotely using video-identification methods.
SC01ter: Legal relationship of prescribers with the Prescription System
This control is created to clarify what type of relationship is established between prescribers and the prescribing system.
SC03: Patient access to the electronic prescription system
This control is modified to clarify what type of access is allowed to patients when a professional must prescribe an electronic prescription.
IN03: Interoperable verification of electronic certificates
This control is modified to clarify concretely what must be obtained in the verification of an advanced or qualified e-signature, a non-cryptographic e-signature and an electronic time stamp.
PD02: Security measures derived from the confidentiality of the information stored in the Repository
This control is modified to indicate that the documents provided are approved by the company holding the certification.
As I recently commented with some providers of computer solutions for electronic private medical prescription, every day more the patient wants the prescription to arrive by email, wants to go to the pharmacy and that his prescription is there, he wants a series of digital services that without this approval he can not obtain. That is why when a clinic has an approved software, its positioning, its image, its customer-oriented service, etc. improve significantly, since probably its competition either already has it or will have it, in such a competitive business ecosystem every difference is a difference value.
If you are a customer or manufacturer of an electronic prescription solution, ensure that it is approved by CGCOM. As the main external auditor of Spain of this approval, contact me and I will advise you, with my great demonstrable experience, how to obtain this approval, where the key points are, that the Onboarding of the prescriber can be implemented, how the provision of identity is carried out, how the electronic signature of prescriptions is carried out, how we can manage system events, etc.