15 May Other approved private electronic medical prescription software
When we talk about electronic private medical prescriptions, we are talking about security in the confidentiality, integrity and availability of medical prescriptions that are generated in private clinical environments, fundamentally. Whether the doctor prescribes for a third-party clinic or is a “pure private doctor” where he prescribes in his own office, we are faced with the need to obtain this approval that guarantees the use of secure software. I have recently been able to collaborate as an external auditor in yet another solution on the market that has obtained approval.
Other approved private electronic medical prescription software
Having collaborated with the majority of electronic medical prescription software that has obtained approval and as the main private electronic medical prescription auditor in Spain, I have the great honor of having collaborated with a new solution that has recently obtained this approval.
Generally, my work as an external auditor is also as an advisor, collaborating on my own methodology and documentation that I deliver to my clients, accelerating this process as much as possible. Specifically, I want to name the 4 phases that I find in the entire process of homologating private electronic medical prescriptions.
Phase 0. Training and advice
With my own documentation, the result of the work carried out since 2017 in this area, I deliver material for my clients and train, as an external consultant, in the requirements that they must implement and carry out properly with the regulations. Specifically, issues such as the Onboarding of the doctor, if he is “purely private” or collaborates with a third entity, issues of digital signature or sealing, use of electronic certificates, electronic DNI of the doctor or patient, drug treatment, prescriptions of special confidentiality , integration with Nodofarma, data protection, patient information sheet, cybersecurity and/or information security, integration with authorization of the collegiate, etc. are issues that we discuss with those responsible for the product and its technical team so that, point by point , my clients know what they should implement and where are the key or delicate points to take into account, including a complete checklist that I give to my clients.
Phase 1. Phase 1 audit.
Phase 1 of the audit consists of, once the client confirms that everything is developed and implemented, I request all the relevant documentation that demonstrates this evidence. With all this material and my checks, my client presents Phase 1 of the audit, which, as I often say, is similar to an “application” to obtain approval. In my document I assure that I have evidence and capacity to demonstrate that this software is ready to obtain approval.
Phase 2. Phase 2 audit.
Once the WTO confirms that it has approved the “candidacy”, we move on to phase 2. In this phase, similar to how I do my job as a judicial expert, I capture all the necessary evidence to demonstrate in detail to the WTO that the software complies with all the requirements. Once we have collected evidence of all the control points, my client submits my phase 2 report and all the material collected that faithfully evidences compliance.
Phase 3. Corrections
Given that the requirements and controls to obtain approval are many and require important detail to pass the final audit of the WTO, issues to be corrected usually arise, both requests for expansion of evidence and, on some occasions, corrections of controls.
Once these phases have been completed, my clients obtain the long-awaited homologation that ensures their compliance.
If you are a developer of a private electronic medical prescription software solution, oriented towards general medical prescriptions, dentistry or podiatry sector, you are affected by this homologation. Contact me when you want to receive more information about it.
Luis Vilanova Blanco. Spain’s main auditor of electronic private medical prescriptions.