Among the texts published in Tunisia Republic’s Official Journal on April 12, 2022, is a presidential decree outlining the general requirements for the practice of telemedicine and the areas in which it may be applied.
The new presidential decree seeks to build a regulatory framework for telemedicine, which has exploded in popularity during the pandemic.
Here Is What You Need To Know
- Under the new law, code-named Decree 2022–318, the operations of telemedicine in Tunisia is now subject to prior authorisation from the Ministry of Health, after due consideration of an evaluation committee, in addition to and authorization granted by the national authority for the protection of personal data (INPDP) in Tunisia.
- The Ministry of Health must respond to permit requests within 90 days after receipt of a complete file.
- In the event of a refusal, the refusal must be in writing and justified.
- The telemedicine platform must also be used pursuant to an agreement between the platform’s owner and the physician or dentist in question. For physicians and dentists in private practice, the agreement must be approved by the appropriate professional organization. The agreement must be endorsed by the relevant sectoral ministry for physicians and dentists practicing in the public sector.
- The application for authorization to establish the telemedicine platform must include a full description of the user fees that will be charged to various user categories. The charges associated with the platform’s utilization are established in such a way that health practitioners have fair access to telemedicine services regardless of the number of procedures conducted.
- There are no expenses associated with utilizing the telemedicine platform’s pharmacists to ensure the delivery of medications based on electronic medical prescriptions.
- Telemedicine for patients residing abroad must be disclosed in advance to the responsible departments of the Ministry of Health and the relevant professional orders.
- Under no circumstances may the telemedicine platform be used as a vehicle for advertising health items or as a means of guiding patients to any health service provider.
- The data processed in the context of telemedicine acts must be housed and stored in Tunisia, either through a cloud service provider or locally, in line with applicable legislation and regulations regarding computer security and personal data protection.
- Telemedicine data must be quickly transferred and saved in the patient’s electronic medical record in a central database maintained by the Ministry of Health’s technological services. The data processed in the course of telemedicine activities performed in organisations and enterprises under the Ministry of National Defense are hosted, saved, and transferred via a dedicated database.
- Pharmacists who own retail pharmacies may dispense medicines to the public, except for those listed in Table B and psychotropic drugs subject to the Ministry of Health’s control, through the use of an electronic medical prescription and a secure information system that ensures the protection, security, and reliability of documents and personal data in accordance with applicable law.
- All information connected to the act of telemedicine must be traceable, and personal data must be retained for at least ten (10) years. These records must be accessible, with the patient’s or legal guardian’s approval, in the event the patient contacts another doctor to undertake a telemedicine act.
- Interoperability, transfer, exchange, and reversibility of acquired data, within the framework of a standard that enables their use by other responsible professional structures and/or other duly authorized platforms.
- Before performing any act of telemedicine, the patient’s or, where applicable, his legal guardian’s free and informed consent must be sought, after informing him of the necessity, the interest, the consequences, and the extent of the act, as well as the means used to carry it out.
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Charles Rapulu Udoh
Charles Rapulu Udoh is a Lagos-based lawyer, who has several years of experience working in Africa’s burgeoning tech startup industry. He has closed multi-million dollar deals bordering on venture capital, private equity, intellectual property (trademark, patent or design, etc.), mergers and acquisitions, in countries such as in the Delaware, New York, UK, Singapore, British Virgin Islands, South Africa, Nigeria etc. He’s also a corporate governance and cross-border data privacy and tax expert.
As an award-winning writer and researcher, he is passionate about telling the African startup story, and is one of the continent’s pioneers in this regard. You can book a session and speak with him using the link: https://insightsbyexperts.com/view_expert/charles-rapulu-udoh