Starting an office or facility isn't as simple as placing a sign and starting to receive patients. Health regulations establish a series of procedures and obligations that doctors, nutritionists, dentists, physiotherapists, psychologists, cosmetologists, spas and many more professionals must comply with in order to operate legally. Failure to do so may face fines, closures, or even the inability to exercise.
If you are a health professional and are about to open your own office or clinic, this article will guide you to the procedures necessary to comply with health regulations.
It is very important to emphasize that each procedure must be adapted to the particular establishment and practice, so the following information represents, in a general way and in no specific order, what we must all comply with:
At least thirty days before starting operations, it is mandatory to carry out the procedure for Notice of Operation and Health Responsible Before the COFEPRIS (Federal Commission for Protection against Health Risks). This document notifies the authority of the existence of the office or establishment and guarantees that it meets the basic operating requirements.
Every medical consultation involves the management of sensitive personal data, such as medical history, study results and treatments. To protect patient information, it is mandatory to have a Privacy Notice in accordance with the Federal Act on the Protection of Personal Data Held by Individuals.
Some information you should include:
If you think promote your health services individually on social networks or any other means of dissemination, you must process a Advertising Notice before COFEPRIS.
If you don't process it, the authority can order you to Suspension and cancellation of all your advertising within a period not exceeding 24 (twenty-four) hours.
Carry a Clinical Record is mandatory and must comply with the NOM-004-SSA3-2012. This document is key to keeping a detailed record of the patient's evolution and legally protecting the health professional in the event of complaints.
It is an extremely important legal support for any type of conflict with the patient, as well as a medical obligation that must, yes or yes, be fulfilled.
For an office to be considered safe and functional, it must meet, among others, the requirements established in the NOM-005-SSA3-2010, which regulates the infrastructure conditions, equipment and sanitary measures of facilities for outpatient medical care.
We must remember that COFEPRIS is entitled to visit your office, and if you do not meet the specifications contained in this standard, you may face a Final closure and, therefore, the paralysis of your operations and professional practice.
Conclusion
Opening an office or providing health services in Mexico involves more than just medical knowledge; it is essential to comply with health regulations to avoid sanctions and ensure patient safety.
In Rodriguez, Manzano & Garcia Lawyers we are specialists in health and regulatory law. If you need advice to process your Operating Notice, Advertising Notice or any other legal requirement, contact us. We ensure that your office complies with all regulations so you can practice without worries.
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