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Telehealth Compliance

Is my health app considered a medical device?

If your app provides diagnosis, treatment recommendations, or monitors specific diseases, it likely classifies as "Software as a Medical Device" (SaMD) and requires regulatory approval. General fitness or lifestyle trackers usually fall under "Wellness" and have lighter regulations.

Can I sell user health data to third parties?

Selling identifiable health data without explicit, informed user consent is illegal under Georgian and international laws (like GDPR). Data usually must be fully anonymized and aggregated before any commercial sharing is permitted.

What are the rules for AI in healthcare?

AI algorithms used for medical purposes (diagnosis, treatment planning) must undergo rigorous validation to prove safety, efficacy, and lack of bias. They are regulated similarly to medical devices and require a robust legal framework for liability.

How do I draft a Privacy Policy for a health app?

A health app's Privacy Policy must be extremely detailed. It should specify exactly what health data is collected, how it is stored, who has access to it, and how users can request deletion, complying with strict data protection standards.

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Telehealth Compliance covers a broader spectrum of digital health than just video consultations with a doctor. This field regulates mobile health applications (mHealth), wearable devices, remote patient monitoring systems (RPM), and AI-based diagnostic software. Unlike classic telemedicine, here we often deal with automated systems and Big Data. Consequently, the legal challenges differ: Is the app a "medical device"? Who owns the data collected by a smartwatch? How to ensure the reliability of a diagnosis made by an algorithm? This service is vital for HealthTech startups, app developers, and medical technology manufacturers.

Specialists on Legal.ge offer specialized services for the legal assurance of telehealth products:

  • Medical device classification: Analyzing whether your app or device is subject to registration as a medical product (Software as a Medical Device - SaMD).
  • User rights and privacy: Drafting Privacy Policies and Terms of Use tailored to the specifics of health data.
  • Data ownership: Defining ownership and usage rights for user-generated data.
  • Advertising and marketing compliance: Legal review of health-related claims to prevent misleading consumers.
  • Artificial Intelligence regulations: Creating a legal framework for the use of AI algorithms in diagnostics and treatment.

Practical examples include fitness apps that start giving "medical advice." If an app tells a user they have a heart problem based on data, this is already medical diagnostics and requires appropriate regulations. Startups often fail to realize this boundary and risk fines for illegal medical practice. Also critical is the issue of data monetization — can anonymous user data be sold to pharmaceutical companies for research? This requires transparent consent mechanisms.

In Georgia, the telehealth sector is regulated by the "Law on Health Care," the "Law on Personal Data Protection," and the "Law on Protection of Consumer Rights." Medical device regulations (based on EU directives) are becoming increasingly relevant for software as well. A lawyer helps you determine which category your product falls into — "Wellness" or "Medicine," which radically changes the regulatory burden.

Working with a specialist begins with a detailed study of the product's functionality. The lawyer assesses risks and helps you modify the product description or features to stay in the "safe zone" or prepare for full medical registration. This process ensures the viability of your innovation in the market.

Legal.ge is the platform where technology meets law. Our experts possess unique experience in the HealthTech field and will help you successfully and legally launch your digital product. Do not put your startup at risk — protect it with the help of professionals.

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