Healthcare startups (HealthTech) in Georgia represent one of the fastest-growing yet strictly regulated sectors. Launching an innovative medical app, telemedicine platform, or online clinic requires not only technological readiness but also adherence to a rigorous legal framework. Healthcare is a high-risk area where any mistake can impact human life and health; therefore, legislation imposes strict requirements regarding licensing, data protection, and medical liability. Many startups fail precisely because they do not consider regulatory barriers from the outset, leading to substantial fines or suspension of activities. "Healthcare Startup Compliance" is a specialized service helping innovators navigate the bureaucratic maze and build a legal, sustainable business model.
What does the Healthcare Startup Compliance service cover?
Our service provides full legal support for startups from idea to launch:
- Activity Classification & Licensing: Determining whether your app or service requires a medical activity license/permit from the Ministry of Health.
- Data Protection (GDPR) Implementation: Patient health information is "special category data." We create security policies compliant with Georgian and international standards.
- Telemedicine Regulations: Establishing a legal framework for online consultations and defining rules for remote doctor-patient interaction.
- Contract Package: Drafting Terms of Use, cooperation contracts with doctors, and privacy policies.
- Liability Insurance: Assessing professional and product liability risks and selecting the appropriate insurance model.
Common Scenarios and Needs
Startups often face the following challenges: Booking Platform: An app connecting patients with doctors. The main question is whether this is merely an information service or medical mediation. Diagnostic AI: Artificial intelligence providing preliminary diagnoses. Liability in case of error is critical here. Medical Tourism: A portal connecting foreign patients with Georgian clinics requiring robust international contracts. Online Pharmacy: Remote sale of medications, strictly regulated by pharmaceutical legislation.
Georgian Legislation and Regulations
The sector is regulated by the Law on Health Care and the Law on Licenses and Permits. For telemedicine, relevant decrees from the Ministry of Health are crucial. Regarding personal data, the Law on Personal Data Protection applies, which is particularly strict for processing health data (requiring written consent and high security standards). E-commerce aspects are governed by the Law on E-commerce and the Law on Consumer Rights Protection.
Step-by-Step Process
The process begins with a legal audit of the business model. The lawyer assesses whether the activity falls under a regulated sphere. Then, mandatory documentation (charter, policies) is prepared. If a license is needed, the lawyer prepares an application for the Agency for Regulation of Medical Activities. Concurrently, the website or app is legally set up (checkboxes, consent forms). The final stage involves training doctors and staff on data protection issues.
Why Legal.ge?
Healthcare innovation requires specific knowledge combining medicine, law, and technology. Legal.ge offers lawyers experienced in managing HealthTech projects. We will help you create a safe and legal product that gains the trust of patients and investors. Protect your startup from regulatory risks with Legal.ge.
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