HealthTech

Digital health businesses face a layered regulatory environment that combines general data protection law with health-sector-specific obligations. In the EU, health data is a special category under GDPR, and the European Health Data Space (EHDS) regulation is reshaping how patient data can be accessed and reused. The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) extend to software that qualifies as a medical device (SaMD), including AI diagnostic tools. In Türkiye, the Kişisel Sağlık Verilerinin İşlenmesi Hakkında Yönetmelik imposes additional restrictions on health data processing. In the US, HIPAA remains the baseline, but state-level laws, including Washington's My Health MY Data Act, are significantly expanding obligations.

HealthTech products frequently cross these jurisdictions simultaneously. A remote-patient-monitoring platform sold into EU hospitals, US health systems, and Turkish clinics must satisfy three distinct regulatory regimes for data, device classification, and clinical validation. We map those requirements early in product development, helping clients avoid costly redesigns and regulatory setbacks at market entry. Our team advises on CE marking strategy, FDA digital health pathways, and Turkish TITCK compliance where relevant.

Beyond regulatory compliance, HealthTech companies require robust contractual infrastructure: data processing agreements with hospital and clinic customers, API and interoperability agreements with EHR systems, clinical partnership frameworks, IP ownership arrangements in co-development relationships, and employment and contractor agreements for clinical and technical staff. We handle the full commercial layer alongside the regulatory work.