HealthTech and Digital Health Compliance

Understanding Regulatory Compliance for Digital Health Companies

A guide to navigating SaMD classification, EU AI Act requirements, and health data regulations for software-driven healthcare solutions.

Key regulations

SaMD classification

Software as a Medical Device must be classified according to its intended purpose and risk level. Regulatory pathways differ across the EU, FDA, and international frameworks depending on classification.

EU AI Act

The EU AI Act introduces risk-based requirements for AI systems, including those used in healthcare. High-risk AI applications face conformity assessments, documentation obligations, and ongoing monitoring requirements.

Digital therapeutics

Prescription and non-prescription digital therapeutics face regulatory requirements that vary by jurisdiction, including clinical evidence standards, quality management, and post-market obligations.

Health data regulations

Processing health data is governed by overlapping frameworks including GDPR, HIPAA, and emerging regulations like the European Health Data Space, each with distinct requirements for consent, security, and data handling.

Key compliance challenges

•Determining whether software qualifies as a medical device and navigating classification frameworks that differ across jurisdictions.
•Keeping pace with rapidly evolving regulations like the EU AI Act while simultaneously meeting existing medical device and data protection requirements.
•Managing overlapping compliance obligations across GDPR, HIPAA, MDR, and AI governance frameworks for a single product.
•Building clinical evidence and quality management systems appropriate for software that updates frequently.

Want to stay informed?

Read our latest insights on healthtech and digital health regulatory compliance.

Browse HealthTech articles →