What Are Key Compliance Requirements for Digital Health Interoperability?
Digital health interoperability must adhere to data privacy and security regulations to protect patient information as it flows between systems. In the U.S., the Health Insurance Portability and Accountability Act (HIPAA) requires covered entities and business associates to implement administrative, physical, and technical safeguards for Protected Health Information (PHI), conduct risk assessments, and enforce access controls and audit logging. In Europe, the General Data Protection Regulation (GDPR) mandates lawful data processing, explicit patient consent, data minimization, and breach notification. Compliance certification—such as ONC Health IT Certification in the U.S.—validates that interoperability solutions meet these regulatory standards.
Market snapshot
The global digital health interoperability market was valued at $3.24 billion in 2025 and is projected to reach $18.1 billion by 2033 at a 12.6% CAGR. Key drivers include rising healthcare IT modernization, regulatory mandates (e.g., U.S. 21st Century Cures Act), and increasing adoption of telehealth. Constraints involve data privacy concerns, legacy system integration challenges, and fragmented standards adoption. Leading players—Cerner, Epic, InterSystems, and Mulesoft—offer middleware, APIs, and cloud-based platforms to enable end-to-end interoperability solutions.
Regulatory notes
Regulatory frameworks like the U.S. 21st Century Cures Act and EU’s Digital Health and Care Initiative mandate open APIs and prohibit information blocking. The FDA issues guidelines for Software as a Medical Device (SaMD) and interoperability testing, while ONC enforces TEFCA for standardized health information exchanges. Data security regulations—HIPAA in the U.S. and GDPR in Europe—govern patient data privacy. Compliance with these regulations is essential for vendors and providers to achieve certification (e.g., ONC Health IT Certification) and avoid penalties.
Next: See the Biopharma & Life Sciences guide or the full 2025–2033 report for forecasts and detailed methodology.
