Download The 2025 Black Book Report of The Middleware Mandate

Healthcare’s data economy is being redefined at the middleware layer. In its September 2025 report, Black Book Research captures how interoperability platforms, APIs, repositories, and gateways have become the control plane for compliance, ROI, and AI readiness. With 2,484 validated survey responses from provider, payer, and national health system leaders across the U.S., Europe, Canada, APAC, and the Middle East, this 90-page study sets the first comparative benchmark for middleware vendors under TEFCA and EHDS.

What You’ll Learn

Global & Regional Rankings

• Comparative performance of 53 middleware and interoperability vendors
• KPI-driven benchmarking across U.S. (TEFCA readiness), Europe (EHDS compliance), and Rest of World initiatives

Adoption & Market Trends

• 72% of organizations expanding interoperability in 2025 report their largest new IT spend is middleware—not EHRs.
• TEFCA’s network-of-networks: 44% of U.S. buyers actively onboarding with QHINs.
• EHDS law drives Europe: 71% of EU buyers cite compliance as their #1 filter for 2026.
• APAC systems hit ROI in a median 16 months; Gulf states lag at 23 months.

Vendor Archetypes & Differentiators

• Speed Leaders (e.g., Redox, Smile Digital Health): onboarding in 6–8 weeks, ROI under 12 months
• Compliance Anchors (e.g., Health Gorilla, Dedalus, InterSystems): regulatory credibility for TEFCA/EHDS
• Legacy Bridges (e.g., Lyniate, InterSystems): still vital for HL7v2-heavy environments, but lagging in FHIR maturity
• Global Cloud Backbones (Microsoft, AWS, Google): scale and analytics, but challenged on sovereignty and cost predictability_399U28_Middleware Report Sept 2…

KPI Insights

• Onboarding speed is the single most predictive KPI for ROI: ≤8 weeks correlates with 2.3× higher chance of ROI <18 months.
• Consent granularity lags in U.S. (32%) but leads in APAC (52%).
• FHIR coverage now a procurement filter: leaders support 80–90% of resources; laggards under 40%.

Strategic Guidance

• TEFCA alignment is becoming a baseline procurement requirement in the U.S. by 2026
• EHDS compliance is shifting from guidance to law in Europe—vendors without dataset roadmaps risk exclusion
• Middleware maturity is now a proxy for AI readiness, accelerating deployment of predictive analytics and secondary-use research

Who Should Download

• Hospital & Health System Executives navigating interoperability investments
• CIOs, CMIOs, Compliance Leaders managing TEFCA onboarding and EHDS mandates
• National Program Leaders & Policymakers designing digital health infrastructures
• Investors & Advisors tracking middleware’s role as healthcare’s strategic control plane

About Black Book Research

Black Book Research is healthcare’s leading independent benchmarking source, trusted globally since 2011. With over 2.5 million technology users surveyed across 18 KPIs, Black Book delivers unbiased performance data on vendors, services, and digital infrastructure. Our mission is to equip providers, payers, policymakers, and investors with intelligence that strengthens healthcare through smarter, safer technology