From compliance-driven modernization to AI-first architectures—new twin reports map the next decade of LIS/LIMS transformation on both sides of the Atlantic.
NEW YORK CITY, NY / ACCESS Newswire / October 29, 2025 / Black Book Research today released The State of Healthcare Laboratory Information for Europe and North America, a dual-market analysis that benchmarks how laboratory information systems (LIS/LIMS) are evolving under the combined force of regulation, reimbursement, interoperability mandates, and AI. Together, the reports document a decisive shift from siloed lab software to standards-based, cloud-ready, intelligence-driven platforms operating across national networks and cross-border exchanges.
Why this matters now
Interoperability is no longer optional: it's the law. Europe's European Health Data Space (EHDS) moves interoperability from ambition to legal requirement, placing laboratory data at the center of both primary care and secondary use (research, AI, public health). More than 450 million EU citizens are projected to have EHDS-accessible lab data by 2030, with national funding programs tying procurement to standards compliance (FHIR, SNOMED CT, LOINC).
North America hardens the data backbone. ONC's HTI-1 rule pushes certified health IT toward USCDI v3 by Jan 1, 2026; TEFCA goes live through designated QHINs, shifting labs from bespoke HL7 bridges to national exchange backbones; while PAMA/SALSA volatility forces LIS/RCM alignment to protect margins.
AI exits the pilot stage. In Europe, nearly 30% of hospital laboratories are piloting or deploying AI for QC, sample prioritization, and predictive TAT; vendors with validated pipelines now embed AI directly into LIS dashboards.
Europe: policy-led scale and vendor consolidation
Europe's market is consolidating around vendors that combine EHDS-ready APIs, IVDR compliance, and sovereign cloud options. Our analysis estimates 2025 shares led by Dedalus (21%), followed by CliniSys (14%), CompuGroup Medical (10%), Tietoevry (8%), LabWare (7%), and Siemens Healthineers (6%).
Procurement is increasingly funding-gated: compliance, consent management, and traceability are now prerequisites for public digital investments across Germany (KHZG), France (Ségur/Health Data Hub), the UK (FDP), and Italy (PNRR).
What leading European labs are doing
Baking IVDR dashboards and audit-trail automation into new LIS buys, now present in ~65% of Western Europe procurements and leaning on vendors for workflow digitization services (≈€180M EU-wide).
Moving to localized, sovereign cloud; >70% of public hospital labs in France/Germany/Austria now process lab data exclusively in EU-certified data centers.
Strategic takeaway: Compliance and interoperability have become the go-to-market, not a feature list. Vendors that arrive EHDS-native will capture outsized share as national tenders consolidate buyers.
North America: Lab architecture as strategy
The U.S./Canada landscape is modular by necessity: legacy platforms dominate high-volume centers while cloud-native tools expand in smaller facilities; best-of-breed innovation fills pathology imaging, molecular, vocabulary, QC, and analytics gaps. Winning labs master integration across these layers.
Regulatory fault lines every CIO must engineer for
USCDI v3 & HTI-1 stiffen payload structure (FHIR/CDA) and transparency for decision support-expect LIS/middleware upgrades.
TEFCA shifts result routing toward QHIN hubs-treat interoperability as a national partnership, not a local IT build.
PAMA/SALSA reimbursement resets and MolDX requirements must be automated in LIS/RCM to protect margins.
Benchmarking highlights
First vendor-agnostic scorecards that cut across EHR-embedded, best-of-breed, and cloud-forward models, with category leaders such as Clinisys (core enterprise LIS) and Orchard (community/ambulatory).
Methodology grounded in 808 qualified lab IT users, yielding ~±3.3% precision at 95% confidence for a 25k-lab universe-more than double the minimum needed for ±5% precision.
Five provocative findings for 2026 planning
Funding compliance becomes market access. Expect national and EU tenders to exclude non-EHDS/IVDR-ready stacks, accelerating consolidation and sunsetting HL7 v2-only interfaces.
TEFCA will be the de facto U.S. transport layer for many labs by 2027; the integration premium shifts from "number of interfaces" to QHIN alignment and FHIR eventing.
AI moves from pilots to SLAs. With 30% of EU labs already deploying AI, buyers will begin contracting on validated model performance and governance, not demos.
Digital pathology is regulated IT. Whole-slide imaging has clinical validation; LIS/AP must manage image lifecycle, PACS integration, remote reads, and audit trails at parity with chemistry/hematology.
Revenue resilience = informatics discipline. Reimbursement volatility (PAMA/SALSA) is now a systems problem; LIS + RCM must adapt to edits, Z-codes, and payer rules-or margin is at risk.
Vendor landscape signals (Europe)
Dedalus' multi-country EHR-LIS architecture positions it as the policy-tech leader; CliniSys strengthens pathology/digital imaging; CGM and Tietoevry ride data-sovereignty mandates; LabWare holds hybrid LIS-LIMS strongholds.
What decision-makers should do next
Design to standards, not sites. Build to EHDS/USCDI v3/TEFCA endpoints and FHIR subscriptions, then localize.
Institutionalize data governance. Master catalog/LOINC mapping and consent controls are the new uptime.
Contract for adaptability. Require upgrade paths tied to regulatory milestones and payer edits, not just feature backlogs.
Access the reports
Europe:The State of Healthcare Laboratory Information: Europe (2026)- download link available at https://blackbookmarketresearch.com/register-for-the-2026-black-book-research-report-of-state-of-healthcare-laboratory-it-solutions-europe
North America:The State of Healthcare Laboratory Information: North America (2026)- download link available at https://blackbookmarketresearch.com/the-2026-black-book-report-of-the-state-of-healthcare-laboratory-it-solutions
About Black Book Research
Black Book rankings blend 18 KPIs across product and vendor performance, using a broad, open respondent pool spanning hospital/IDN cores, AMCs, reference, specialty/genomics, public health, and ambulatory labs-delivering a ground-up, user-validated picture of LIS/LIMS performance.
Black Book independently surveys and benchmarks healthcare technology from the client perspective, recognized globally for unbiased methodology since 2005. Media Contact research@blackbookmarketresearch.com • www.blackbookmarketresearch.com
Source documents: The State of Healthcare Laboratory Information-Europe (Oct 2025) and North America (2025-2026). Key figures cited above are drawn from these reports.
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SOURCE: Black Book Research
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