Solutions advancing healthcare in the US & EU
Healthcare IT is at an inflection point — FHIR mandates, AI medical devices, and cross-border data spaces are reshaping how care is delivered. Here are the solutions trending now.
Market snapshot
Where the US and EU are investing — and the regulations driving transformation.
United States
- FHIR interoperability (USCDI v3 mandate)
- AI clinical decision support (950+ FDA devices)
- Cybersecurity (updated HIPAA Security Rule)
- Value-based care and population health
European Union
- EHDS implementation (cross-border by 2029)
- EU AI Act for medical devices
- Digital therapeutics frameworks (DiGA model)
- NIS2 healthcare cybersecurity obligations
Trending solutions
Six high-impact HealthTech solutions that US and EU providers, payers, and regulators are prioritizing — with market context and what we deliver.
AI Clinical Decision Support
Evidence-based recommendations at the point of care
readiness
AI-powered CDS systems analyze patient data in real time — flagging drug interactions, suggesting diagnoses, and prioritizing care pathways. Hospitals using AI CDS report 30 % fewer diagnostic errors and 22 % shorter time-to-treatment for critical conditions.
FDA has cleared 950+ AI/ML-enabled medical devices (as of Jan 2026). ONC's HTI-1 rule requires certified EHRs to support clinical decision support interventions. CMS value-based care programs incentivize AI-driven quality improvement.
The EU MDR classifies clinical AI software as medical devices requiring CE marking. The EU AI Act designates medical AI as high-risk — requiring conformity assessments, human oversight, and post-market surveillance. EMA's reflections on AI emphasize transparency in algorithmic medicine.
What we deliver
Remote Patient Monitoring (RPM)
Continuous care beyond hospital walls
readiness
RPM platforms connect wearable devices and home monitors to clinical teams — enabling early intervention for chronic conditions, reducing hospital readmissions by 38 %, and improving patient satisfaction scores by 45 %.
CMS expanded RPM reimbursement codes (CPT 99453–99458) in 2024 — 43 % of US health systems now offer RPM programs. The 2024–2030 Federal Health IT Strategic Plan prioritizes 'care anywhere' infrastructure. RPM is projected to reach $117 B in the US by 2027.
The EHDS enables cross-border sharing of RPM data. The European Commission's 2024 Digital Health Strategy calls for scaling telehealth and remote monitoring. Germany's DiGA framework has approved 60+ digital health apps for prescribing.
What we deliver
Digital Therapeutics (DTx)
Evidence-based software as medicine
readiness
DTx products deliver clinically validated therapeutic interventions through software — treating conditions from diabetes and insomnia to substance use disorder and ADHD. The market is growing at 26 % CAGR as regulatory pathways mature and payer reimbursement expands.
FDA's Digital Health Center of Excellence has a dedicated De Novo/510(k) pathway for DTx. Pear Therapeutics' reSET-O and Akili's EndeavorRx set precedents for prescription digital therapeutics. 28 % of US payers now cover at least one DTx product.
Germany leads globally with its DiGA (Digitale Gesundheitsanwendungen) fast-track — 60+ DTx apps available on prescription with statutory health insurance coverage. France (PECAN), Belgium, and Sweden follow with national DTx frameworks.
What we deliver
FHIR-First Interoperability
HL7 FHIR R4 / USCDI / EHDS — seamless health data exchange
readiness
Interoperability is no longer optional. FHIR-based APIs are the standard for health data exchange — mandated by US regulation and foundational to the EU EHDS. We build FHIR-native systems that connect EHRs, patient portals, and public health registries.
ONC's HTI-1 Final Rule mandates USCDI v3 (effective Jan 2026) and FHIR R4 APIs for certified health IT. CMS Interoperability rules require payers to expose member data via Patient Access APIs. 96 % of US hospitals now have FHIR-capable EHRs.
The EHDS Regulation (EU 2025/327) establishes FHIR-based European EHR Exchange Format (EEHRxF) for cross-border data sharing. Priority categories (patient summaries, ePrescriptions, lab results, medical images) must be interoperable by March 2029.
What we deliver
Healthcare Cybersecurity
Protecting patient data and clinical operations
readiness
Healthcare is the costliest sector for data breaches — $10.93 M average per incident (IBM 2025). Ransomware attacks on hospitals doubled in 2024. We deliver defense-in-depth security designed for the unique challenges of clinical environments.
HHS updated the HIPAA Security Rule in 2025 with mandatory MFA, encryption at rest, and 72-hour incident reporting. CISA's Healthcare Cybersecurity Performance Goals (CPGs) guide hospitals on minimum security controls. 86 % of health systems increased cyber budgets in FY 2025.
NIS2 Directive extends cybersecurity obligations to healthcare entities from Oct 2024. The EHDS requires security measures for health data processing. ENISA's healthcare cybersecurity guidelines emphasize supply-chain risk management and incident response.
What we deliver
Population Health & Analytics
Data-driven insights for public health and value-based care
readiness
Population health platforms aggregate clinical, claims, and social determinants data to identify at-risk cohorts, optimize care pathways, and demonstrate outcomes for value-based contracts. Health systems using advanced analytics see 18–25 % improvements in quality metrics.
CMS's ACO REACH and MSSP programs cover 13 M+ beneficiaries in value-based arrangements. USCDI v3 includes SDOH data elements (housing, food security). CDC's Data Modernization Initiative invested $1 B+ in public health data infrastructure.
EHDS secondary use provisions enable anonymized data for research, policy, and public health surveillance. The European Health Data Space is expected to unlock €5.4 B in health data value by 2030. EU Beating Cancer Plan leverages population-level data for screening optimization.
What we deliver
Why health systems choose us
Compliance-native
HIPAA, GDPR, EHDS, MDR, EU AI Act — compliance is embedded in every design decision, not an afterthought.
Clinical context
Our teams include clinical informaticists who understand EHR workflows, care pathways, and the realities of clinical adoption.
Regulatory strategy
From FDA 510(k) to DiGA fast-track to CE marking — we help you navigate the regulatory pathway alongside development.
Ready to build next-gen health IT?
Tell us your clinical and regulatory requirements — we'll scope a HIPAA/EHDS-compliant solution aligned to your care delivery model.