The typical implementation process for Cardiomatics software:
Account Setup: Register on the Cardiomatics platform and receive login credentials for web-based access.
Integration & Device Check: Verify compatibility with ECG recorders (over 40 supported); no hardware installation is required, as the solution is cloud-based and device-agnostic.
Training & Onboarding: Cardiomatics provides intuitive user interface walkthroughs and free onboarding support for clinicians and technical staff.
Uploading ECG Signals: Clinics upload raw ECG data from Holter monitors or patches to the Cardiomatics cloud for AI-powered analysis.
AI-Powered Automated Analysis: Cardiomatics algorithms process the signal and generate diagnostic reports within minutes.
Quality Review & Access: Reports are automatically available for clinical review and can be accessed or downloaded via the web platform.
Cardiomatics can be customized to fit specific business needs across device integration, data formats, workflow features, and reporting options—though core diagnostic analysis is standardized per medical requirements.
Device Compatibility: Cardiomatics is hardware-agnostic, supporting integration with more than 40 ECG monitoring devices—including Holters and patches—enabling organizations to use existing equipment and scale workflows as needed.
Data Format Support: The software can analyze ECG signals recorded in various data formats, ensuring flexible deployment regardless of which devices or systems are already in use.
Report Customization: Users can customize ECG reports, access raw signal data directly from the report panel, and export bulk data for integration with other analytics or research tools—critical for clinical, research, or administrative workflows.
Integration Options: Cardiomatics can be integrated in multi-clinic networks and large organizations, as seen with deployments at PZU Zdrowie medical centers and university hospital partnerships, facilitating tailored workflows for specific clinical or research use-cases.
Feature Selection: The platform enables the selection or prioritization of diagnostic modules (e.g., arrhythmia detection, atrioventricular block analysis, fast-track urgent reads), allowing clinics to align features with patient populations or institutional requirements.
Workflow Configuration: With real-time cloud access, report notifications, multi-user support, and bulk upload/export functionalities, clinics can adapt platform usage to optimize staff processes and throughput.
API/Cloud Integration: Cardiomatics runs on AWS cloud infrastructure and is positioned for connection with third-party healthcare and research IT systems, maximizing interoperability for tailored digital health ecosystems.
Multi-language and Accessibility: The solution is available in multiple languages and runs on any web-enabled device, allowing global clinics to tailor access for local teams and patient communication.
Cardiomatics offers training and support options for new users, designed to ensure quick onboarding and effective clinical use. Support is tailored for healthcare teams, including clinicians, administrators, and IT staff.
Cardiomatics Academy: Free educational program for universities and clinics, including hands-on training sessions and guided lessons on AI in cardiology; access includes use of Cardiomatics Cloud for experiential learning.
Guides and Tutorials: User guides and online documentation are available, covering topics from ECG upload to interpreting reports and using advanced platform features.
Personalized Onboarding: Clinics and hospitals receive tailored onboarding support from Cardiomatics’ clinical and technical support teams, including setup walkthroughs, best practices, and optimizing workflow for rapid adoption.
Webinar and Video Training: Video tutorials demonstrate software use, workflow integration, and best practices for automatic analysis and report review; suitable for staff at multiple experience levels.
Technical Support: Real-time help via chat, email, or phone is provided for troubleshooting, data upload, or device integration.
Clinical Support: Access to expert clinical advisors for help interpreting complex cases, optimizing report review, and addressing diagnostic questions.
Continuous Updates and Feedback Loops: Cardiomatics collects user feedback to evolve software features and training resources according to user needs.
Cardiomatics employs extensive security measures to protect patient data, meeting both industry and medical regulatory requirements for cloud-based cardiac diagnostics.
Cloud Security and Infrastructure: Cardiomatics leverages AWS (Amazon Web Services) for robust cloud data storage and computational resources, providing encryption, redundancy, and firewall protection to ensure security and uptime.
Data Encryption: All data is encrypted both in transit and at rest, ensuring that sensitive patient information cannot be intercepted or accessed by unauthorized parties.
Medical Device Compliance: The software adheres to IEC EN 60601-2-47:2015 standards for ambulatory ECG devices, covering core medical device safety and data management requirements.
Regulatory Certifications: Cardiomatics holds CE-mark and MDR certification for medical device software, confirming compliance with stringent European health tech data protection laws and safety protocols.
Patient Privacy Regulations: The system is designed for GDPR (EU), HIPAA (US), and other major jurisdictional privacy standards, safeguarding protected health information and imposing strict user access controls.
Access Controls and Authentication: Multi-factor authentication (MFA) and role-based user access help limit data exposure, ensuring only authorized clinical and administrative staff can view or modify sensitive records.
Security Auditing and Incident Response: Routine audits, penetration testing, and a proactive incident response plan are standard, with protocols for notification, remediation, and traceability in case of a breach.
Cardiomatics releases software updates frequently, typically every month, with major feature announcements occurring at least once or twice per year. Updates are managed through its cloud-based platform, ensuring all users benefit instantly without manual installation or downtimes.
Monthly minor updates are typical for bug fixes, security improvements, and optimizations.
Major releases—such as new diagnostic modules, UI improvements, or compliance features—occur several times each year, with communicated changelogs and feature documentation.
As a cloud SaaS, updates are deployed automatically; users always access the latest version by logging in, and no manual installation is needed.
Product teams collect feedback and usage analytics to shape release priorities and drive feature improvements for clinical needs.
Users are notified of significant changes via platform alerts, support channels, or the company’s knowledge base and news section.
Cardiomatics’ policy ensures that healthcare organizations and patients retain data ownership, with robust rights for data access, export, erasure, and portability under GDPR and medical device regulations.
Patient/Provider Ownership: Clinics and healthcare organizations (and by extension their patients) are considered the legal owners of ECG and patient data uploaded and processed through Cardiomatics.
Not Proprietary to Vendor: Cardiomatics does not claim proprietary ownership over clinical data generated or stored in its system—data processed is regarded as belonging to the data controller (the clinic or provider).
Right to Receive Data: Users have the right to receive their personal and patient data in a structured, commonly used, machine-readable format (e.g., for transfer to other software, systems, or providers).
Right to Direct Transfer: Data can be transferred directly to another entity at the user’s request, supporting interoperability with EMRs, HIS, or research databases.
Self-service Export: The Cardiomatics platform enables clinicians to download ECG reports, raw signals, and analysis data for local archiving or transfer at any time.
Data Portability for Research: Clinics can export anonymized patient datasets for research or audit purposes, complying with GDPR portability and scientific collaboration needs.
User Consent: Individuals have the right to withdraw consent for data processing at any time.
Right to Erasure and Correction: Clinics can request deletion or correction of data within the platform, except where retention is mandated by law (e.g., for medical record-keeping).
Cardiomatics offers flexible terms to scale up or down usage and contract scope, allowing organizations to adapt their subscription and feature set as business needs change.
Volume-based Subscription: Contracts can be upgraded to higher volume tiers, supporting more monthly ECG analyses and reports as patient numbers or service lines grow. Plans range from “Core” to “Enterprise” (e.g., 10 reports/month to 500+ reports/month).
Feature Expansion: Clinics can add more features or integrations (e.g., longer maximum ECG signal lengths, advanced diagnostic modules, API support) during the subscription or at renewal.
Data Storage and Turnaround: Higher-tier plans offer extended data storage, faster report turnaround, and customizable branding options for larger organizations.
Seamless Upgrade Path: Upgrading typically takes effect at the next billing cycle or contract renewal; custom terms can be negotiated for large or urgent scaling needs.
Custom Plans: Cardiomatics offers tailored plans for hospitals, research centers, or multi-clinic networks based on specific features, data volumes, or integration requirements.
Downgrade Flexibility: Clinics may reduce their monthly report volume or features (e.g., selecting a lower tier, removing advanced options) at contract renewal.
Prepaid Package Option: Organizations can switch to prepaid credits—useful for unpredictable volumes—to avoid wasted spend.
Cardiomatics offers annual and multi-year subscription contracts, with terms for renewal and cancellation that reflect standard SaaS industry practices. Clinics should always review their organization’s specific agreement for exact provisions.
Annual or Multi-year Options: Subscriptions are available for 1 or 3 years (longer terms may be negotiated directly).
Automatic Renewal: Unless explicitly cancelled before the renewal date, contracts often renew automatically for another term.
Advance Notice Requirement: Most agreements require written notice of cancellation before the renewal date, typically 30 to 90 days prior; failure to notify may lead to automatic renewal.
Negotiable Renewal Terms: Renewal sometimes allows renegotiation of pricing, service scope, or user counts based on usage or clinical needs.
Option for Longer Terms: Custom contract duration and renewal timing can be arranged with Cardiomatics upon request for large clinics or multi-institutional networks.
User-initiated Cancellation: Clinics can terminate at the end of a contract period by submitting a cancellation request within the prescribed notice period.
No refund for unused subscription time: If the software is not used during an active subscription, there is no credit/refund for unused time or credits.
Immediate Termination Rights: Cardiomatics reserves the right to suspend or terminate contracts for material breach, non-payment, unauthorized use, or violation of compliance standards.
Cardiomatics meets extensive compliance standards for medical software, data protection, and device safety, ensuring alignment with global healthcare regulations.
EU MDR Certification: Cardiomatics is certified under the latest European Union Medical Device Regulation (MDR, 2017/745), specifically for AI-based long-term ECG interpretation software, which includes rigorous safety, efficacy, transparency, and post-market surveillance requirements for medical devices.
CE Marking: The software is CE-marked as a Medical Device Class IIa/IIb, demonstrating conformity with EU health, safety, and environmental protection standards.
GDPR Compliance: All data processed on Cardiomatics is protected under the General Data Protection Regulation (GDPR), which governs privacy and security for European patient and healthcare data.
ISO 13485 Quality Management: The platform’s underlying quality management system is certified per ISO 13485, covering design, development, deployment, and support of medical devices.
IEC EN 60601-2-47:2015: Conforms to international standards for safety and performance in ambulatory ECG devices, strengthening clinical reliability and interoperability.
ANSI/AAMI EC57/EC38 Standards: Algorithms validated against standard ECG performance and arrhythmia reporting requirements.
HIPAA Compliance: Cardiomatics ensures data protection practices align with the US Health Insurance Portability and Accountability Act (HIPAA) protocols where required, especially for clinics operating internationally.
