Trusted Platform, Protecting Data and Empowering Care
How Etiometry protects patient data and meets the regulatory and quality standards hospitals depend on.
Request Demo Contact Us
Data Ownership and Governance
Etiometry processes data that provides:
- Clinical decision support
- Quality improvement
- Reporting capabilities
Including more than 150 million hours of de-identified physiologic data governed by the hospital’s Master Services Agreement and applicable Data Use Agreement.
Access Controls & Identity Management
Etiometry supports role-based access controls that enable hospitals to manage user access based on clinical roles and responsibilities including enterprise authentication, single sign-on (SSO), and integrations with leading EHRs (including SMART-on-FHIR).
Access patient data, physiologic trends, and risk indices from:
- Central monitoring stations
- Remotely from home via VPN
- Bedside workstations
- Workstations on wheels
Security, Compliance & Regulatory Clearances
Etiometry is a regulated medical device company with 11 FDA 510(k) clearances, including clearances meeting FDA Section 524B cybersecurity requirements, CE Mark certification (EU MDR), Health Canada licensing, UAE licensing, and Saudi Arabia licensing. The company is ISO 27001 certified, supports HIPAA compliance, and undergoes independent security audits to help protect patient data.
Supporting Quality Improvement & Research
Etiometry’s Quality Improvement Application provides access to a searchable, de-identified clinical database that has supported 170+ quality improvement initiatives and clinical research studies.
Get your custom view.
Tell us what’s important to you and we’ll prepare a demo that aligns to your goals.
FAQ
The hospital retains ownership of its patient data. Etiometry securely processes the data to provide clinical decision support, quality improvement, and reporting capabilities, while the hospital maintains access to its data in accordance with the terms of the agreement.
Etiometry has accumulated more than 150 million hours of de-identified physiologic data, which has been used to develop and validate its risk algorithms and support ongoing research and quality improvement initiatives. Any use of de-identified data is governed by the hospital’s Master Services Agreement and applicable Data Use Agreement..
Yes. Etiometry supports role-based access controls that enable hospitals to manage user access based on clinical roles and responsibilities.
Etiometry also supports enterprise authentication and single sign-on (SSO) through integrations with leading EHRs, including SMART-on-FHIR where supported, allowing hospitals to leverage their existing identity and access management infrastructure.
Etiometry is a regulated medical device company whose platform has received multiple FDA 510(k) clearances, CE Mark certification under the European Medical Device Regulation (MDR), and Health Canada licensing. Etiometry achieved ISO 27001 ISMS certification and is compliant with the SOC 2/HIPAA Trust Services Criteria for managing its Information Security Management System, undergoing third-party operational audits, and signing Business Associate Agreements to protect health data.
Etiometry’s tenth FDA 510(k) clearance (K241479), received in February 2025, incorporated cybersecurity requirements aligned with FDA Section 524B, demonstrating compliance with the FDA’s cybersecurity expectations for connected medical devices.
In addition to the 10th clearance, we have the 11th clearance under Section 524B(c) of the FD&C Act. During the last two FDA reviews, the Etiometry Platform was identified as a “cyber device” under Section 524B(c) of the FD&C Act (December 29, 2022). The currently cleared Etiometry Platform received FDA 510(k) clearances under K241479 on Feb, 12, 2025, and K254066 on April 3, 2026.
Etiometry achieved ISO 27001 ISMS certification and supports HIPAA compliance through administrative, technical, and physical safeguards designed to protect protected health information (PHI). Specific security controls, including encryption, access management, audit logging, incident response, and Business Associate Agreement (BAA) provisions, are documented as part of Etiometry’s security and compliance program and made available during the customer onboarding and security review process.
Yes. Etiometry is a secure, web-based platform that enables clinicians to access patient data, physiologic trends, and risk indices from bedside workstations, workstations on wheels, central monitoring stations, or remotely from home via VPN, subject to the hospital’s IT and security policies.
Etiometry also supports seamless single sign-on (SSO) through EHR integration, allowing authorized users to launch the platform directly from the EHR without a separate login where supported.
Yes. Etiometry’s Quality Improvement Application provides hospitals with access to a searchable, normalized database of de-identified clinical data that supports quality improvement initiatives, clinical research, and academic collaboration. The platform has informed more than 150 million hours of de-identified patient data and has supported over 170 quality improvement initiatives and clinical research studies.
Hospitals may access and use their de-identified data for research and external academic collaborations, subject to applicable institutional policies and IRB requirements.