Medical device data

Medical device data refers to information generated, captured, transmitted, or processed by medical devices that are used for diagnosing, monitoring, or treating medical conditions. Just about every aspect of patient care inside and out of a hospital setting can be instrumented. This data is often collected and managed by healthcare systems, software applications, or medical device interfaces to support clinical decision-making, patient care, regulatory compliance, and device performance monitoring. Machine data also makes it simpler for medical professionals to analyze both patient and anonymous data across a broader range of geographically distributed regions — for example, to see how certain diseases are affecting a group of people more than another.

Examples of medical device data include the following:

• Physiological measurement data: Data collected by medical devices monitoring a patient's vital signs or other physiological parameters
• Diagnostic imaging data: Images and data generated by diagnostic imaging devices
• Therapeutic device data: Information related to devices that deliver therapy or treatment
• Device operational data: Logs or metadata generated by the operation of medical devices
• Lab and test results: Data from devices that perform laboratory tests or analyses
• Alert and alarm data: Notifications or warnings generated by medical devices
• Wearable device data: Data collected by wearable health devices used for continuous monitoring
• Surgical and procedural data: Data generated during surgeries or medical procedures

Medical device data is subject to stringent regulations, such as FDA (U.S.), EU MDR (Medical Device Regulation), and HIPAA (Health Insurance Portability and Accountability Act), which govern data accuracy, security, and privacy. It is often stored in specialized formats like DICOM (for imaging) or HL7/FHIR (for health records), ensuring interoperability across systems. Medical device data is frequently integrated into healthcare information systems like EHR (Electronic Health Records) and HIS (Hospital Information Systems) for comprehensive patient care.