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Medical Records and Tests

Import medical records and lab tests from EHRs into clinical trial databases with automated data validation and PII anonymization.

Solution by Mahalo
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Overview

Mahalo's Medical Records and Tests module is part of the Mahalo eClinical platform, designed for clinical research teams that need to import patient data from Electronic Health Record (EHR) systems directly into their Electronic Data Capture (EDC) environment. It is intended for organizations running clinical trials who want to reduce manual data entry and streamline the integration of real-world data (RWD) with clinical study data.

The platform connects with multiple EHR systems, including Epic and Cerner, without requiring custom integration work for each study. When setting up a clinical study, teams configure which data to retrieve from EHRs, the frequency of data pulls, and how the data maps to study participants.

Patient Experience and Data Collection

  • Patients log into their EHR portal through the eClinical app
  • Patients grant access, enabling the app to retrieve their records
  • Data is automatically pulled into Mahalo's EDC
  • Automatic data pulls can be scheduled on an hourly or daily basis
  • Eliminates errors associated with manual data entry

Data Validation and Formatting

  • Reduces or eliminates the need for source data verification (SDV)
  • Supports configurable rules to check the accuracy of data synced from patient records
  • Checks minimum and maximum values to identify possible data errors
  • Maps units between each connected EHR and the Mahalo EDC
  • Links real-world data to clinical study data

Types of Real-World Data Available from EHRs

  • Medical histories, suitable for both short-term and long-term studies
  • Adverse event records
  • Lab test results
  • Medical diagnostic test results
  • Medical imaging data, including MRIs and CT scans

Data Privacy and Security

  • Data fetched from EHRs is secured using the HL7 FHIR standard
  • Documents and records are scrubbed for Patient Identifiable Information (PII) to maintain participant anonymity

Mahalo Health operates under a range of compliance frameworks, including Good Clinical Practice (GCP), ISO, HIPAA, and GDPR. The platform is part of a broader unified digital health offering that also covers DTx development and a unified data platform.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Integration / Middleware
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GDPRGxPHIPAAICH