healthie 2.0

healthie™ 2.0 is a registry platform developed by Pulse Infoframe Inc., designed to collect and analyze real-world evidence (RWE) for rare diseases, chronic illnesses, and cancers. It functions as a centralized evidence generation solution, built to support organizations managing drug development, post-marketing assessments, and observational research across similar or disparate disease areas.

The platform addresses several challenges in modern life sciences research: the need for a single flexible system that supports multiple research initiatives, the requirement to foster collaboration among researchers, key opinion leaders, patients, and industry partners, and the demand for improved data sources, access, and quality to support ambispective observational studies such as patient journey and natural history data. healthie™ 2.0 operates as a cloud-based system and upholds regulatory, security, and privacy requirements to support worldwide collaboration, including the ability to share de-identified data between diseases or research initiatives through a documented governance process.

Core Platform Features

• Advanced User Experience: Provides an interface designed to simplify workflows for data input, management, and analysis, with support for querying and cohort exploration.
• Data Mapping and Ingestion: Connects to electronic health records, claims data, genomics, and proteomics data across geographies using global data mapping standards including OMOP, mCODE, and CDISC. Data can be mapped according to a data dictionary defined for a specific research initiative.
• Platform Compliance and Security Services: Role-based access and privacy controls ensure the platform is used only by authorized users on an ongoing basis.
• Content Management and Integration: Connects to content management services such as Veeva Vault and SharePoint via API.
• Natural Language Processing: Extracts and structures clinical information stored as free text in notes using an NLP model.
• Research Portal and Analytics: Browser-embedded analytical tools allow users to configure queries, view registry status in real time, and generate insights directly within the platform.

Visualization and Analytics Capabilities

• Analytical tools support biostatisticians, epidemiologists, and medical researchers in selecting data elements of interest and generating visualizations and biostatistical measures, including descriptive statistics.
• Built-in tools enable creation of publication-ready tables and figures.
• Supported statistical functions include mean, median, standard deviation, and minimum/maximum/percentile values for continuous variables, as well as frequencies and percentages for categorical variables.
• Data filtering and stratification are supported within the platform.
• BYOA (Bring Your Own Analytics) support allows users to connect external tools such as Tableau, SAS, or Pentaho to the data repository. All data is regulatory-ready and can be queried using standard SQL.

Extensible Core Data Model

• The H2O core data repository is designed to extend dynamically, allowing data from a variety of disparate sources to connect and evolve together.
• Users can view, analyze, and visualize data based on their specific roles and authorization levels, ensuring access is restricted to authorized individuals.
• The data model is built to accommodate evolving research requirements over time.

healthie™ 2.0 is a cloud-based platform offered by Pulse Infoframe Inc. It supports integration with external content management and analytics systems via API and standard SQL, and is designed to meet regulatory, security, and privacy requirements for global research collaboration.