Frequently Asked Questions

A curated, well-defined data collection resource provides a rich repository for all participants. Benefits include:

• A better understanding of long-term trends in a specific patient population
• Improved design and more efficiently populated data that ultimately provides high-quality clinical trials, bringing treatments to patients faster and at lower costs
• More detailed characterization of specific diseases and their biomarkers
• Real-world evidence to support healthcare policy and funding decisions

No. In the past, registries were rigidly designed databases supporting a particular purpose, such as collecting names and addresses or recording complex clinical data. A registry without appropriate structure and endpoints provides limited options for future functionality.

Today, state of the art technology enables registries that start with one function (e.g., a patient portal) to grow as the organization requires. New registry designs that allow for direct data input from patients and clinicians alike are built for the future, and the same platform can be used as requirements evolve and organizations grow. Cloud-based solutions permit access from anywhere in the world, making always-current global registries possible.

There are five important differentiators that Pulse Infoframe delivers to its clientele:

• A single platform containing multiple registries, which provides an overview for different diseases and enables identification of common insights.
• A long-lasting platform with multiple viewpoints, which provide a rich natural history and a wider breadth of data than other registries.
• Easy-to-use analytics, ensuring that data are up to date and available for use.
• Experience in overcoming the challenges of multi-site, international deployment and data collection.
• Clinical relevance and FDA and EMEA compliance; many other registries focus only on administrative information or benchmarking.

Yes! We apply rich security access controls and segregate the application and the data for our clients to prevent physical access to the information. We apply 512 KB digital certificate encryption and SSL for all members accessing the system. Through the healthie™ researcher portal, all data is automatically de-identified, and users can only view their assigned sets of data.

healthie™ supports both Active-Directory- and LDAP-based single sign on and authentication.

Clinicians can directly enter patient-specific data into healthie™. EHR and genomic diagnostic lab interfaces, legacy registries, and other documents can also be uploaded directly. Participants can consent electronically using DocuSign, facilitating signup to clinical trials and studies, and their data can be collected remotely. Longitudinal data can also be collected at your convenience, either scheduled or ad-hoc. All collected data can be exported directly to Microsoft Excel.

We believe that patient privacy and data security are of paramount importance, and security is integrated into all aspects of healthie^™. Patients have access to and can use data they have entered in healthie^™. Registry participants share data for the purposes outlined in a clear and transparent consent form that is digitally available and verified by DocuSign. Patients ultimately have access to their own data and can consent to share their data with providers and other relevant parties.

Our cloud-based platform technology is designed to meet international regulatory data standards. We offer a suite of modular offerings designed to encourage collaboration, deliver real-world evidence insights, enable fact-based decision-making and improve efficiency. Available modules include:

• Patient Engagement Portal: view and update patient information in a user-friendly environment; includes assessment instruments, clinical results, and other educational and engagement tools
• Data Mapping: access the latest OMOP data mapping standards to facilitate ongoing real-world evidence research and analytics
• Research Portal and Analytics: easy-to-use, browser-embedded tools to configure queries, understand registry status in real time, and glean instant insights
• Core Graphical User Interface: interface and workflow are aligned with your specific needs
• Platform Compliance and Security Modules: ensure proper use by authorized users in their assigned roles
• Clinician Portal and Analytics: user-friendly search function, dashboards, workflow and task queues, analytics, scorecards, reporting, and collaboration tools

healthie^™ is a web-based application, accessible through mobile devices, tablets, and desktops. It can also be reached from your preferred clinical system without logging out. No downloadable applets are required.

All functions such as data entry, reading, editing, and printing can be done from any PC on your network (subject to user privileges), including integrated delivery networks.

It can also be re-branded or white labeled to client specifications. Clients retain their own software environment, including web application and database servers, VPNs, and operating system.

healthie^™ is designed to be intuitive and easy to learn. While not required, there are training courses available for those who prefer them or wish to sharpen their skills.

Administrators can build and maintain disease specific surveys with healthie™. There is an internal logic to refer participants to questionnaires based on disease/symptoms, and these questionnaires have advanced branching and question skip logic to find the most complete, accurate data. Participants can view their previously answered questionnaires on the healthie™ platform.

Yes, using the platform, patients may meet one another and compare disease specificities if they so choose. Users also have the option to link their accounts into families.

healthie™ can send custom automated messages to users, including emails, push notifications, and reminders about upcoming events and appointments.

healthie™ requires little day-to-day maintenance. The Pulse Infoframe team performs patch management, backup oversight, periodic log review, and quarterly updates.