A global leader in the medical device industry faced a complex challenge in advancing its Digital Health Initiative and obtaining approval for its cutting-edge medical devices, navigating the intricacies of the highly regulated and technically demanding medical device industry. Seeking a partner with expertise in Digital Health and Medical device domains, the medical device company turned to York for technical assistance and services.
Technology
Scope
Empowering Success: York’s Dual Application Solutions
York met the organization’s needs with two vital applications: a web-based clinical study administration tool for clinicians and administrators, and a mobile app for patient engagement. The latter gathered clinical data through user interactions, sensor inputs, and Bluetooth connections with medical devices. Ensuring the utmost security for health information, all data, treated as Highly Personal Information (HPI), was encrypted in transit and at rest. FHIR protocols and APIs were utilized, storing device and clinical data in Amazon HealthLake. Authentication was handled by Amazon Cognito, while York implemented a custom role-based permissions system for safeguarding sensitive data and accommodating diverse user roles.
