Digital Health


What is Digital Health?

The definition of Digital Health varies from author to author, but in general, it can be said that digital health is the convergence of health-related sciences and digital technologies to enhance healthcare delivery. The FDA has recently amended the definition of 'device' in the Food, Drug, and Cosmetic Act to exclude certain software functions through the (21st Century Cures Act), and has continued to develop the regulatory framework for digital health technologies. In recent years, the FDA has released several guidance documents, white papers, and proposed regulatory framework outlining their current thinking. 

Digital Health, from a commercial perspective, has opened up the medical device space to new players from other sectors, specifically the Tech Industry. These companies traditionally produce consumer goods and/or conduct business related to research development. As computing and software technologies permeate other sectors, hybrid industries such as Digital Health, emerge to offer novel approaches to existing problems. The marriage of tech and medicine can lead to reducing inefficiencies, improving access to healthcare, improving patient-physician relationship, reducing healthcare costs, increasing healthcare quality, and individualize medicine.

Digital Health includes a wide network of medical devices, clinical tools, and healthcare technologies, such as:

  • Software as Medical Device (SaMD)
    - Mobile Medical Apps
    - Artificial Intelligence (AI)
  • Wireless Medical Device
    - RFID
    - Medical Telemetry 
  • Clinical Decision Support Software
    - Device DC
    - Non-Device CDS
  • Medical Device Data Systems
    - Health Analytics
    - Data Visualization
  • Telemedicine and Telehealth
    - Video Conferencing
    - Streaming Media
    - Mobile Health (mHealth) communication
  • Health IT
    - Electronic Health Records
    - Hospital Network Infrastructure
  • General Wellness
    - Fitness and Health Trackers


Our Experience in Digital Health

Our team has industry-leading experience with advanced first-in-class digital health medical devices. MCRA offers top quality advisory and representation for companies navigating the evolving regulatory framework for digital health medical devices, 

MCRA's Digital Health services include:

  • Full Service Regulatory Program Support
  • Strategy and Advisory
  • Digital Health Regulatory Policy Assessment and Advisory
  • Test Plan Development and Review
  • Documentation Development and Review
  • Regulatory Submission Development and Review
  • Risk Assessment Development and Review
  • Market Pathway Strategy 
  • Medical Device Cybersecurity Risk Assessment, Strategy, and Advisory.