Digital Health


What is Digital Health?

The definition of Digital Health varies from author to author, but in general, it can be said that the concept of digital health is that of 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 (21st Century Cures Act). As such, the concept of Digital Health from a regulatory perspective was born. From the FDA's perspective, Digital Health stems from those certain software functions, which encompass a broad scope of categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, as well as personalized medicine. The FDA has several guidance documents related to oversight of medical device software and Digital Health.

Digital Health, from a commercial perspective, has opened up the Medical Device space to new players from other industries, specifically the Tech Industry/Technology Sector. These companies traditionally conduct business related to research development and/or distribution of technology-based goods and services, such as electronics, software, computers, and IT products/services. As computer-based technologies permeate other non-directly related products, hybrid industries such as Digital Health, emerge to offer novel approaches to existing problems. Some of the benefits that can be conferred from the marriage of tech and healthcare are a reduction of inefficiencies, improving access, reducing costs, increasing quality, and individualize medicine.

Some of the new product/service categories that may be considered part of Digital Health are:

  • mHealth
  • eHealth
  • Wireless Health
  • Health 2.0
  • Healthcare IT
  • Quantified Self
  • Telehealth/Telemedicine
  • Precision Medicine
  • Personalized Medicine
  • Connected Health
  • Medical Device Data Systems
  • Interoperability
  • Software as a Medical Device (SaMD)
  • General Wellness



  • Digital Health
  • Cybersecurity
  • Health IT (HIT)
  • Medical Device Data Systems (MDDS)
  • Internet of Medical Things (IoMT)
  • Software as a Medical Device (SaMD)
  • Software as an Accessory to IVDs
  • Connected Medical Devices
  • eHealth
  • mHealth
  • Due Diligence


Our Experience in Digital Health

Our team has industry-leading experience with advanced first-in-class medical devices with significant software components. MCRA offers top quality advice and representation for companies navigating the complex route to market of Medical Device Data Systems, Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), Software as an Accessory to IVDs, Connected Medical Devices, as well as eHealth, and mHealth projects.

MCRA's experience includes:

  • Software
  • Applications
  • Due Diligence
  • Health IT
  • Data Systems