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 New Era of Medicine demands digitization of most of the aspects of healthcare. Digital health tools have vast potential with an improved ability to accurately diagnose and treat disease. The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. These technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. Digital tools are giving providers a more holistic view of patient health through access to data and giving patients more control over their health. 

Digital health offers real opportunities to improve medical outcomes and enhance efficiency. From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. The use of technologies, such as smartphones, social networks, and internet applications, is not only changing the way we communicate, but also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together, these advancements are leading to a convergence of people, information, technology, and connectivity to improve health care and health outcomes. While patients and consumers can use digital health technologies to better manage, track their health and wellness related activities,  providers and other stakeholders are using digital health technologies in their efforts to:

  • Reduce inefficiencies,
  • Improve access,
  • Reduce costs,
  • Increase quality, and,
  • Make medicine more personalized for patients.

FDA has given green signal to human digitization technologies in life sciences. In 2019, FDA released a guidance to continue to encourage the development of innovative digital health tools and to ensure the agency’s approach to overseeing these technologies advances along with it. FDA has developed an appropriate regulatory framework taking into account the realities of how technology advances plays a crucial role in the efficient development of digital health technologies. The FDA's Center for Devices and Radiological Health (CDRH) has established the Digital Health program, which seeks to better protect and promote public health and provide continued regulatory clarity by:

  • Fostering collaborations and enhancing outreach to digital health customers, and
  • Developing and implementing regulatory strategies and policies for digital health technologies.

The FDA's Center for Devices and Radiological Health is excited about these advances and the convergence of medical devices with connectivity and consumer technology. The following are topics in the digital health field on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:

STS Digitization Consulting team of professionals will help you in making informed decision about the development of your digital product and provide guidance to the right strategy to create quality digital product in compliance with regulations.