Digital Health: A Promise of Health for All

MaxCare Healthy Life promises health to everyone with its Digital Diagnostic Center.

Digital health, or digital healthcare, is a broad, multidisciplinary concept that includes concepts from an intersection between technology and healthcare. Digital health applies digital transformation to the healthcare field, incorporating software, hardware and services.

Digital health technologies help patients self-manage their health conditions through regular monitoring and tracking of symptoms. More importantly, it is a tool for the early detection of significant changes to disease progression in a patient, before lung health has been irreversibly compromised.

As MaxCare we are planning to implement a system in which the patient goes physically to the Diagnostic Center, and with an algorithm first in the world it will guide him through several questions to a diagnosis.

What Are the Benefits of Digital Health Technologies?

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.

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 health care settings. 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.

• Patients and consumers can use digital health technologies to better manage and track their health and wellness-related activities.

The use of technologies, such as smart phones, 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.

The FDA’s Focus in Digital Health

Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved, authorized, or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored.

Many stakeholders are involved in digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to the FDA regulatory requirements, such as mobile application developers.

The FDA's Center for Devices and Radiological Health (CDRH) 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:

· Software as a Medical Device (SaMD)

· Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device

· Cybersecurity

· Device Software Functions, including Mobile Medical Applications

· Health IT

· Medical Device Data Systems

· Medical Device Interoperability

· Telemedicine

· Wireless Medical Devices

As another important step in promoting the advancement of digital health technology, CDRH has established the Digital Health Center of Excellence which seeks to empower digital health stakeholders to advance health care.