Some of the medical technology available includes products used to do which of the following?

Many innovative leaps in health technology have been made in the centuries people have been practicing medicine, yet few have had as much widespread influence or impact as digital technology. Dramatic improvements in networking and computers have not only expanded options for medical treatments but have also transformed how clinicians perform their jobs.

Although forward thinkers started discussing the possibility of using computers in medicine as early as the 1960s, computers were initially too expensive and unreliable for medical practices to rely on. As technology improved and costs came down, policies and data standards were created to encourage healthcare organizations to adopt new technology not just for medical equipment, like diagnostic imaging machines, but also for everyday record keeping. Paper medical records were digitized and mostly replaced with electronic health records (EHRs) that help make it easier for health data like test results or diagnoses to be accessed efficiently and securely.

Using EHR systems or other technologies while engaging with patients and creating treatment plans is now standard practice. Laptops and tablets have become just as common in healthcare settings as stethoscopes, and there's growing evidence that EHRs are having a positive effect on accessing and exchanging health information.

However, one large challenge EHRs have created is the accumulation of large amounts of unintegrated and unstandardized data. Currently, most healthcare organizations have a wealth of data they could use to improve their procedures and business practices, but they might not have the tools or expertise to uncover insights in that data. Newer technologies, like cloud, blockchain and AI tools based on machine learning, can help healthcare organizations uncover patterns in large amounts of data while also making that data more secure and easier to manage.

As the healthcare industry faces new challenges, technology solutions are helping leaders to improve performance, increase collaboration across systems and manage costs. As demands on organizations increase, healthcare technology can streamline processes, automate tasks and improve workflows at a scale that’s not possible for humans alone. As providers at hospitals and health systems embrace value-based health reimbursement models, these solutions are helping healthcare professionals to improve patient care, create better experiences and reduce burnout.

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.

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. Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual.

Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products.

On this page:

• What are the benefits of digital health technologies?
• The FDA’s focus in digital health
• Who regulates mobile health apps?

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.

Who Regulates Mobile Health Apps?

If you are developing a mobile health app that collects, creates, or shares consumer information, use the tool on the Federal Trade Commission's website to find out when the FDA, Federal Trade Commission (FTC), or Office of Civil Rights (OCR) laws apply.

Which laws apply to my mobile health app?

For more information, see Device Software Functions, including Mobile Medical Applications.

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What refers to the use of electronic communications and information technologies to provide or support clinical care at a distance?