Digital Health Technologies

Overview

The FDA defines Digital Health Technologies (DHTs) as systems that use computing platforms, connectivity, software, and sensors for health care and related uses. DHTs can include wearable devices, mobile medical apps and software, and artificial intelligence and machine learning. Depending on the intended use, DHTs may meet the definition of a medical device, requiring FDA oversight.

This webpage includes:

FDA Oversight
Types of DHTs and When They are a Medical Device
IRB Review Considerations

FDA Oversight

Projects involving DHTs may require FDA oversight in addition to IRB oversight if the intended use of the technology meets the FDA's definition of a medical device. Software on its own can be considered a medical device when it does not rely on a physical device to achieve its intended medical purpose.

The intended use refers to the general purpose of the technology, not limited to its use in a particular project.

FDA oversight applies to clinical investigations that determine the safety and effectiveness of a medical device, or if the results of the clinical investigation are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

Medical Device
Section 201(h)(1) of the Food, Drug, and Cosmetic Act (FD&C Act), defines a medical device as: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (…) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (…)

Software as a Medical Device (SaMD)
Per FDA Guidance, Software as a Medical Device is defined as: Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Clinical Investigation
Per FDA Guidance, a Clinical investigation is defined as: Any experiment that involves a test article and one or more human subjects.

Types of DHTs and When are They a Medical Device

The section below outlines the different types of Digital Health Technology and provides examples for when they are considered a medical device when used in human subjects research.

Artificial Intelligence and Machine Learning (AI/ML) in Software
Clinical Decision Support (CDS) Software
Computer - Generated Imagery
General Wellness Products
Mobile Medical Applications
Wearable Devices
3D Printed Technology

Artificial Intelligence and Machine Learning (AI/ML) in Software

Per FDA Guidance:

Artificial Intelligence (AI) is a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments.
Machine Learning (ML) is a set of techniques that can be used to train AI algorithms to improve performance at a task based on data.

Intended Use	Example(s)	Is it a Medical Device?
AI/ML used to compile and provide information using publicly available sources	Patients interact with a Chatbot that provides information from WebMD	No
Development of a model that will be designed to perform the function of a health care professional (HCP)	Obtain data via medical records review to build and train a model that will monitor disease progression - safety and effectiveness will be evaluated in a later study	Yes
Validation/implementation of AI/ML model in a clinical setting for diagnostic/treatment decisions	Testing the effectiveness of an AI/ML model to detect tumors using computed tomography (CT) images	Yes

Clinical Decision Support (CDS) Software

Per FDA Guidance, the FD&C Act, section 520(o)(1)(E) excludes certain software functions from the definition of a device, provided that the software functions meet all four of the following criteria:

Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;
Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);
Intended for the purpose of supporting or providing recommendations to a health care professional (HCP) about prevention, diagnosis, or treatment of a disease or condition; and
Intended for the purpose of enabling HCP to independently review the basis for such recommendations that such software presents so that it is not the intent that such HCP rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.

Intended Use	Example(s)	Is it a Medical Device?
Software that is intended for displaying, printing medical information about a patient	Matching patient-specific medical record information (e.g., diagnosis, treatments, allergies, signs or symptoms) to referenced information routinely used in clinical practice Drug-drug contraindication notifications	No
Software that is intended for supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition	Evidence-based clinician order sets for a healthcare professional to use and tailor for a specific condition/disease Drug-drug and drug-allergy contraindication notifications to avert adverse drug events	No
Software intended to acquire, process, or analyze a medical image or signal from an in vitro diagnostic device or from a signal acquisition system	Software that analyzes biometrics (e.g., perspiration rate, heart rate, eye movement, breathing rate) from a wearable device to monitor heart attack or narcolepsy episode Software that analyzes patient-specific information to detect a life-threatening condition, such as stroke or sepsis, and generate an alarm to alert a healthcare provider	Yes
Software that uses patient image sets to create an individual treatment plan for review by HCP	Software that analyzes CT images to create a treatment plan for cancer patients Software that manipulates bone density scans to create a 3D model for planning a dental surgical implant	Yes

Computer - Generated Imagery

Computer-Generated Imagery (CGI) is a technology that uses computer software to create images and scenes that can be static or dynamic (e.g., film/television, video games, virtual/augmented reality (VR/AR), etc.).

Intended Use	Example(s)	Is it a Medical Device?
Used as a tool for entertainment purposes	VR headset that plays a video for children to “relax” and “distract” during a scan, but not for the treatment of anxiety	No
Used as a tool to facilitate/assist with diagnosis or treatment	Augmented reality device, such as Smart Glasses, that provide visual guidance during surgical procedures Virtual reality used to assist in the treatment of mental health conditions such as anxiety disorder or PTSD	Yes

General Wellness Products

Per FDA Guidance, general wellness products are intended to be used to (1) maintain/encourage a general state of health or healthy activity OR (2) relate the role of healthy lifestyle with helping to reduce the risk of certain chronic disease/conditions.

Intended Use	Example(s)	Is it a Medical Device?
Promote general wellness or healthy activity	Software that tracks daily food consumption and physical activities to promote awareness and improve/maintain cardiovascular health Mobile app that sends regular reminders to perform breathing exercises to improve mental focus and mood	No

Mobile Medical Applications

Per FDA Guidance, mobile apps are software programs that run on smartphones and other mobile communication devices, along with compatible accessories (e.g., watches, rings, glasses, etc.). Mobile Medical Applications (MMAs) are mobile apps that incorporate software functionality that meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Intended Use	Example(s)	Is it a Medical Device?
Collection of health data using a mobile app	Mobile app that monitors and displays continuous glucose monitoring (CGM) data for glucose correction Mobile app that analyzes electrocardiogram (ECG) data to detect arrhythmia	Yes
Evaluating the safety and/or effectiveness of a Mobile Medical App	Testing the effectiveness of a mobile app that analyzes signals from a wearable device to monitor narcolepsy episodes Evaluating whether a FitBit can accurately detect sleep disorders	Yes

Wearable Devices

Wearable Devices are electronic and software-based devices that are designed to be worn on the body, offering functionality and real-time data (e.g., smart accessories, fitness trackers, etc.).

Intended Use	Example(s)	Is it a Medical Device?
Collection of physiological or activity data from a wearable	FitBit activity tracker used to collect movement data during a clinical trial	No
Evaluating the safety and/or effectiveness of the wearable device in diagnosis or treatment of diseases or conditions	Testing the effectiveness of a new activity monitor to track movements in patients with gait disorders Assessing the use of a smart watch to determine the effectiveness of monitoring for cardiac abnormalities	Yes

3D Printed Technology

Per FDA Guidance, 3D printing technology creates a three-dimensional object by adding layers of a material, until a final object is formed, based on a digital design.

Intended Use	Example(s)	Is it a Medical Device?
3D printed anatomical models used for education/training	Use of a 3D model in a training course for surgical residents	No
3D printed anatomical models used for diagnosis/treatment	Anatomical models used for surgical preparation Customized prosthetics, surgical instruments, implants, etc. Bio-printing (e.g., tissue, organs, etc.) for implantation	Yes

IRB Review Considerations

The following considerations should be addressed in the IRB protocol application and consent form, when applicable:

Specify how the device and its output will be used in the research, any potential (current or future) impact on patient care, and what patient data will be used to build, train, and/or apply the DHT.
Describe the plan for data storage and management.
Describe the potential risks to participants, including (as applicable):
- Possible breach of confidentiality;
- Incurred expenses (e.g., data usage plan, app purchase, etc.); and
- Risks associated with DHT malfunction or not working as intended.

Page updated August, 2025