DIGITAL HEALTH INDUSTRY CATEGORIZATION
Digital health products have many different purposes and functions. End users, clinicians, and payers should understand thesedifferences and know what to expect from each product in terms of function, clinical evidence, and regulatory oversight.
This categorization is based on products’ primary mechanism of action at the functional level and will be updated regularly to reflect
the quickly evolving digital health industry.

DIGITAL HEALTH
DIGITAL MEDICINEDIGITAL THERAPEUTICS
DEFINITION

Digital health includes technologies,
platforms, and systems that engageconsumers for lifestyle, wellness, andhealth-related purposes; capture, store ortransmit health data; and/or support life
science and clinical operations.

Digital medicine includes evidence-based
software and/or hardware products thatmeasure and/or intervene in the service ofhuman health.1

Digital therapeutic (DTx) products deliver
evidence-based therapeutic interventions toprevent, manage, or treat a medical disorder
or disease.2

CLINICALEVIDENCE

Typically do not require clinical evidence.

Clinical evidence is required for all digital
medicine products.

Clinical evidence and real world outcomesare required for all DTx products.

REGULATORY These products do not meet the regulatory
OVERSIGHT
definition of a medical device3 and do not
require regulatory oversight.

Requirements for regulatory oversight vary.
Digital medicine products that are classified
as medical devices require clearance orapproval. Digital medicine products used
as a tool to develop other drugs, devices,or medical products require regulatory
acceptance by the appropriate review
division.

DTx products must be reviewed and clearedor certified by regulatory bodies as required
to support product claims of risk, efficacy,
and intended use.

PRODUCT
EXAMPLES

Measurement products

Software that delivers a therapeuticintervention

Data & information capture, storage, anddisplay• User-facing technologies-- Lifestyle apps-- Fitness trackers-- Nutrition apps-- Medication reminder apps-- Scheduling apps
• Health Information Technology (HIT)4-- Electronic medical record systems-- Electronic prescribing5 and order entrysystems• Consumer health information-- Online repositories-- Personal health records-- Patient portals• Digital diagnostics-- Software-driven connectedtechnologies that detect or confirm thepresence of a disease or condition ofinterest or to identify individuals with asubtype of the disease• Digital biomarkers-- Digital tools that measure patientcharacteristics that are objectively
measured and evaluated as anindicator of normal biologic processes,
pathologic processes, or biologicalresponses to a therapeutic intervention-- Includes all BEST biomarkers• Electronic clinical outcome assessments-- Digital measures of how patients feel,function, or survive

Medical claims include:• Treat a disease
Digital therapeutics that deliver a medical
intervention to treat a disease.
• Manage a diseaseDigital therapeutics that deliver a medical
intervention to manage a disease.
• Improve a health function
Digital therapeutics that deliver a medical
intervention to improve a health function
and/or prevent a disease.

DIGITAL HEALTH
DIGITAL MEDICINEDIGITAL THERAPEUTICSPRODUCT
EXAMPLES(continued)

Data & information transmission

Measurement products (continued)• Telehealth-- Telemedicine virtual visits-- Remote care programs that do notinclude remote monitoring• Remote patient monitoring-- Remote monitoring tools-- Medication adherence tools-- Sensor technologies that measurevitals and physiologic data• Decision support software that:6-- Presents information for independent
clinician review-- Does not make recommendations
that the user could not find throughchannels other than the software• Enterprise support-- Clinical trial operations & management
tools-- Trial management software-- Trial recruitment platforms• Clinical care administration &management tools-- Revenue cycle management tools-- Clinical staffing management tools-- Length of stay monitoring andmanagement tools• Decision support software that:7-- Relies on data inputs from medical
imaging or in vitro diagnostic devices-- Process or analyze this information
without clinician input
Measurement & intervention products• Digital companion8-- Digital component integrated witheither a drug or biologic-- Ingestible sensors-- Connected drug delivery device-- Insulin pumpCore principles all digital therapeutics
must adhere to: 9• Prevent, manage, or treat a disease• Deliver a software-driven medicalintervention• Employ design, manufacture, and quality
best practices• Ensure end user engagement• Implement privacy and security
protections• Apply product deployment andmaintenance best practices• Conduct clinical trials and publish
results• Undergo applicable regulatory reviews• Make appropriate claims• Utilize real world outcomes• Digital products that both 1) measureand intervene, and 2) do not require
human intervention to serve primary
purpose-- Artificial pancreas-- Pacemaker-- Cochlear implant-- CPAP

1 https://www.dimesociety.org/index.php/defining-digital-medicine
2 https://www.dtxalliance.org/dtxproducts/
3 It is important to check with local regulatory requirements in each jurisdiction the product is manufactured, registered, or used in.
4 In the United States, ONC-certified EHR functions are not devices according to the FD&C Act, as amended by 21st Century Cures Act.
5 In the United States, while these do not require FDA oversight, there may be rules within specific states that govern these technologies.
6 https://www.fda.gov/media/109618/download
7 Ibid.
8 Note: 1) integration of the digital tool with an existing drug or biologic requires a label change for the drug or biologic, and 2) regulatory requirements may recognize digital tools coupled with adrug or biologic as a combination product.
9 https://www.dtxalliance.org/aboutdtx/Version date: November 2019