You are hearing it everywhere or even some might be using it. Do you know the difference between Digital Therapeutics Vs Digital Medicine Vs. Digital Health? Are they regulated? Read below to know more.
Digital Therapeutics AKA DTx is software that can treat, manage, or prevent a health condition. Think of all the ios/andriod apps that catapulted in Covid for weight loss, meditation, etc. They can
👉 Help you manage diabetes or even help guide insulin dosing
👉 Help you with depression using therapy sessions
Digital Medicine is the superset of DTx. However the major difference between DTx and Digitial medicine is their apps or devices collect and provide information to Health Care providers (HCP). A digital medicine product has evidence that backs up its claims so HCP’s can recommend them to patients. Here are few examples
👉 Wearable sensors such as continuous glucose monitors (CGMs)
👉 Pills that have built-in cameras that can be used instead of a colonoscopy (ex: Medtronic’s PillCam)
Digital Health is an umbrella term that covers many types of technology used in the healthcare community and includes DTx and Digital medicine. For example Telehealth, wearable devices, electronic health records, etc.
💡 So, in a nutshell
DTx apps typically only tracks health information
Digital medicine tracks and collects information
Digital Health apps tracks, collects and provides treatment changes based on collected data
Does the FDA regulate digital health?
Since digital health is so broad, many regulatory organizations may be involved, including the FDA. The FDA generally does not regulate many wellness apps and devices on the market. But it will become involved if a product or app makes a medical claim about their technology.
For instance, if an app says it can help you manage your sleep by tracking your sleeping habits, the FDA may not look into it. In comparison, if an app claims it can diagnose or treat insomnia, then the FDA would want to review the evidence to support that claim.
Image credit: Dealroom
Subash Rajavel is the founder and Chief editor at xGenom. He has 15 plus years of experience in Health care and Life Sciences. His primary focus are Patient centric solutions, Digital Health and Next-gen Clinical Trial solutions.
You can reach him at subash@xgenom.com
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