At-Home Diagnostic and Wellness Devices
Seemingly every day, new products come to the market which reside in a gray area of the medical/wellness world. Specifically, these products and services often claim to provide a medical diagnosis (or are incorrectly assumed to do so).
The FDA has a somewhat vague policy about which products are considered medical products and which are considered wellness products. Essentially, if a product doesn’t claim to provide diagnostic capabilities, it falls under the wellness umbrella, leading to less paperwork and effort needed to get the product to market.
Unfortunately, this misunderstood policy can muddy the waters of the diagnostic field and can cause problems for both patients and physicians. In this article, we will examine the issue of at-home wellness devices and outline how physicians should consider dealing with this unique, new issue.
Trending Wellness and Medical Devices
There are a number of very popular direct-to-consumer (DTC) health products available on the market today. Some of these are subject to FDA regulation, and some are not. Let’s start with those that are considered wellness products, which require no FDA oversight.
Popular Wellness Products
A wellness product can be generally thought of as a device or tool that helps people achieve a health-related goal. There are tons of these products available both in-store and online. However, they are very broadly defined and can, unfortunately, vary widely in quality. The following list features some of the most popular wellness apps available for download and use online.
- Google’s Dermatology App
In 2021, Google announced the release of their new dermatology app that allows users to take pictures of any skin blemishes in an effort to determine whether a growth may be cancerous. The FDA has not approved this device and therefore is not considered a medical product, but rather a wellness product.
As of now, the app is unavailable in the U.S.
- Hyfe App
The Hyfe app is geared toward capturing respiratory data, specifically cough data, to determine whether or not a specific bodily sound is a sign of a more serious disease. Similar to Google’s dermatology app, the Hyfe app is a wellness app and is not considered a medical device.
- Headspace App
A lifestyle wellness app that has become very popular in the last few years is the Headspace app. Headspace provides guided meditation services with combined audio and visual cues. While the app developers seek FDA approval to achieve the status of a medical service, it is currently still waiting to receive said status as an official health tool.
Popular Medical Devices
Medical devices often have a diagnostic quality and are subject to higher scrutiny by the FDA. These devices are not a substitute for physician assessment but are an excellent adjunct method of monitoring symptoms and keeping the patient-physician continuum of care in good order.
- Apple Watch ECG
The popular Apple Watch now contains a feature to identify certain abnormal heart rhythms such as atrial fibrillation. With its recent FDA clearance, this feature of the device can be considered a medical product.
- Diabetes Manager by WellDoc
WellDoc collects and analyzes blood sugar levels to help patients stay on top of their diabetes symptoms. In addition, the system offers research-based solutions and coaching to create an all-in-one AI health service.
- The Welch Allyn Ophthalmoscope
The Welch Allyn Ophthalmoscope is an attachment that can plug into almost every smartphone. The device can identify many common ailments affecting the visual system. In addition, patients can easily store, print, and save pictures taken with the ophthalmoscope and then directly share them with their ophthalmologist for further analysis.
What Makes for a Good At-Home Diagnostic Device?
There are a few things that doctors and patients should seek out in at-home diagnostic devices to ensure they are high quality.
Ease of Use for Patients
Whether it’s an app or a physical device, the diagnostic device in question needs to be simple enough that patients can easily figure out how to use. Specifically, all apps and devices listed in this article are straightforward to use, adequate for even the least tech-savvy patients.
Free or Reasonably Priced
Many apps are free to download, allowing companies to get a foot in the door and demonste to patients how useful they are regardless of the cost.
Accuracy and Reliability
Above all else, diagnostic devices need to be accurate and reliable. Patients who aren’t able to verify the accuracy of an at home device may become frustrated by the technology as a whole. Furthermore, they are unlikely ever to trust an automated diagnostic device again.
Ability for Patient-Physician Communication
While AI devices and at-home solutions are critical in this day and age, physicians need to monitor patient data regularly and provide feedback. Without this capability, there may be little to no human oversight of a patient’s progress. In addition, lack of physician communication could create gaps in check-ups and missed diagnoses based on key findings that the at-home device didn’t adequately flag.
Narrow Scope
Perhaps one of the biggest traps a company or individual can fall into is trying to do too much. A diagnostic device or app should have a specific and narrow focus. For instance, the Welch Allyn Ophthalmoscope focuses on the eyes, the WellDoc Diabetes Manager focuses on diabetes symptoms and blood glucose levels, and the Hyfe app focuses on respiratory health. If any of these apps started expanding and trying to capture millions of different diseases of different systems of the body, they would sacrifice the one thing that they do better than any other apps.
Conclusion
The world has moved toward technological and at-home solutions for health-related issues. The progress we’ve made toward devising at-home diagnostic tools has been remarkable, but some regulatory issues have made the field confusing and open to interpretation. For this reason, both physicians and consumers should be wary about devices that aren’t subject to regulation by the FDA or similar groups around the world. Instead, they should ensure that wellness apps contain the above criteria for being a good users’ choice.
For physicians looking for a way to better help their patients monitor respiratory issues, the Hyfe app offers the perfect solution. Check out the complete list of benefits on the Hyfe website today.
