Fitness Monitors, Smartwatches are Not Medical Devices

Wearable electronics are booming.

The Consumer Technology Association (CTA), in its CT Ownership and Market Potential Study, found 26% of U.S. households owned a wearable fitness tracker at the beginning of 2018, considerable growth for a category that had not existed five years before. That study also projected sales of 12.5 million smartwatches in the U.S. during 2018, generating revenues of $3 billion.

This year, market research firm Gartner predicts worldwide shipments of wearables will reach 225 million, up 25.8% from 2018 levels.

A big part of the trend of wearable computing has been the popularity of wearable health and fitness devices. According to research from market research firm Parks Associates, as of the second quarter of last year, 12% of heads of households with broadband in the U.S. owned a smartwatch with activity tracking features; another 9% owned a dedicated fitness tracker.

One of the selling points of many wearable devices is that they can help users get healthy and stay healthy. They should not be confused with true "medical devices," however.

A medical device, as defined by the U.S. Food and Drug Administration (FDA), is one "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease." Wearable medical devices perform functions like monitoring blood pressure (hypertension), measuring glucose levels (diabetes), and helping with pain management.

"Very few of the current medical-grade consumer health devices are wearables," says Parks Associates senior analyst Kristen Hanich. For example, she said, only about 1.5% of U.S. broadband households owned an insulin pump, according to data from Parks' survey. (Data from the U.S. Centers for Disease Control and Prevention indicate more than 30 million people in the U.S., or roughly one person in 10, have some form of diabetes.)

Convergence

Manufacturers of consumer devices tend to paper over the distinction in their marketing. Apple, for example, calls the Apple Watch a "proactive health monitor." The Apple Watch can use an electrocardiogram (ECG) app to generate a basic electrocardiogram and alert users to possible atrial fibrillation (and recently did just that for a New Hampshire man).

"The Apple Watch Series 4, with its FDA-cleared EKG sensor, is the first of the medical-grade wearables to be targeted to the wider consumer market," says Hanich.

At the same time, medical device manufacturers are not ignoring the health wearables market. Omron Healthcare, which has offered FDA-approved home blood pressure monitors since the 1970s, in January unveiled the HeartGuide wearable monitor in a wristwatch form factor, as well as other wearables. "We have dabbled in the fitness area a little bit," says Omron vice president for sales and marketing Rob Schneider. "We do have activity trackers, body composition monitors, and things like that. We think it's a nice addition, but it's a smaller part of our overall focus."

Nevertheless, Schneider says, the distinction is important. "There are different technologies that can give you an estimated blood pressure, while our products use the standard oscillometric approach. Estimated blood pressure is nice to have, but let's say you're off by 10%; that's probably fine for 'did I walk 8,000 steps or 8,800 steps today?' but with blood pressure, 10% can be the difference between a medication change or not."

Similarly, "No doctor's going to use the Apple Watch to make the first diagnosis of atrial fibrillation," says Dr. Joshua Newman, chief medical officer for Salesforce. "They want something a little smarter."

Still useful

That's not to say that the trillions of pieces of data being generated by consumer wearable devices can't be useful.

Cardiogram, a self-described "digital health provider built on consumer wearables," makes "personal healthcare assistant" apps for the Apple Watch and for Google Wear OS devices that rely on an algorithm developed with a neural network to assess a patient's risk of heart disease or stroke, based on readings from those devices. Starting in 2016, the company worked with the University of California, San Francisco to develop the algorithm based on heart rate data from 9,750 patients, focusing first on atrial fibrillation. When they tested the algorithm on 51 new patients, "They showed they could achieve 97% accuracy in detecting atrial fib," says Harish Kilaru, a business development manager at Cardiogram.

The company then started applying the same technology to detecting other conditions, achieving 81% to 85% percent accuracy in detecting hypertension, sleep apnea, and diabetes, according to Kilaru. "This was super-exciting, because we were able to use these devices you can get at Best Buy to detect signs of these chronic conditions," he says.

In addition to being able to provide at least preliminary indications of a health problem, Newman points out that consumer wearable health devices can motivate users to take steps that will improve their health. "Let's go back to when they first came out," he says. "We saw a lot of people saying 'I'm using this thing and it's motivating me to run, to work out.' When I read that, I got excited that we could start using them to affect the health of the population in general. That hasn't been the case at all; the research showed that people tend to put these things away after they get them."

Not everybody puts them away. "The demographic that buys these fitness wearables for fun or for exercise is very rarefied," Newman says. "These are people that pay for technology. There's no question that there are a bunch of motivated people who love working out, and having a device that measures their steps makes it easier to have goals."

Regulatory issues

The spread of health and fitness wearables means that consumers trust these devices with their medical information. Medical device manufacturers have long been aware of the privacy and security issues that raises.

"Our devices, app, and cloud storage are all HIPAA-compliant," says Omron's Schneider. HIPAA, the Health Insurance Portability and Accountability Act, establishes rules for the handling of personal medical and healthcare information. "But once a user takes their own action to send any data outside of our Omron-protected environment (for example, email or other data transmission), then the responsibility shifts."

Fitbits and smartwatches are not required to be HIPAA-compliant, but that doesn't mean the FDA is ignoring the privacy and security of the health data they capture. "The FDA has recognized that it is a very quickly growing area," says Pamela Hepp, an attorney with the Pittsburgh-based law firm Buchanan, Ingersoll & Rooney who specializes in healthcare issues. What the FDA is concerned about, says Hepp, is both how the product will be marketed, and the degree of risk users might face. General health and fitness devices are considered low risk compared to those that may be used for diagnosis or treatment.

To address lower-risk consumer devices, the FDA has been conducting a pilot precertification program for software as a medical device, says Hepp. "They are looking at the manufacturers, rather than on a product-by-product basis. The idea behind it is that the FDA will look at (each manufacturer's) culture and their design criteria. It doesn't spell out specific technology or specific privacy or security measures; they're looking at it more from the organizational standpoint of the entities involved to make sure they have robust measures with respect to product design."

The pilot program, begun in 2017, was aimed at developing criteria for precertification. Once precertified, companies such as Fitbit, Apple, and Samsung (all participants in the pilot program) can offer consumers some assurance that they have appropriate measures in place. As of January 2019, the FDA has taken the next step, announcing a regulatory framework and test plan to see if the criteria developed are adequate.

A wearable future

What's the real potential for all this activity?

"Medical functionality is the next frontier for smart watches, and we expect to see more wearables players enter into this space," says Hanich.

For its part, Cardiogram hopes to be woven into consumers' overall healthcare system. "We are working with big health plans and employers to support Cardiogram as an in-network provider," says Kilaru. "For example, let's say we think that you have hypertension based on your heart rate data. We'll notify you in the app and say, 'we'd like to offer you a complimentary blood pressure test.'"

Similarly, Fitbit promotes its Fitbit Care solution, composed of wearable devices, health coaching, and virtual therapy, to employers and health plans.

"I think using these types of devices gives you a much fuller picture than if you just looked at it once a year," says Kilaru.

"Some of the benefit is a little more educational, to be frank," agrees Newman. "There aren't many cardiologists that will use the EKG apps for actually reading someone's heart rhythm, but it lets people get a sense of what their heart rhythm is and ask intelligent questions. I think it's just good for people to know."

"This is definitely a hot area right now for anybody and everybody to be jumping into," says Schneider, "but at the end of the day it's all good, so long as people understand what they're looking at, how to use it, and what to do with the data."

Jake Widman is a San Francisco, CA-based freelance writer focusing on connected devices and other Smart Home and Smart City technologies.