With a growing number of wearable devices becoming available to consumers – ranging from fitness trackers to mobile monitors for pregnant women and their fetuses – it's clear that the regulatory waters for these technologies can be a bit murky. Companies can find themselves under the auspices of several regulatory agencies before getting a device to market, given the mix of data privacy, bandwidth and patient safety.
Earlier this year, the FDA tried to simplify its stance on wearable devices. The agency released draft guidance noting that many wearable devices and mobile health apps won't be subject to regulation. For those devices that don't claim to solve specific and chronic medical conditions, government oversight isn't required.
Though the guidance may seemingly provide clarity and freedom for companies, some firms are still dissuaded from developing certain wearables due to little or no experience in the healthcare sector, said James Moar, an analyst with Juniper Research.
"The areas we've seen the most development in are the 'quasi-healthcare' areas, like diabetes and cardiac outpatients, who generally use self-reported data anyway," Moar, told Medical Device Daily. "Where precise medical data is required, the same standards are likely to apply to wearable devices as other measurement tools. However, many wearables [developers] are avoiding this area because they do not like the idea of negotiating the regulatory landscape."
Nersi Nazari, president/CEO of Vital Connect (Campbell, California), which received the FDA nod for its HealthPatchMD, said that the firm's experience in the regulatory cycle was fairly pleasant, but noted that companies unable to see the total picture regarding device approval could run into issues.
"I think some companies have had trouble dealing with the FDA because they don't speak 'medical' they want to speak technology," Nazari told MDD.
David Collins, senior director of Health Information Systems at Healthcare Information and Management Systems Society (HIMSS; Chicago) agreed with Nazari's assertion that some companies in the space were only focused on developing the technology and not the market it would impact.
"Most of these types of devices weren't developed with healthcare in mind," Collins told MDD. "They might not have encryption; they might not have a longer battery life and things like that. However, some of these devices are being developed with the healthcare patient or provider in mind because they're seeing the need."
FTC, FCC, FDA, depending on the device
The field becomes tricky with the emergence of the unlikely players, because when these companies enter the healthcare landscape, the Federal Trade Commission (FTC) and Federal Communications Commission (FCC) can get involved, depending on the product.
"The bigger picture I think is FTC," Collins said. "They have quite a fair amount of oversight in the app world. They're kind of an enforcement area; if apps claim to do something and they put patient safety at risk, FTC is the agency that's stepping in and enforcing the market. You have FTC in that role, you have FCC with bandwidth resource allocation. Finally you have FDA providing guidance documents on what is regulated and what's not regulated and what's up to their enforcement discretion."
Along with regulation of the devices, there's also the question of how to keep the data private.
"It comes down to making sure people are taking the appropriate steps to user privacy and product efficacy," said Mac Gambill, co-founder and CEO of Nudge, a healthy lifestyle hub.
Ultimately these companies will need to produce HIPPA-compliant technology if the intent is to become successful.
"For anything medically related, HIPPA is going to apply," Kate Boeckman, a product manager for wearable and emerging technologies with Thomson Reuters, told Medical Device Daily. "People are worried about sharing their information as well as who owns this data and who has access to it."
Boeckman laid out a hypothetical situation that's unlikely to occur now, but could in the future:
"Let's say 10 years down the line that an insurance company sees that I'm only getting seven hours of sleep at night instead of eight, and because of that the providers want to charge me more for a premium based on that information. That's a little bit concerning [because] people don't really see the potential ways [information taken from these devices] could be used against them in ways they might not be aware of."
The predictive value card
Boeckman said the data from these devices will shape the growth of the space and lead to more complex products that can offer predictive value for the user.
"As sensors get more interesting – beyond monitoring steps – where you can detect some perspiration for example and you can detect a patient's emotional state, then you can get into predictions," she said. "You can look at data over time and eventually we're going to get to the point where we'll know if a person should get emergency services to prevent an [ailment]. We're still in the very early phase, but I think that's where we're headed."
Analysts with Pricewaterhouse Coopers (New York) echoed statements similar to Boeckman's assessment and noted that firms are striving to uncover the regulatory parameters coupled with functionality to develop the most effective devices possible.
"What we're witnessing right now are the first wave of wearables," Williams told MDD. "Technologists as well as designers and consumers are all trying to find out where that optimal intersection is of aesthetic design, functionality and accuracy of the devices. These different parties are exploring where and how this fits and what's the user's experience. That's part of a collective experimentation that's going on. That's the proverbial gold rush that's lying before us."
Editor's note: This is the final installment of a three-part series. Part 1: Interest, market size for wearable tech growing considerably, appeared in the June 8 edition, and Part 2, Vital Connect thrives in wearables space; Glass brings on market, appeared on June 9. //