POPS! Diabetes Care is an Oak Park Heights company that offers a glucose sensor that integrates with your smartphone.

In Minneapolis, Perk Health offers Coach Chris, a virtual personal trainer with artificial intelligence that is customized to your personality.

Another Minneapolis company, Learn to Live, offers online cognitive behavioral therapy that lets people with mild to moderate mental health problems access help without worrying about being stigmatized.

“Digital health is part of everything now,” explained Shaye Mandle, chief executive of Medical Alley, the state’s med tech trade group, which now includes 47 small digital health businesses among its hundreds of members.

Minnesota’s burgeoning digital health sector encompasses the state’s largest and smallest companies.

Medtronic, the world’s largest medical device maker, just announced a plan to distribute data from Garmin’s vivofit personal activity tracker through its care management system.

Reemo Health, a 10-person software start-up in Minneapolis, analyzes senior citizens’ movements gathered by a special wrist watch. Factoring in personal health histories, Reemo “differentiates between healthy and risky activity” and transfers the information to seniors, their family members and care­givers. The company’s proprietary analytics should let more older Americans live safely at home for as long as possible, said company co-founder Al Baker.

Still, wristband technology is not the be-all of digital health. Mandle named four buckets into which digital health companies usually fit:

• Big information technology systems that specialize in handling massive amounts of electronic medical records.

• Clinical support systems and tools.

• Mobile health and telemedicine applications of ­technology.

• Consumer health information gathering, such as wristband activity trackers.

Annual reviews conducted by Medical Alley show that funding for Minnesota’s digital health companies has risen 540 percent from $19.6 million in 2012 to $128 million in 2016.

Worldwide, an analysis by the German-based business consultant Roland Berger predicted that market volume for digital health should more than double from less than $80 billion in 2015 to more than $200 ­billion in 2020.

“In the U.S. alone, over $4.5 billion of extra financing went to health care start-ups in 2015,” Roland Berger reported. The consultancy said that new blood and old blood will mix as more innovators enter the market, and that anyone in the health care sector who wants to stay relevant will need to “open up to digitization both culturally and structurally.”

The rise of digital health across the U.S. recently led the Advanced Medical Technology Association (AdvaMed), the nation’s most powerful device trade group, to establish a digital division. AdvaMed Digital breaks the traditional device maker mold.

“AdvaMed Digital represents a wider set of companies [than traditional medical device makers], some that may never have a product approved by the FDA,” said Andy Fish, AdvaMed’s chief strategy officer.

Regulatory void

As things like machine learning and artificial intelligence play an increasing role in health care, a government regulatory void may exist. Organizations like AdvaMed Digital and Medical Alley want a voice in how the government fills that void.

“How things are cleared and used is not clear,” Zach Rothstein, an AdvaMed vice president for technology and regulatory affairs, explained. “We want to identify slightly more futuristic technologies that might not have a way to come to market in the current environment.”

For now, AdvaMed Digital’s inaugural 40 members represent mostly the trade group’s biggest players, including Minnesota mega-employers and state-based companies such as Medtronic, Abbott Laboratories (which just acquired Minnesota’s St. Jude Medical), Boston Scientific, Smiths Medical and CVRx.

But Fish and Rothstein say a push is on to attract companies of all sizes and descriptions, and they expect membership to grow substantially by year’s end. To “throw open a big tent,” the trade group has a purposely flexible, broad definition of digital health that encompasses “development and use of technologies that collect data, parse data and distribute data.”

With people more capable than ever of gathering detailed personal health information in real time, privacy and data security issues present challenges. Quality of information is another challenge. Is it, asked Mandle, “actionable” in terms of providing care?

Boston Scientific tries to answer that question by aiming its digital health initiatives at devices embedded under the skin rather than worn on the outside of a ­person’s body.

“We’re focused on reliable data,” said David Feygin, the company’s chief digital health officer. The company’s cardiac implants, like defibrillators and pacemakers, “all do things actively to maintain heart rhythm.”

Boston Scientific is also looking to “leverage technologies” by connecting start-ups with data management infrastructure “built up over the last 10 years,” Feygin said.

Medtronic declined to comment for this story, but a company news release on syncing Garmin’s vivofit data with Medtronic’s Care Management Service called activity levels “one of many important factors in remotely assessing a patient’s health status, whether it is monitoring a chronic condition or a post-discharge recovery process.”

Lonny Stormo, a co-founder of POPS!, suffers from moderate diabetes, the condition his smartphone-connected glucose sensor seeks to monitor. Stormo believes the success of digital health depends on personalized, easy to use devices.

“We really have the opportunity with digital health to change the way health care is delivered,” Stormo said. “But the burden can’t be bigger than the results.” Otherwise, people just stop using the product.

Mental health, too

Dale Cook, a co-founder of Learn to Live, wanted to bring relief directly to people with mild to moderate mental health issues who might profit from cognitive behavioral therapy. Cook said many people who could use the kind of education and counseling Live to Learn’s $149 online regimen offers would never seek it in other forums because of accessibility, stigma or cost. Learn to Live now has thousands of alumni and a track record that has attracted partnerships with some private employers, including Blue Cross-Blue Shield of Minnesota, as well as universities, Cook said.

At Perk Health, Zach McGill, a mechanical engineer, and Doug DeBold, a mathematician, decided that lifestyle decisions drive most of U.S. health care spending. The pair, pals and track teammates at Minnetonka’s Hopkins High School, sought a product that offered exercise experiences so positive that they made it easier to stick with wholesome lifestyle changes.

Thus was born Coach Chris, the spawn of artificial intelligence that assesses each Perk Health customer’s personality traits to figure out an exercise program that keeps him or her happy but active. Based on that new care paradigm, the company has raised $750,000 so far through angel investors and other supporters while increasing its revenue.

“What’s so powerful about digital health is that it allows interaction with people where life really happens,” McGill said. “And that’s not at the hospital.”