SAN FRANCISCO – The inaugural Digital Health Showcase, a start-up within the upstart Biotech Showcase meeting this week, highlighted what CBT Advisors founder and CEO Steve Dickman called "a kind of Cambrian explosion" of health care IT companies, still emerging with great speed and diversity and with little order imposed – something he sees as both "very exciting and very risky."

The drivers of the ecosystem are almost as rich and varied as the companies themselves. Though longstanding themes attracting drugmakers to the hot sector remain the same, such as prescription adherence issues and the shift to values-based pay, a maturation of thinking is also taking place. Whereas even some of the biggest players started off in friction with regulators, they're now embracing it; and where companies seemed to be obsessed with consumer applications, like smartphone-based trackers and reminders, new energy has flowed to software for drug development tools.

With the changes have come disruption, and with disruption, of course, fear.

"What keeps a lot of life sciences executives up at night is that variability that we can't control will dilute the value of their products," said Aaron Nelson, a general partner for Drx Capital, a joint investment company of Novartis AG and Qualcomm Inc. Digital health solutions help highlight, sustain and enhance the value of other expensive interventions in the health care system.

Start-ups looking to address such issues, such as Vancouver, British Columbia-based Ayogo Inc., are partnering with drugmakers like Astrazenca plc, Merck & Co. Inc. and Sanofi SA to take those steps, trying to integrate new habits into patients' lives while also figuring out how to engage those patients in ways that are meaningful to them.

Despite best efforts, companies seeking to gain traction for big picture interventions are facing increasing regulatory challenges. Though some have been spooked by episodes of regulatory interest in ventures such as 23andme Inc. and, more recently, Lumosity, those episodes have spotlighted the irreplaceable nature of validating studies and, furthermore, made clear an idea that is more popular now than just a few years prior: the notion that the FDA can be a digital health company's best friend, creating barriers to entry for competitors who have to face equal regulatory scrutiny along the path to commercial success, just as in the therapeutics space.

But can the relatively slow-moving world of medical products regulation keep pace with the fast-moving world of technology? "I think that many of the regulatory agencies are eager to get involved and eager to be engaged [in digital health]," said Nelson. It's very easy to blame regulators for moving too slowly and failing to provide appropriate and contemporary guidances, he noted. Rather, he said, "it's incumbent on us to bring forward new models to the agencies," just as in drug development, where companies have helped bring the agency up to speed on various issues.