(...) "Legislation has been an area of concern and confusion for many in the field. Digital health technologies, when used by physicians to administer healthcare, are subject to governmental regulation, but by whom, and in what manner, remains unclear. Many came to the conference hoping for greater clarity on this issue. Not coincidentally, the summit coincided with Silicon Valley Congressman Mike Honda's new bill to create an Office of Wireless Health at the FDA. Honda said that he seeks "consistent, reasonable, and predictable regulatory framework for wireless health issues." Conference presenter Joseph Kvedar, founder of the Center for Connected Health, felt optimistic that "the FDA and FCC have both been increasingly clear on how this space will be regulated, and that creates a path for innovation."
While regulation is of great concern for doctor-operated products, for the consumer-oriented market, so long as a product makes no explicit promises about diagnosis or treatment, the FDA does not need to be involved. This apparently slight distinction has a host of consequences for the markets in question.
For one, it's much easier to bring a consumer-oriented product to market than a physician-oriented one. As an example, an application tracking a diabetic person's blood sugars need not go through the FDA so long as it remains separate from actual clinical practice. Unfortunately, this creates a disincentive for developers who might have otherwise built the application to inform both physicians and patients. At the same time, it has fostered explosive growth among consumer-operated applications -- in many cases providing patients with data their doctors couldn't collect even if they wanted to.
Another corollary of this regulatory distinction is an increasing cultural divide. On the West Coast, specifically the Bay Area, consumer-oriented developers hold hackathons, and focus groups, and seek funding from angels, VCs, or even the crowd. Many of the physician-oriented tools, by contrast, are emerging from the East Coast, where developers have more often partnered with government and industry, especially pharma (Johnson and Johnson) and insurance companies. Both markets hope to improve health outcomes, increase data points, and lower costs, but the consumer-oriented culture speaks also of empowerment and access." (...)