ACT is sponsoring a digital health conference tomorrow at Stanford and it’s a pretty big deal. That’s because we’re bringing mHealth experts and a senior FDA official to provide definitive answers about what will, and won’t, be regulated in the new medical app marketplace.
ACT represents startups and app makers from around the country. We are the voice for more than 5,000 tech companies that want someone on their side to limit government intervention that stunts innovation.
Digital health is an area where innovation is coming fast. $1.5 billion was invested in this area through the third quarter of last year. But what makes this marketplace so compelling is that mobile health solutions are dramatically improving patient outcomes. And while it may seem counterintuitive to some, the FDA’s recent regulatory action will actually spur more investment in this life-changing technology.
ACT had a modest role in that. After the FDA announced plans to regulate medical apps, we advocated tirelessly for a light touch and rules that could be easily understood. Over two years, we repeatedly delivered this message to agency officials.
When the new rules finally came out in September, we found that the FDA had been listening. It provided considerable detail in its guidance, outlining many types of apps that would not be regulated. The agency also included a regulatory exemption for several categories of apps in order to allow for further marketplace innovation. The clarity and exemptions offered by the FDA will help investors and app makers chart their path to success.
This was welcome news to ACT member Ideomed whose asthma monitoring app, Abriiz, was included in one of these regulatory-free zones. Abriiz helps kids keep to their medication schedule and allows parents to track their child’s progress. It works really well.
A recent study found that children using Abriiz experienced an eighty percent drop in episodes requiring an emergency room visit. Insurance companies were so pleased with the results that they now provide Medicaid beneficiaries free smartphones loaded with the app because the improved health outcomes results in lower costs for everyone.
To help startups and investors learn about opportunities like these, we’re bringing the Mobile Medical App Roadshow to Palo Alto. Our own executive director Morgan Reed will be on hand to speak about the new regulatory landscape and how it will impact new entrants. Legal and mHealth experts will provide regulatory guidance and the FDA will field questions from the audience.
For this event, and other Roadshow stops across the country, ACT is joined by industry leaders like the Consumer Electronics Association, CTIA the wireless association, the National Venture Capital Association and other leading health organizations and academic institutions.
To attend tomorrow’s event, you can register here and submit questions for the FDA using this email address.