Version 2.0 of a plan to create an Office of mHealth in the U.S. Food and Drug Administration should be out soon. The office of U.S. Rep. Mike Honda, Silicon Valley’s Democratic Congressman who authored the legislation, said the next draft will at the least fine-tune the way the office would work with other federal agencies.
But is the big-ticket item – a new office dedicated to adding more context and understanding of mHealth within the federal agency – the most interesting thing about the bill? I don’t think so. Read through the details and see if you agree.
How badly does the country need an FDA Office of mHealth? Honda has been outlining that vision with a Silicon Valley point of view in the past year (he’ll also elaborate even more on issues like the legislation, the future of mobile health, innovation and the power of healthcare as one of the keynote speakers at MedCity ENGAGE, MedCityNews.com’s summit on patient engagement and healthcare delivery on June 5-6 in Washington, D.C.)
“The tech community needs confidence in a consistent, reliable framework for wireless health,” Honda recently told The Wall Street Journal. “The FDA has a critical role to play. Today, there is no confidence [among] industry. It’s nonexistent. We’re still talking to technology associations, law firms, venture firms, caregivers, patient-safety groups. We want all these players to be involved.”
The first version of the legislation proposes the following:
- An Office of mHealth that would “better clarify and simplify existing regulations while providing sorely needed expertise in this important field.” Honda later explained the The Wall Street Journal: “The situation today is kind of like the judicial system, back when there were early lawsuits about technology. No judge really knew about that stuff. They had to be trained. The FDA will have to find the expertise [both from inside and outside the agency]. As for staffing, it would be up to the FDA.”
- A mobile health developer support program in the Department of Health and Human Services. The program would provide educational materials to help developers create new products that meet privacy regulations.
- New grants, challenges and prize-driven contests – described as “The Disruptive Technologies Prize Program” and a competition styled after the “X-Prize” – to help develop more mobile health products focused on improving quality of care and reducing reduce.
- A low-interest small business loan program to medical offices to buy new technologies, and grants to clinicians for workforce training around health IT.
Honda is correct – the FDA needs more context around health IT (it’s similar in some ways to the federal understanding of follow-on biologics). Plus, the money to the techies is fine – who doesn’t need more non-dilutive capital these days?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
But the last bullet point is the most interesting. I’ve already gone on record saying one of the biggest bottlenecks in healthcare isn’t the federal government, but instead the risk-averse culture among clinicians who are on the front lines treating patients. If Congress can find the money to provide those loans and workforce grants, clinicians can combine their knowledge of healthcare with the tech savvy to implement the best and most important emerging health IT solutions.
The mHealth legislation makes it an opportune time to hear from the Congressman when he comes to ENGAGE on June 6 to give the Day 2 opening keynote.
U.S. Rep. Mike Honda is one of the a diverse chorus of empowering and insightful speakers taking part in MedCity ENGAGE, MedCityNews.com’s summit on innovations in patient engagement and healthcare delivery on June 5-6 in Washington, D.C. Review the agenda, look at all the speakers and then join us in Washington D.C. in June.
