With events such as the Consumer Electronics Associations' 2013 International CES conference this week in Las Vegas, featuring a dizzying 3,000 global app companies and a digital health summit, there is a lot of hype around what apps can do for healthcare.
But as the apps flood forth, what about regulation, in a world where the sluggish wait for FDA approval is a dirge often heard? What do experts advise doctors to look for when they want to use an app?
Kerry McDermott, the former director of healthcare for the Federal Communications Commission (FCC), now senior director of health care technology policy for West Health Institute, a non-profit organization focused on lowering healthcare costs, said there is “a lot of consternation in the market.”
“[Vendors] can innovate faster than the regulatory environment can keep up with," she explained. "The FDA is trying to set up guidance in the mobile app space. They are really trying to take a light-touch approach. There are so many apps that can do good; regulators want to let them flourish. Policy is a very blunt instrument. In today's world that doesn't cut it anymore. We need something to be more tailored."
It comes down to this question, she said: Is the app turning the phone into a traditional medical device? “If the app can make your phone into a stethoscope, for example, then that app needs to be regulated.”
In his new paper, “mHealth in an mWorld: How mobile technology is transforming health care,” Harry Greenspun, MD, senior advisor at the Deloitte Center for Health Solutions examines factors driving the adoption of mHealth and opportunities it presents to lower costs and improve patient outcomes.
Greenspun believes there is tremendous promise with mhealth technology. But, he sees three key challenges that require resolution to achieve the full promise of mHealth:
- Business models need to allow investors to see a return.
- Regulatory and technical issues around privacy and security of personal health information need to be resolved.
- Clarity around the regulatory environment needs to allow for mHealth solutions to be mainstreamed into healthcare product and service delivery.
“People are looking at mobile as an obvious transformation aspect in healthcare,” Greenspun said. “But, people aren't stepping back and [asking], ‘Are we really doing this intelligently? Will this make a difference in access, cost and quality?’”
“It’s a complex relationship between payers, providers and the government, working to make technology a critical enabler,” he added.
Greenspun strongly believes the answer comes in aligning incentives. If doctors aren’t paid to use healthcare apps, they aren’t as likely to consider them. Moving toward value-based healthcare will have an impact on outcome and reimbursement. If payers start paying doctors to be better and faster, suddenly doctors will start enlisting tools to do that – including apps.