The explosion of medical devices and apps that integrate with smartphones has the potential to transform the healthcare system by allowing doctors to collect information about patients in real-time.
The marketing research firm Research2Guidance projects the global business in “mHealth” technology will grow 61 percent from 2013 to rake in $26 billion in revenues by 2017.
{mosads}While healthcare providers and doctors are enthusiastic about the technology, federal officials are grappling with how the apps fit in with the broader regulatory system that is intended to protect patients.
The Food and Drug Administration (FDA) is charged with overseeing of all medical devices in the United States, including apps that integrate with smartphones.
Lawmakers including Reps. Michael Burgess (R-Texas) and Marsha Blackburn (R-Tenn.) had criticized the FDA’s approach to mHealth technology, warning a heavy regulatory hand could slow innovation and prevent useful tools from reaching the marketplace.
In response, the FDA said it would use its discretion to avoid regulating the overwhelming majority of mHealth technology, because it poses only minimal risk to consumers.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
Bradley Merrill Thompson, an attorney with Epstein, Becker and Green and an expert in the medical device industry, said the FDA’s guidance was “extremely” well received by developers but still left a lot of unanswered questions.
In particular, Thompson said the guidance has left a “gray zone” that has created uncertainty about medical devices and apps that are made for low-risk use but could be used for high-risk purposes.
It’s clear that some new devices will fall under FDA regulation. One example is meters that allow patients with diabetes to track their glucose levels on their smartphones.
But it’s not yet clear how the FDA will handle other devices, such as heart rate monitors used by runners that could be used by doctors to keep track of patients at risk for heart attacks.
Another technology that falls into the gray area is wearable baby monitors that let parents track their child’s heart rate and sleep patterns from their phones. Some device makers have claimed the monitors can prevent sudden infant death syndrome (SIDS).
These claims recently led the FDA to issue a notice that the agency has not vetted any such products and “is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.”
The FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communication Commission held a meeting in May to talk about strategies and regulatory frameworks to oversee mHealth, which they plan on turning into a report to Congress sometime late this summer or early fall.
Thompson says the overwhelming number of stakeholders would prefer to see the agencies regulate the devices and apps instead of having Congress step in and legislate.
“The reason I want to work with the FDA is because the questions that I have are very detailed and Congress is not capable of rendering that kind of detail,” he said. “All Congress can do is high-level legislation, and high-level legislation isn’t where the problem is.”
Janet Marchibroda, director of the Bipartisan Policy Center, praised the FDA’s guidance on mHealth, but says there’s also room for legislation to help set the parameters for regulation.
One bill working its way through Congress is Blackburn’s Sensible Oversight For Technology Which Advances Regulatory Efficiency (SOFTWARE) Act.
The bill aims to create three regulatory categories of mHealth, based on levels of risk similar to the FDA’s guidance. But the legislation also specifies that the FDA should only regulate technology that directly affects patients without physician involvement. In such a case, mHealth devices such as blood glucose meters monitored by physicians would not need FDA regulation.
The Bipartisan Policy Center supports Blackburn’s bill but said industry and other stakeholders are still at odds over what devices and apps should fall into each category.
Marchibroda said the mHealth industry is begging for more clarity because the uncertainty about the categories is making it harder to attract capital and investors.
“We are so delighted with the [FDA’s] plan but it is just a plan, it’s not law,” Marchibroda said. “The reason for legislation and law is to carry it to the next level.”
Thompson said the mHealth industry is mostly waiting on the sidelines to see how things play out in Congress, but warned legislation could hinder the emerging business.
“Right now no one knows enough about this area to be able to craft legislation,” he said. “Frankly what the issues are today will be different from what the issues are tomorrow because the technology is moving so quickly that freezing it in legislation would be very problematic.”