cWASHINGTON – The questions and comments are pouring in over the U.S. Food and Drug Administration’s draft guidance on mobile medical apps, making it obvious that the government’s first attempt to clarify its regulatory authority over this fast-growing field won’t be the last.
While the 30-page draft establishes three categories of devices that would fall under FDA perusal, it leaves out – either specifically or by omission – several other uses. Among them: App sellers (like Apple), telecommunications providers and handset manufacturers, to name a few.
“What we have done is we have taken that approach and formulated policies that were narrowly focused on a very small subset while allowing apps that are out there to foster and continue developing that space,” said Bakul Patel, an FDA policy advisor who helped draft the guidelines, in news reports. “We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. … (If) somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.”
Chuck Parker, executive director of the Continua Health Alliance, a 230-member global alliance of healthcare and technology companies working to improve the quality of personal healthcare, said the draft “opens up the market” by giving the industry rules to work with.
“It sort of clears the thoughts out a little bit, and that does help us out,” he said.
“It’s pretty consistent with what I expected them to do,” said Yarmela Pavlovic, an associate with the global law firm of Hogan Lovells. “What’s been happening (in the mobile medical app space) is very, very fast development, and there needed to be an interpretation of existing regulations.”
Zachary Bujnoch, a senior industry analyst for telehealth and healthcare with Frost & Sullivan, called the draft document a much-needed entry into a “market full of hype.” He said the regulations will help “vet out the market” and target the thousands of healthcare apps on the market.
“This is going to hinder innovation in the market – there’s no doubt about it,” he said. “But that’s good. It’s a very confused market right now … that needs clarification.”
Pavlovic said she was “surprised by the way they narrowed” the classifications of apps to come under FDA guidance. “There’s definitely things that fall outside the categories that will be discussed,” she said. For example, she said, should accessories apps be treated the same as their connected devices?
Both Parker and Bujnoch questioned whether electronic health records should fall under FDA review (electronic and personal health records currently fall outside the FDA’s scope, according to the draft). An issue expected to generate a lot of comment, both said, is the definition of clinical decision support. If a device takes healthcare data and translates that into a clinical decision that can affect one’s healthcare, should it fall under the FDA’s guidelines?
“It depends on where the decision factor comes in,” said Parker. “Who defines the intelligence that gets sent back to the individual?”
The FDA draft will be a topic of discussion at two upcoming conferences. On Wednesday, it’s on the agenda for the American Telemedicine Association’s Policy Summit in Washington, D.C. (co-hosted by the Continua Health Alliance); and it will be the subject of a keynote panel discussion during the World Congress 3rd Annual Leadership Summit on mHealth, scheduled for Friday, July 29.
The mHealth Regulatory Coalition is also expected to weigh in, taking part in the ATA/Continua conference on Wednesday and issuing its own version of mHealth guidelines within a few weeks.
In addition, the Northwest Regional Telehealth Resource Center, based in Billings, Mont., will co-host an August 15 “”Brown Bag Webinar” with the Center for Telehealth & e-Health Law on the topic. The webinar, titled “Are You a Medical Device Manufacturer: The FDA’s Final Rule on Medical Devices,” will feature Anthony Pavel, an attorney with the law firm of K&L Gates and a CTeL board member.
While the 30-page draft establishes three categories of devices that would fall under FDA perusal, it leaves out – either specifically or by omission – several other uses. Among them: App sellers (like Apple), telecommunications providers and handset manufacturers, to name a few.
“What we have done is we have taken that approach and formulated policies that were narrowly focused on a very small subset while allowing apps that are out there to foster and continue developing that space,” said Bakul Patel, an FDA policy advisor who helped draft the guidelines, in news reports. “We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. … (If) somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.”
Chuck Parker, executive director of the Continua Health Alliance, a 230-member global alliance of healthcare and technology companies working to improve the quality of personal healthcare, said the draft “opens up the market” by giving the industry rules to work with.
“It sort of clears the thoughts out a little bit, and that does help us out,” he said.
“It’s pretty consistent with what I expected them to do,” said Yarmela Pavlovic, an associate with the global law firm of Hogan Lovells. “What’s been happening (in the mobile medical app space) is very, very fast development, and there needed to be an interpretation of existing regulations.”
Zachary Bujnoch, a senior industry analyst for telehealth and healthcare with Frost & Sullivan, called the draft document a much-needed entry into a “market full of hype.” He said the regulations will help “vet out the market” and target the thousands of healthcare apps on the market.
“This is going to hinder innovation in the market – there’s no doubt about it,” he said. “But that’s good. It’s a very confused market right now … that needs clarification.”
Pavlovic said she was “surprised by the way they narrowed” the classifications of apps to come under FDA guidance. “There’s definitely things that fall outside the categories that will be discussed,” she said. For example, she said, should accessories apps be treated the same as their connected devices?
Both Parker and Bujnoch questioned whether electronic health records should fall under FDA review (electronic and personal health records currently fall outside the FDA’s scope, according to the draft). An issue expected to generate a lot of comment, both said, is the definition of clinical decision support. If a device takes healthcare data and translates that into a clinical decision that can affect one’s healthcare, should it fall under the FDA’s guidelines?
“It depends on where the decision factor comes in,” said Parker. “Who defines the intelligence that gets sent back to the individual?”
The FDA draft will be a topic of discussion at two upcoming conferences. On Wednesday, it’s on the agenda for the American Telemedicine Association’s Policy Summit in Washington, D.C. (co-hosted by the Continua Health Alliance); and it will be the subject of a keynote panel discussion during the World Congress 3rd Annual Leadership Summit on mHealth, scheduled for Friday, July 29.
The mHealth Regulatory Coalition is also expected to weigh in, taking part in the ATA/Continua conference on Wednesday and issuing its own version of mHealth guidelines within a few weeks.
In addition, the Northwest Regional Telehealth Resource Center, based in Billings, Mont., will co-host an August 15 “”Brown Bag Webinar” with the Center for Telehealth & e-Health Law on the topic. The webinar, titled “Are You a Medical Device Manufacturer: The FDA’s Final Rule on Medical Devices,” will feature Anthony Pavel, an attorney with the law firm of K&L Gates and a CTeL board member.
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