We’ve been considering FDA oversight of medical apps for a while, over at Medgadget.com. Now, the public comment period has concluded on the FDA’s draft of how this oversight might look. The story:
The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:
* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.
* Applications that allow the user to view patient-specific lab results.
* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.
Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:
“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”
“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”
For their part, the FDA said it’s nothing to worry about: Read more »
*This blog post was originally published at Blogborygmi*
The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
In 1994 Congress (pushed by Senators Harkin and Hatch) passed DSHEA (the Dietary Supplement Health and Education Act). As regular readers of SBM know, we are not generally happy about this law, which essentially deregulated the supplement industry. Under DSHEA supplements, a category which specifically was defined to include herbals, are regulated more like food than like medicinals.
Since then the flood-gates opened, and there has been open competition in the marketplace for supplement products. This has not resulted, I would argue, in better products – only in slicker and more deceptive claims. What research we have into popular herbals and supplements shows that they are generally worthless (except for targeted vitamin supplementation, which was already part of science-based medicine, and remains so).
A company can essentially put a random combination of plants and vitamins into a pill or liquid and then make whatever health claims they wish for their product, as long as they stay within the “structure-function” guidelines. This means they Read more »
*This blog post was originally published at Science-Based Medicine*
Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines.
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.
This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release: Read more »
*This blog post was originally published at iMedicalApps*
Last week I had some blood tests taken before a doctor’s appointment. I went to a commercial lab facility, one of several dozen centers for collecting specimens have opened up in otherwise-unrented Manhattan office spaces lately.
I have to say I really like getting my blood work done at this place, if and when I need blood tests. And it’s gotten better over the past few years.
First, pretty much all they do in the lab center is draw blood and collect other samples based on a doctor’s orders. So the people who work there are practiced at phlebotomy, because it’s what they do most of the time. The guy who drew my blood last week did the same a year or two ago, and he was good at it back then. He used a butterfly needle and I didn’t feel a thing.
Second, they seem organized and careful about matching specimens to patients. The man who drew my blood didn’t just confirm my name and date of birth, but he had me sign a form, upon my inspecting the labels that he immediately applied to the tubes of blood he drew from my right arm, that those were indeed my samples and that I was the patient named Elaine Schattner with that date of birth and other particulars. Read more »
*This blog post was originally published at Medical Lessons*