FDA issues final guidance on mobile medical apps

Released from the FDA on Sept 23, 2013:

FDA issues final guidance on mobile medical apps
Tailored approach supports innovation while protecting consumer safety

Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.

The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.

Verizon jumping into Remote Health Monitoring with FDA clearance

In case you missed this last week (announced on Aug 8):

Verizon Gains FDA Clearance for Remote Health Monitoring Solution

Medical Device to Help Clinicians More Effectively Manage Patients’ Health From Their Home or When They are On the Go 

BASKING RIDGE, N.J. – Verizon announced today that it has received U.S. Food and Drug Administration 510(k) clearance for Converged Health Management, a cloud-based, remote patient-monitoring medical device.  This marks the first time Verizon has sought and gained FDA clearance for a healthcare solution.

Verizon’s new solution, which resides in the company’s HIPAA-ready cloud, provides clinicians with access to up-to-date patient data from connected biometric devices so they can more efficiently monitor and manage patients from their home, or when they are on the go.

FDA issues an inquiry letter to mobile medical app uChek urine analyzer

uChek by Biosense Technologies Pvt is a mobile medical app for the iPhone. Originally designed and used in India, Dr Abhishek Sen from the Biosense team said, "If it can work in India, it can work anywhere"

uChek urine analyzer is designed to use the iPhone camera to read urine test strips and analyze the urine for glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.

According to the FDA: The uChek Urine analyzer appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.

The FDA recently issued an inquiry letter to Biosense Technologies Private Limited, saying:

We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the uChek Urine analyzer. We request that you provide us with the FDA clearance number for the uChek Urine analyzer. If you do not believe that you are required to obtain FDA clearance for the uChek Urine analyzer, please provide us with the basis for that determination. Please provide the requested information within thirty (30) business days.

This may be the first example of the FDA issuing a letter regarding a mobile medical app/device. Will we see other examples in 2013?

Office of Mobile Health at the FDA?

The U.S. House of Representatives will be evaluating a bill called the Innovation and Marketplace Technologies Act (HIMTA). Under that act, the FDA would establish an Office of Mobile Health which would provide recommendations regarding issues related to mobile health apps. You can read more about this here.

Someday, we'll look back on the wild and unregulated days of mobile health apps when developers released anything and everything related to health care just to get an app on the app store. We'll reminisce about all those crazy, wacky mobile apps that even made health claims but never got scrutinized or reviewed by the FDA.

Videos from the Mobile Devices Roundtable are now available

Did you miss last week’s Mobile Devices Roundtable event? Did you attend the event and want to share the experience will colleagues? Do you know a health care provider or health IT professional who may find the discussions useful?

Event videos and materials from the Friday, March 16, 2012, Mobile Devices Roundtable are now available online.

Background: One of the key goals of the Federal Health Information Technology Strategic Plan is to inspire confidence and trust in health IT and electronic health information exchange by protecting the confidentiality, integrity, and availability of health information. ONC’s Office of the Chief Privacy Officer (OCPO), along with the HHS Office for Civil Rights (OCR), recently launched a privacy and security mobile device project. The project builds on the existing HHS HIPAA Security Rule - Remote Use Guidance and is designed to identify privacy and security good practices for mobile devices. The identified provider use case scenarios and good practices to address those scenarios will be communicated in plain, practical, and easy to understand language for use by health care providers, professionals, and other entities.

Search #FDAApps to read about the FDA Twitter chat regarding mobile apps

The FDA held a Twitter chat yesterday on mobile apps. Search for the hashtag “#FDAApps” to view comments, tweets, and short discussions regarding the FDA and mobile apps.

FDA's Twitter account is @FDADeviceInfo.

FDA Releases Draft Guidance on Mobile Medical Applications

The FDA has released a Draft Guidance document on Mobile Medical Applications. Here's a snippet regarding the definition of a "mobile medical app" here:

C. Mobile Medical Application (Mobile Medical App)
For purposes of this guidance, a "mobile medical app" is a mobile app that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)4; and either:

• is used as an accessory to a regulated medical device; or
• transforms a mobile platform into a regulated medical device.

The intended use of a mobile app determines whether it meets the definition of a "device." As stated in 21 CFR 801.4,5 intended use may be shown by labeling6 claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.

ResolutionMD Mobile featured on CNN

There's a feature story on CNN titled, "Mobile app helps doctors diagnose strokes."

STORY HIGHLIGHTS

• A smartphone app allows specialists to accurately diagnose a stroke, a study says
• Doctors reach the same diagnosis using phone as when on a terminal in 94% of trials
• Experts have been skeptical about the utility of using such a small screen
• The FDA is currently deliberating on whether to approve the app for U.S. use

Read the full story here.

How will the FDA regulate mobile health apps?

I doubt that the FDA will regulate every mobile health app that makes it to the Apple App Store, the Android Market, or the BlackBerry App World. How will the FDA choose which apps to regulate? What will this regulated environment look like?

We’re all still waiting for the FDA to explain how they plan to regulate mobile health apps. Here’s a critical question/equation that will determine how the FDA will regulate this space:

mobile device + mobile health app = a medical device ?

If the combination of a mobile device plus a mobile health app results in a “medical device,” then the FDA will be involved in regulating these types of apps. So, is a symptom checker running on a smartphone considered a medical device?

How does Section 201(h) of the Federal Food, Drug, and Cosmetic Act define a medical device?

“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man...”

Based on this broad definition, it would seem that computers and smartphones will be classified as medical devices if physicians are using computers to diagnosis or treat a disease.

Medical smartphone apps from the US government

I want to thank Dr. Stephen Sun, Medical Officer in Controlled Substance Staff at the US Food and Drug Administration (FDA), for sharing this information with me on LinkedIn:

US Gov't Medical WebApps (Access these sites via your smartphone browser)

1. CDC: http://m.cdc.gov
2. AIDSinfo Mobile (NIH): http://m.aidsinfo.nih.gov
3. MedlinePlus (NIH): http://m.medlineplus.gov
4. PubMed (NIH): http://lnkd.in/JH8k4d
5. DailyMed (NIH): http://lnkd.in/JH8k4d

What a great list! Thanks Stephen!

3rd mHealth Networking Conference March 30-31, 2011

Concerns, fears, expectations, and hopes are widespread regarding FDA regulation of mobile devices. Through dialogue and collaboration with the FDA, the mHealth Regulatory Coalition (MRC) is addressing development of new policies about and approaches to medical device regulation that factor in the impact of rapidly accelerating mobile and wireless technology developments.

Whether you are a user, an IT specialist, a developer, a vendor, or other healthcare stakeholder, you need to know about these issues.

So, the mHealth Initiative is presenting A Panel Discussion on The FDA and mHealth at the 3rd mHealth Networking Conference, March 30-31, at the Crowne Plaza Chicago O'Hare Hotel & Conference Center.

The FDA and mHealth Panel, led by Dane Stout, Executive Director of the mHealth Regulatory Coaltion, also includes Kent Dicks, CEO of MedApps; Dr. Joseph Smith, CMO of West Wireless Health Institute; Mark Gryzwa, Director of Research and Development at Boston Scientific; and representatives from Qualcomm and Nokia. Discussion topics include:

* The current confusion and lack of clarity in mHealth Regulation
* Why staying engaged in productive dialogue with the FDA is a better alternative than direct confrontation or ignoring the issue
* What their companies wish FDA knew about their technologies and why current policies just won't work
* How policy decisions being contemplated today will impact future product development strategies in mHealth

FDA clears first diagnostic radiology application for mobile devices

Provides wireless access to medical images for iPhone, iPad users

A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.

The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

“This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.

Epocrates FDA Reporting Resource for Clinicians

Have you tried using the FDA Reporting Resource for Clinicians from Epocrates? Here's what it offers:

When

Whenever you think a medical product may be associated with a serious event (seizure, bronchospasm, GI bleed, hospitalization, life-threatening illness, disability, congenital anomaly, etc.) You need not be sure about causality; if you suspect the product is associated with a serious event, FDA is interested.

What

Reporting is easier than you think. Although the form asks for many details, the only required info is the product and a description of the problem.

MedWatcher (iPhone app) tracks drug safety

Here's an interesting story from the Boston Globe:

The team from Children’s Hospital Boston that brought “Outbreaks Near Me” to smartphones during last year’s H1N1 epidemic has now launched a similar application for tracking and reporting problems with drug safety.

MedWatcher, another app for the iPhone available for free at the iTunes store, holds information about thousands of medications from US Food and Drug Administration databases. It sends alerts from FDA and news media sources on drugs, tailored to the user’s interests.

Here's a description of the app:

Stay up to date with the latest news and government safety alerts for the prescription medicines you take. Submit any side effects you experience to the US Food and Drug Administration (FDA) to make drugs safer for everyone.

MedWatcher is a mobile tool for both healthcare professionals and the general public. Anyone can submit an adverse event report to FDA using the easy-to-use form on MedWatcher, or post to our online community to talk to others taking the same meds. In the MyDrugs section, you can make a quick list of all the prescription medicines your family or patients take and track the latest developments.

Clinicians will find MedWatcher to be a vast improvement over the paper and fax FDA MedWatch form. No more cramped text boxes or tiny font! Do it at your convenience and fulfill your professional obligations in a convenient way. Get your patients involved in their health.

Take control. Participate in your health care.

This is a project of Childrens Hospital Boston, Harvard Medical School, and the University of North Carolina.

Click here to learn about this app on the Apple App Store.

mHealth Regulatory Commission

Have you heard of the mHealth Regulatory Commission? The FDA currently does not regulate mobile apps on devices like smartphones. Recent discussions between the FDA and the FCC suggest that they're planning on forming some type of regulatory framework, but we don't know when or how this will get rolled out. So, in the meanwhile we will rely on the private sector's mHealth Regulatory Commission to govern what's happening in the mobile health space. This organization will probably only exist temporarily, but it's desperately needed given that so many new medical and health apps are appearing on various types of smartphone app stores.

New drugs on Epocrates

Here are some new drugs that have been recently added to Epocrates.

* Agriflu (influenza A and B (seasonal flu) vaccine)
* Berinert (C1 inhibitor (human))
* budesonide inhaled (first-time generic for Pulmicort)
* Cervarix (human papillomavirus vaccine (recombinant))
* Influenza A H1N1 2009 Vaccine (GSK) (influenza A H1N1 2009 (swine flu) vaccine)
* ketorolac ophthalmic (first-time generic for Acular)
* lansoprazole (first-time generic for Prevacid)
* valacyclovir (first-time generic for Valtrex)
* Vibativ (telavancin)
* Votrient (pazopanib)
* Zenpep (pancrelipase)

Wow, it's hard to believe how quickly some of these drugs have gone generic. It seems like yesterday when drugs like Valtrex were approved by the FDA (this goes to show you how quickly time flies). If you're using Epocrates, make sure to keep your software current by performing regular updates.

Drug reference guides and dietary supplements

Do you know how the FDA regulates dietary supplements like omega-3 fatty acids (http://www.omega3.org)? What drug reference guides provide this type of information? Can you rely on the FDA? Here's what the FDA currently says about dietary supplements:

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

It's difficult to find reliable information about nutritional supplements and herbal products. Therefore, it's important to find reliable sources of information about specific agents. For example, there's a site called http://www.omega3.org and it contains information about omega-3 fatty acids. The topic of fish oil supplements and cardiovascular health has been explored at great depths. You'll see many published papers on this topic. As a result, we have stronger levels of evidence regarding certain nutritional supplements and alternative remedies. The evidence may be much weaker for other agents.

Epocrates Rx Pro and Epocrates Essentials includes information about Alternative (herbal) medicines. If you look up "fish oils" or "omega-3 fatty acids," the list of Reported Uses is very long. Then if you look at the Reported Doses section, it starts with:

Safety/efficacy may not be established; concentration of active ingredients may vary widely between products.

You can also find agents like fish oil in the PDR for Herbal Medicines (Physician's Desk Reference for Herbal Medicines). Skyscape offers the Drug Interaction Facts: Herbal Supplements & Food. As the interest in dietary supplements continues to grow, there will be an increased demand for medical apps and websites like http://www.omega3.org.