This takes it a bit too far (like most cartoons do), but it sometimes feels like this is reality. As I read yesterday, the FDA isn’t designed to regulate the digital health technologies that are hitting the market today. I think that’s the biggest challenge they face. They have to remake who they are if they’re going to start regulating all that’s happening.
We’re in a funny spot right now where the doctors don’t trust many apps because the FDA hasn’t approved them and so they’re not sure if they can be trusted and the app makers largely don’t want to go to the effort and cost of FDA approval. In many cases, it would be like trying to fit a square peg in a round hole. Somethings gotta give.
Next week I’m going to the International CES (Consumer Electronics Show) in Las Vegas. Obviously, being a consumer show, the health applications are very much consumer focused. They have a whole section of the show dedicated to digital health and it’s been growing each year (up 60% this year I’m told).
I’m on the press list and I’ve been really interested in the wave of fitness devices that have passed through my inbox. They come in all shapes and sizes and record everything from steps to heart rate to blood pressure to every in between. Basically, I see a whole plethora of applications and devices that are measuring various aspects of our health. The wave is here. Who’s going to win this race isn’t all that clear to me, but the fact that we’re going to have devices measuring our health is clear.
What’s also not clear is how these measurements are going to bridge over to the medical community. Sure, there are targeted pilot programs where some of these devices are used by doctors or hospitals. However, most of these consumer monitoring and device companies aren’t thinking about the medical implications. In fact, many of them are staying far away from it as they avoid any sort of FDA oversight.
While I understand the desire to not have to make the bridge to the medical community, I don’t think most of these devices and apps will make it without making the bridge. If I’ve already recorded all of my blood pressure data on my iPad using a blood pressure cuff at home, I’m going to want an easy way that I can provide that data to my doctor.
Maybe this is an opportunity for an innovative company to provide that bridge. I’m sure most of these mobile health developers would be happy to tap into a public “utility” that would connect their data to the medical community. The problem is that it’s not sexy to be a utility.
I’ll admit that I’m not an expert on FDA clearance, but I found this notice from the FDA to 23andMe really interesting. As stated in the notice, “23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
The letter does specify that 23andMe has been working with the FDA since July 2, 2012, but something has gone wrong in 23andMe’s clearance process. It does offer the following explanation of the issues the FDA has:
This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.
The 23andMe website doesn’t say anything about the FDA letter, but the company did put a statement for the media on their Facebook page. I guess Facebook is the new media hub for organizations (although, I found it from this tweet)
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.
That’s a pretty vague statement. It is interesting that they chose to acknowledge that they haven’t met the FDA’s expectations. You can be sure there’s a whole lot more to this story and 23andMe’s interactions with the FDA.
Considering the big name people behind 23andMe, it will be really interesting to see this battle play out. It could certainly set precedent for many other healthcare applications in the future.
Today the FDA announced the issuance of the final guidance on mobile health apps. You can find a PDF of the full mobile medical app guidelines here. The guidance won’t come as a surprise to those of us familiar with the industry. The guidance is basically what we expected the FDA to do with mobile health applications. The FDA plans to only offer regulatory oversight to those mobile medical apps which they define as a medical device. Here’s how they describe it in their press release:
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.
Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
They further went on to explain that the FDA will focus its oversight on mobile health apps that:
are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Here’s the overarching premise of the FDA’s approach to mobile health app regulation, “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 Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
The last comment is what so many mobile health application developers have wanted. Hopefully this guidance will give them that assurance and clarity. Although, it’s a bit annoying when the final guidance document says “Contains Nonbinding Recommendations” at the top of every page. Legalese aside, I believe this document will provide the foundation for the FDA’s mobile health efforts going forward.
Here’s another gadget to add to my ever-growing, paranoid (or more, perhaps, cautious) parent list. I’ve read about this at three separate sources today, so I figure it’s probably worth mentioning here.
Students at Brigham Young University have created what they call The Owlet baby monitor. This device is supposed to help combat SIDS, which is the leading cause of death for infants in the United States. It is a sock-like monitor that is placed on a baby’s foot while they sleep, and uses pulse oximetry to indicate if a child stops breathing, has low-levels of blood-oxygen, or irregular vital signs. The creators hope that it will help alert parents to potentially fatal and harmful situations. Here is a picture of the sock monitor, as well as the app.
The team who created it had personal reasons for wanting to create a monitor like this. In an interview with KSL.com, co-founder of Owlet, Kurt Workman said that he partly came up with the idea because his wife was a near-SIDS victim as an infant, and a cousin had passed away from SIDs as well. Another one of the team members, Jacob Colvin, is a father and understands how parents worry about their child breathing. The tagline for Owlet is “up all night, so you don’t have to be.” I definitely think that statement has some truth to it.
There are some other monitors out there to help monitor an infant’s breathing, but I think this one is definitely different. I love that it shows the blood-oxygen level. I think I’ve mentioned before that my son was in the hospital when he was a few weeks old with RSV. A few days before his admittance, he had his two-week appointment. His levels were pretty low (around 85), and the nurses just said the machine wasn’t working. However, that wasn’t true — his levels truly were too low, and he went a few days without getting adequate oxygen. While the doctors and nurses should have acted on this, rather than dismissing it as a fluke, I wish we could have had this monitor then, so we could have seen his oxygen was low earlier on. I’m grateful that nothing happened, but it would have been nice to have something to alert us that something really was amiss with our son.
I posted this article to Facebook, and a friend immediately responded, stating how much she wanted it. When her daughter was first born, she had some episodes where she quit breathing. Luckily, my friend was always around, but it has made her very nervous to let her daughter sleep by herself. This monitor would truly give many mothers (and fathers) peace of mind. Parents of babies don’t get a lot of sleep to begin with — not feeling the need to wake up every few hours to ensure that their child is breathing might give everyone a little more sleep (I’ll be the first to admit that not only have I woken up to check on my son, but I’ve woken him up in the process, when it’s so dark, I’m half asleep, and I can’t tell if he’s asleep.)
The Owlet won first place in the Student Innovator of the Year competition that was sponsored by the Ira A. Fulton College of Engineering and Technology and the Rollins Center for Entrepreneurship and Technology. They won $6,000 to help with the improvement of their device, and got valuable feedback from judges. While the Owlet won’t be on the market for awhile, its creators are motivated to get it into the mainstream market, and approved by the FDA. I like how Jacob Colvin described some of his motivation in this device:
If we can hear just one mother say that we made a difference, it would all be worth it. That makes all the difference in the world.
The “Raiing” is a small device that is placed under the armpit. Not only does it give the temperature of an individual, but it has the ability to continually track for a period of time, all the while having the information sent via bluetooth to an iPhone, iPad, or iPod touch. A “pre-set temperature” can be selected, and if it is reached or surpassed, an alert is sent to the mobile app. For anyone worried about their own temperature (or a child’s) throughout the night, this could really bring some piece of mind and perhaps a few less sleepless nights.
72 hours can be recorded before the information has to be synchronized with the mobile device, and a record can be kept as well — either on the phone, or on the cloud service provided by Raiing.
This image below is from the website, and shows a little bit how it works, and what the interface of the app looks like.
And here is an actual screenshot of the app:
This looks like it’s the first smart phone thermometer available, and it looks like it has been well-thought out. I didn’t see anything about pricing on the website, or the ability to purchase it, but the accompanying app can be downloaded here from iTunes (and is free).
I’d love to see this available for Android devices sometime in the future. Hopefully if it is successful on iOS devices, then it will be offered to Android as well. This is definitely something I would be willing to invest a little bit of money into getting.
Currently, the question is should the FDA’s Center for Devices and Radiological Health be in charge of regulation, or should an entirely new department be created? Some believe that special attention needs to be given to mHealth, including Rep. Mike Honda. He is introducing a bill called “Healthcare Innovation and Marketplace Technologies Act,” which proposes creating the “Office of Mobile Health.” Severalsources state that this bill will “ensure that competition, innovation, and entrepreunership in the mobile app market” won’t be subject to the “regulatory issues” that are usually applied to “traditional, non-software device types.”
As is expected, there are mixed feelings on this, but according to The FDA Law Blog, this “proposed bill is likely to be welcome by many mobile app developers – in particular the same or startup ones who still wonder why their products would be subject to FDA regulatory oversight at all.”
The article finishes with this:
So the question still remains as to whether medical mobile apps should be regulated by FDA’s CDRH, another office independent CDRH, or simply an office separate from FDA altogether.”
They option they failed to mention though, is the possibility of no regulation at all. Regulating mHealth apps could very well stifle creation. If there are a whole bunch of rules and regulations put in place, many would-be app creators may not want to go to the effort of getting approved, and some ideas may never go further. It’s definitely something to think about. Personally, if the only options are to be regulated by the CDRH, or have an mHealth office created, the mHealth office would be more preferable. Then there would be more focus on getting apps and devices regulated quickly and efficiently, and hopefully more willingness to work with app creators. And, if it is true that competition and innovation won’t be affected negatively, it might not the worst thing ever. We’ll see.
There have been a few posts over the last couple months concerning the FDA potentially monitoring medical apps. Some think it’s a great idea, others, not so much. Well, the latest news has arrived: It is potentially being delayed until 2013.
The reason for the delay? Iowa Senator Tom Harkin recently proposed a bill (S.3187)that, if passed, would require the FDA To provide a “full-scale report to Congress on its plans for regulating mobile medical apps.” In addition, Senate would have to give its sign off before the FDA could even finalize its mobile apps guidance.
If passed, the FDA would have 18 months to finalize this report, which would take a lot of effort to get it completed.
This has caused a bit of an uproar among different people. Bradley Thompson, an FDA-expert for the Epstein Becker Green law firm said he hopes this doesn’t happen. According to the Fierce Mobile Healthcare article, “he and other proponents are ‘actively talking with Senate Staff’ about the FDA’s timeline, and pushing for the guidance ‘not to be held up.’ With the pace the market is growing and changing, healthcare providers, app developers and other need clarity now on what the FDA expects, and what the regulatory process will be—not in late 2013.”
To me, it seems like if this bill is passed, the mHealth market growth might be hindered. I mean, are the developers of mHealth technology going to want to put a ton of effort into creating different products, when there is a possibility that it may not be in-line with FDA guidelines a year later? I don’t think so. While I am still not sure how I even feel about the FDA monitoring mobile health apps, if it’s going to happen, I’d rather it occur in whatever fashion will be most beneficial for developers. The article I mentioned above says that “it will be interesting to see if it turns into a partisan battle on Capitol Hill.” That it will.
Last year, the FDA announced plans to regulate some smart phone apps that involve medicine or health. The specific apps that would be regulated “are used as an accessory to medical device already regulated by the FDA [or] transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.” In addition, apps that suggest potential diagnoses or treatments for the person using it.
As I was perusing comment boards for various articles about this, the feelings were mixed. Some think that the FDA already has too much control. Others think it totally makes sense. A comment from someone on a Washington Post article sums up how I feel:
Yes, some software that turns a smartphone into medical use has to follow the same rules as developing a medical device — from the first moment you think about it. It’s not hard, but you had better know what you are doing because what the FDA gives you is basically the right to market the device and if you don’t follow the rules, you could end up with is a really neat program that you can’t even talk about to your customers.
I think it definitely makes sense to regulate these things. I mean, there are quack doctors out there that we don’t know about, who seem legitimate; how are we supposed to discern between a quack health app, and one that can actually be trusted? There needs to be some kind of regulation, but the question is — how much?
The issues I find with certain apps, is that if they get too advanced (such as an x-ray), people might start avoiding the doctor because they diagnose themselves. Basically, I think that without regulation, certain apps may seem awesome, but in reality, they have fatal flaws that could be just that — fatal. There shouldn’t be a chance that bad apps could possibly act as an authoritative source.
In the Washington Post article I previously referenced, Bakul Patel, a FDA adviser was interviewed. I thought he made a good point when he said:
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.
I mean, that totally makes sense. Just because something is digital doesn’t mean it should be able to bypass requirements. A stethoscope is a stethoscope. End of story.
Overall, I agree with the regulation. If medical and health apps are going to actually be taken seriously, we should be able to see right of the bat if it can actually be trusted as a medical device. I’m not a huge fan of the government controlling everything, so there should definitely be regulation on the apps that could actually determine the health status of a person. However, the rules shouldn’t be so strict that people can’t be creative in what they create. That’s my two cents on the issue, what are your thoughts?
Like so many other things the government may start making life more difficult for mHealth companies in the future through regulations. It really does not surprise me as they like to stick their nose in everything, but there are a few different perspectives at this point. There is a great article by Brian Dolan at mobihealthnews.com about FDA Cleared Mobile Health Devices. I have included a few interesting parts of the article below. It is clear that the FDA will change their involvement the question is now what impact they will have.
“We need to balance our desire for safety with rational risk tolerance and transparency,” the West Wireless Health Institute’s Chief Medical Officer Dr. Joseph Smith said during his presentation at the Institute’s Health Care Innovation day in Washington, DC last week. “And I think — I’ve not shared this with them — but I think we need to get the FDA out of the business of assuring absolute safety and into one of absolutely assuring transparency around risks and making sure decisions are well-informed as opposed to trying to protect all of us from the rare circumstances of failed technology.”At the event FDA officials confirmed that a draft guidance document focused on how the agency might regulate health apps would likely publish in the coming months. Officials acknowledged that apps included just a small sliver of the activity going on in mobile health, but it is a start. The FDA will seek commentary on the draft document from the industry during a 60 or 90 day period, officials said.
“Our intent was to support both patients and healthcare providers in the management of chronic disease,” Sysko said. “As we looked at the regulations as early as 2005 of the software that the FDA had published, it was really clear to us that we were an accessory to a medical device — an accessory to a blood glucose meter… We thought that there were sufficient guidelines from a software perspective to go ahead. Little did we know that it would be a long journey and there were many bumps along the way — many self-inflicted — but we felt that it was absolutely something we would have to do to bring our product to market.”