Apple Watch and Apple Research Kit
In March 2015, technology fans tuned in from around the world to watch the Apple announcement of the Apple Watch which didn’t disappoint.
It was the much anticipated announcement of the first major foray into the promising wearables space by the worlds’ most valuable company. But in addition to the excitement of the Apple Watch announcement, Apple surprised and enticed many in the Healthcare industry with the announcement of its “Research Kit” platform.
During the keynote, an exciting video was shown in which doctors, researchers, and patients extolled the benefits of using an iPhone for medical research. The video shows how Research Kit promises to revolutionize Health Care research and clinical trials by enabling the secure, reliable collection of data and consent from the hundreds of millions of iPhones already being used by patients and researchers around the globe.
The Promise of Research Kit — Open or Closed?
Adding Research Kit software to the raw data gathering capabilities of the Watch — and the ability to easily fill out a consent form from the convenience of your phone — means that researchers have a new platform including hardware and software in order to perform research at a scale and velocity never before possible.
With its bevy of sensors, and its obvious ability to collect heart rate, temperature and activity at all hours, the Apple Watch itself holds exciting potential for moving the needle on health applications.
ResearchKit turns iPhone into a powerful tool for medical research. When granted permission by the user, apps can access data from the Health app such as weight, blood pressure, glucose levels and asthma inhaler use, which are measured by third-party devices and apps. HealthKit™ is a software framework Apple introduced with iOS 8 to provide developers the ability for health and fitness apps to communicate with each other. ResearchKit can also request from a user, access to the accelerometer, microphone, gyroscope and GPS sensors in iPhone to gain insight into a patient’s gait, motor impairment, fitness, speech and memory.
Another exciting reality is that due to the sheer size of the user base and physical distribution means vastly higher upper limits on the size of the data sets — at the time of writing Apple reports 700 Million (2015) of the devices are being used in the real world.
But not every patient has an iPhone (or the funds to purchase one) — much less a minimum $350 extra for an Watch… So what about Android? Well ResearchKit is a front-end development technology, so despite being Open Source Apple says Research Kit will be open source platform. In theory then, developers will race to implement Android and Windows phone apps that match these capabilities. And of course many open source projects have failed to live up to the hype so the jury is still out on how open the Research Kit platform will eventually be.
So where’s the catch? Does this represent the brave new world of medicine — a Star Trek-like future with a TriCorder in every pocket?
The FDA and mHealth Apps: When is an App Going to be Regulated?
The fact is that despite the excitement around the recent Apple announcements, there are plenty of reasons to be cautious and even skeptical of the immediate benefit of the health apps in general.
Before developers and researchers dive head-first into the mHealth app market, it is important to step back and take a look at what regulations are developing around these tools in the real world. And it’s also important to consider the
Are mobile health apps considered a “Medical Device”? A lot depends upon whether the app could lead to mishandling of treatment, impacting outcomes, handling of privacy data, and of course false or misleading health related marketing claims.
On February 9, 2015 FDA released their staff guide on the topic: Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (pdf)
From this guide, we see the distinction largely comes down to whether the App and the device capabilities (aka sensors, data connectivity, data gathering capability etc.) in combination function as a medical device.
This distinction makes sense. After all, the heart rate monitor in the iWatch is in itself not a regulated medical device as it clearly offers no more function than placing one’s fingers on the wrist. But this simple sensor clearly becomes a medical device when it is combined with a data collection app that combines heart rate information with other sensor data such as accelerometer and software algorithms that further analyze this data to create diagnostics and/or treatment recommendations.
From the guide:
Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these two categories.
Consistent with the FDA’s existing oversight approach that considers functionality rather than platform, the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. This subset of mobile apps the FDA refers to as mobile medical apps.
Are mHealth Apps Doing More Harm Than Good?
This guidance can’t come soon enough. According to a March 16, 2015 New York Times article on the benefits and dangers of the explosion of health and medical-related mobile apps, there are now more than 100,000 health apps are available in the iTunes and Google Play stores, (Research2guidance.)
By 2017, it is estimated, the market for such tools, known as mHealth apps, will be $26 billion.
Not Replacing Doctors with Apps (yet)
So with an always-connected sensors strapped to our bodies, and the ability of AI “Expert Systems” like IBM Watson to diagnose and recommend, are we heading towards a world in which AI replaces the human physician?
We’re not there yet for sure, and it has long been established that technology is equally well suited to improving the human connection in medicine.
Research done between 2009 and 2011 by the Mayo Clinic shows that using technology to connect doctors and patients — instead of replacing doctors with computers, enhancing the doctor-patient relationship. This is the roadmap to a near-term future in which “traditional” electronic health platforms are extended to the “last mile” of health care, bringing patients and doctors together online for electronic consultations, bringing medicine to the patient, thus making it more efficient, and scalable.
Mayo Clinic ran the study to determine the utility and outcome of electronic specialty consultations between primary care physicians and specialists at a large, multispecialty academic practice and to determine best practices for this model.
From the abstract (emphasis added):
Method: Use of a common electronic health platform for the provision of ordering specialty care. A new model was put in place in which an electronic consultation with a specialist could substitute for a face-to-face consultation for certain defined conditions. The financial model for this type of consultation was set up at the Mayo Clinic. All electronic consultations from January 2009 to September 2011 at the Mayo Clinic Rochester were evaluated for appropriate condition ordered, clarity of question, time to completion and time saved for the specialty practices.
Results: Thirty-nine specialties participated in this new model of care to define 158 conditions; 6,253 electronic consults were performed with a greater than 98% quality rate for appropriate condition ordered and clarity of question, with 93% completed within 2 business days. These consultations, termed eConsults, were accomplished in roughly one-half to one-third of the time of a face-to-face consultation, saving time for the specialist.
Conclusions: The electronic consult is a new modality for a primary care physician to solicit specialists’ input. While this model is not appropriate for every circumstance, it can provide significant value beyond that of a traditional face-to-face consultation.
But Will it all Improve Our Health?
Many questions about technology in healthcare. Privacy, accuracy, access, and the impact of these developments on medical research are just beginning to take hold.
But one thing is certain, the pace of mHealth tech is not slowing down, and we are all in for major changes in the machine body interface.
Ultimately, only time will tell who will be the winners and losers as we increasingly turn to hardware and software for answers and solutions to our health issues in the future.