I am a clinician and a clinical trialist. Medical research in some form or another (performing it, consuming it, reviewing it, editing it, etc.) occupies much of my time. Therefore, you can imagine my excitement while watching Apple’s product announcement yesterday when they introduced a new open source software platform called ResearchKit. Apple states ResearchKit could:
“revolutionize medical studies, potentially transforming medicine forever”
ResearchKit allows clinical researchers to have data about various diseases collected directly from a study participant’s iPhone (and perhaps other devices in the future — see below). The software is introduced as a solution to several important problems with current clinical studies, such as:
- limited participation (the software allows everyone to participate; anyone with an iPhone can download a specific app for every study they want to participate in)
- frequent data entry (patients can enter data as often as required/desired, rather than only at limited opportunities such as hospital or clinic visits)
- data fidelity (currently-used paper patient “diaries” are prone to entering implausible or impossible values — the iPhone can limit the range of data entered)
Specifically, the website states:
ResearchKit simplifies recruiting and makes it easy for people to sign up for a study no matter where they live in the world. The end result? A much larger and more varied study group, which provides a more useful representation of the population.
This is a bold claim. We’ll see below that it doesn’t yet ring true.
For now, the answer is “we don’t know”.
But… the question is very important and worth tracking over the coming months. Let’s not assume that open source will equate to “open”.
What is ResearchKit?
Apple’s press release provided an overview of ResearchKit:
Apple® today announced ResearchKit™, an open source software framework designed for medical and health research, helping doctors and scientists gather data more frequently and more accurately from participants using iPhone® apps. World-class research institutions have already developed apps with ResearchKit for studies on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease.
…With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research,” said Jeff Williams, Apple’s senior vice president of Operations. “ResearchKit gives the scientific community access to a diverse, global population and more ways to collect data than ever before.”
Many members of the research community have had high praise for ResearchKit. For more details and perspectives about ResearchKit, see the list of articles appended at the bottom of this post.
You got me. I still won’t cop to eating at a Cheesecake Factory, but I am all about the Apple Store. In fact, I’m a teensy bit over the top about it. Seriously, I beg of you—could we, please, have just a little genius bar with our health care?
I’m no doubt somewhat of a freak (I got up at 2:55 a.m. ET on September 19th to, you know, pre-order the iPhone 6). A month or so later, I was more than ready to upgrade my aging iPad2, so obviously at the first opportunity I ordered a new iPad Air 2 online from the Apple website. I requested pick-up at my local Apple Store—because it’s convenient—and, well, I just love going there. A few minutes after I made my online purchase, I received an email informing me that the store staff was ready for me. My new baby was waiting! Serious goose bumps.
I made my way to the mall. It was pretty crowded, as usual. I walked right past The Cheesecake Factory, into the mall, turned left and into the gleaming Apple Store—smiling, not quite skipping, all along. Several staff members greeted me almost the minute I arrived. I explained why I was there. When she understood my reason for coming to the store, the first staff person handed me off to another. I showed him the email on my iPhone. We traded some numbers. He entered those on his iPhone and went back to get my waiting . . . Air 2!!
MU stage 2 is making everyone miserable. Patients are decrying lack of access to their records and providers are upset over late updates and poor system usability. Meanwhile, vendors are dealing with testy clients and the MU certification death march. While this may seem like an odd time to be optimistic about the future of HIT, nevertheless, I am.
The EHR incentive programs have succeeded in driving HIT adoption. In doing so, they have raised expectations of what electronic health record systems should do while bringing to the forefront problems that went largely unnoticed when only early adopters used systems. We now live in a time when EHR systems are expected to share information, patients expect access to their information, and providers expect that electronic systems, like their smartphones, should make life easier.
Moving from today’s EHR landscape to fully-interoperable clinical care systems that intimately support clinical work requires solving hard problems in workflow support, interface design, informatics standards, and clinical software architecture. Innovation is ultimately about solving old problems in new ways, and the issues highlighted by the current level of EHR adoption have primed the pump for real innovation. As the saying goes, “Necessity is the mother of invention,” and in the case of HIT, necessity has a few helpers.
I was absent-mindedly playing with my iPhone today and took special notice of a feature I have rarely used before. If you swipe all the way to the left on the home screen, you will get a search bar to search all of your iPhone. This includes contacts, iMessages, and apps. I’ve never needed to use this before—a testament to the iPhone’s ease of use. Just prior to this, I was working on some patient notes using my hospital’s electronic medical record (EMR). In contrast, each task I performed required a highly-regimented, multi-click process to accomplish.
Criticizing EMR interfaces is a well-loved pastime among clinicians. Here, however, I am going to take an oblique approach and reflect instead on what has made good interfaces (all outside of medicine, it turns out) recognized as such.
The Google Algorithm often gets credit for Google winning the Great Search Engine War. Indeed, there are whole teams dedicated to improving it. However, if you compare algorithms today, even 5 years ago, the differences in results have been only marginal. How does Google stay ahead? Speed. Google has done extensive research to determine what keeps users coming back and it is unequivocally speed of results. It has been much of the motivation for creating their own browser (Chrome) and operating system (Android). Speed means more searches and more searches means more money for Google.
With EMRs, wait times to store and retrieve data can be extremely long. Moreover, it frequently takes multiple clicks to get to the precise page you want, further compounding the problem. But how slow is slow? Research in web user behavior indicates that 47% of consumers expect a web page to load in 2 seconds or less and that 40% of people abandon a website that takes more than 3 seconds to load. It regularly takes over 3 seconds to retrieve an important piece of data from an EMR. That makes the experience constantly frustrating; I wish there was another EMR I could switch to. (As a fun aside, I often find myself logging into two computers side-by-side in the hospital to save precious seconds waiting for the computer to load.)
A lot of people think Google Glass can be used as a development platform to create amazing healthcare apps. So do I.
Many of these ideas are relatively obvious, and many of them could be relatively simple to develop. But we won’t see most of them commercialize in the first year Glass is on the market. Maybe even 2 years. Why?
The most obvious analogy to Glass is the iPhone. It’s a revolutionary new technology platform with an incredible new user interface. Glass practically begs the iPhone analogy. Technologically, the analogy has the potential to hold true. But economically, it does not. Because of the economics of Glass, many of these great ideas won’t see the light of day anytime soon.
First, there’s the cost. Glass will run a cool $1500 when it lands in the US this holiday season. The most obvious analogy to Glass is the iPhone. It’s a revolutionary new technology platform with an incredible new user interface. Glass practically begs the iPhone analogy. Technologically, the analogy has the potential to hold true. But economically, it does not. Because of the economics of Glass, many of these great ideas won’t see the light of day anytime soon. There’s no opportunity for a subsidy because Glass doesn’t have native cellular capabilities.
With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?
At this point, no one knows. We are entering into new, uncharted medicolegal territory.
But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.
This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:
Doctors wanting to determine a patient’s atrial fibrillation burden have a myriad of technologies at their disposal: 24-hour Holter monitors, 30-day event monitors that are triggered by an abnormal heart rhythm or by the patient themselves, a 7-14 day patch monitor that records every heart beat and is later processed offlineto quanitate the arrhythmia, or perhaps an surgically-implanted event recorder that automatically stores extremes of heart rate or the surface ECG when symptoms are felt by the patient. The cost of these devices ranges from the hundreds to thousands of dollars to use.
Today in my clinic, a patient brought me her atrial fibrillation burden history on her iPhone and it cost her less than a $10 co-pay. For $1.99 US, she downloaded the iPhone app Cardiograph to her iPhone.
Every time she feels a symptom, she places her index finder over the camera on the phone, waits a bit, and records a make-believe rhythm strip representing each heart rhythm. With it, comes the date and time.
Dr. Elizabeth Cote, from Harvard Humane Initiative collects patient data at Fond Parisien, Haiti using iPhone and iCharts from www.CareTools.com. The developers were kind enough to customize the form in less than a week to support fields and info required to comply with international disaster data collection standards. HT / Dr. Enoch Choi
How many of us can remember a world without cell phones? Today’s medical students would undoubtedly be among that group. So it is no wonder these future physicians rely heavily on technology as they embark on their career path. We surveyed more than 1,000 medical students who are Epocrates subscribers about technology (software, hardware and EMRs) and other pressing industry topics.
The survey found 45% of respondents currently use an iPhone or iPod-touch, followed by Palm and BlackBerry devices. Even prior to the launch of the iPhone, Apple has connected with this younger generation and continues to play to its strengths. Our survey did not address carrier preference, but it appears students may be more device focused; nearly 60% of non-smartphone users planning to purchase an iPhone within the next year. It is also worth noting that students may be looking at what device residents or attending physicians are using as well. In the first year of availability, over 100,000 physicians are actively using Epocrates software on an iPhone/iPod touch. We still see a significant number of physicians using BlackBerry and Palm devices, so we expect those respective populations to grow as well.