The highly anticipated unveiling of the Apple Watch Series 4 caused a news and social media sensation. Apple coined the iconic timepiece as the “guardian of your health”, with health tracking functionalities such as the ability to detect atrial fibrillation (AFib) by a self-performed electrocardiogram (ECG). But from patients’ and carepartners’ perspectives, there is a long road to a universally accessible, seamlessly implemented, mass-adoption, and meaningful use for this wearable technology.
Many experts, such as Dr. Eric Topol a cardiologist at the Scripps Research Institute, and other reports, were quick to highlight concerns about the consequences of false positives. The Apple Watch was criticized as a source for unnecessary anxiety. A letter from the Center for Devices and Radiological Health (CDRH) of the FDA, which cleared the ECG app as a class II over-the-counter (OTC) device, highlighted the risks to health and potential mitigation measures that the Apple Watch posed. Unfortunately, the vast majority of concerns in the public domain haven’t emphasized the risks to health due to poor implementation, integration, and adoption strategies of digital tools and wearables.
The current health care system needs to be significantly refreshed as it is not positioned to simply drop in advancements, such as those offered by the Apple Watch Series 4, into everyday patient care. Having Dr. Ivor Benjamin, president of the American Heart Association (AHA), endorse the Apple Watch at the Apple Keynote Event did wonders for the mass marketing appeal. It would’ve have been more credible and demonstrated more value if he stated that the AHA devised a strategic clinical practice implementation guide for cardiologists, created patient education materials for using the Apple Watch, partnered with payers to incentivize doctors to adopt the technology, and reimburse for virtual consults to support remote patient monitoring (RPM).
Let’s talk about the real-world use of the Apple Watch Series 4. Imagine I receive an alert from my Apple Watch that AFib has been detected. Here’s the cascade of questions that follow:
- Who do I call: my primary care physician (PCP), cardiologist, or 911?
- When do I confidently ignore, act upon, or wait to make actionable decisions about alerts I’ve received?
- What do I do if I don’t have a PCP or cardiologist and I need to wait 3 – 4 weeks for a new patient appointment?
- What if my care team doesn’t use this wearable technology in their practice or recognize the value of the data that is generated?
- Does Apple have a national registry of physicians by zip code that I may call for a virtual consult?
These are only a few questions that come to mind. From a patient’s perspective, the vastness of the uncertainties can be overwhelming. As a patient, if I can’t get answers for my urgent questions, I’ll just stop wearing the watch so I don’t have to deal with the alerts. Cue the discussion on what the industry calls “poor patient engagement”, “patient non-compliance”, and “difficult to change behaviors”.
There isn’t a switch that can be flipped for mass adoption of this technology by all physicians. Currently, digital tools can’t be dropped into traditional patient care workflows and operations. Seamless implementation requires proactive methodical planning to identify barriers that will be encountered both internally from a workflow and operations standpoint, as well as externally by patients using the technology. As more digital technologies become available for RPM and digitization of the patient experience, strategic support tools must be provided to physicians and health care organizations to properly plan and prepare for the implementation of these technologies into their workflows and daily operations. If data is collected by RPM technologies, such as the Apple Watch, but there is no standardized process in place for reviewing that data and making it actionable, we have failed patients and simply created another data silo.
The readings obtained by the Apple Watch are not a substitute for professional medical advice or traditional clinical ECGs but serve as a screening tool. Alerts and symptoms will need follow-ups and medical attention. There are grave concerns in mass marketing this technology via direct-to-consumer (DTC) and over-the-counter (OTC) in a fee-for-service ecosystem. Poor health literacy, lack of patient education materials, fear, anxiety, lack of real-time medical support, and poor coordination of care may lead to significant overdiagnosis, overtreatment, potential increases in emergency room use, and increased costs incurred without evidence-based benefits to the end users.
With the digitization of the patient and point-of-care, we must address concerns about privacy and health data use. At the Apple keynote event, Apple CEO Tim Cook said “At Apple, we believe your personal information belongs to you. You should decide who you share it with and who gets to see it. Period. All your health and fitness data are encrypted on the device and in the cloud.”
But what about de-identified data? While Apple states it safeguards patient data privacy and has gone to great measures to implement differential privacy, will this new watch functionality become an underground pipeline for access to mass quantities of health data that may be de-identified, aggregated, and sold for commercial purposes to third-party vendors? The genomic testing company, 23andMe, created a DTC genomic test, built up a customer databank of over four million participants that consented to research, and sold access to that databank in an exclusive partnership with pharma company GlaxoSmithKline (GSK).
It is well known that vast quantities of patient data are needed to power machine learning algorithms to advance AI-based platforms. Medical data trading is a multi-billion-dollar industry, unbeknownst to patients and the general public. Patients want to partner to advance human data science and should be offered transparent opportunities to do so as well as informed ways to opt-out. Access to one’s health data, even if it’s been anonymized, should be compensated. There are great opportunities to elevate industry standards on data privacy and transparency with the launch of wearable technologies. As the self-proclaimed guardian of people’s health and one of the world’s most powerful and influential companies, Apple is perfectly positioned to disrupt the way we imagine healthcare of the future and the way we advance human data science: inauthentic, transparent partnership with patients.
There is a significant difference in disrupting to be the first-in-class for a designated technology and disrupting to authentically improve patient care and the patient experience. The two are not synonymous. The creation of a digital technology alone is not disruption. The seamless implementation and universal adoption of a digital technology, deeply rooted in transparency and partnership with patients, is what leads to not only disruption but rather an enhancement of care as we know it. No single entity alone can disrupt healthcare. It must be a non-siloed, collaborative approach with every stakeholder working together.
Grace Cordovano, Ph.D., BCPA is a board-certified patient advocate and patient experience enhancer, who blogs at Enlightening Results and is passionate about elevating the patient’s and carepartner’s voice.
Wow – Grace – your article is full of insightful comments and I hope it will be read as a clear statement of the many challenges facing the utility and benefit of patient acquired data in the delivery of health care. For example – Currently, digital tools can’t be dropped into traditional patient care workflows and operations.” That sentence alone opens so many ‘worm-cans’. Topics such as APIs, EHR interoperability and yes – FAX machines are vexing issues that are – to be kind ‘medieval’ – in their deployment.
The next one: “strategic support tools must be provided to physicians and health care organizations to properly plan and prepare for the implementation of these technologies into their workflows and daily operations”. There is no way physicians nor the ‘medical guild” is prepared for the use of data they (physicians) themselves do not gather. Knowledge management, data management are completely outside the medical education process.
Please see my review of the challenges facing the ‘Medical Guild’ – https://www.linkedin.com/pulse/why-digital-health-still-pitiful-part-ii-krucik-bsc-cs-md-mba/
Below are some excerpts.
Again thanks for a great article – I hope it is widely embraced as a view on the many challenges – highlighted by the new Apple Watch.
George Krucik, MD MBA
“Medicine today persists as a guild and medical schools are still turning out ‘guild-ready novitiates’ – individuals without the skills that are needed to shape the change necessary to incorporate knowledge management or digital health. Just 25 years ago most incoming medical students had NO knowledge of or had even heard of the Internet – how could they – it really didn’t exist. [The first real browser – Netscape – was released in 1994]. These are the doctors age ~45 that are at the prime of their practices and are professors at our medical schools.
Indicus Medicus was their first stop to researching the latest medical knowledge – today it is Google Scholar. A consult for obscure symptoms or problem diagnosis – it was your local ‘Dr. House’ and/or grand rounds – today it is Medscape, Isabel or your favorite symptom checker. How to manage your medical information was not even conceived to be available on a tablet in your lab coat – of course that didn’t exist either – it was the pocket Merck Manual peppered with Post-Its.
Here is a learned assessment posted in the American Journal of Medicine over 10 years ago that is even more true today: “Through technology, the practice of medicine is also becoming more efficient. Computerized records, order entry, and information systems have reduced wasted time. However, computerization has not reduced the time it takes to talk to or examine a patient, nor has it reduced the need and time required to study the ever-expanding knowledge base that defines the field.” “Internal medicine residency training in the 21st century”: https://www.amjmed.com/article/S0002-9343(05)00442-0/fulltext
Do I have an answer – well it is not a pleasant one – the ‘guild’ leadership in medicine and the guild training will have to undergo a radical transformation to begin to be a positive force for change and produce doctors for the mid 21st century. Why – check out one of the guild’s most recent and pitiful approach to training docs to meet the challenge of managing medical information and digital health with modern technologies.
The US Medical Guild announced an answer in 2011: Clinical Informatics Subspecialty Board – which qualifies you to be a clinical informaticist following completion of any one of a number of board specialties and a one day, multiple choice examination. Check it out: https://www.amia.org/clinical-informatics-board-review-course/history http://www.certificationmatters.org/abms-member-boards.aspx
This is the absurdity of a guild – board certified in clinical informatics AFTER membership has been secured in another specialty guild and after the 2018 ‘grandfather period’ another two years of ‘coursework’- then a one-day multiple choice exam.
You have got to be kidding me.
How could someone who has spent 4 plus 4 plus maybe 2 more years (10 years) – spent heads-down on getting the specialty guild master certificate (aka become a ‘specialist’) in any way be prepared to undertake a meaningful clinical informatics guild certificate – even after spending ANOTHER two years in some academic ‘informatics’ pursuit?
Outside of some future research career – the course work and experience to get a clinical informatics guild certificate results in nothing more than learning how to deploy an EMR system by learning about its bits and pieces. Or worse still getting an MPH degree. Most MPH curricula contain zero computer science courses. Learning how to instruct and/or browbeat doctors in your hospital to use EPIC makes sense if you think of an informatics guild membership in the same vein as learning to replace a light bulb and then calling yourself a master electrician.
To gain sufficient computer science knowledge and to meaningfully contribute to the design and workplace fit of an EMR for example – that would take years of college course work in computer science, statistics and software engineering and then workplace experience – all in the mold of medicine’s own guild mentality.
I posit that there is no net benefit to any level of specialty training prior to clinical informatics training if the real goal is meaningful mastery of the tools of knowledge management. Also that combined specialty set (specialty + informatics specialty) does not provide a reasonable salary or guild leadership positioning to effect change. The real reason to combine those incompatible dual specialty certificates is that the Medicine Guild has no way to compensate those combined masters outside of a part time subsidized clinical practice (i.e. no ‘informatics’ CPT codes).
Almost every CMIO position comes with the requirement of 20% of time spent doing clinical care. Again demonstrating that any potential knowledge management is deemed a part time job only made viable by providing specialty medical services.
Clinical informatics skill development has to start during medical school with core subject matter – training physicians in all the knowledge management skills cited above. Clinical informatics deserves its own real specialty. Practicing medicine is also important and maybe the experience of a specialty will benefit an appreciation of the workflow challenges. But if knowledge management skills are acquired the ‘practitioner’ of the ‘informatics craft’ will know how to observe, question, analyze and synthesize the work of a clinician with digital tools to create or invent viable technology solutions. Sadly the way things work now – such physicians would be outside of the power structure of the guild with only ‘entry level’ status in the Medicine Guild – so this appears at first blush to be a naive suggestion.
Oh well – maybe by 2060 someone will have figured it out and we will have doctors with knowledge management skills who put patients first and use the digital tools we have and those that have not yet been invented – to good use.
P.S. Take a short read on Wikipedia on the subject of ‘guilds’ – it is depressing – as many of the negative characteristics apply to medicine. https://en.wikipedia.org/wiki/Guild
Also I have appended an interesting article by miles.org. https://mises.org/library/bring-back-guild-system “
Right on target, Grace. The health care system still doesn’t know how to deal with the reality of patients telling them, “Nothing about me without me…but sometimes without you.”
It’s so silly. This isn’t a “nice-to-have” strategy but rather should be recognized as essential business strategy, let alone striving to deliver value-based, human-centered care that is truly actionable.
We need the always monitoring, always measuring, always messaging health tech platform — with services on top and then actual care delivery on top of that. Someone needs to provide it–and it could be Apple. but as grace points out, they’re just chucking in pieces of tech right now
I think “consent to share” is the common denominator. The existing model for consenting to share data is “prehistoric”. Limited to clinical data between covered entities/business associates. What about non-clinical data – the data that will be coming off all these helpful but non-clinical devices/apps and much of it consumer generated? Does the average person really understand covered entities? I’ve advocated for “transaction-based consent”. Akin to the credit card model – buy a product, settle the financial transaction. Healthcare should be – I decide to go to a new doc, buy a health management app – settle the transaction/enable the transaction by authorizing specified data to flow to that doc/app, etc. A “utility” function that merely documents consent to share and allows for the passage of authorized data. Non-competitive – everyone benefits. (Well maybe like Visa/Mastercard/Amex – a limited number of entities.)
What I’ve found – Apple, United Health, Ascension, HCA – prefer to do these functions themselves. Of course, each is competitively conflicted within their space. It’s a shame the health industry can’t recognize that a bit of collaboration would benefit all. The consumer and shareholders end up paying the price for inefficiency.
There are many easy solutions to this. Every stakeholder in the healthcare ecosystem should be contributing to the success of digital health and digitization of the patient experience and patient care. We can’t move forward working in silos. Literally shooting ourselves in the foot (repeatedly) through our greatest innovations.
Thank you for this sane and practical commentary. The obvious answer to the question of how to manage the atrial fib alert: truck on over to the Emergency Room for your six hour $2500 visit, and a real, multi-lead EKG and the cardiology consult that follows. Which you will pay out of pocket because you have a $5000 deductible HDHP health insurance plan.
Not only no obvious path to connect rationally to the health system, but also no viable business model to support consumer response to the alert. This is, sadly, the current state of telehealth in miniature. I love the Apple MacBook Pro I am typing this on, but . . . Silicon Valley is simply baffled by the real world of our health system.
Thank you Jeff. The technology is obviously there. Presenting it on a sleek stage vs implementing in real life are 2 completely different worlds. Hasn’t anyone mapped what this actually looks like in real-life? Clearly isn’t a priority. We can and must do better.
Apple CEO Tim Cook said “At Apple, we believe your personal information belongs to you. You should decide who you share it with and who gets to see it. Period. All your health and fitness data are encrypted on the device and in the cloud.”
As long as the consumer and provider are using Apple products/cloud. If not, the burden remains with the consumer to “get their data to their desired destinations”. A problem in healthcare is the industry at large seeks to solve the problem of data portability for their own benefit and to hell with the consumer.
While it is exciting to see non-traditional companies enter the health market with the potential to disrupt the industry, it is frustrating to see the formation of new data silos. Do health consumers now have to shop for “Apple/Android compatible health providers?” Let’s not make healthcare any more complex.
Great comment. I could not agree with you more. I have posted at recurrent length on my KHIT.org blog about glossed-over issues with what i’ve irascibly called “interoperabble.” Moreover, personally, I’m now 5 weeks out of open heart aortic valve replacement surgery. Ongoing relevant monitoring is of interest to me, but some of this stuff I’ve looked at is simply not viable — “worried well” toys that docs are not gonna have time nor interest in. Beyond that my 2018 chart (in Epic) to date is hopelessly complex and voluminous. Getting all of it, and then sharing it appropriately and effectively, well…
And I’m an advanced analyst and Health IT person. Imagine some ordinary patient.
Exactly – “it is not the data, it is the application of data that provides value…or not”. Data in the hands of the physician requires one level of interpretation, data in the hands of a consumer, another. All of it can be actionable with proper interpretation. Until we have an open and consistent flow of data – there is a barrier for innovators to develop solutions that interpret data across a range of stakeholders.
First of all, best wishes to you on your recovery. It is a sobering reality…”imagine the ordinary person”.
These innovations that will bring us to healthcare of the future are indeed creating new age silos and digital social determinants of health. It’s all avoidable by including ALL stakeholders of the healthcare ecosystem in the launch of new tech and mhealth innovations.