By Robert Jarrin
A former factory worker suffers from chronic obstructive pulmonary disease (COPD). Her day begins the night before as she periodically coughs during her futile attempt at restful sleep. She typically awakes exhausted, cranky, and unprepared for the day ahead. Her lungs, ravaged through years of occupational exposure to smoke, dust, and chemicals, are severely restricted because of inflammation and lung damage. Her COPD is being treated by different specialists through a variety of medical solutions that provide therapy, oxygen, and non-invasive ventilation. One such device is a mobile sensor that works with her inhaler to coordinate reminders, track dosage, provide local environmental information, and communicates her adherence and progress to a care team. Her ventilator, durable medical equipment, is modern and has mobile connectivity to deliver her data to a cloud-based online patient monitoring system that serves as a repository for diagnostic, prescription, and therapy information. Once per week a respiratory therapist or physician may access and monitor the data for clinical insights, to change settings on the device, or to intervene if she becomes non-compliant.
Across town from her lives a middle-aged former competitive athlete who recently was diagnosed with mild hypertension, high cholesterol, and insomnia. He sought medical attention after experiencing frequent palpitations and light-headedness. Given family history, weight, and an otherwise healthy diet, his general practitioner ruled out a serious condition. However, he made note of a higher than average blood pressure and suggested the man buy a few consumer medical devices to watch his heart. The man, being technologically curious purchased a personal medical-grade EKG and a blood pressure watch. The wafer-thin EKG served to quickly rule out atrial fibrillation but instead helped him discover harmless premature atrial contractions. The blood pressure watch provides ongoing oscillometric measurements using an inflatable cuff built into the watch band to take random clinically accurate blood pressure readings. It also provides contextual data on sleep to analyze his lack of rest and how it may affect his heart health. He shares this information with a cardiologist in hopes of determining whether he needs medications and what may be affecting his blood pressure.
A few miles away from the man, a woman struggles to start her morning. She suffers from a genetic autoimmune disorder that has caused hypothyroidism further triggering depression. Over time she’s also become obese. Fearing an onset of co-morbidities, a savvy and proactive clinician in her healthcare plan helps to enroll her in a national Type 2 Diabetes prevention change program where an applied health signals company may provide her with a suite of digital tools for self-monitoring (mobile apps, an online dashboard, digital medical grade weight scale, and an activity tracker). She would also have access to an interactive online community and an expert coach that could regularly check in on her. Both the online community and her coach could provide an alternative mechanism for coping as she struggles through her journey.
Outside her home, sitting on a school bus in morning traffic is a ten-year-old boy who suffers from Type 1 diabetes and wears a continuous glucose monitor (CGM). Every few minutes the device measures his blood sugar. He carries a smartphone that displays the medical information but just as importantly submits the data into the cloud where his parents (or his pediatricians if necessary), can follow his condition as needed. Until recently, only the boy could track the information on his device – whether a sudden rise or fall in his blood sugar – because most of these devices did not communicate with the cloud. And let’s face it, he’s still a kid who occasionally indulges in a tasty treat, or worse, skips a meal. After years of worrying and struggling to keep their son close at hand, a new CGM provides his family with the peace of mind they’ve wanted all his life: the ability to track his condition remotely.
Digital health has come a long way in a relatively short amount of time. Scenes like those described above are playing out every day in many corners of the world. Like these examples, there are dozens of other exciting consumer health and medical innovations that are changing the practice of medicine and transforming health care delivery. But as easy and seamless as these stories may sound, at its core, digital health is anything but easy. It requires an enormous amount of capital, clinical validity, organizational acceptance, dedication, evidence, modern infrastructure, multi-layered interoperability, sophisticated information technology, training, technical staffing, precise workflows, security protections, legal frameworks, specialized expertise, regulatory compliance, and complex business arrangements that ensure a solid return on investment and risk mitigation for all parties involved.
Consider the woman in the first example with COPD. It’s not uncommon for someone with complex illness to be under the care of numerous specialists. Each separately treating and prescribing her for multiple conditions. What if each device were provided by a different supplier, using different platforms that don’t share information? What if each utilized a separate EHR (Electronic Health Records) which did not have agreements in place with other EHRs for interoperability and data sharing? Each specialist would not be able to access all the information from all her devices and have only limited views of her health. What about the myriad federal regulatory documentation needed to provide coverage for her various therapies and devices (hint: it’s mostly paper and not digital).
In the case of the former competitive athlete, Medicare does not reimburse for those consumer medical devices like the personal EKG or blood pressure watch. Taking that one step further, what if his general practitioner was reluctant to utilize the information he’s providing because she’s worried it won’t suffice coding requirements to ensure Medicare coverage and payment for her services? What if her practice did not have the ability to capture and triage any of the automated patient-generated health data that his devices provide?
Now imagine the woman who suffers from depression and obesity, wouldn’t it be more efficient if her healthcare plan without the fear of privacy violations could use her anonymized data to proactively identify interventional benefits programs? The example illustrates how the woman is provided a suit of digital tools but in reality, Medicare has disallowed widespread implementation of a similar program as it further assesses the virtual format.
And finally, picture the boy who relies by the minute on a continuous blood glucose meter. The part omitted in the story is how after years of being unable to view his blood glucose data, his parents took matters into their own hands. They joined an online movement that taught them how to engineer a solution for their existing monitoring device that allowed them to constantly access his data no matter where they were. The browser-based visualization enabled them to remotely monitor their son’s glucose levels. Such a case happened leading FDA (US Food and Drug Administration) to work with a do-it-yourself community for sensible collaboration.
Such is the case with new technologies, industries, and sectors. Out of chaos, uncertainty, hype, and frustration – often flourishes stability. According to Rock Health, $5.5B has been invested in digital health through the first three quarters of 2019, with over $36.3B since 2011. That’s real money poured into an evolving sector. Helping to fuel that growth has been progress made by the federal government to eliminate or at least acknowledge barriers to digital health adoption. Over the past six years FDA has actively delivered regulatory clarity through dozens of guidance documents. CMS (US Centers for Medicare & Medicaid Services) has recently provided coverage and payment for a number of services including virtual check-ins, e-Visits, and remote patient monitoring. ONC (US Office of the National Coordinator for Health Information Technology) and CMS are on the cusp of delivering final rules and clarifications concerning interoperability and data blocking. Since 2009, the US Congress has passed ARRA (US American Recovery and Reinvestment Act of 2009), MACRA (US Medicare Access and CHIP Reauthorization Act) and Cures (US 21st Century Cures Act) – each modernizing different aspects of healthcare, sometimes through technology, for decades to come. Even the unthinkable has become the actual with large retailers stepping into the digital health world with others looking to follow suit. Thus, digital health is not a cliché… it’s just not easy and still finding its way.
Consumer Technology Association (CAT)®