Predictivve AI By David Alex Schulz, CHP

PRN: Take as Needed

On Wearables, Health Care and Predictive AI

By David Alex Schulz, CHP

Halloween, 1957: A Minneapolis child dies because an ACpowered pacemaker failed in a power outage. Before a month is out, local engineer Earl E. Bakken prototypes the world’s first battery-operated, transistorized, external pacemaker. The founder of Medtronic has ushered in a new paradigm for health care: portable wearable electronic devices.

Before his death in 2018, Bakken saw Medtronic and other companies shrink devices, standardize them and interconnect them. From ‘fitness’ watches to devices monitoring blood pressure, electromyography, glucose, temperature and oxygen levels, portable wearable devices are ubiquitous. A similar revolution in implantable devices brought about infusion pumps, neurostimulators and cardioverter defibrillators (ICDs) to join the implanted pacemaker.

All are members of the “IoT,” the Internet of Things, accessible to a network through either wifi or Bluetooth. Connectivity permits noninvasive monitoring and control of the device, but the collection and sharing of data is only barely secondary in importance. The question with new tech, as always: Just because we can do something, does it mean we should? Hazards are present such as Bakken and his successors never considered. It will take extraordinary strategic planning and deployment of equipment and its data to lower the risk to acceptable. Most obvious is the question of digital security, not only in the theft of data, but breaching the device controls themselves.

Upon taking office, Vice President Dick Cheney insisted on disabling his pacemaker’s connectivity, fearful of assassination by hacking. In 2019, the Department of Homeland Security warned that hackers could wirelessly access implanted pacemakers made by Medtronic. Three months later, the company recalled some of its insulin pumps for similar reasons. The healthcare industry needs to address remote device security or it will be less prepared than it was for ransomware. The pandemic supercharged home health care, tele-medicine and Remote Patient Monitoring with an uptake in patients adopting pulse oximeters, digital thermometers, otoscopes, personal ECG and others. All carry inherent cyber-risk.

Less obvious are problems due to peoples’ whims and personalities – call it the microcosm of medical anthropology. While generally thought that patients should take greater ownership of their own health care, we live in an age of extremes.

Take Bill, whose lifelong tendency for anxiety led him to buy a Fitbit Sense in late 2020 during lockdown.

CNET reporter Lisa Eadicicco relates the story, “He thought it would reassure him that he was healthy if he was able to take an electrocardiogram reading when he felt something abnormal, such as heartburn or an accelerated heartbeat.”

Yet Bill only grew more anxious after receiving inconclusive ECG results his device, not unusual in casual, uncontrolled circumstances, where the device couldn't get a reliable reading. He began taking up to 20 ECGs a day because of his anxiety around springtime. Realizing he was hypering himself into a frenzy, he finally abandoned the device and his anxiety lessened. The industry is in its adolescence, and while data collection of consumer devices is continually more refined, companies are still figuring out the best ways to deploy wearables, and make sense

of that data without overstepping the boundaries of what a non-medical device should do. "There is a distinction between measurements for wellness, which provide general guidance and would encourage you to exercise in a way that's helpful for you and to eat more healthy foods, and a medical device," Dr. Paul Friedman, a cardiologist in the Mayo Clinic's AI in Cardiology Work Group. "And I think the blurring of those is causing some confusion."

While Apple will gladly point on its website to occasions the Watch was instrumental in lifesaving warnings, the company recognizes its limitations and makes no claims as a healthcare device. That’s why Medtronic went straight to Rockley Photonics, the company underlying Watch technology, to invent a super-enhanced Watch to monitor a whole host of health factors. The resulting devices track a range of data points, including body temperature, blood pressure, heart rate, pulse oximetry and hydration, as well as alcohol, lactate and glucose levels, among others. If users are educated in their purposes, and the data regularly downloaded and interpreted by healthcare providers, great potential for good can be seen, advancing wellness, and addressing chronic illness.

A study was recently conducted by the American Society of Clinical Oncology (ASCO) involving 357 patients with head and neck cancer. One group of these patients used a Bluetooth-powered blood pressure cuff and a mobile app to track their symptoms – researchers observed fewer severe symptoms among these patients whose conditions were monitored regularly. Chronic patients are significantly more likely to visit the emergency room and are more likely to receive long-term medical care because they are unable to proactively manage their illnesses and keep up with their care plan. "This study demonstrates the power of leveraging smart technology to improve the care of people with cancer. These tools helped simplify care for both patients and their care providers by enabling emerging side effects to be identified and addressed quickly and efficiently to ease the burden of treatment. I hope that these or similar technologies will be broadly available to patients soon," said ASCO President Bruce E. Johnson, MD, FASCO.

So we begin with Bakken’s wearable, add a variety of sensing capabilities to monitor vital stats, stir with IoT connectivity and the result is massive data collection. Massive data brings us to the threshold of artificial intelligence. Data-driven AI can spot patterns in healthcare data, uncovering significant trends and associations between factors previously thought to be unrelated. The promise is real, and so is the threat. Without consideration of both security and user education, the hacking of the device (and the human) is a definite liability. This is where the National Institutes of Health enters the story, launching the All of Us research project in 2015 with a lofty goal: support research on many aspects of health, not just a single medical or biological research question. The data platform enables research that can increase wellness and resilience, and promote healthy living.

All of Us will build a database of the fully sequenced genomes of at least one million Americans of diverse backgrounds that can then be used by scientists to improve diagnostic and drug development, clinical trial recruitment and our overall understanding of human disease. This spring, scientists are getting access to the genes of nearly 100,000 Americans in a uniquely diverse genomic database − part of the NIH’s quest to reduce health disparities and end cookie-cutter care.

But the Genome Project is only one aspect of All of Us, and with the pandemic, the program focused on COVID. With 350,000 participants from all 50 states, some taking monthly detailed health questionnaires, other participants providing access to their EHRs, All of Us has the power to help answer questions that few other groups can. Now with more than half-a-million participants, 288,000 EHRs and 350,000 bio samples, scientists across the U.S. are able to access immense datasets, half of which come from people representing racial and ethnic groups that have been historically underrepresented in medical research. “There is a unique depth and dimensionality to the All of Us platform that sets it apart from other resources in the field. It’s also designed with team science in mind, allowing researchers to explore topics in an open and collaborative way,” said Gail Jarvik, MD, PhD, a principal investigator at one of the program’s sequencing centers at the University of Washington.

FDA approval of wearables is inevitable – In 2021, the wearable medical devices market was estimated at $16.2 billion, and it is expected to reach $30.1 billion by 2026. The publics’ appetite for a connected lifestyle, happily adopting IoT devices from their refrigerator to their most intimate personal instruments, appears unlimited. If the NIH is right, solutions to previously unanswered medical mysteries may be found in data provided by your Fitbit, your neighbor’s EMG pain reducer and an unknown stranger’s insulin pump. Oh, Brave New World!

David Alex Schulz, CHP is a community member of the BCMS Publications Committee.