June 2016 by SMCMA

S a n M at e o C o u n t y

June 2016

Physician

IN S ID E

S A N M AT E O C O U N T Y M E D I C A L A S S O C I AT I O N

Volume 5 Issue 6

Wearable technology and sleep disorders

The influencer vs. the institution

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Physician Editorial Committee Russ Granich, MD, Chair; Judy Chang, MD; Uli Chettipally, MD; Sharon Clark, MD; Carri Allen Jones, MD; Edward Morhauser, MD; Gurpreet Padam, MD Sue U. Malone, Executive Director Shannon Goecke, Managing Editor

SMCMA Leadership Michael Norris, MD, President; Russ Granich, MD, President-Elect; Alexander Ding, MD, SecretaryTreasurer; Vincent Mason, MD, Immediate Past President Alex Lakowsky, MD; Richard Moore, MD; Michael O’Holleran, MD; Joshua Parker, MD; Suzanne Pertsch, MD; Xiushui (Mike) Ren, MD; Sara Whitehead, MD; Douglas Zuckermann, MD; Dirk Baumann, MD, AMA Alternate Delegate; Scott A. Morrow, MD, Health Officer, County of San Mateo

Editorial/Advertising Inquiries San Mateo County Physician is published ten times per year by the San Mateo County Medical Association. Opinions expressed by authors are their own and not necessarily those of the SMCMA. San Mateo County Physician reserves the right to edit contributions for clarity and length, as well as to reject any material submitted.

June 2016 - Volume 5, Issue 6 Columns President’s Message: Swan song................................................................. 5 Michael Norris, MD

Feature Articles Wearable technology and sleep disorders.............................................. 7 Melissa Lim, MD, FCCP, FAASM

The influencer vs. the institution. . ......................................................... 11 Uli Chettipally, MD, MPH

Of Interest Upcoming events, classfied ads, index of advertisers.......................... 14

Acceptance and publication of advertising does not constitute approval or endorsement by the San Mateo County Medical Association of products or services advertised. For more information, contact the managing editor at (650) 312-1663 or smcma@smcma.org. Visit our website at smcma.org, like us at facebook.com/smcma, and follow us at twitter.com/SMCMedAssoc. © 2016 San Mateo County Medical Association

On the cover: IR Milky Way, 2014, by Flickr user Dirk Essl. Reprinted with permission under Flickr Creative Commons license. (https://www.flickr.com/photos/dirkessl/)

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President’s Message

Swan song

Michael Norris, MD President

This is my last message as president of the San Mateo County Medical Association. I find it hard to fathom that I have held this position for an entire year. However, on June 23 I will step aside and pass the presidential gavel to Russ Granich. Russ is a superb physician, a specialist in palliative care, based at Kaiser South San Francisco. Russ is extremely intelligent and thoughtful. One of the great joys of my time as president has been getting to know and work with, doctors from all areas of our county and from different practice models. I have learned that we all have the same principles, the same dreams and goals. The SMCMA opens doors for us to see the entire scope of physician experience; I have learned a lot.

The passing of the torch...

One thing I did not have to learn, that I already knew, was how fortunate we are to have Sue Malone serve as our executive director, guiding this association for many years, as physician officers came and went. She has been the constant force, sharing her knowledge and experience to advance our goals. Sue works hard. This spring, the SMCMA staff member handling the Walk with a Doc program left to take another position. Sue immediately took on the responsibilities of that job, schlepping tables, signage, and refreshments to venues throughout the county every Saturday morning. I have witnessed very few senior administrators take on the jobs that Sue does on a regular basis.

I have mentioned that Russ Granich will be our president for the coming year. Our presidentelect will be Alex Ding. When I realize that I followed Vincent Mason as president, and will be followed by Russ and Alex, I wonder how I ever got into this lofty contingent. Just luck, I guess. Joining Russ and Alex on the Executive Committee will be Sara Whitehead, a dermatologist in private practice in Palo Alto. You might think “isn’t Palo Alto in Santa Clara County?” It is clear that Sara likes us better. Sara has been a valuable member of our Board of Directors and will assume the office of Secretary-Treasurer. Joining the board this year are Paul Jemelian, Brian Tang, and Mamatha Chivukula. Paul is an Internist at the Menlo Medical Clinic, part of Stanford Healthcare. He joined Menlo after many years in solo practice in San Mateo. Dr. Chivukula is a pathologist with Peninsula Pathologists Medical Group. Brian Tang is affiliated with Palo Alto Medical Foundation as a pediatric subspecialist. Each of our there new members brings different experiences from solo practice, small group, university, and large group situations. SMCMA is an ecumenical outfit.

I have learned that we all have the same principles, the same dreams and goals. The SMCMA opens doors for us to see the entire scope of physician experience; I have learned a lot.

So I head off into the sunset, knowing that the association will be in good hands in the future. I will bow out at our Annual Meeting on June 23. I will likely give a short speech. Though the title of this message is “Swan Song,” do not expect me to sing, as Vincent Mason did in his presidential farewell last year. Vincent is very talented—check his vocals on Glide Memorial’s Youtube channel. Me? I couldn’t carry a tune in a bucket. Adios. ■ JUNE 2016 | SAN MATEO COUNTY PHYSICIAN 5

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Wearable technology and sleep disorders

by Melissa Lim, MD, FCCP, FAASM The wearable technology market was a $20 billion dollar market in 2015 and is on pace to reach $70 billion by 2025.1 Whether glasses, shirts, watches, footwear, or skin patches, the largest sector for this market is healthcare. Multiple factors are driving this growth, but we may be witnessing the powerful convergence of new technology, improved health awareness, rising healthcare costs, and decreased access to face-to-face care. As the general population grows up with personal virtual connectivity, the comfort level for medical virtual connectivity is rising as well. The use of wearable devices in sleep medicine is not a new concept. In fact, the utility of wrist actigraphy in patients with circadian rhythm disorders and insomnia is well established in the sleep literature. Wrist actigraphy does not, however, give feedback to the user, but rather provides useful information to the provider for both diagnostic and treatment purposes. The modern wrist actigraph now is embodied in relatively inexpensive devices such as Fitbit, Jawbone UP, among others. The new concept in these modern devices is the actionable feedback given to the user regarding their sleep behaviors. Already there are many patients who open up their smartphone apps to show their doctors their data, in order to get assistance deciphering the reams of data provided by such devices. Moreover, some devices go too far in telling users about “deep stage” versus “light stage” sleep, as sleep stages are determined only by electroencephalographic information, something not provided by wrist-worn wearables. Various studies over the past few years have addressed the accuracy of fitness/activity trackers compared to research-grade counterparts.2, 3 In general, fitness trackers are more accurate at some measures than others, and there is variability in the accuracy among different trackers. For example, the original Fitbit overestimated sleep by >one hour and underestimated calories burned,

but was extremely accurate in counting steps, even at vigorous levels of exercise.2 Researchers from the Sansom Institute at the University of South Australia took 21 (healthy, ambulatory >18) subjects and had them wear seven different consumer devices and two different medical actigraph watches for 48 hours, under free living conditions.3 Concurrent measurements allowed the researchers to compare each device to the medical device, but also to compare the consumer devices directly to each other. The devices chosen were the Fitbit One*, Fitbit Zip, Jawbone UP*, Misfit Shine*, Nike Fuelband, Striiv Smart Pedometer, and the Withings Pulse*. All seven measured physical activity parameters, four (marked with *) measured sleep parameters. The research grade devices selected were the BodyMedia SenseWear Model MF (validated for total daily calories burned and total sleep time) and ActiGraph GT3X+ (validated for step count and moderate-vigorous physical activity). The researchers compared the consumer wearables to their research grade counterparts in

Continued on page 9 JUNE 2016 | SAN MATEO COUNTY PHYSICIAN 7

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Wearable technology and sleep disorders Continued from page 7 terms of the following parameters: steps, sleep duration, total daily energy expended (TDEE), i.e. calories burned, and moderatevigorous physical activity (MVPA). The strongest performers across all categories were the Fitbit One, Fitbit Zip, and Withings Pulse. Price did not reflect product validity, since the most expensive device, the Nike Fuelband, was one of the worst performers. The devices with the highest correlation coefficients for measuring sleep duration were the Fitbit One and the Pulse, 0.92 for both. Of note, all four devices over-estimated amount of sleep compared to the reference device, from 22-47 minutes. The wearer gains information that may result in changes in their behavior. The usefulness of self-help devices, whether worn or

will be the larger challenge, and one that may be solved only by patients actively participating in self-care. Wearable devices may play a key role in both sides of the care continuum. ■ Notes 1.

Harrop, P et al., Wearable technology 2015-2015: technologies, markets, forecasts, IDTechEx, Feb 2015.

Takacs J, et al., Validation of Fitbit one activity monitor device during treadmill walking. J Sci Med Sport 2013; 17(5): 496-500.

Ferguson, T et al., The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross sectional study. Int J Behav Nut Phys Act. 2015; 12:42 DOI 10.1186/s12966015-0201-9.

What does this mean for those who are using fitness trackers to measure sleep? The current devices on the market are: 1. able to distinguish sleep from wakefulness better than they are able to distinguish among the different sleep stages, and 2. tend to overestimate sleep quantity when compared to an external reference device, but 3. may be helpful in gauging and modifying one’s own behavior. In the author’s view, this makes current wearable devices useful much in the same way that peak flow meters are helpful to asthma patients. not, however, is optimized by interactive guidance from a healthcare provider. Over the next ten years, as the wearable industry matures, the sensors that measure our physiology will be smaller, less invasive, and more versatile, and the data collected will be compiled and communicated quickly to both ourselves and our doctors. Polysomnography, the current gold standard of sleep testing, will not be exempt from these advancements. Sleep medicine, even as a younger specialty, has changed rapidly over the past ten years, with the number of sleep centers at one time expanding and now contracting, due to reduced reimbursements and perhaps to increased utilization of home sleep testing. We will be forced to shift our thinking and practice again with the next phase of improved wearable monitoring devices. But even with improved diagnostic tools at our fingertips, we will have only addressed one aspect of the sleep care bottleneck. Expanding diagnostic services to more people may be the easier hurdle to overcome; providing treatment

About the author Melissa Lim, MD, FACP, FAASM, is the Medical Director and founder of Redwood Pulmonary Medical Associates. Dr. Lim is board certified in internal medicine, pulmonary diseases, and sleep medicine. Dr. Lim earned her medical degree at the Ohio State University College of Medicine. She completed her internship and residency in internal medicine at Boston City Hospital and Boston University. JUNE 2016 | SAN MATEO COUNTY PHYSICIAN 9

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THE INFLUENCER VS. THE INSTITUTION by Uli Chettipally, MD, MPH Silicon Valley is famous for people and companies, who come up with ideas, products and services that disrupt well established industries. Uber and Airbnb are often cited as examples of this phenomenon in the transportation and hospitality industries. New information technology makes it possible for start-up companies backed by venture capital, to provide a service, that can quickly scale up to compete with large, established companies. This would have not been possible only a few decades ago. We have also seen smart people who are solving complex problems and gaining hero status as influencers. In order to protect the public from harm and perform their duty, regulatory bodies (institutions), like the FDA, have a duty to regulate the new players. Inevitably there will be challenges for both sides in this situation. The institutions have to understand the business model, technology and methodology of the disrupters, which may not be like anything they have encountered in the past. The old ‘rules’ may not be applicable to the disrupters. On the new entrants’ side, they may feel that the ‘rules’ are archaic and do not make sense. Usually the new entrants and influencers are from other industries and may not understand how healthcare industry works. They may also feel that since they are playing the role of disrupters, they have to be the trail blazers and create a new path by breaking the ‘rules’. We have seen these tensions between the Influencers and the Institutions playing out over the last few years. Reality TV star Kim Kardashian got the makers of Diclegis into trouble with the FDA. This occurred when she endorsed this prescription medi-

cine for morning sickness, on social media with a selfie, without the usual warnings that the FDA requires of consumer ads. The company 23andme faced a difficult time with the FDA in 2013, when they had to stop marketing their direct-to-consumer genetic testing service until they got FDA’s approval. And more recently, Theranos, a lab testing company had to close its operations in California, when CMS found deficiencies which put it out of compliance with CLIA. When should start-ups start working on being compliant with these rules? I would say that, the sooner you start thinking about it, the better. No one would want to see the time, money and effort go to waste. So, what are the regulations that start-ups have to be aware of? Here is a sample (not a comprehensive list) of the regulatory bodies and their areas of administration:

Continued on page 13 JUNE 2016 | SAN MATEO COUNTY PHYSICIAN 11

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The influencer vs. the institution Continued from page 11

1. U.S. Department of Health and Human Services

About the author

The U.S. Department of Health and Human Services (HHS) is the principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

Uli Chettipally, MD, MPH, is an emergency phy-

The Centers for Medicare & Medicaid Services (CMS) administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children’s Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act (HIPAA), quality standards in long-term care facilities through its survey and certification process, clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments (CLIA), and oversight of HealthCare.gov. The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The Office of the National Coordinator for Health Information Technology (ONC) is at the forefront of the administration’s health IT efforts and is a resource to the entire health sys tem to support the adoption of health information technology and the promotion of nationwide health information exchange to improve health carae.

2. Federal Trade Commission The Federal Trade Commission (FTC) is a bipartisan federal agency with a unique dual mission to protect consumers and promote competition. The FTC protects consumers by stopping unfair, deceptive, or fraudulent practices in the marketplace. By enforcing antitrust laws, the FTC helps ensure that U.S. markets are open and free. Healthcare is a highly regulated field. As people are realizing, changing healthcare business is a slow and painful process, due to its complexity and well-entrenched players. Regulation that is designed to protect the public from harm, can become a road block for fast moving companies. There will be many bumps in the road to commercialization and consumerization of new technologies. Be prepared for the long haul! ■

sician, researcher and innovator at Kaiser Permanente Medical Center, South San Francisco. He is also co-founder of the Bay Area Chapter of the Society of Physician Entrepreneurs (SoPE), a nonprofit, global biomedical and healthcare innovation and entrepreneurship network.

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