Presented by Medidata and the New York Academy of Sciences
Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials
Posted December 15, 2015
Mobile technology has become ubiquitous in everyday life, and mobile devices are now being used to improve human health. Wireless medical sensors, or mobile biosensors, allow clinicians and researchers to gather real-time biometric data on a massive scale, via wearable gadgets and implantable medical devices. The information retrieved from mobile biosensors could revolutionize how clinical research is conducted and how disease therapies are delivered.
On September 30 and October 1, 2015, professionals from science, engineering, analytics, health care, business, and government gathered for a conference on Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials, presented by Medidata and the New York Academy of Sciences. Participants explored the promise of wearable biosensors and mobile apps to improve patient care and clinical outcomes. The conference featured presentations on new devices and on commercial and clinical implementation and regulation of technology. Speakers discussed strategies for managing data from mobile devices and described the broad societal implications of mobile health technologies, including legal and data-privacy considerations.
Use the tabs above to find a meeting report and multimedia from this event.
Presentations available from:
Pam C. Baker (FierceBigData)
Brian Bot (Sage Bionetworks)
Stan W. Berkow (Sense Health)
Michelle Crouthamel, MS (GlaxoSmithKline)
John D. Hixson, MD (University of California, San Francisco)
David C. Magnus, PhD (Stanford Center for Biomedical Ethics)
Linda A. Malek, JD (Moses and Singer LLP)
John J. Mastrototaro, PhD (Medtronic)
Veena Misra, PhD (North Carolina State University)
Bernard Munos, MS, MBA (FasterCures, a center of the Milken Institute)
Aydogan Ozcan, PhD (University of California, Los Angeles; Howard Hughes Medical Institute)
Tomasz Sablinski, MD, PhD (Transparency Life Sciences)
Leonard Sacks, MD (U.S. Food and Drug Administration)
Christian Stammel, MBA (Wearable Technologies AG)
Pei Wang, PhD (Icahn School of Medicine at Mount Sinai)
How to cite this eBriefing
The New York Academy of Sciences. Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials. Academy eBriefings. 2015. Available at: www.nyas.org/MobileHealth2015-eB
- 00:011. Introduction; The asthma health app
- 03:552. The launch and media coverage; Data management and confidentiality
- 08:183. Initial findings; Downloads and enrollments
- 13:284. Data collection breakdown; Reaching patients with severe asthma
- 18:285. Worse asthma, higher response rates; Improved activity level; Using HealthKit data
- 23:376. Challenges in analyzing digital health data; Conclusion
- 00:011. Introduction and background
- 07:002. Electronic informed consent; Measurement
- 11:273. Mobile tech groups; Regulatory considerations
- 16:164. Past experience; Summary of registrational trial endpoints
- 20:345. Where helpful; Clinical example
- 25:556. Meaningful clinical benefit; Considerations, advantages, and concerns
- 31:367. Conclusio
Can mobile biosensor technology revolutionize health care?
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New designs for clinical and health care applications
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Mobile-health devices and platforms
An open-source software framework for researchers and developers to create apps for use in medical studies.
COPD Assessment Test.
A questionnaire to measure how COPD affects a person's life, and how this changes over time.
Cyrcadia Health. iTBra.
A wearable technology that provides monthly breast-wellness screening.
A wearable device for seizure monitoring.
Epilepsy Foundation. Mobile epilepsy diary.
A self-management tool to help patients record, track, and manage seizures and epilepsy.
Metronic. ZephyrLIFE Home Remote Patient Monitoring.
A device for remote patient monitoring and medical support.
A wireless blood pressure monitor.
Sage Bionetworks. Synapse.
A platform for open research projects.
Sage Bionetworks. mPower app.
A mobile Parkinson's disease study.
Glen de Vries
John J. Mastrototaro, PhD
John Mastrototaro is vice president of informatics at Medtronic, where he is developing a strategy for big data and advanced analytics to improve health care delivery and reduce costs through remote-monitoring and disease-management services. He was previously chief technology officer at Medtronic Diabetes, overseeing research and development of drug-delivery products, including the artificial pancreas, and managing the company's global activities to meet specific needs in local areas. He holds MS and PhD degrees in biomedical engineering from Duke University and over 50 U.S. patents.
Bernard Munos, MS, MBA
Bernard Munos is a senior fellow at FasterCures and the founder of InnoThink, a consultancy focused on pharmaceutical innovation. He was previously an advisor for corporate strategy at Eli Lilly, where he focused on disruptive innovation and research and development redesign. Munos serves on the advisory council of NIH's National Center for Advancing Translational Sciences (NCATS). He is a member of the Institute of Medicine's Forum on Drug R&D and Translation and an advisor to Science Translational Medicine. Munos received his MBA from Stanford University and holds graduate degrees in agricultural economics and animal science from the University of California, Davis, and from the Paris Institute of Technology for Life, Food and Environmental Sciences.
Fiorenzo Omenetto, PhD
Fiorenzo (Fio) Omenetto is a professor of biomedical engineering at Tufts University, where he leads the laboratory for Ultrafast Nonlinear Optics and Biophotonics and holds an appointment in the Department of Physics. His research interest include optics, nanostructured materials (such as photonic crystals and photonic crystal fibers), nanofabrication, and biopolymer-based photonics. He proposed and pioneered (with David Kaplan) the use of silk as a material platform for photonics, optoelectronics, and high-technology applications. Omenetto was formerly a J. Robert Oppenheimer Fellow at Los Alamos National Laboratory and a Guggenheim Fellow for 2011. He is a fellow of the Optical Society of America and of the American Physical Society. He holds a PhD from the University in Pavia, Italy.
Leonard Sacks, MD
U.S. Food and Drug Administration
Leonard Sacks received his medical education in South Africa, completed fellowships in immunopathology and infectious diseases, and worked as an attending physician in the U.S. and South Africa before joining the FDA in 1998. As a medical reviewer in the Office of New Drugs, Sacks was involved in the development and review of new anti-infective agents. He later served as acting director of the Office of Critical Path Programs and is now the associate director for clinical methodology in the Office of Medical Policy at the Center for Drug Evaluation and Research. He is involved in the design and analysis of clinical trials and has maintained a special interest in tuberculosis and other tropical diseases. He is board certified in internal medicine and infectious diseases and holds an academic appointment as associate clinical professor of medicine at George Washington University.
Melanie Brickman Stynes, PhD, MSc
The New York Academy of Sciences
Brooke Grindlinger, PhD
The New York Academy of Sciences
Daniel Radiloff, PhD
The New York Academy of Sciences
Ian Ferguson is the vice president of worldwide marketing and strategic alliances at ARM. The company designs scalable, energy-efficient processors and related technologies in sensors and servers, smartphones, tablets, digital TVs, enterprise infrastructure, and the Internet of Things. Ferguson previously held positions at Enigma Semiconductor, QuickLogic, IDT, and Motorola.
Christian Stammel, MBA
Wearable Technologies AG
Christian Stammel is the founder and CEO of Wearable Technologies AG, an innovation and business development platform for wearables. He founded his first two companies during university and since the mid-1990s has founded more than 10 companies in the fields of geo data, navigation, internet, open innovation, and technology consulting. He developed the open innovation platform, Innovation World Cup Series, through which he and his team support hundreds of companies every year.
Pam C. Baker
Pam Baker is a freelance industry analyst and journalist specializing in technology and science. She is the author of Data Divination: Big Data Strategies, among other books. She is currently the editor of FierceBigData. Her freelance reporting is also published and reprinted in publications including InformationWeek, Institutional Investor, The Washington Post, The New York Times, Genome Alberta blogs, CIO, NetworkWorld, ComputerWorld, and IT World. She is a member of the National Press Club (NPC) and the Internet Press Guild (IPG).
Stan W. Berkow
Stan Berkow is the founder and CEO of Sense Health, a company whose vision is continuous health care with support that never stops. Before founding Sense Health, Berkow coordinated clinical trials in the Department of Behavioral Medicine at the Columbia University Medical Center. While there, he experienced firsthand how difficult it can be to support trial participants and how lacking are technologies to effectively aid the process. Berkow graduated from Bowdoin College with a BA in neuroscience.
Brian Bot is a principal scientist at Sage Bionetworks and a community manager for its mobile and technology platforms. He was previously a statistician in the Department of Biomedical Statistics and Informatics at the Mayo Clinic. He is involved in both computational oncology research and technology development. Bot is an open-science advocate and is active in several national efforts to promote a research ecosystem in which participants are treated as partners in the research process.
Michelle Crouthamel, MS
Michelle Crouthamel is the founding member and project manager of the Digital Platform Performance Unit (DPPU) at GlaxoSmithKline. The team focuses on using digital technologies and platforms to transform clinical trials. She previously led preclinical and clinical development projects at Merck and GSK. Crouthamel holds multiple patents and has published in the areas of neuroscience and oncology, focusing on BACE inhibitors for Alzheimer's disease and AKT inhibitors for cancer therapy. She holds has a Master's degree from the Neuroscience Institute of National Yang-Ming University in Taiwan.
John D. Hixson, MD
John Hixson is a practicing neurologist and digital health researcher at the University of California, San Francisco, and the San Francisco VA Medical Center. His interest in mobile health and sensor technologies arose from his clinical practice in the field of epilepsy, where he recognized a need to gather better data from patients outside the standard health care settings. Hixson holds multiple regional and national leadership roles in clinical informatics in the VA system. He completed his medical training at the Johns Hopkins School of Medicine and undertook a neurology residency at the Hospital of the University of Pennsylvania.
David C. Magnus, PhD
David Magnus is the Thomas A. Raffin Professor of Medicine and Biomedical Ethics, a professor of pediatrics, and director of the Center for Biomedical Ethics at Stanford University. He holds a PhD in philosophy from Stanford University. He is co-chair of the Stanford Hospital and Clinic's Ethics Committee and a member of its End of Life Work Group, Palliative Care Board, and Innovative Care Committee. He has spearheaded the ethics training programs offered to medical students and clinicians. Magnus is editor-in-chief of the American Journal of Bioethics. He is widely published on topics including brain death, health care reform, research ethics, end-of-life care, and genetic technology in academic journals, including the New England Journal of Medicine, Science, and the Journal of Law, Medicine and Ethics, and in media outlets such as Time, Newsweek, The Wall Street Journal, and The New York Times.
Linda A. Malek, JD
Moses & Singer LLP
Linda A. Malek is a partner at Moses & Singer LLP and chair of the firm's Healthcare and Privacy & Cybersecurity Departments. She works on regulatory, technological, and business in the health care industry, advising clients on issues in translational research, genomics, mobile health technology, data privacy, and tissue banking. She also represents and counsels academic medical centers, biotechnology companies, pharmaceutical companies, biorepositories, scientific research consortia, and research foundations. She has written and lectured on legal topics relating to health care technology, data privacy in the context of clinical research, transparency in clinical research, and new compliance obligations in the context of the increasing federal and state scrutiny of these issues. She earned her JD from University of Virginia School of Law.
Veena Misra, PhD
North Carolina State University
Veena Misra is the director of the National Science Foundation Nanosystems Engineering Research Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST). She is a professor of electrical and computer engineering at North Carolina State University and an Institute of Electrical and Electronics Engineers Fellow. She holds a PhD in electrical engineering from North Carolina State University, Raleigh. She studies state-of-the-art low-power CMOS devices, power devices, alternative high-mobility substrates, nanoscale magnetics, and energy-harvesting technologies. Misra received the 2001 National Science Foundation Presidential Early CAREER Award, the 2011 Alcoa Distinguished Engineering Research Award, and the 2007 Outstanding Alumni Research Award. She served as the general chair of the 2012 IEEE International Electron Device Meeting.
Aydogan Ozcan, PhD
Aydogan Ozcan received his PhD in Stanford University's Electrical Engineering Department. After a short postdoctoral fellowship at Stanford University, he was appointed a research faculty member at Harvard Medical School Wellman Center for Photomedicine. Ozcan joined the UCLA faculty in 2007 and is now the Chancellor's Professor and a Howard Hughes Medical Institute investigator, leading the Bio- and Nano-Photonics Laboratory of the Electrical Engineering and Bioengineering Departments. He is also the associate director of the California NanoSystems Institute (CNSI) at UCLA. Ozcan holds 31 patents and has more than 20 pending patent applications for his inventions in nanoscopy, wide-field imaging, lensless imaging, nonlinear optics, fiber optics, and optical coherence tomography.
Tomasz Sablinski, MD, PhD
Tomasz Sablinski is founder and CEO of Transparency Life Sciences, a crowd-sourced drug development enterprise. Sablinski previously held management positions at Celtic Therapeutic Development and Novartis Pharmaceuticals, and before that was an instructor in surgery at Harvard Medical School and a member of a Transplantation Biology Research Center team at Massachusetts General Hospital. Sablinski is a board-certified surgeon, and his clinical work concentrated on renal transplantation and general surgery. Sablinski received his MD and PhD degrees at Warsaw Medical School in Poland.
Pei Wang, PhD
Pei Wang received her PhD in statistics from Stanford University. She served on the faculty at the Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, before joining the Icahn Medical School at Mount Sinai as an associate professor of genetics and genomics. Wang's research focuses on developing statistical and computational methods to answer scientific questions using data from high-throughput biological and genetics experiments. Particularly, she is interested in understanding cell activities and disease initiation/progression at a systems level by integrating information from diverse biological sources, such as genetics and genomics, proteomics, and phenotypic data.
Ann R. Griswold holds a PhD in biomedical sciences and a Master's degree in science writing. She is a board-certified editor in the life sciences and writes about health and medicine for scientific journals and organizations including PNAS, Partners Innovation, the American Epilepsy Society, and the College of American Pathologists.
Wearable Technologies AG
The smartphone is becoming a hub for information from wearable devices.
Companies are exploring commercial opportunities to customize and expand the use of wearables.
The wearables market is adapting to include different categories of devices and uses, with crossovers in traditional industry segments such as health and fitness.
Operating in the age of activity trackers, smart bandages, biostamps, and other mobile technologies, researchers have unprecedented access to biometric data. Most mobile devices and biosensors provide real-time data that are consistent, granular, and accurate. But the data gathered can also be noisy, non-standardized, cumbersome, and lacking context—and consequently open to misinterpretation. Researchers must contend with the technical and logistical challenges presented by large data sets.
A 2014 report from the Health Data Exploration Project showed that only 30% of Americans surveyed share health data collected by a mobile device with a health professional. More than 75% of respondents said they would probably or definitely share such data for research purposes if given an opportunity. More than 95% said the data should remain at least somewhat anonymous. These results suggest that mobile devices could be used more widely to collect health data than researchers may appreciate.
This conference featured discussion of how to expand and improve mobile health technologies, which include such devices as smartphone-connected sensors, wearable or implantable devices, and biotic–abiotic interfaces. Speakers discussed the advantages and challenges of wearable and mobile devices and presented technologies poised to enter the market.
An opening keynote address by Ian Ferguson illustrated the transformative power of mobile devices, particularly wearable and smartphone-connected devices, in the health care market. Session one focused on the potential for mobile technologies to save time, effort, and cost in health settings. The speakers also noted several technical challenges and other hurdles for implementation.
Session two explored commercial applications of mobile biosensors and devices, including how existing smartphones can be adapted to perform feats like photographing DNA. Session three featured trends and breakthroughs in mobile biosensor development and health-tracking apps, highlighting how new designs could improve the quality and usefulness of the data generated. Session four explored how mobile biosensor data should be managed and shared among researchers.
In the second keynote address, Christian Stammel shared insider insights about the wearable technology market. Session five focused on legal and regulatory challenges in the field. The conference ended with a look at the societal implications of mobile health, including the ways in which technologies can improve health care and clinical trial infrastructure and create opportunities for patients to be more actively engaged in health.
Keynote: mobile biosensors and health care
Keynote speaker Ian Ferguson of ARM opened the conference with a synopsis of challenges and opportunities in wearable technologies for health care. The smartphone, he noted, is an ideal central storage point for information generated from wearable devices. An estimated 1.5 billion smartphones will be sold in 2015 alone, and approximately 18 million so-called wearables were sold in the second quarter of the year.
Wearable devices could revolutionize medicine, Ferguson argued, by narrowing gaps in health care coverage in the U.S. and abroad, and by improving the management of chronic diseases, such as diabetes. But existing wearable devices could be better customized; for example, with specific functions or sensors.
"The first wave of wearables were built because they could [be]. If you open up a number of these smart watches at the moment, fundamentally the same building blocks are in there as in a smartphone. But I think the use case for a smart watch is somewhat different," Ferguson said.
He explained that the sector should shift its focus to meet patient needs. Existing devices do not pass the "turnaround test": consumers who inadvertently leave a device at home are not apt to turn around to retrieve it. Although many activity trackers have been sold, for example, the percentage of consumers actually using the devices is low. Wearable devices with more uniquely defined uses could also reduce malaise in the market.
"We need to think of a broader set of wearables," Ferguson said. The devices of the future will include artificial retinas and technology-equipped shirts and beds. "A few years ago," he said, "it was all about gigahertz"—storage capacity rather than utility. But the next wave of smartphones are competing with features other than the processor. "If you look at the quality of cameras in smartphones these days—stunning," he said. "Access to other types of sensors, hubs [will] be the next phase. We're growing up as an industry."
Keynote: market consequences of wearable devices
In his keynote address Christian Stammel of Wearable Technologies AG described the wearable technologies market as diversifying rapidly. Wearable devices include trackers for sports, fitness, and wellness; health care devices such as blood pressure monitors; wearable cameras; smart watches, smart glasses, and smart clothing; and wearable 3D-motion sensors.
Categories of devices and uses that were previously discrete—for sports and fitness, medicine, lifestyle tracking, fashion, industry, safety, and wellness—are merging. For example, several medical-grade wearable devices originated in the fitness sector. Crossover between segments has implications for payment; many patients now pay out-of-pocket for fitness-type devices that can be used for medical purposes. Stammel described an FDA-certified device that was recently sold commercially for the first time. The device, a blood pressure monitor, is not necessarily used in the context of illness, a factor that typically separates medical wearables from devices in other sectors.
Stammel argued that wearable devices must be Internet-connected, with data stored and analyzed remotely via Cloud computing. Without feedback in the form of meaningful data, which can be generated by algorithms that draw upon additional environmental information, users tend to lose interest. Devices that recently won the IOT / M2M Innovation World Cup (Internet of things / machine-to-machine) competition include a posture-monitoring device called UpRight, a device for diffusing drugs into the skin called dermoPatch, a next-generation wearable vital-sign monitor for use at home, and a Cloud-computing health care platform called MEDESK.
Stammel explained that wearable devices are changing from so-called "early adapter" products, focused on technology and performance, to "early majority" products, emphasizing solutions and convenience. A wearable device "just has to work," he said. "Putting it on, it's connected, and it gives you some meaningful, helpful data. If we are coming out with products that are able to do that, we will enter the early majority market, a mass volume market, reaching big figures. There, people are saying, 'Ah! This is a cool device. What kind of display are you using? What kind of processor are you using? What are you measuring?' "
Transparency Life Sciences
John D. Hixson
University of California, San Francisco
John J. Mastrototaro
Transparency Life Sciences
John D. Hixson
University of California, San Francisco
John J. Mastrototaro
Mobile health technologies could save time, effort, and cost in medical research and care and improve the quality of clinical trials.
Researchers must assess whether health data collected by mobile devices is valuable enough to justify technical challenges or concerns about data quality.
Medically relevant data can be used to monitor patient outcomes, to evaluate treatment approaches and interventions, and to avoid harmful and costly events.
Data from electronic medical records can be combined with health data from mobile apps and used in clinical trials.
Implementating mobile technology in clinical trials
"The world of clinical trials is not about gigabytes, and it's not even about cell phones. If you go to a clinical research conference, you'll hear people talking about reducing the number of pages that are faxed. Here we are in 2015 and the clinical trial industry is operating in the 1980s," said Tomasz Sablinski of Transparency Life Sciences. Clinical trials cannot continue on this trajectory: modern technologies must be incorporated to streamline trials and bring industry infrastructure into the 21st century.
The use of mobile devices could improve clinical trial protocols, reduce inefficiencies in patient recruitment, reduce the time clinicians spend with patients, and reduce the need for expensive infrastructure at clinical care facilities. But, Sablinski argued, these benefits are only possible if data collection through mobile devices is accompanied by a comprehensive digitization of clinical trials. Despite the challenges that come with adopting new technologies, the benefits are clear: cheaper trials, new endpoints, and novel designs—leading to more effective clinical research.
Lost in translation? A clinician's perspective on the mobile health opportunity
Clinical trials are not the only area of medicine in need of innovation, explained John D. Hixson of the University of California, San Francisco, who pointed to the paper logs and patient reports epilepsy specialists often depend on to gather information about seizure control. Health care could benefit from the use of sophisticated wearable devices, biometric sensors, and health-related mobile applications. Hixson described several requirements that should govern the use of mobile devices in health care.
Data accuracy, reliability, and integrity are paramount. "In many clinical situations, medical-grade data is essential, and it may often need to be validated against established gold-standard metrics," Hixson said. Digital seizure diaries, for example, with features such as time-stamped entries, might be easier for patients and providers to access and less likely than paper logs to be lost. But the data are self-reported, and thus no more credible than paper diaries.
Companies developing mobile devices should evaluate whether the data collected are superior to traditional data. Mobile technologies add value by generating information on a rolling basis, allowing clinicians to monitor trends over time so that medical decisions need not be based on data from a single office visit. But existing technologies are insufficiently specific and often lose value because of patient nonadherence, technical glitches, and restrictions on data sharing.
Researchers and clinicians need to design protocols to integrate large volumes of data into clinical practice. It is important to consider these practical needs at the design stage. Hixson noted that because many mobile technologies are not yet ready for mainstream clinical use there is time for strategic planning and development.
Patient-centered disease management: building integrated systems
"As we look at what's happening in health care today, we think of it very simply as having three universal health care needs: improving clinical outcomes for patients, expanding access of therapies to patients globally, and optimizing costs and efficiencies," said John J. Mastrototaro of Medtronic, a medical device manufacturer. Medtronic focuses on therapy innovation, globalization, and economic value, and Mastrototaro said that all three areas could benefit from mobile health technologies.
Technologies enabling remote monitoring and support could improve patient care. Medtronic is building systems to aggregate diverse patient data including social and medical information. The data will be used to inform treatment and early-intervention strategies, to use in predictive models, and to improve the performance of medical devices.
Mastrototaro described examples of patient-centered disease management tools for heart failure and type 1 diabetes. He also presented a smartphone app that continuously measures heart rate and other variables. In a clinical trial, elderly adults with late-stage chronic heart failure who used app had fewer hospital visits. Medtronic's long-term goals are to use medically relevant data—from physiological sensors, electronic medical records, insurance claims, and other sources—in an integrated care-coordination system.
Using electronic medical records and ePRO data in clinical trials
GlaxoSmithKline's mobile health initiative began in 2013, when Michelle Crouthamel and a group of clinical scientists approached the company to propose the use of mobile health technologies, which would save cost and time in clinical trials by allowing for direct data capture and would improve the efficiency of patient recruitment and monitoring.
Since the Health Information Technology for Economic and Clinical Health Act (HITECCH) passed in 2009, health care providers in the U.S. have been moving toward an electronic medical records system. Infrastructure that combines information from electronic records with data from mobile applications has made new clinical trial designs possible. Several digital clinical trials, such as biotelemetry trials that assess movement in stroke and amyotrophic lateral sclerosis patients, are underway at GlaxoSmithKline, using apps that provide electronic patient-reported outcomes (ePRO) data. GlaxoSmithKline's chronic obstructive pulmonary disease test is one example of a simple, reliable ePRO tool that is widely used to assess how the symptoms of the disease affect patients' health status.
"By actively engaging with our patients, we can minimize a lot of the protocol amendment, increase our trial feasibility, and determine meaningful endpoints," Crouthamel said.
Panel: mobile biosensor technology and commercial health applications
Moderator Bernard Munos of FasterCures opened the panel discussion by noting that biosensors and wearable devices allow patients, researchers, and clinicians to make better-informed decisions. So why, he asked, continue operating the old-fashioned way? Mastrototaro replied that traditional clinical trial protocols are often used because they are tried, true, and FDA-approved. Hixson noted that even a simple miscalculation in the design of a clinical trial can result in failure. He suggested that pre-validating new mobile health technologies might avert such an outcome. Sablinski argued against pre-validating new technologies, pointing out that if a technology is validated in a phase II trial it will be outdated by the time of the phase III trial; researchers must take risks.
Munos asked the panel whether differing perceptions of economic benefit might encourage smaller companies to move forward with manufacturing wearable devices more readily than large companies would. No, answered Sablinski, because project leaders at large companies are likely to be unaware of the budget and do not always consider finances when risks are evaluated. Moreover, the fear of risk is larger at smaller companies.
University of California, Los Angeles; Howard Hughes Medical Institute
North Carolina State University
Transparency Life Sciences
John D. Hixson
University of California at San Francisco
John J. Mastrototaro
Smartphones can perform an array of sophisticated functions, such as microcopy and data analysis.
Future innovations in wearable technology will rely on low-power sensor platforms with longer battery life.
Materials at the biotic–abiotic interface can be built for specific functions, in versatile forms.
Mobile imaging, sensing, and medical diagnostics
Aydogan Ozcan of UCLA and the Howard Hughes Medical Institute described cell phone–based sensors and microscopes. His laboratory aims to use the phones as a platform for optical imaging and sensing (recording physical measurements) in mobile diagnostics.
Smartphone cameras are advanced enough to be used as microscopes, capable of viewing individual viruses and fluorescently labeled DNA molecules. "Recently we pushed this to the level where you can stretch DNA molecules and measure individual DNA with about kilobase-pair accuracy," Ozcan said.
The phones' capabilities go beyond image capture: their graphics processors allow for image analysis and reconstruction. Smartphones can also perform machine-learning algorithms or be transformed, for example, into imaging flow cytometers or biomarker detectors—capturing time- and space-stamped data that is highly medically relevant.
Designing the next-generation of wearables to be energy efficient and sensitive
Veena Misra of North Carolina State University described efforts at the National Science Foundation's Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST) to find solutions to the power problems facing wearable technologies.
"I think it is safe to assume that wearables are achieving a saturation level. The satisfaction level is not continuing to grow. Why is not totally clear, but it's hard to argue against factors such as high-power consumption, which leads to limited lifetime, limited functionality of the data, limited sensor modalities, inaccurate data, and limited user value," Misra said. She explained that wearable devices as designed cannot meet current health care needs.
The sector must progress from the Fitbit-style technologies of today. ASSIST is designing self-powered, energy-efficient platforms, prioritizing devices with high-energy storage capacity; low-power computation, communication, and sensors; and sensitivity, flexibility, stretchability, and wearability. Misra described a respiratory-health tracker that monitors exposure to air pollution, a self-powered wearable device for continuous electrocardiography (ECG), and a biochemical-sensor platform that measures biomarkers in human sweat.
Connected materials at the biological interface
Fiorenzo Omenetto of Tufts University spoke about materials at the biotic–abiotic interface. He described engineering innovations such as biologically active inks and edible sensors that can be inserted into fruit. His research group has designed compostable electronics as well as resorbable and wireless electronics and biointerfaces for phototherapy.
"If we assume that we have processing power and we're trying to gather information on physiological relevance, how can we make this interface better?" he asked. "How can we identify materials that can ride the biotic–abiotic interface seamlessly and bring technology and biology together?"
Most of these technologies are in the design phase, and if researchers hope to deliver mobile technologies in biologically compatible forms, a combination of form and function will be needed. Interface materials can take various physical forms, such as nanoparticles and flexible electronics, and can be customized to meet specifications for pH, viscosity, shear, concentration, water content, crystallinity, electric field, and other factors. Materials can incorporate special features, such as sustainability, edibility, and implantability, or be designed to undergo controlled degradation or to preserve biofunction.
Omenetto predicted that the materials of the future will have smart, interactive features, such self-repair and self-decomposition, as well as the ability to sense and respond to the surroundings.
Panel: pharmacoeconomics of mobile sensor technology in health care and clinical trials
Moderator Bernard Munos began the panel discussion by noting that the U.S. health care system has infrastructure for prescribing and paying for drugs but no equivalent system for prescribing or paying for apps. He asked whether that situation hinders the widespread adoption of mobile technology. Hixson noted that the current health care system emphasizes medication interventions, and that is not likely to change. Apps, however, can act as an adjunct to medications, particularly if the intervention is helpful to patients and available at low cost, and could prompt lifestyle changes that reduce the need for drugs.
Kara Dennis noted that there is not yet a body of literature to convince a health insurance company that it is worthwhile to reimburse patients for using apps. Such evidence might best come from a trial conducted by a large health care system assessing benefits to patients. Welldoc treated an app it developed for type 2 diabetes management like a medical device, testing it in a clinical trial to demonstrate a clinical benefit and acquiring FDA approval, in a process that generated evidence to justify patient reimbursement. Sablinski questioned whether an app would convince patients to exercise more or to change eating habits, but he said there is no reason the industry should not pursue these outcomes; Welldoc did not wait for the system to change before pursuing a mobile-health goal.
Icahn School of Medicine at Mount Sinai
Pam C. Baker
Open-access platforms are available to support large mobile-based clinical trials.
Mobile technologies allow clinical trials to be performed without direct contact between patients and physicians.
Researchers should think broadly and not allow mainstream trends or the selection of available devices dictate the information to be collected in a clinical trial.
The beginnings of an open ecosystem in mHealth
Brian Bot spoke about a science research commons hosted by Sage Bionetworks that emphasizes collaboration, citizen engagement, data sharing, and continuous use of devices. With funding from the Robert Wood Johnson Foundation, Sage Bionetworks, a nonprofit, has made available an open-source software platform that supports recruitment, management, and analysis for large-scale observational research. Using the platform, Sage and others have built mobile applications with Apple's ResearchKit to conduct studies in diseases such as Parkinson's disease, breast cancer, diabetes, cardiology, asthma, and melanoma.
Sage has established a tiered approach to help researchers use mobile apps to generate actionable health data. First, researchers must gain online consent by informing users about data collection, protection, sharing, and privacy. Providing such information increases user confidence and ensures compliance with human-subjects and data-storage guidelines for clinical research. Next, Sage gives researchers access to population-level data, which can be used for analyses of trends and other parameters that would be difficult to assess using data from individual participants. Finally, a data-sharing platform, also hosted by Sage, allows researchers to share results with one another.
Bot concluded with an overview of Sage's current research goals, which include improving the functionality of its mPower app, developed for a large Parkinson's disease clinical trial.
Using ResearchKit for an asthma mobile health study
An asthma mobile health study at Mount Sinai's Icahn School of Medicine is among the many large clinical trials using ResearchKit. Pei Wang described lessons learned in its first 6 months.
The Mount Sinai trial enrolled more than 7500 patients—approximately the same number as the Centers for Disease Control and Prevention's 2003 National Asthma Survey—and obtained data through the Asthma Health app. The researchers found that participants with severe asthma were most likely to respond to the survey. Participants who continued using the app reported increased physical activity levels over time.
"ResearchKit is a very innovative, highly efficient, and cost-effective platform to conduct clinical research," Wang said. "In our initial period, we have demonstrated the feasibility and potential of using a mobile health app without direct [in-person] participant contact."
Managing biometric big data: promises and challenges
Pam C. Baker of FierceBigData offered practical advice to clinicians and researchers using mobile health applications. She suggested that researchers think broadly and not allow mainstream trends or the selection of available devices to dictate the information to be collected in a clinical trial. It is important first to evaluate research needs and then to find devices or apps to match. Machine learning should be incorporated into every project, she suggested, because it can uncover findings not accessible via other analyses.
"We can collect data from many more places than are typically considered," Baker noted. "Some sensors are ingestible, some are injectable, some are implantable, and some are wearable." Trial participants may be using several sensors at once, and it is important to consider whether one sensor could interfere with another's operation.
Baker described how mobile technologies could reduce research costs, allowing researchers to share resources, distribute effort across projects or institutions, and make open-access data more accessible. Certain information, such as algorithms or processes, can also be sold on a virtual marketplace to recoup costs.
She cautioned researchers to be mindful of data security and privacy, particularly when using Cloud computing to store data. Most wearable devices are designated part of the Internet of Things (IoT) and vulnerable to associated security breaches. Mobile devices are in a category of their own with another set of security considerations, including usage policies, third-party applications, and content management.
U.S. Food and Drug Administration
Linda A. Malek
Moses & Singer LLP
Stan W. Berkow
David C. Magnus
Stanford Center for Biomedical Ethics
Trial endpoints must be pre-specified to strengthen the analysis of massive data sets that mobile technologies generate.
Regulations are evolving; researchers should be proactive about protecting patient privacy and data security.
The mobile health market has a strong potential to disrupt the pharmaceutical industry.
Citizen science could change how mobile health technologies are used and could generate new research models.
Regulatory considerations for the use of biosensors in clinical trials
Leonard Sacks of the U.S. Food and Drug Administration offered a regulator's perspective of the opportunities and challenges presented by mobile technologies in clinical trials. One advantage of wearable devices and mobile apps is continuous data collection, capturing everyday life. The devices can also make participation in trials more convenient for patients and thus improve compliance.
There are currently no regulatory restrictions on mobile technologies. However, Sacks pointed to several clinical concerns, such as biosensor sensitivity and specificity and data reproducibility and attributibiliy (the ability to link data to specific events or outcomes). Studies using mobile devices can include geographically distant participants and electronic data transmission. Researchers using off-site data collection tools must navigate issues such as clinician registration and experimental drug distribution in different U.S. states. Studies must also have robust patient contact systems and procedures to ensure patient safety.
"With all the gigabytes of information that come in from these devices, it's tempting to make lots of different measurements and choose those that most accurately show the drug effect. That's a definite no-no from FDA's point of view. It raises the problem of multiplicity. There's always a chance that if you do something many, many times you're going to get a positive result. So endpoints have to be pre-specified," Sacks said.
Data privacy, cybersecurity, and health IT legal issues
Linda A. Malek of Moses & Singer LLP explained some of the legal implications of mobile health technologies. Biosensors are medical devices regulated by the FDA, she noted, but the same term is often used to describe wearable technologies in general.
Malek discussed the main regulations that affect privacy and cybersecurity. Implanted or wearable medical devices that rely on radio technology must be certified by the Federal Communications Commission (FCC) and must receive FDA authorization before being imported, operated, or marketed in the U.S. The Federal Trade Commission (FTC) sets rules for consumer privacy and data security. The NIH offers guidelines for data management. Malek recommended that clinical trials using mobile devices should adhere to the rules for U.S. states with the most stringent privacy and security laws to ensure that all state regulations are met.
"Because this area of the law is evolving so much, it's going to be important to deploy best practices," Malek said. "Be proactive, because so much of what's happening with respect to technology doesn't necessarily fit into a regulated category. Look at what does fit into the regulated category and try to anticipate that the law will eventually catch up to what you're doing."
Regulatory considerations for effective implementation
While working at Columbia University Medical Center, Stan W. Berkow of Sense Health worked on clinical trials of exercise- and nutrition-based interventions. Patients' lack of adherence to the interventions—at least without extensive encouragement by researchers—was a common problem. Berkow found that a human connection made all the difference. He and a team of study coordinators improved the participants' adherence to the trials by communicating with patients individually and holding them accountable for implementing the lifestyle modifications.
"At the end of the day, it wasn't money or incentives that we gave people to show up to their appointments. It wasn't apps where they could track the process and make it fun. It was really the fact that I would call them and check in and see how they were doing, and they knew they could text me and communicate. That was driving people to be adherent to our studies," Berkow said.
Berkow is now the founder and CEO of Sense Health, a company that provides a mobile platform for clinical trial researchers, health care providers, and care managers to communicate with patients. He described Sense Health's experience navigating the Health Insurance Portability and Accountability Act HIPPA regulations and other privacy concerns for text message-based applications and mobile apps, which must also adhere to the Telephone Consumer Protection Act. To comply with HIPPA, the Sense Health system controls and blocks communication to participants. For example, all outbound messages and automated reminders, other than an initial welcome message, are withheld until the participant has replied to the first message to consent to the communication.
Sense Health uses text messages and automated phone calls to inform participants of the risks associated with sending confidential health information by text message. These risks differ, Berkow noted, from those associated with mobile apps or landline telephones. Text messaging cannot be turned off, making it difficult to conceal the contents of incoming messages. However, many phones are passcode-protected, affording some privacy.
"While a lot of the emphasis today is on sensors and devices and very sophisticated technologies, we're finding even at the simple level of communicating through basic channels that there are a lot of associated concerns and risks. We're trying to find smarter ways to work within those concerns and make people aware of the risks, while still facilitating the type of communication that participants and patients are really interested in utilizing," Berkow said.
Panel: developing guidelines and standards for mobile sensor technology in clinical trials and health care
Wearable and mobile health devices are most often used by consumers in the 15–35 year-old demographic, noted moderator Bernard Munos. Could there be a clash between this population's casual attitude toward privacy and the conservative privacy regulations that are in place? In particular, he noted, few young people take time to carefully read privacy disclaimers before signing them. Malek predicted that consumer and regulator concerns will eventually align in response to breaches of private health information (for example, from website hackers) that consumers may consider stigmatic. Berkow noted that technology development has outpaced regulations; existing regulations do not specify how certain types of data should be handled, or do not anticipate the privacy risks posed by newer technologies. Sacks argued that balance is needed; if privacy concerns were magnified so as to make research impossible, the whole medical research field would suffer.
Societal consequences of mobile biosensor technologies
In his talk, Munos explored what the mobile health market means for society. "All of this is about being smarter," he said. "It's about doing things that we already do in a smarter and cheaper way. And the impact of that will be a profound transformation of drug R&D, of medicine and—ultimately—of society."
Disruptions in the pharmaceutical industry brought about by the mobile health market would free massive resources that are currently misallocated, Munos explained, citing the $140 billion spent on research and development yearly to produce only 30 to 40 new drugs each year. The industry could use mobile technologies with new capabilities for tracking patient health and could implement the technologies widely, providing much-needed resources for rich and poor countries alike.
If the mobile health sector can adapt to offer fast, relevant, convenient, transparent, personalized, and affordable devices and applications, society would see significant cost savings in health care and patients would be better informed and more engaged. The technologies could also transform research by allowing scientists to study diseases while also using the data for clinical care.
The ethics of wearables: challenges and opportunities for citizen science
David C. Magnus of the Stanford Center for Biomedical Ethics further described current issues for the wearables market, including privacy, confidentiality, accuracy, liability, authenticity, and regulation across state borders. He also outlined opportunities for change that these technologies make possible, including in citizen science, crowdsourcing, and gamification. He suggested that the design and vetting of new mobile health technologies should take these opportunities into consideration.
"Looking forward, this technology is going to push research further. Instead of data that's collected and goes back to researchers, we'll see much more of a two-way street. We'll see the rise of citizen science and patients playing a much more active role in the actual development of research," Magnus said, noting that the collection of data from mobile health apps could allow citizen scientists to, for example, crowd-source innovative solutions for disease management.
According to Magnus, a shift toward citizen science could transform society's understanding of how science works, how it takes place, and who does it. If that happens, scientists will need to consider how best to adapt existing mobile health regulations to meet new demands.
How can regulations keep up with technology development? What kinds of new regulations are needed for wearable devices?
How will wearable devices develop to better meet consumer needs and specific medical purposes? How can mobile devices be improved to collect more useful data?
Are cell phones the most appropriate device to serve as a hub of information for elderly patients?
Will casual attitudes toward privacy and data security among the public adapt to match the strict approach of regulators?
How can researchers be proactive about protecting patient privacy and data security?
How will technical challenges for managing big data and concerns about data quality be answered?
What incentives could be provided to help the clinical trial industry adopt new technologies?
How best can data collection via mobile device be incorporated into clinical trial protocols?
Will the mobile health market strongly disrupt the pharmaceutical industry?
Will citizen science change how mobile health technologies are used and generate new research models?