Seeing ahead of the curve VISION 2020:

“

” >The Hon. John E. Porter Chair, Research!America

You can change the image of things to come. But you can’t do it sitting on your hands.

”

CONTENTS A Message from Research!America……………………..……..1-2

Federal Investment and Innovation……….……………....…….3-6

Current Research Initiatives………….………………..…..……….…7-8

Policy Tracker…………….……………………………………….………..…9-10

Perspectives………………………….………………….…..………...……11-12

Member Spotlight…………………………………………..………….………13

Public-Private Partnerships…………..………….………………..……14

The Bottom Line…………..………………..……….…...……………..…..…15

Methodology…………..……………..…..………………………………..……..16

We live in a time of growth, innovation, and discovery. Our lives are becoming more connected. Healthcare is

evolving to be present in our lives every day–not just when we’re sick.

This huge shift towards patient-centered care is because of technology. Technology has always been about enabling human potential and now this potential has come to health. Smart phones have put the power of knowledge into our hands and pockets and we are fast approaching a future where everything can be collected. We–the public–will be augmenting existing research paradigms and as medicine and research evolves, the emphasis will be on knowing and understanding–a theme of observation. We will not be changing what we research, per se, but with how we apply that research.

We’re in a new era of collaboration. Whether you call it digital health, mobile health, or health IT, the system is changing. But soon, health IT will not be a niche advocacy area; health IT, digital health, mobile health–they will all

just be health. No longer are medical breakthroughs relegated to academic or NIH labs; tech giants and small

start-ups alike are getting into the business of cures. Everything from health apps and public-private partnerships, to the digitization and development of patient registries are propelling this change. We are adding connected devices –also known as the Internet of Things (IoT)– at an alarming rate. With more and more of these devices being related to health, it is now, more than ever, time to look at the future of medical research advocacy.

At Research!America, we embrace this spirit of change with our Vision 2020: Seeing Ahead of the Curve. This

report will serve as a sampling of the current state of health IT and will serve as a navigator for Research!America through this changing landscape.

A Message from Research!America

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Our mission | Research!America is a not-for-profit public education and advocacy alliance dedicated to making research to improve health a higher national priority. Through our innovative programs and advocacy tools, we work to foster a legislative and regulatory climate that supports research and public and private sector innovation from bench to bedside.

|Our vision See ahead of the curve

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Federal Investment Spurs Innovation

Medical breakthroughs are no longer relegated to the labs of NIH. From funding basic biomedical research to advancements in cloud computing, the federal government invests in a multitude of agencies that have the potential to spur medical breakthroughs.

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There is certainly no lack of innovation when it comes to new health technologies. Unfortunately, many of these

new advancements are unable to be distributed to the general public. Many clinical trials and research programs unwillingly exclude certain

members of the public that could otherwise benefit because of location or accessibility and the Office of Behavioral and Social Sciences

Research at the National Institutes of Health (NIH) is funding mobile health (mHealth) projects to combat this. Awards are given to research

projects that create a research resource that uses mobile phone technology to create a diverse registry of potential research

participants in conjunction with a partner from a mobile telecom company. This initiative will create systems and

technologies that can enhance the promise of mHealth and bring its benefits to as large a group as possible, while addressing

security and privacy concerns.

NATIONAL INSTITUTES OF HEALTH

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

The Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) is currently working on the convergence of medical devices with connectivity and consumer technology; some areas of interest for the center are wireless medical devices, mobile apps, telemedicine, and cybersecurity. The CDRH has also established the Digital Health Program to promote public health and to provide transparency about regulatory topics by encouraging collaborations and outreach and by developing smart and effective strategies and policies for these emerging technologies.

Research into the implementation of health IT is equally as important as developing the technology itself. According to an

early report by the Agency for Healthcare Research and Quality (AHRQ), electronic health records (EHRs) have the great potential to reduce healthcare costs, reduce errors, and improve access. In

FY14, the agency appropriated $4 million for health IT research. Some of this will be spent on funding research on the impact of

health IT on patient safety.

FOOD AND DRUG ADMINISTRATION

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A major concern of the digitization of health is how our information will be kept secure. The National Cybersecurity Center

of Excellence at the National Institute of Standards and Technology (NIST) released a practice guide “Securing Electronic Records on Mobile

Devices” to demonstrate how organizations can protect patient information in electronic health record (EHR) systems and mobile

systems and adhere to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.

NATIONAL INSITUTE OF STANDARDS AND TECHNOLOGY

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE

NATIONAL SCIENCE FOUNDATION

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For future breakthroughs in health and medicine, advancements in biomedical research need to happen in tandem with advancements

in technology and engineering. The Directorate for Computer & Information Science & Engineering, the Directorate of Engineering, and the Directorate for Social, Behavioral & Economic Sciences at

the National Science Foundation (NSF) together with the NIH developed the Smart and Connected Health (SCH) program to

accelerate the transformation of healthcare. High-risk, high-reward projects like the advancement in the understanding of robotics are

among the projects funded. l

A large source of data in this new era of health is patient generated. The Patient-Centered Outcomes Research Institute (PCORI) was established in 2010 to close the gaps in the evidence needed to improve key health outcomes. To achieve this vision, they developed a system of clinical care networks to harness the power of patient reported data: Clinical Data Research Networks (CDRNs) that originate in healthcare systems and Patient-Powered Research Networks (PPRNs) that originate from groups of patients participating in research. Through funding methods to better harness the data generated by these large networks, PCORI is [at the front of the pack in terms of the technological shift towards patient centered care happening...]

“ ” > The Hon. Paul G. Rogers

Without research, there is no hope.

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The promise of big data is huge. However, the lack of appropriate tools, data accessibility, and insufficient training are major roadblocks to the unlocking its true potential; that’s where the Big Data to Knowledge (BD2K) initiative comes in. Launched in 2012 by the NIH, this initiative enables biomedical research as a digital research enterprise, to facilitate discovery and support new knowledge. BD2K will ultimately develop new methods and approaches that will enhance the use of biomedical Big Data that will lead to data sharing, discovery, privacy, and more.

The promise of Big Data is there, we just need the right tools to unleash its full potential.

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Big Data 2 Knowledge

® Precision Medicine Initiative

MISSION STATEMENT: To

enable a new era of medicine through research, technology, and

policies that empower patients, researchers, and providers to

work together toward development of individualized

treatments

We are at an exciting time in medical progress. We have sequenced the human genome, we have improved our technologies for analysis, and we have progressed leaps and bounds in terms of computing power and data storage. President Obama has recognized this progress and in his 2015 State of the Union address, unveiled the Precision Medicine Initiative (PMI)®. Precision medicine is an emerging approach for disease prevention and treatment that takes into account people’s individual variations in genes, environment, and lifestyle. The PMI will generate the scientific evidence needed to move the concept of precision medicine into clinical practice.

This initiative aims to, in the near-term, apply precision medicine to cancer and innovate clinical trials. In the long term, The PMI will develop a cohort of 1 million or more volunteers who will share their genetic data, biological samples, and diet and lifestyle information that will be linked to their electronic health records. With this wealth of data, the PMI will pioneer a new model for research.

MISSION STATEMENT: enable

biomedical scientists to capitalize more fully on the Big Data being

generated by those research communities

R E S E A R C H AT T H E N I H

TELE-MED Act

Introduced by Reps. Nunes (R-CA) and Pallone (D-NJ), this bill would allow a Medicare provider to provide

telemedicine services to a Medicare beneficiary who is in a different state from the one in which the provider is licensed or authorized to provide healthcare services.

Patients would be able to be seen by the best doctors even if they are in a remote area or unable to travel long distances for frequent appointments for

chronic care.

TELEM

EDICINE

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Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff

The FDA released a guidance document in February 2015 to provide clarity and predictability for manufacturers of mobile medical apps. This guidance lays a

framework for how the FDA is going to approach regulating emerging technologies and defines various digital health terms like “mobile platform”,

“mobile application”, “mobile medical application” and more. According to this version of the guidance, the FDA does not intend to regulate mobile apps like

those that are intended to help patients manage their disease; however, apps or devices that transforms the mobile device into a medical device will fall under FDA’s jurisdiction. The FDA also released an appendix of devices that may fall

under its jurisdiction at some point, like apps that provide patient-specific screening, to provide examples and assistance to companies navigating this

regulatory area.

FDA GU

IDANCE

Medical Device Tax

The medical device excise tax of 2.3% was went into effect in 2013 as part of the broader Affordable Care Act passed in 2010. “Medical devices” can refer to

anything from pacemakers to infusion equipment to treat cancer. In 2013, an analysis by Ernst & Young showed that venture capital investments in medical devices in 2013 fell 17% from the previous year. With how advancements in digital health technologies is

advancing, this tax would hinder innovation. Its repeal has strong bipartisan and bicameral support and in June of 2015, the House passed the Protect

Medical Innovation Act that repeals it.

America COMPETES Reauthorization Act

In its current iteration, the America COMPETES Act which authorizes research programs at NSF, NIST, and

DOE, places arbitrary restrictions on many research programs. The Directorate for Social, Behavioral and Economic Sciences at the NSF is cut by 58% in this

version that passed in the House (the Senate process is still ongoing). Many cross-directorate initiatives, like the “Understanding the Brain” initiative, and cybersecurity

research depend on the social sciences directorate and would be adversely affected if these research limitations

were to become law.

AM

ERICA C

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PETES ACT

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MEDICAL D

EVICE S

Policy Tracker

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“Many providers in our states have found that adopting technologies, such as wireless and

remote monitoring of patient-generated health data, has increased quality of care; reduced

hospitalizations; avoided complications; improved satisfaction and convenience –

particularly for the chronically ill; expanded access; and reduced costs, among other

benefits. A review by AHRQ of literature would be valuable in making policy decisions on how

best to advance this technology and reduce health care costs.”

- Letter to the AHRQ with Senator Bill Nelson (D-FL) 12/2014

“The uncertainties of emerging technologies can make it difficult or even impossible for regulators to apply traditional risk-benefit

analyses, because they may have neither a definitive idea of what to look for nor a means

to identify it…Technology innovates faster than our regulatory system can adapt.”

- Science 7/2015 R. Alta Charo, JD: professor of law and bioethics at the University of

Wisconsin—Madison; former policy advisor on emerging

technology issues at the FDA.

Donna Cryer: President and CEO of the Global Liver Institute; liver

transplant patient

“Next generation is high tech and high touch. There is a patient behind all that

data. #mdchat #qualitytalks” - Tweet 8/2015

Senator John Thune (R-SD): Chairman, Senate Committee on Commerce,

Science, and Transportation

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P E R S P E C T I V E S

P E R S P E C T I V E S

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“#PMINetwork provides golden opportunity to test wearables & see how they improve outcomes. Cool apps + evidence = better

health” - Tweet 9/2015

Francis Collins, MD, PhD: Director, National Institutes of Health; leader of the Human Genome

Project

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“I am prescribing a lot more apps than medications these days.”

- NBC Interview 1/2013

Eric Topol, MD: Director, Scripps Translational Science Institute;

cardiologist; professor of genomics; author of The Patient Will See You Now and Creative Destruction of Medicine

GLO

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Dr. Bearden led a research effort on severe Bipolar Disorder (BPD) in genetically isolated populations in Latin America. She collected data via wearables and was able to identify risk factors and track who was most at risk for BPD. She believes that health IT has the

potential of managing and even pre-screening people with mood disorders.

- Research!America Interview 10/2015

Carrie Bearden, PhD: clinical psychologist; Joanne and George

Miller Family Endowed Term Chair, Department of Psychiatry and

Biobehavioral Sciences and Brain Research Institute, UCLA.

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With every new app launch or research initiative release comes the promise of a healthcare or research “revolution”. However, new digital health technologies often have trouble getting to the finish line of production and are left promising unachievable break-

throughs. That’s where the Center for Digital Health Innovation comes in. After seeing the issues that many technologies had with delivering on the radical promises, the University of California – San Francisco created the Center for Digital Health Innovation (CDHI). With its location in the heart of the tech revolution, UCSF, a Research!America member, is well-equipped to handle these challenges and has the infrastructure and brain-power to accomplish it.

CDHI is also collaborating with private partners to address unique concerns in the digital health community. The university is partnering with Cisco©, the network technology giant, to test and scale the interoperability platform across different devices, IT systems and software

P a r t n e r s h i p sMember Spotlight

C E N T E R F O R D I G I T A L H E A L T H I N N O V A T I O N Innovate

We provide UCSF faculty, students, and staff with the essential support and

resources to create and incubate transformative technologies.

Integrate We focus on the integration of new

technologies in real clinical environments.

Validate We leverage UCSF's clinical trial resources

to test, validate, and iterate on novel technologies.

Educate Using our ecosystem for learning, we design digital education for the next

generation of health leaders.

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P a r t n e r s h i p s ResearchKit™

Clinical trials often have issues with recruiting patients as location and accessibility are often barriers to entry. On March 9, Apple© introduced ResearchKit™, a new open source framework designed for health and medical research that helps doctors and scientists gather data more frequently and more accurately from participants using iPhone apps. And since ResearchKit™ works seamlessly with HealthKit, researchers can access even more relevant data for their studies — like daily step counts, calorie use, and heart rate.

Apple© is partnering with a variety of research institutions for this endeavor. One example of which is the “MyHeart Counts” project with Stanford Medicine and University of Oxford. It uses surveys and tasks to help researchers more accurately evaluate how participants’ activity and lifestyle relate to their risks of cardiovascular disease. Other apps include Parkinson’s research, asthma tracking, and diabetes management, with many more surely on the way.

In addition to clinical trials, Apple© is also conducting research into human behavior to make mobile health apps more effective by asking questions like would users be willing to step through the app’s entire consent flow? Would they continue to use the app after installation? Preliminary results say yes and further research will only make these mobile health apps and trials more effective.

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Ultimately, at the very core of what Research!America does, what we’re good at, is getting everyone to the table. We provide the vital connections between researchers, policy makers, regulators, industry, and patients that keep the wheel of scientific innovation and progress running. Health IT, medical health, digital health, and its many other iterations will be central to biomedical research advocacy and to navigate this changing landscape, we are seeing ahead of the curve.

2020 promises big changes and so do we.

The Bottom Line

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Methodology:

This project was created by Abby Barry for the Burroughs's Wellcome Science Policy Internship at Research!America and was presented on October 28th, 2015.

The Vision 2020 concept was adapted from Vision 2020 examples from a variety of organizations. The opinions and examples used here were curated over the course of the internship by attending events, reading white papers, and following trending health IT stories on social media.

Credits:

Thank you to all of the individuals and agencies mentioned in this report for providing insights and pertinent examples relevant to health IT and Research!America’s mission.

Federal agency information was gathered from agency websites and UCSF research was collected from UCSF.edu.

ResearchKit, the ResearchKit logo, and the Apple logo are trademarks of Apple Inc.

NIH.gov NSF.gov CDC.gov AHRQ.gov FDA.gov

CMS.gov HEALTHIT.gov NIST.gov VA.gov PCORI.org

M e t h o d o l o g y

Research!America 1101 King Street, Suite 520 Alexandria, Virginia 22314

703.739.2577 1.800.366.CURE

Fax 703.739.2372 www.researchamerica.org info@researchamerica.org