vision 2020 final
TRANSCRIPT
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
OM
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
SC
IEN
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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
PH
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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
BA
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ALT
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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 [email protected]