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Bakul PatelAssociate Director for Digital Health, Office of Center Director
U.S. Food and Drug Administration, Center for Devices and Radiological Health
Digital Health:
Advancing Healthcare
@_bakulpatelBakul Patel
2 February 13, 2015
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Digital Health – a convergence of people,
information, technology and connectivity in healthcare
3 February 13, 2015
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Technology in healthcare is becoming truly impactful
4 February 13, 2015
Moving
healthcare from
the clinic to the
patient
Seeking to
understand the
patient’s
behavior and
physiology
Focusing on
prevention
L E V E R A G I N G C O M P U T I N G P O W E R A N D
C O N N E C T I V I T Y
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By 2020, $233.3 Billionwill be spent globally on digital health
Projected CAGR for the global digital health market from 2013 to 2020, by segment
5 February 13, 2015
Source: Statista, Arthur D. Little; GSMA Intelligence; Allied Market Research; Accenture; IHS; MarketsandMarkets; ID 387875
6%
36%
46%
23% 21%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
EHR/EMR Mobile health Telehealth Wireless health Other*
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As of May 2014, there were nearly 7 Billionmobile subscriptions worldwide
An equivalent of 95.5 percent of the world
population have a mobile subscription.
Nearly 1 billion handheld units were shipped in
2013 (up 42%+ from 2012) … 53.6 percent
were smartphones.
6 February 13, 2015
Sources: International Telecommunication Union –
May 2014; Gartner – February 2014.
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Healthcare providers and consumers are using
technology to communicate
Consumers’ willing to use
selected technologies to
communicate with
healthcare providers.
(Fall 2013 U.S. based survey)
7 February 13, 2015
Source: Statista 2015 (http://www.statista.com/statistics/297827/healthcare-providers-and-consumers-use-of-communication-technolog/)
69%
49%
45%
40%
Online chat or web portal
Text message
Mobile health applications
Percentage of respondents
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Technology is changing how we monitor
cardiac patients in modern day healthcare
Access to 7 billion people will create new demands
and solutions.
New knowledge and evidence will lead to improved
outcomes
8 February 13, 2015
$686M
$867M
0
100
200
300
400
500
600
700
800
900
1000
2011 2016
Ma
rke
t va
lue in
mill
ion U
.S. d
olla
rs
Source: Statista 2015 (http://www.statista.com/statistics/259810/global-
revenue-from-mems-motion-sensors-in-wearable-fitness-devices/)
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Huge data and smarter systems driving
Intelligent healthcare
• Big data revolution is just beginning to touch
the most sacred aspect of our lives: our health.
• Mobile devices have the potential to generate
huge amounts of personal health data, and
computing advances may enable big data
analytics to promote health and wellness.
• Health data may empower understanding our
health like never before.
9 February 13, 2015
It has been estimated that as much as 90% of all data
in the world has been generated in the past two years.
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FDA is shaping oversight policies to make it happen
10 February 13, 2015
• Focused on patients and innovationCDRH’s Vision
• Balanced and smart regulatory approachesSmart Approach
• Advancing healthcarePromoting Safe
Innovation
CONFIDENTIAL © MobCon Digital Health. All rights reserved.11 February 13, 2015
• Patients in the U.S. have access to high-quality, safe, and
effective medical devices of public health importance first in
the world.
• The U.S. is the world’s leader in regulatory science, medical
device innovation and manufacturing, and radiation-emitting
product safety.
• U.S. post-market surveillance quickly identifies poorly
performing devices, accurately characterizes real-world
performance, and facilitates device approval or clearance.
• Devices are legally marketed in the U.S. and remain safe,
effective, and of high-quality.
• Consumers, patients, their caregivers, and providers have
access to understandable science-based information about
medical devices and use this information to make health care
decisions.
Vision
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Oversight Approach
12 February 13, 2015
Risk based
Functionality focused
Platform independent
Promote innovation
Narrowly tailored
Promote patient
engagement
ProtectPatientsafety
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Mobile Medical Apps (MMA)
The U.S. FDA’s approach to
13 February 13, 2015
Mobile apps that meet “device”
definition that are either intended
• To be used as an accessory to
already regulated medical device,
or
• To transform a mobile platform
into a regulated medical device.
focus of oversight
MMA
• Patient self-management apps
• Tools to organize and track their health information (not
for treating or adjusting medications)
• Tools to access to health information document and
communicate with health care providers
• Tools that automate simple health care providers tasks
Lower risk mobile apps that
meet “device” definitionbut not considered “MMA”
No intention to enforce regulations
Mobile apps not considered
“medical devices”
No regulatory requirements
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Mobile Medical Apps (MMA)
The U.S. FDA’s approach to when an app is a
14 February 13, 2015
focus of oversight
MMA
“mobile medical app” is a mobile app that
meets the definition of device in section 201(h)
of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) ; and either is intended:
• to be used as an accessory to a
regulated medical device; or
• to transform a mobile platform
into a regulated medical device
Examples in Section V-A +
Appendix C of the Guidance
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Mobile Medical Apps (MMA)
+ clarifying when an app is not a
15 February 13, 2015
• Library of clinical descriptions
• Medical flash cards
• Certification or recertification preparation apps;
• Games to train health professionals in advanced
CPR skills.
• Allow users to input pill shape, color or imprint
and displays pictures and names of pills that
match this description;
• Find the closest medical facilities;
• Help guide patients to ask appropriate questions
to their physician
• Track, review and pay medical claims and bills
online;
• Manage or schedule hospital rooms or bed space
• Help patients (i.e., users) self-manage their
disease or conditions without providing specific
treatment or treatment suggestions;
• Provide patients with simple tools to organize
and track their health information;
• Provide easy access to information related to
patients’ health conditions or treatments;
• Help patients document, show, or communicate
potential medical conditions to health care
providers;
• Automate simple tasks for health care providers;
or
• Enable patients or providers to interact with
Personal Health Record (PHR) or Electronic
Health Record (EHR) systems.
Mobile apps –NOT Medical Devices
Mobile apps –NOT Focus of Oversight
E x a m p l e s o f M o b i l e
Ap p s w h i c h a r e n o t
c o n s i d e r e d M M A
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Re-evaluating current regulations
The U.S. FDA’s approach to
MDDS and medical Image storage and communication device
- Generally were considered lower risk - class I
- Systems that record, share, and use of medical device data have become a
significant in a connected healthcare system
- These inter-communication functionality is foundational in an interoperable
digital health ecosystem.
Proposed draft guidance (June 2014) intended to
- Provide continued clarity in Digital Health
- Narrowly focus on higher risk products
- Create and impetus for devices to share data and ultimately become
interoperable with other systems16 February 13, 2015
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Draft General Wellness Guidance – Policy for Low Risk Devices
The U.S. FDA’s approach to
PROPOSES A POLICY THAT
Does not intend to examine low risk general wellness products to determine whether
they are “devices” within the meaning of the FD&C Act, or
If they are “devices”, FDA does not intend to enforce compliance to regulatory
requirements for devices under the FD&C Act
PRODUCTS COVERED UNDER THE PROPOSED POLICY
Products intended for only general wellness use, and
Products which inherently present a very low risk to users’ safety.
PRODUCTS INTENDED FOR GENERAL WELLNESS USE CAN BE MARKETED
Without any reference to diseases or conditions, or
With a disease-related general wellness claims that contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.
17 February 13, 2015
C o m m e n t s
D u e B y
A p r i l 2 0 ,
2 0 1 5
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Draft Accessories Guidance
The U.S. FDA’s approach to
DEFINES “ACCESSORIES” NARROWLY –
Accessory: A device that is intended to support, supplement, and/or augment the
performance of one or more parent devices.
Parent Device: A finished device whose performance is supported, supplemented,
and/or augmented by one or more accessories.
PROPOSES A POLICY WHERE
Classification of accessories will be similar to the risk-based classification that FDA
applies to all medical devices, and
- Risk of an accessory are the risks that it presents when used with the
corresponding parent device as intended
Allows for a de-novo submission requesting FDA to make a classification
determination for new accessory types.
18 February 13, 2015
C o m m e n t s
D u e B y
A p r i l 2 0 ,
2 0 1 5
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Categories of Health IT FunctionalityFDASIA Health IT Report : Proposed strategy and recommendations
19
Administrative
Functionality*
Health Management
Functionality*
Medical Device
Functionality*
No Additional Regulatory Oversight Primarily FDA
Oversight
Primary Focus of Proposed Health IT
Framework
• Health information and data
management;
• Data capture and encounter
documentation;
• Electronic access to clinical results;
• Most clinical decision support;
• Medication management;
• Electronic communication (e.g.
provider-patient, provider-provider,
etc.);
• Provider order entry;
• Knowledge management;
• Patient ID and matching.
• Admissions;
• Billing and claims processing;
• Practice and inventory
management;
• Scheduling;
• General purpose communications;
• Analysis of historical claims data;
• Determination of health benefit
eligibility;
• Reporting communicable diseases;
• Reporting on quality.
• Computer aided detection
software;
• Remote display or notification of
real-time alarms from bedside
monitors;
• Radiation treatment therapy
planning software;
• Arrhythmia detection.
* Examples provided.
Not intended to be
an exhaustive list
of functionalities.
February 13, 2015
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Proposed Approach for Clinical Decision SupportFDASIA Health IT Report
20
Administrative Functionality
No Additional Regulatory Oversight
Administrative Functionality
No Additional Regulatory
Oversight
Health Management Functionality
Primary Focus of Proposed Health IT
Framework
Medical Device Functionality
Primarily FDA Oversight
Health Management CDS1
• Clinician order sets:
• Drug-drug interactions and drug-allergy
contraindication alerts;
• Drug dosing calculations;
• Drug formulary guidelines;
• Reminders for preventative care;
• Access to treatment guidelines;
• Calculation of prediction rules.
Medical Device CDS2
• Computer aided detection/diagnostic
software;
• Remote display or notification of
real-time alarms from bedside
monitors;
• Radiation treatment planning;
• Robotic surgical planning and
control;
• Electrocardiography analytical
software.
February 13, 2015
1 If a product with health management functionality meets the statutory definition of a medical device, FDA does not intend to focus its oversight on it.2 CDS that have medical device functionality and present higher risks warrant FDA’s continued focus and oversight.
The Agencies will engage in a public process that includes a public meeting and public comment period, and FDA’s issuance
of draft guidance for public comment to clarify the types of medical device clinical decision support that should be the focus
of FDA’s oversight.
Clinical Decision SupportEncompasses tools intended to enhance, inform, and influence
health care decisions.
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• Enable “patient centered” public health as
digitization touches every aspect of health
care
• Foster trust in innovative technologies as an
enabler of a new healthcare paradigm
• Prepare a "digital-future ready” infrastructure
@CDRH that understands innovators needs
and expectations
CDRH Objectives
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Address the evolving landscapeU.S. FDA has implemented the infrastructure to
Web page for mobile medical app
- Maintain a list of exemplary types that are not considered devices, not subject to
compliance, or actively overseen
- http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/Mobil
eMedicalApplications/default.htm
Avenue to ask questions –
Digital health team provides internal coordination to maintain consistent
policy decisions
22 February 13, 2015
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Better HealthcareAnd continues to partner in innovations to enable
How can technology be a catalyst for …
Preventing a disease or condition
- Medication compliance/adherence
- Healthy lifestyle …
Understanding human physiology
- For example:
- 1954 - American Heart Association recognizes ECG as we know it today
- 2015+ - ?????????
23 February 13, 2015
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In Summary
FDA excited to participate in creating a better healthcare
system through evidenced based and safe innovation
Patient safety and protected patient information is the
cornerstone of a better healthcare system
24 February 13, 2015
WOR K TOGETHER
R EA C H A LL PA TIENTS
B ETTER TR EA TM ENTS A ND OUTC OM ES