MobCon DH 2015 - Bakul Patel - digital health advancing healthcare

CONFIDENTIAL © MobCon Digital Health. All rights reserved.


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


Digital Health – a convergence of people,

information, technology and connectivity in healthcare

3 February 13, 2015


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


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*

http://www.statista.com/statistics/387875/forecast-cagr-of-worldwide-digital-health-market-by-segment/


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.


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%

Email

Online chat or web portal

Text message

Mobile health applications

Percentage of respondents


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/)


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.


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


Oversight Approach


Risk based

Functionality focused

Platform independent

Promote innovation

Narrowly tailored

Promote patient

engagement

ProtectPatientsafety


Mobile Medical Apps (MMA)

The U.S. FDA’s approach to


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



The U.S. FDA’s approach to when an app is a


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



+ clarifying when an app is not a


• 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


Re-evaluating current regulations


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


Draft General Wellness Guidance – Policy for Low Risk Devices


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.


C o m m e n t s

D u e B y

A p r i l 2 0 ,

2 0 1 5


Draft Accessories Guidance


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.


C o m m e n t s

D u e B y

A p r i l 2 0 ,

2 0 1 5


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


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.

CONFIDENTIAL © MobCon Digital Health. All rights reserved.21 February 13, 2015

• 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


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 –

[email protected]

Digital health team provides internal coordination to maintain consistent

policy decisions



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+ - ?????????



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


WOR K TOGETHER

R EA C H A LL PA TIENTS

B ETTER TR EA TM ENTS A ND OUTC OM ES


Bakul Patel

25

Questions ?

February 13, 2015

Associate Director for Digital Health, Office of Center Director

U.S. Food and Drug Administration, Center for Devices and Radiological Health

@_bakulpatelBakul Patel

Thank You!

Date post:	17-Jul-2015
Category:	Healthcare
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