Presentation to PrIME Health Collaborative at Galvanize in Denver, Colorado on October 29, 2013 covering an overview of the FDA "Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff."
How to Determine if Your Mobile App is a Medical Device?EMMAIntl
Where do you feel you have the best digital user experience? A web or a mobile app? I have been a web developer for almost four years, but still, I prefer the Amazon app to order gadgets instead of the Amazon web application. Mobile devices and applications themselves are very handy because they easily fit in our pockets, their UIs show the most significant data with minimal clutter, and most importantly, they provide the same services and results as provided by web applications....
How to Determine if Your Mobile App is a Medical Device?EMMAIntl
Where do you feel you have the best digital user experience? A web or a mobile app? I have been a web developer for almost four years, but still, I prefer the Amazon app to order gadgets instead of the Amazon web application. Mobile devices and applications themselves are very handy because they easily fit in our pockets, their UIs show the most significant data with minimal clutter, and most importantly, they provide the same services and results as provided by web applications....
Health 2.0 San Antonio Does your Health APP need FDA Approval? HEALTHeDesigns LLC
This is a primer to get you thinking about whether or not your mobile health app is going to need FDA approval. If you are just tripping across the internet and found this, check the date, this was given before the FDA finalized their guidelines.
How mobile apps become necessary for any field? What is the role of mobileapps in Helathcare Industry? Here we introduction Gusani Infotech Mobile Solutions for the Healthcare Industry.
Once the testing process is completed, a telemedicine app is deployed to the app store. There are many factors that are required to be checked while publishing an app especially when it belongs to the healthcare industry. These factors should be taken care of stringently.
To know more visit- https://www.sparxitsolutions.com/blog/telemedicine-app/
Online doctor consultation app doctor appointment booking appAPPNWEB Technologies
We are here to development Doctor Appointment Booking Mobile App for you. if you want to develop it for your business, know about to it's Benefits, Market overview and cost of development.
For More Info:- https://www.appnwebtechnologies.com/blog/doctor-appointment-booking-app-development-a-run-through/
RapidValue White Paper on Regulations and compliance for enterprise mHealth a...Nageena Vijayan
Healthcare organizations and software firms looking to make investments in mobile applications need to assess implications of HIPAA and FDA in order to protect patient health information and
ensure compliances are met. This document outlines some of the key evaluation criteria on regulations and security considerations in healthcare sector that need to be addressed while
implementing mobility applications.
Market Research Reports, Inc. has announced the addition of “The Mobile Healthcare (mHealth) Bible: 2015 - 2020” research report to their offering. See more at- http://mrr.cm/ZuA
This article is intended for the customer facing risk managers, sales staff, and IT staff of a medical device manufacturer and their medical doctors and IT hospital and clinical counterparts. It is intended to give an overview and highlight process considerations for incident management and reporting of cybersecurity issues.
In my software engineering career, I was lucky enough to work on some amazing frameworks and technologies, but nothing compares to the features and computing power enabled by Artificial Intelligence (AI). It is often utilized in cases of predictions, reducing computations, recommendations, and now based on my research, it is heavily being used in the healthcare sector...
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
Health 2.0 San Antonio Does your Health APP need FDA Approval? HEALTHeDesigns LLC
This is a primer to get you thinking about whether or not your mobile health app is going to need FDA approval. If you are just tripping across the internet and found this, check the date, this was given before the FDA finalized their guidelines.
How mobile apps become necessary for any field? What is the role of mobileapps in Helathcare Industry? Here we introduction Gusani Infotech Mobile Solutions for the Healthcare Industry.
Once the testing process is completed, a telemedicine app is deployed to the app store. There are many factors that are required to be checked while publishing an app especially when it belongs to the healthcare industry. These factors should be taken care of stringently.
To know more visit- https://www.sparxitsolutions.com/blog/telemedicine-app/
Online doctor consultation app doctor appointment booking appAPPNWEB Technologies
We are here to development Doctor Appointment Booking Mobile App for you. if you want to develop it for your business, know about to it's Benefits, Market overview and cost of development.
For More Info:- https://www.appnwebtechnologies.com/blog/doctor-appointment-booking-app-development-a-run-through/
RapidValue White Paper on Regulations and compliance for enterprise mHealth a...Nageena Vijayan
Healthcare organizations and software firms looking to make investments in mobile applications need to assess implications of HIPAA and FDA in order to protect patient health information and
ensure compliances are met. This document outlines some of the key evaluation criteria on regulations and security considerations in healthcare sector that need to be addressed while
implementing mobility applications.
Market Research Reports, Inc. has announced the addition of “The Mobile Healthcare (mHealth) Bible: 2015 - 2020” research report to their offering. See more at- http://mrr.cm/ZuA
This article is intended for the customer facing risk managers, sales staff, and IT staff of a medical device manufacturer and their medical doctors and IT hospital and clinical counterparts. It is intended to give an overview and highlight process considerations for incident management and reporting of cybersecurity issues.
In my software engineering career, I was lucky enough to work on some amazing frameworks and technologies, but nothing compares to the features and computing power enabled by Artificial Intelligence (AI). It is often utilized in cases of predictions, reducing computations, recommendations, and now based on my research, it is heavily being used in the healthcare sector...
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
Regulatory Considerations in Mobile ProgramsDale Cooke
This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include:
* FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff
* Determination of whether a mobile app is a medical device subject to FDA enforcement action
* Scope of FDA’s regulatory discretion regarding mobile apps
* FDA’s conflicting guidance on dosage apps
* How to meet key requirements of promotional labeling in mobile programs
* The growing area of mobile apps as promotional messaging platforms
This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics.
The framework flow chart shown in this presentation is available here: http://ow.ly/qMxse
The global market for mobile apps is valued at 25 billion dollars. The market for health apps in particular is booming; the FDA predicts 500 million smartphone users will use a mobile medical app this year, and the number is expected to rise to 1.7 billion by 2018. In the past, medical software has been regulated using the same model as medical devices.
Recently, the FDA realized it needed a new and different approach to support a rising number of apps, especially those aimed at patients. In addition to the rapid growth of the market, some health app developers have made claims that can’t be supported. This prompted the FDA to issue a new guidance in February of this year.
View the presentation to learn more about the FDA's Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff including:
1. Key points of differentiation between health apps and mobile medical apps
2. The common mistake developers make when defining their product
3. What developers of non-regulated health apps should avoid when marketing their application
The healthcare industry is making significant advancements with a patient-centric approach to healthcare app development. Find out more.
Read: https://www.peppersquare.com/blog/an-all-inclusive-guide-on-how-to-develop-a-stellar-healthcare-app/
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
Improving Healthcare App Development- Reasons Why You Should Invest in it.Techugo
Customers are looking for ways to find different specialists in their fields (including prescriptions and medicine), so the healthcare industry is searching for innovative approaches to make things more efficient.
It is common to combine healthcare services with cell phones and innovation. For example, 47.526 iOS Human service apps and 325,000 mHealth Android apps exist. This is why all healthcare specialists must shift towards the mobile economy.
The Mobile healthcare app development company allows the user to not only manage patients’ care better but also enable them to monitor operational efficacy in clinics and hospitals.
Improving Healthcare App Development Reasons Why You Should Invest in it.pdfTechugo
The Mobile healthcare app development company allows the user to not only manage patients’ care better but also enable them to monitor operational efficacy in clinics and hospitals.
Patients will be satisfied with long lines because you have stopped the experience of using the emergency clinic app culture and medical services with mobile application patterns.
Improving Healthcare App Development Reasons Why You Should Invest in it.pdfTechugo
In today's digital age, healthcare app development is a rapidly growing industry that offers immense potential for healthcare providers and patients alike. By investing in healthcare app development, healthcare providers can improve patient engagement, streamline medical procedures, and enhance the overall quality of healthcare delivery. With the use of advanced technologies such as AI and blockchain, healthcare apps can also provide personalized treatment plans, secure medical data sharing, and real-time remote monitoring. Investing in healthcare app development can help healthcare providers stay ahead of the curve and meet the evolving needs of patients in the modern era.
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
Empowering Healthcare: The Evolution of Healthcare App Development ServicesElina619459
In today's digital age, healthcare is no longer limited to traditional brick-and-mortar clinics and hospitals. The advent of healthcare app development services has ushered in a new era of accessible, efficient, and patient-centric healthcare solutions. These applications have transformed the way patients interact with healthcare providers, manage their health, and access vital medical information.
Overcoming Cloud-Based Mobility Challenges in HealthcareAnyPresence
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Presentation - Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff 131029
1. Mobile Medical Applications:
Guidance for Industry and Food and Drug
Administration Staff
October 29, 2013
Jason D. Haislmaier
jason.haislmaier@bryancave.com
Copyright 2013 BryanCave LLP
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
Copyright 2013 BryanCave LLP
2. This presentation is intended for general informational purposes only and should not
be construed as legal advice or legal opinion on any specific facts or circumstances,
nor is it intended to address specific legal compliance issues that may arise in
particular circumstances. Please consult counsel concerning your own situation and
any specific legal questions you may have.
The thoughts and opinions expressed in this presentation are those of the individual
presenters and do not necessarily reflect the official or unofficial thoughts or opinions
of their employers.
For further information regarding this presentation, please contact the presenter(s)
listed in the presentation.
Unless otherwise noted, all original content in this presentation is licensed under the
Creative Commons Creative Commons Attribution-Share Alike 3.0 United States
License available at: http://creativecommons.org/licenses/by-sa/3.0/us.
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
4. The FDA
U.S. Food and Drug Administration (FDA)
www.fda.gov
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
5. FDA Authority
Federal Food, Drug, and Cosmetic (FD&C) Act
• 21 USC Chapter 9
• Passed by Congress in 1938
• Provides authority to the FDA to oversee the safety of food, drugs, and
cosmetics
• Also provides FDA with authority over “medical devices”
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
6. Mobile Medical Applications
History of FDA Scrutiny
• FDA has long recognized that the “unique characteristics” of mobile
platforms may “pose additional or different risks”
• FDA has noted the increasing proliferation of mobile medical apps
– Currently 97,000 mobile health apps in Apple's App Store that have generated
3 million free and 300,000 paid downloads
– 500 million smartphone users worldwide will be using health care apps by 2015
– 50 percent of the more than 3.4 billion smartphone and tablet users will have
downloaded mobile health apps by 2018
– While a significant number (43%) of apps are primarily designed for healthcare
professionals, users will increasingly include consumers and patients
• Guidance by the FDA is not at all surprising
Source: Global Mobile Health Market Report 2010-2015, research2guidance, http://www.research2guidance.com/500m-people-will-be-using-healthcare-mobile-applications-in-2015/
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
7. Mobile Medical Applications
Many Drivers for FDA Concern
• Increasing sophistication of mobile medical apps
– Capable of transforming mobile platforms into medical devices
– Appearing as “accessories” to regulated medical devices
– Apps running through a network connected mobile platform (the “cloud”)
• Increasing demand for clearance
– In the last 10 years, FDA has cleared around 100 mobile medical apps
– Includes about 40 in the last 2 years
• Increasing need for certainty
– Clarify limits of regulation
– Encourage mobile medical app development
– Oversee safety and effectiveness
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
8. Mobile Medical App Guidance
Background
• Officially, Mobile Medical Applications: Guidance for Industry and Food
and Drug Administration Staff (the “Guidance”)
• Issued September 25, 2013
• Similar to the July 19, 2011 draft version, but with many improvements
• Product of extensive comments and FDA research
• Explains the FDA’s oversight of mobile medical apps as devices
• Not intended to expand the FDA’s universe, but to apply longstanding
tenets of medical device regulation to apps
• Guidance document (not legally binding)
• Template for compliance
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
9. Mobile Medical App Guidance
“We have worked hard to strike the right balance,
reviewing only the mobile apps that have the potential
to harm consumers if they do not function properly.”
Dr. Jeffrey Shuren,
FDA, Director for
Radiological Health
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
Devices
and
10. Mobile Medical App Guidance
Overview
• Focus is on apps that present a greater risk to patients
• Distinguishes among several categories of mobile apps
– Not medical devices (not regulated)
– May be medical devices (but will be subject to "enforcement discretion")
– Are medical devices (and will be regulated)
• Focus is on apps, not platforms
• Not just about what is regulated – significant guidance as to what apps
are not regulated
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
11. Mobile Medical App Guidance
Focus on Mobile App Manufacturers
• Guidance applies to “mobile medical app manufacturers”
• Under the FD&C Act, being deemed a medical device “manufacturer”
has potentially significant consequences
– Medical device reporting when malfunctions, injuries or deaths occur (21
C.F.R. Part 803)
– Reporting of device corrections or removals (21 C.F.R. Part 806);
– Establishment registration and listing and premarket notification (510(k)) (21
C.F.R. Part 807)
– Quality Systems/Good Manufacturing Practice requirements (21 C.F.R. Part
820)
• No surprise then that the Guidance applies to mobile medical app
“manufacturers”
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
12. Mobile Medical App Guidance
Focus on Mobile App Manufacturers
• Provides examples of a mobile medical app “manufacturer”
– Creates, designs, develops, or labels
– Initiates specifications or requirements
– Procures product development services
• Includes specific exclusions and boundaries too
– Excludes mere distributors, including app store operators and
mobile platform makers
– Distinguishes between “authors” of specifications and “developers” who
implement those specifications
• Particular focus on authority – those involved in design, development, or
creation
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
13. Mobile Medical App Guidance
Apps Are Regulated as Medical Devices
• Section 201(h) of the FD&C Act defines a medical “device”
• Guidance clarifies that apps are subject to potential FDA regulation
if they meet the definition of a “device”
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
14. Mobile Medical App Guidance
“When the intended use of a mobile app is for the
diagnosis of disease or other conditions, or the cure,
mitigation, treatment, or prevention of disease, or is
intended to affect the structure or any function of the
body of man, the mobile app is a device.”
FDA Mobile App Guidelines
(Section III.C.)
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
15. Mobile Medical App Guidance
Only a Subset of Apps Are Subject to Regulation
• FDA’s intention is to focus oversight on the subset of mobile apps that
meets the definition of device and are:
– Intended to be used as an accessory to a regulated medical device
(e.g., an app that provides the ability to control inflation and deflation of a
blood pressure cuff through a mobile platform)
– Intended to transform a mobile platform into a regulated medical device
(e.g, an app intended to analyze and interpret EKG waveforms to detect heart
function irregularities)
• Focus is on
– Function of the mobile app (not the mobile platform)
– Intended use of the mobile app
– Risk to patient safety if the app were to malfunction
• Labeling claims, advertising materials, and statements by manufacturers
(or their reps) are instructive
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
16. Mobile Medical App Guidance
Guidelines Create Categories of Apps
• Guidelines separate apps into three categories:
(1) Apps that do not meet the statutory definition of a device and thus are not
subject to FDA oversight
(2) Apps that may meet the statutory definition of a device, but present such a
low risk of patient harm that the FDA is not going to exercise oversight
(“enforcement discretion”)
(3) Apps that do meet the statutory definition of a device, and present potential
patient risks warranting FDA oversight
• Numerous examples provided in the Guidelines
• Still not always an easy analysis
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
17. Mobile Medical App Guidance
Examples: Apps That Are NOT Medical Devices
• Intended to provide electronic “copies” of medical textbooks or other
reference materials with generic text search capabilities
• Intended for health care providers to use as educational tools for medical
training or to reinforce training previously received
• Intended for general patient education and facilitate patient access to
commonly used reference information
• Automate general office operations in a health care setting
• Generic aids or general purpose products
• Provided that none of the foregoing are intended for use in the diagnosis
of disease or other conditions, or in the cure, mitigation, treatment or
prevention of disease
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
18. Mobile Medical App Guidance
Examples: Apps Subject to Exercise Enforcement Discretion
• Provide or facilitate supplemental clinical care, by coaching or prompting,
to help patients manage their health in their daily environment
• Provide patients with simple tools to organize and track their health
information
• Provide easy access to information related to a patients’ health conditions
or treatments (beyond providing an electronic “copy” of a medical
reference)
• Specifically marketed to help patients document, show or communicate to
providers potential medical conditions
• Perform simple calculations routinely used in clinical practice
• Enable individuals to interact with personal health record systems or
electronic health record systems
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
19. Mobile Medical App Guidance
Examples: Apps Subject to FDA Regulatory Oversight
• Extensions of one or more medical devices by connecting to such
device(s) for purposes of controlling the device(s) or displaying, storing,
analyzing or transmitting patient-specific medical device data
• Transform the mobile platform into a regulated medical device by using
attachments, display screens or sensors or by including functionalities
similar to those of currently regulated medical devices
• Become a regulated medical device (software) by performing patientspecific analysis and providing patient-specific diagnosis, or treatment
recommendations (i.e., similar to or perform the same function as those
types of software devices previously cleared or approved)
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
20. Mobile Medical App Guidance
Significance of Regulation
• Regulated medical devices are divided into three classes:
– Class I - General Controls
– Class II - Special Controls in Addition to General Controls
– Class III - Premarket Approval
• Classes determine the level of control exercised by FDA
• Controls take the form of premarketing and postmarketing submissions,
applications, and approvals required for FDA clearance to market a device
• If an app falls within a medical device classification, the manufacturer is
subject to the requirements associated with that classification
• Must meet the same requirements any other manufacturer of a device in
that classification must meet
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
21. Mobile Medical App Guidance
Recommendations for Other Apps
• Strong recommendation that manufacturers of any app that meets the
definition of a “device”
– Follow FDA’s Quality System regulation (which includes good manufacturing
practices) in the design and development of the app
– Initiate prompt corrections to apps, when appropriate, to prevent patient and
user harm
• FDA research found that the majority of software-related device failures
are due to design errors (including basic failures to validate software prior
to routine production)
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
22. Mobile Medical App Guidance
Scope and Limitations
• Guidelines only cover FDA regulation of mobile apps
• Mobile apps are (potentially) subject to many other forms of regulation
– FDA published important guidance regarding interoperability for mobile health
devices (i.e., hardware) in August, 2013
– Federal Trade Commission (FTC) has investigated and taken action as far back
as 2011 against mobile medical apps for false advertising
– FTC has also been extremely active in data privacy and security enforcement,
including in particular guidance covering mobile apps
– HIPAA and HI-TECH Act specifically regulate protected health information,
including on mobile apps
• This can (very) challenging – even for medical device companies
• Do not go it alone
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave
23. Mobile Medical App Guidance
Where to Next?
• FDA has reserved the right to issue additional guidance (as always)
• Congressman Marsha Blackburn (R-TN07) led a bi-partisan team to that
introduced the Sensible Oversight for Technology which Advances
Regulatory Efficiency (SOFTWARE) Act (HR 3303) on October 22nd
• Intended to build on the Guidance by amending the FD&C Act
• Offers definitions to differentiate “medical software” (i.e., regulated) from
“clinical software” and “health software” (i.e., not regulated)
• Seeks to:
– Provide (additional) clarity
– Focus authority on products that pose a potential risk to human health
– Better define FDA regulatory authority over medical software
– Provide better understanding of what applications require review and approval
Copyright 2013 BryanCave LLP
Copyright 2012 Bryan Cave