The document discusses the FDA regulatory approach for mobile medical apps. It defines a mobile medical app as a mobile app that meets the definition of a medical device by either being an accessory to a regulated medical device or transforming a mobile platform into a regulated device. The FDA has issued guidance indicating which mobile medical apps fall under regulatory requirements based on their intended uses, interactions, and determinations of functions like amplifying or measuring. Mobile medical apps must go through the same FDA regulatory process as other medical devices, being classified based on their risk level and whether substantial equivalence to other devices exists.
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.
Real World Evidence in the MedTech IndustryEMMAIntl
Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has recently pushed for an increase in using RWE to support regulatory submissions, in an effort to promote public health. To define what constitutes RWE, we must first start with defining Real World Data (RWD)...
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.
Safer Technologies Program for Medical DevicesEMMAIntl
FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available options that treat diseases that are non-life threatening...
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or device-led combination product) that will “provide for more effective treatment or diagnosis of life-threatening or irreversibility debilitating diseases or conditions”...
This deck was presented at the 2013 Food & Drug Law Institute's Advertising & Promotion conference. I provided advice to people responsible for the selection and/or upgrade of electronic promotional review systems used in the review and approval of marketing materials for prescription products.
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
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.
Real World Evidence in the MedTech IndustryEMMAIntl
Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has recently pushed for an increase in using RWE to support regulatory submissions, in an effort to promote public health. To define what constitutes RWE, we must first start with defining Real World Data (RWD)...
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.
Safer Technologies Program for Medical DevicesEMMAIntl
FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available options that treat diseases that are non-life threatening...
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or device-led combination product) that will “provide for more effective treatment or diagnosis of life-threatening or irreversibility debilitating diseases or conditions”...
This deck was presented at the 2013 Food & Drug Law Institute's Advertising & Promotion conference. I provided advice to people responsible for the selection and/or upgrade of electronic promotional review systems used in the review and approval of marketing materials for prescription products.
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
ASCVD EHR Integration Pilot Using FHIRDino Damalas
Copy of Dr. Gluckman's presentation during HIMSS 16 that discusses the value of the ASCVD Risk Estimator and pilots being conducted by the American College of Cardiology to integrate the tool with EHRs using FHIR.
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDale Cooke
This is the slide deck I used to introduce a session on how sponsors of prescription drugs, biologics, and medical devices can take advantage of the newer means that both consumers and healthcare professionals are using to access information, while remaining compliant with FDA regulations.
Pharmacovigilance Training in Oracle Argus Safety Database with ProjectBioMed Informatics
Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
Healthcare Mobile App Development And Top 3 Innovative Mhealth AppsSeasia Infotech
They say health is true wealth. Healthcare mobile app development, can keep you updated on your health stats. Tech startups, medical professionals, and hospitals are building these creative healthcare applications to connect and assist the patients better. Healthcare mobile apps can drastically improve the lives of both doctors and patients in several ways. Let's check out the benefits of the Mhealth app & the top 3 innovative Mhealth apps
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given that dealing with the FDA isn’t usually a quick transaction, there is a provision in place called the Emergency Use Authorization (EUA) which allows the use of unapproved medical products when there are no other adequate or available alternatives...
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
Search engines are the gateway to the Internet for most people, and FDA has a lengthy history of taking enforcement against companies for inappropriate promotion of prescription drugs via this vital tactic. This presentation from DIA's 2021 ad-promo conference was updated with the latest enforcement.
In this instance, InstantPHR™ was skinned and branded to the look and feel of the ADA and configured using the InstantPHR™ toolset of widgets. This application also stores patient data directly into Microsoft HealthVault with InstantPHR™ as the data visualization layer for ADA.
Presenting an update on building BlueButton on FHIR at CMS to enable beneficiaries to point their data at applications, services or research programs they trust using a REST API and HL7 FHIR structured data formats.
Presented to CinderBlocks3 in Grantsville, MD on May 20th, 2016.
FHIR® in Action: How UCSF Uses FHIR® to Enable Innovation by Ed Martin HealthDev
Ed Martin is the Director, Technology at CDHI at UCSF.
“FHIR® in Action: How UCSF Uses FHIR® to Enable Innovation”
This presentation showcases some examples of digital health apps to tackle the problem areas that are strategic for UCSF. The areas include healthcare research, patient access, care team coordination, and virtual care. The apps include bespoke, in-house developed software and 3rd party vendor solutions. The talk also covers how UCSF governs access to its EHR’s FHIR® API’s to help ensure improved clinical outcomes.
Development of a mobile medical application for imaging and analysis of arthr...Nick MacKinnon
Development of a mobile medical application for imaging and analysis of arthritis of the hand:
Nicholas MacKinnon, Shanil Gunasekara, Fartash Vasefi
eTreat Medical Diagnostics Inc., Vancouver, BC, Canada
This project introduces a new smartphone and tablet deployable mobile medical application that utilizes device sensors, internet connectivity and cloud-based image processing to document and analyze physiological characteristics of hand arthritis. The application facilitates image capture and performs image processing that identifies hand fiduciary features and feature metrics to report and quantify the progress of arthritic disease. In addition to describing this process, we discuss the technical issues and regulatory challenges related to development and deployment of mobile medical applications with reference to the 2013 FDA Final Guidance on Mobile Medical applications, HIPA requirements, and compliance with the ISO/IEEE 11073-10201 Domain Information Model (DIM) standard for integration with personal or institutional health records.
Presented at The Canadian Medical and Biological Engineering Society Conference CMBEC 37 in Vancouver Canada May 21 2014
ASCVD EHR Integration Pilot Using FHIRDino Damalas
Copy of Dr. Gluckman's presentation during HIMSS 16 that discusses the value of the ASCVD Risk Estimator and pilots being conducted by the American College of Cardiology to integrate the tool with EHRs using FHIR.
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDale Cooke
This is the slide deck I used to introduce a session on how sponsors of prescription drugs, biologics, and medical devices can take advantage of the newer means that both consumers and healthcare professionals are using to access information, while remaining compliant with FDA regulations.
Pharmacovigilance Training in Oracle Argus Safety Database with ProjectBioMed Informatics
Pharmacovigilance Training in Oracle Argus Safety Database with Project
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety, SAS Clinical, IPR & Regulatory Affairs trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.
Mode of Training: Instructor Led Class room/Online Training
Online Training Features:
Web based classroom
One faculty/student
Placement support
Regular/Fast track/Weekend batches
Flexible timings
Training Mode: Skype/Teamviewer
Hands-On Training on the Database
Direct access to Oracle Argus Safety Database
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics Medwin Hospitals.
Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: www.biomedlifesciences.com
Healthcare Mobile App Development And Top 3 Innovative Mhealth AppsSeasia Infotech
They say health is true wealth. Healthcare mobile app development, can keep you updated on your health stats. Tech startups, medical professionals, and hospitals are building these creative healthcare applications to connect and assist the patients better. Healthcare mobile apps can drastically improve the lives of both doctors and patients in several ways. Let's check out the benefits of the Mhealth app & the top 3 innovative Mhealth apps
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given that dealing with the FDA isn’t usually a quick transaction, there is a provision in place called the Emergency Use Authorization (EUA) which allows the use of unapproved medical products when there are no other adequate or available alternatives...
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
Search engines are the gateway to the Internet for most people, and FDA has a lengthy history of taking enforcement against companies for inappropriate promotion of prescription drugs via this vital tactic. This presentation from DIA's 2021 ad-promo conference was updated with the latest enforcement.
In this instance, InstantPHR™ was skinned and branded to the look and feel of the ADA and configured using the InstantPHR™ toolset of widgets. This application also stores patient data directly into Microsoft HealthVault with InstantPHR™ as the data visualization layer for ADA.
Presenting an update on building BlueButton on FHIR at CMS to enable beneficiaries to point their data at applications, services or research programs they trust using a REST API and HL7 FHIR structured data formats.
Presented to CinderBlocks3 in Grantsville, MD on May 20th, 2016.
FHIR® in Action: How UCSF Uses FHIR® to Enable Innovation by Ed Martin HealthDev
Ed Martin is the Director, Technology at CDHI at UCSF.
“FHIR® in Action: How UCSF Uses FHIR® to Enable Innovation”
This presentation showcases some examples of digital health apps to tackle the problem areas that are strategic for UCSF. The areas include healthcare research, patient access, care team coordination, and virtual care. The apps include bespoke, in-house developed software and 3rd party vendor solutions. The talk also covers how UCSF governs access to its EHR’s FHIR® API’s to help ensure improved clinical outcomes.
Development of a mobile medical application for imaging and analysis of arthr...Nick MacKinnon
Development of a mobile medical application for imaging and analysis of arthritis of the hand:
Nicholas MacKinnon, Shanil Gunasekara, Fartash Vasefi
eTreat Medical Diagnostics Inc., Vancouver, BC, Canada
This project introduces a new smartphone and tablet deployable mobile medical application that utilizes device sensors, internet connectivity and cloud-based image processing to document and analyze physiological characteristics of hand arthritis. The application facilitates image capture and performs image processing that identifies hand fiduciary features and feature metrics to report and quantify the progress of arthritic disease. In addition to describing this process, we discuss the technical issues and regulatory challenges related to development and deployment of mobile medical applications with reference to the 2013 FDA Final Guidance on Mobile Medical applications, HIPA requirements, and compliance with the ISO/IEEE 11073-10201 Domain Information Model (DIM) standard for integration with personal or institutional health records.
Presented at The Canadian Medical and Biological Engineering Society Conference CMBEC 37 in Vancouver Canada May 21 2014
ATON - Brief Introduction of our new mobile app for on-call doctors' duty roster for Medical College Hospitals.
A product of Macula Healthcare Pvt Ltd ( www.maculahealthcare.com )
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
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
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
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.
Presentation - Mobile Medical Applications Guidance for Industry and Food and...Jason Haislmaier
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."
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.
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....
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/
Medical Mobile Apps: The Regulatory StoryNadja Bester
What's life sciences' take on the booming app industry? If regulatory has anything to do with it, it'll start with a whole lot of responsible development.
2. WhatisaMobileMedical
App?
It is a medical device which is a mobile app, meets the medical device
definition and is an accessory to a regulated medical device (or) transform
a mobile platform into a regulated medical device.
App is likely a device if it
Other factors to be considered are app’s
intended uses, interactions, and determination
Amplifies
Analyses
Attaches
Interprets
Calculates
Controls
Converts
Cures
Detects
Diagnoses
Manipulates
Measures
Monitors
Programs
Trends treats
3. FDA guidance on Mobile Medical Devices
Updated Guidance document was released on February 9, 2015. It indicates which
mobile medical apps falls under medical device regulatory requirements and which
do not.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Gu
idanceDocuments/UCM263366.pdf
Examples of FDA approved and regulated MMA’S
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368784.
htm
4. U.S FDA REGULATORY PROCESS
Mobile Medical App’s fall under the same regulatory requirements as other
medical devices.
Classification is based on the level of risk it poses to users and it is also based on
Whether substantial equivalence (SE) exists.
