MOBILE MEDICAL APPLICATIONS
|
|
- Charles Nelson
- 8 years ago
- Views:
Transcription
1 October 7, 2013 EVOKE HEALTH POINT OF VIEW MOBILE MEDICAL APPLICATIONS FDA GUIDANCE FOR INDUSTRY FOR MORE INFORMATION: Mark McConaghy, VP, Strategy Evoke Health
2 INTRODUCTION On September 23 rd the FDA released its final guidance for mobile medical applications (apps). The document defines those mobile medical apps that are, by their intended purpose and definitions under federal regulation, medical devices. Furthermore, this guidance categorizes them based on potential level of risk to the public health. Most importantly, the document clarifies which types of apps will require FDA regulatory oversight and approval, and those for which the FDA will exercise enforcement discretion. In this Point of View, we define the Evoke Health position on this important topic, and provide an easy-to-use resource as well as additional details that will help marketers make critical decisions when deciding if a mobile app is right for their brand. Marketers are now able to proceed with their mobile application development efforts, knowing whether or not FDA regulatory approval will be required for their specific app. This affects projects that may have been previously stalled due to apprehension toward device regulation, including apps that would be beneficial to patients and prescribers, while advancing brand objectives. Examples of these include apps that are intended to provide coaching, health tracking tools, documentation or sharing of medical records and information, or disease progression details with a physician, as well as those that perform simple calculations. EVOKE HEALTH POSITION The new FDA guidance provides an opportunity for brands to move forward with concepting and developing apps that pose low risk according to the FDA. These apps will not be subject to FDA regulatory requirements and will not require a pre-market FDA submission. As a partner of marketing and commercialization teams in the pharmaceutical industry, Evoke Health is committed to achieving pharmaceutical brand objectives through innovative yet appropriate methods that are derived from a sound strategy. For this reason, Evoke will never recommend the development of an app, simply for the sake of developing an app. Our recommendations for the development of mobile medical apps will always be based on customer insights, which we define through patient journeys, touch-point evaluation, and needs analysis. Historically, those needs that may be addressed through innovative mobile applications tend to fall within the classifications for discretionary oversight by the FDA and can therefore be developed through marketing groups with little risk for regulatory enforcement, eliminating potential repercussions of an FDA warning letter. Evoke has created a decision tree, featured on the following page, to provide a reference to our teams and clients when developing mobile medical apps. This tool highlights the main considerations when determining the review requirements for mobile medical app concepts. 2
3 EVOKE HEALTH MOBILE APP DECISION TREE 3
4 BACKGROUND Previously, the FDA released draft guidance in July 2011 that defined the standards by which an app would be considered a medical device and therefore, subject to regulatory review and oversight. The guidance focused specifically on mobile apps, which in this case, can be defined as software applications designed to run on a handheld device, including apps that run locally, as well as those whose main functions are performed through an external server. According to the final September 2013 guidance, the definition of what a medical device is and is not, has not changed significantly. The determination of status is based on the primary goal of the app whether the app is either informative vs. directive. This key definition, provided in both the draft and final guidance, of an app that falls under regulatory guidelines for approval, is based on the definition of a device in the Federal Food, Drug and Cosmetic Act: Any app, that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man, is a medical device and therefore subject to regulatory guidelines for approval. Under the 2011 draft guidance, virtually all applications that utilize the functionality provided in today s smart phones and portable/tablet computers, with an intended health benefit for patients and clinicians, would fall under this definition. The result was apprehension on the part of many marketers and manufacturers to confidently proceed with the development of mobile medical apps due to the challenges of regulatory submissions for medical devices. Mobile Medical Application Categories Apps that clearly fall within FDA oversight include those that connect to and interact with an external medical device, those that perform the actions of a medical device by using attachments, and those that provide patient-specific diagnosis or treatment recommendations, such as by using patient-specific information to map out a dosage plan for radiation treatment. 4
5 The key update to the final guidance document is the acknowledgment by the FDA that many mobile medical apps fall under the definition of a medical device, pose little-to-no potential health risk to the public. For these apps, the FDA intends to exercise enforcement discretion, meaning that the FDA does not intend to proactively enforce requirements. These low-risk apps for which the FDA intends to use enforcement discretion are divided into six primary categories: 1. Apps that facilitate or supplement clinical care (e.g., a diet and/or exercise planner for patients with diabetes) 2. Apps that provide organization or tracking tools (e.g., dosing reminders, symptom trackers) 3. Apps that provide easy access to information (e.g., a drug-allergy search tool) 4. Apps that document or communicate information to healthcare providers (e.g., stored photos of a patient s skin symptoms to share with their dermatologist) 5. Apps that perform simple calculations (e.g., a Body Mass Index (BMI) calculator) 6. Apps that enable individuals to interact with electronic health records systems (e.g., a tool for patients to view their own medical history) Lastly, the guidance document also defines those apps that are not classified as devices, and are therefore not subject to review, direct or discretionary. Simple patient education apps, for example, will not require FDA review. Examples of these patient education applications include: Unbranded Disease Education FAQs Excerpts from a Peer Reviewed Text Book Clinical Data from a Medical Study To assist in avoiding confusion over the guidelines, the FDA recommends that marketers reach out directly with any questions regarding whether a specific mobile medical app concept falls within FDA oversight. Marketers can submit questions to mobilemedicalapps@fda.hhs.gov. 5
FDA Issues Final Guidance on Mobile Medical Apps
ADVISORY September 2013 FDA Issues Final Guidance on Mobile Medical Apps On September 23, 2013, the U.S. Food & Drug Administration (FDA or the Agency) issued its final Guidance for Industry and Food and
More informationMobile Medical Applications: FDA s Final Guidance. M. Elizabeth Bierman Anthony T. Pavel Morgan, Lewis & Bockius, LLP
Mobile Medical Applications: FDA s Final Guidance Michele L. Buenafe M. Elizabeth Bierman Anthony T. Pavel Morgan, Lewis & Bockius, LLP 1 Background FDA has a long-standing policy to regulate any computer
More informationWhich Apps Does FDA Regulate?
Which Apps Does FDA Regulate? Bradley Merrill Thompson 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 1 Topics for Discussion Which apps does FDA regulate? Enforcement Discretion Pharma Apps Future
More informationMobile Medical Applications: An Overview of FDA Regulation
Mobile Medical Applications: An Overview of FDA Regulation RAPS Annual Convention 2014 Austin, Texas Michael A. Swit, Esq. Special Counsel, FDA Law Practice Duane Morris LLP Standard Disclaimers The views
More informationThe U.S. FDA s Regulation and Oversight of Mobile Medical Applications
The U.S. FDA s Regulation and Oversight of Mobile Medical Applications The U.S. FDA s Regulation and Oversight of Mobile Medical Applications As smart phones and portable tablet computers become the preferred
More informationCENTER FOR CONNECTED HEALTH POLICY
CENTER FOR CONNECTED HEALTH POLICY The Center for Connected Health Policy (CCHP) is a public interest nonprofit organization that develops and advances telehealth policy solutions to promote improvements
More informationRobert Jarrin Senior Director, Government Affairs. May 22, 2013
Robert Jarrin Senior Director, Government Affairs May 22, 2013 1 Section 201(h) FD&C Act "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
More informationTemplates. FDA Mobile Medical App Regulations. Your own sub headline This is an example text. Your Logo
Templates FDA Mobile Medical App Regulations Your own sub headline This is an example text Your Logo FDA Oversight of Medical Devices The latest Guidance from the FDA Tom Richards MD/MS trichards0445@me.com
More informationUse of Mobile Medical Applications in Clinical Research
Use of Mobile Medical Applications in Clinical Research Erin K. O Reilly, PhD RAC Associate Director, Regulatory Affairs Duke Translational Medicine Institute erin.oreilly@duke.edu September 10, 2014 (919)
More informationBreakout Sessions: FDA s Regulation of Mobile Health and Medical Applications
Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications 2015 Annual Conference Washington, DC Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center
More informationMedical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document
More informationMedical Device Software
Medical Device Software Bakul Patel Senior Policy Advisor 1 Overview Medical devices and software Oversight principles and Current approach Trends, Challenges and opportunities Addressing challenges 2
More informationMobile Medical Applications. Guidance for Industry and Food and Drug Administration Staff
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff Document issued on: September 25, 2013 The draft of this guidance was issued on July 21, 2011. For questions regarding
More informationMobile Medical Apps. Purpose. Diane Romza Kutz Fredric E. Roth V. Regulation and Risks. Purpose of today s presentation
Mobile Medical Apps Regulation and Risks Diane Romza Kutz Fredric E. Roth V Purpose Purpose of today s presentation Identify the newly-regulated industry Identify the newly regulated products and the basis
More informationMobile Medical Application Development: FDA Regulation
Mobile Medical Application Development: FDA Regulation Mobile Medical Applications: Current Environment Currently over 100,000 mobile health related applications are available for download; there is an
More informationFDA Regulation of Health IT
FDA Regulation of Health IT May 2014 Marian J. Lee Partner King & Spalding +1 (202) 661 7955 mlee@kslaw.com Agenda FDA s Mobile Medical Applications Guidance FDASIA Health IT Report 2 FDA s Mobile Medical
More informationRethinking the FDA s Regulation of. By Scott D. Danzis and Christopher Pruitt
Rethinking the FDA s Regulation of Mobile Medical Apps By Scott D. Danzis and Christopher Pruitt Smartphones and mobile devices have rapidly become part of everyday life in the United States. It is no
More informationMedical Device Software: Establishing FDA Authority and Mobile Medical Apps
Medical Device Software: Establishing FDA Authority and Mobile Medical Apps Seth A. Mailhot, Partner Lead, FDA Regulatory Practice Overview Applying the Definition of a Device to Software Special Categories
More informationThe Shifting Sands of Medical Software Regulation
The Shifting Sands of Medical Software Regulation Suzanne O Shea Ralph Hall September 10, 2014 What Software is Regulated by FDA? FDA regulates medical devices. FDA regulates software that meets the definition
More informationFDA Regulation of Health IT
FDA Regulation of Health IT September 2014 Marian J. Lee Partner +1 (202) 661 7955 mlee@kslaw.com Agenda FDA s Mobile Medical Applications Guidance FDA Draft Guidance on Medical Device Data Systems (MDDS),
More informationInternational Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update
International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update Kimberly A. Trautman Associate Director, International Affairs Office of the Center Director
More informationRegulation of Mobile Medical Apps
Regulation of Mobile Medical Apps May 30, 2014 Copyright 2014 Software Quality Consulting Inc. Slide 1 Speaker Bio Steven R. Rakitin has over 35 years experience as a software engineer and 25 years in
More informationRisk based 12/1/2015. Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director.
Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director Center for Devices and Radiological Health 1 Oversight Approach Platform independent Promote innovation Promote
More informationGeneral Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff
General Wellness: Policy for Low Risk Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document
More informationMobile Medical Applications
Mobile Medical Applications What Is the Impact of FDA s New MMA Guidance for the Life Science Industry? June 6, 2014, 11:15 AM 12:15 PM Presented by: Mark Gardner, M.B.A., J.D. Agenda 1. How does FDA regulate
More informationCDRH Regulated Software
CDRH Regulated Software An Introduction John F. Murray Jr. CDRH Software Compliance Expert CDRH Regulates Software in the following areas Medical Devices Automation of Production Systems Automation of
More informationLoss Control Webinar Series. Mobile Medical Apps: FDA Regulation and Products Liability Implications 10-23-2013
Loss Control Webinar Series Mobile Medical Apps: FDA Regulation and Products Liability Implications 10-23-2013 www.goldbergsegalla.com NEW YORK PENNSYLVANIA CONNECTICUT NEW JERSEY UNITED KINGDOM Mobile
More informationCutting Edge Issues in Health Care Technology & mhealth. Agenda
Cutting Edge Issues in Health Care Technology & mhealth Vernessa Pollard July 2014 Agenda The Regulatory Landscape Jurisdiction and Authority Over Mobile Health Products Requirements, Compliance and Enforcement
More informationRegulating the Initial Wave of Mobile Medical Apps
Regulating the Initial Wave of Mobile Medical Apps AACC Emerging Technologies Conference Scott L. Cunningham Agenda Basics of FDA Device Regulation Mobile Medical Apps 2 Basics of FDA Medical Device Regulation
More informationALERT. FDA Guidance for Industry and FDA Staff: Mobile Medical Applications. Health & FDA Business November 2013
ALERT Health & FDA Business November 2013 FDA Guidance for Industry and FDA Staff: Mobile Medical Applications On September 25, 2013, the Food and Drug Administration (the FDA ) released final guidance
More informationPerspectives on the FDASIA Health IT Report and Public Workshop
Perspectives on the FDASIA Health IT Report and Public Workshop By Ben Berg, Meaghan Bailey, RAC, and Deborah Baker-Janis On 7 April 2014, a Food and Drug Administration Safety and Innovation Act (FDASIA)-
More informationPotential for Apps in Pharmaceutical Development. Steve Hutson Co-founder Virtual PV
Potential for Apps in Pharmaceutical Development Steve Hutson Co-founder Virtual PV Potential for Apps in Pharmaceutical Development Steve Hutson Co-founder Virtual PV Potential for Apps in Pharmaceutical
More informationCDRH Regulated Software Looking back, looking forward
CDRH Regulated Software Looking back, looking forward Medical Device Software Compliance Expert US Food & Drug Administration at the Regulatory Affairs Professional Society Indianapolis, Indiana Goal of
More informationDraft Guidance for Industry and Food and Drug Administration Staff
Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on:
More informationRegulatory Issues in Genetic Testing and Targeted Drug Development
Regulatory Issues in Genetic Testing and Targeted Drug Development Janet Woodcock, M.D. Deputy Commissioner for Operations Food and Drug Administration October 12, 2006 Genetic and Genomic Tests are Types
More informationRegulatory Considerations for Medical Device Software. Medical Device Software
Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan
More informationREFERENCE DOCUMENT. (DRAFT for Public Comments) Title: White Paper on Medical Device Software Regulation Software Qualification and Classification
AHWP/WG1/R001:2014 REFERENCE DOCUMENT (DRAFT for Public Comments) Title: White Paper on Medical Device Software Regulation Software Qualification and Classification Author: Work Group 1, Pre-Market Submission
More informationOPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES TO MEDICAL PUBLICATIONS
OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES TO MEDICAL PUBLICATIONS April 27 29, 2015 Hyatt Regency Crystal City Arlington, VA, USA 11TH ANNUAL MEETING OF ISMPP 1 ORGANIZED HEALTHCARE
More informationStatement of Robert Jarrin Senior Director, Government Affairs Qualcomm Incorporated
Statement of Robert Jarrin Senior Director, Government Affairs Qualcomm Incorporated Before the U.S. House of Representatives Energy and Commerce Committee Subcommittee on Health Examining Federal Regulation
More informationDeveloping a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA
Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA In this presentation: App stats: Explosive growth Examples already cleared by the US FDA Is
More informationmobile Apps and mobile Devices Safe to Use?
mobile Apps and mobile Devices Safe to Use? John Amoore Consultant Clinical Engineer Reflections on current health care systems Health care challenges: Hospital view Rising front door demand Patient flow
More informationTracking The Likelihood Of Liability From Health Apps --By Kevin M. Henley, Arnold & Porter LLP
Published by Product Liability Law360 on March 11, 2015. Also ran in Health Law360, Life Sciences Law360, and Technology Law360. Tracking The Likelihood Of Liability From Health Apps --By Kevin M. Henley,
More informationThomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015
Thomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015 All slides and accompanying comments, ideas, arguments and other statements of any kind are personal to
More informationHow To Regulate A Medical Device From A Cell Phone
On Behalf of: InTouch Health White Paper FDA Regulation of Mobile Health Technologies The Current Regulatory Framework as Applied to InTouch Health s Telemedicine Solution June 15, 2012 TABLE OF CONTENTS
More informationRegulatory Landscape For Mobile Medical Apps (MMAs)
Regulatory Landscape For Mobile Medical Apps (MMAs) Date: December 6, 2013 Place: Erie County Bar Association, MidDay Learning Program Where value is law. Monika Bhatt mbhatt@hodgsonruss.com Blog: GatewayFDA.com
More informationEHR Software Feature Comparison
EHR Comparison ELECTRONIC MEDICAL RECORDS Patient demographics Manages the input and maintenance of patient information including demographics, insurance, contacts, referrals, notes and more. Consents
More informationUS & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR
US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR A MEDICAL DEVICE IS A MEDICAL DEVICE IS A MEDICAL DEVICE AHWP Medical SW Workshop Taipei, Taiwan November 3, 2012 John G. Abbott,
More informationWhat is a medical device? Medical Devices: Roadmap to Market. Kathryn Klaus, Esq.
Medical Devices: Roadmap to Market Kathryn Klaus, Esq. The last installment of Regulatory 360 discussed the FDA organization in general where it came from and a broad overview of how it operates, as well
More informationMEDICAL DEVICE Cybersecurity.
MEDICAL DEVICE Cybersecurity. 2 MEDICAL DEVICE CYBERSECURITY Introduction Wireless technology and the software in medical devices have greatly increased healthcare providers abilities to efficiently and
More information21st Century Cures Act: Key Provisions Related to Medical Devices
21st Century Cures Act: Key Provisions Related to Medical Devices July 30, 2015 Food & Drug The 21st Century Cures Act ( the Act or HR 6 ) was passed by the House of Representatives on July 10, 2015, by
More informationTEXAS DEPARTMENT OF STATE HEALTH SERVICES. Executive Summary. Report on Regulation of Laser Hair Removal
TEXAS DEPARTMENT OF STATE HEALTH SERVICES Report on Regulation of Laser Hair Removal DAVID L. LAKEY, M.D. COMMISSIONER CHARGE Study the licensing and certification of laser hair removal facilities, including
More informationInformation Sheet Guidance For IRBs, Clinical Investigators, and Sponsors
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Frequently Asked Questions About Medical Devices Additional copies are available from: Office of Good Clinical Practice Office
More informationFDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle
FDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle Kurt R. Karst Associate Hyman, Phelps & McNamara, P.C. 700 Thirteenth
More informationEVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software DECISION SUMMARY
A. DEN Number: DEN140016 EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software B. Purpose for Submission: DECISION SUMMARY De novo request for adjunct data management
More informationWhere s the App for That?
Where s the App for That? Mobile Medical Apps, Cybersecurity and the Regulatory and Litigation Landscape Sharon R. Klein Jan P. Levine Angelo A. Stio, III PBI Health Law Institute 2016 Spring 2016 1 Today
More informationPharmaceutical Quality & Clinical Research Quality: The Interaction
4 th Jerusalem Conference: Quality by Design (QbD)) & Pharma Sciences, May 20-22, 2014 The Edmund Safra Campus, The Hebrew University of Jerusalem Pharmaceutical Quality & Clinical Research Quality: The
More informationRegulation and Risk Management of Combination Products
Regulation and Risk Management of Combination Products Katherine Ulman Associate Scientist Global Regulatory Compliance Manager Dow Corning Healthcare Jim Curtis Senior Specialist, Healthcare Applications
More information2014 Annual Report on Inspections of Establishments
2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered
More informationWellness Consultation Policies. HIPAA Notice of Privacy Practices
Wellness Consultation Policies Cancellation Policy: There is a $50 charge for cancellations of less than 24 hours or failure to show up for a scheduled appointment. Email Policy: Email may be used for
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES NDA 17-854 NDA 21-793 NDA 17-862. [inside address] Dear :
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 17-854 [inside address] Dear : Please refer to your new drug application NDA xx-xxx for
More informationD. Main Section of the proposal
D. Main Section of the proposal The purpose of this project is to improve health outcomes for treatment of tobacco dependence among the Arizona behavioral health population. This will be accomplished through
More information3 rd Asia Pacific Pharmaceutical Compliance Congress And Best Practices Forum Sept 10-12 2013, Kuala Lumpur, Malaysia
3 rd Asia Pacific Pharmaceutical Compliance Congress And Best Practices Forum Sept 10-12 2013, Kuala Lumpur, Malaysia Mai Tran COMPLIANCE ISSUES IN SOCIAL MEDIA AND DIGITAL MARKETING Social media landscape
More informationCombination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
More informationNDA 202439/S-008 SUPPLEMENT APPROVAL
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 202439/S-008 SUPPLEMENT APPROVAL Janssen Pharmaceuticals, Inc. ATTENTION: Alla Rhoge Pharm.D., Associate
More informationGeneric and Brand Name Drugs: Understanding the Basics
Generic and Brand Name Drugs: Understanding the Basics We ve been there. We can help. Joe has just been diagnosed with bipolar disorder. After talking to his doctor, he decides to see a therapist and go
More informationConsiderations for using the Web for Medical Device Applications
Considerations for using the Web for Medical Device Applications MEDS, San Diego August 23 rd, 2012 Daniel Sterling, President Who is Sterling? Your Partner in Medical Device Development What we do: o
More informationDraft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories
14 1 2 3 4 5 6 7 8 9 10 11 12 13 15 16 17 18 19 20 21 22 23 24 25 26 27 Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories Framework for Regulatory Oversight of
More informationWorkshop on Patient Support and Market Research Programmes
Workshop on Patient Support and Market Research Programmes Spectrum of programmes falling under the terms of PSP and MRPs and the and the type of safety data collected Pharmaceutical Industry Associations
More informationPremera is now offering a much broader range of coverage under the new plan including pharmacy coverage
Joint Health Care Committee November 21, 2013 Premera is now offering a much broader range of coverage under the new plan including pharmacy coverage David Testerman: Premera pharmacist Pharmacy is the
More informationConnected drug delivery systems : Increase patient compliance and enable comprehensive, coordinated treatments
Connected drug delivery systems : Increase patient compliance and enable comprehensive, coordinated treatments Eric Dessertenne, PharmD, MBA Head of Business Development & Commercial Operations edessertennne@biocorp.fr
More informationProposed Definition for Clinical Decision Support Software
May 15, 2013 Proposed Definition for Clinical Decision Support Software The International Medical Device Regulators Forum (IMDRF) has recently announced a Work Item on Standalone Software. As we understand
More informationGuidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not
More informationABSTRACT INTRODUCTION PATIENT PROFILES SESUG 2012. Paper PH-07
Paper PH-07 Developing a Complete Picture of Patient Safety in Clinical Trials Richard C. Zink, JMP Life Sciences, SAS Institute, Cary, NC, United States Russell D. Wolfinger, JMP Life Sciences, SAS Institute,
More informationQ(K SVJM~jPagelIof 3
K13 0460 Q(K SVJM~jPagelIof 3 JUL 1 12013 This 51 0(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k)
More informationehealth The issues that matter
ehealth The issues that matter Contents Technology outpacing regulation 4 A new frontier for data privacy 6 Product liability and jurisdictional issues 8 Cyber security rules under observation 10 Your
More informationMeaningful Use Objectives
Meaningful Use Objectives The purpose of the electronic health records (EHR) incentive program is not so much the adoption of health information technology (HIT), but rather how HIT can further the goals
More informationHumulin R (U500) insulin: Prescribing Guidance
Leeds Humulin R (U500) insulin: Prescribing Guidance Amber Drug Level 2 We have started your patient on Humulin R (U500) insulin for the treatment of diabetic patients with marked insulin resistance requiring
More informationGuidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
More informationFuture Biobanking- Developing Smart, Sustainable And Ethically Compliant Biorepositories Market Research By MarketResearchReports.
Future Biobanking- Developing Smart, Sustainable And Ethically Compliant Biorepositories Market Research By MarketResearchReports.Biz MarketResearchReports.Biz Recently Announced Research Report And Forecast
More informationIntroduction to Compliance with FDA Labeling and Advertising Requirements
Introduction to Compliance with FDA Labeling and Advertising Requirements Second Annual Pharmaceutical Industry Regulatory and Compliance Summit Dick Kenny FDA History Basic function of government Oldest
More informationMobile Devices Accelerate Patient Centric Healthcare
Mobile Devices Accelerate Patient Centric Healthcare Steven F. Owens 1, MedNest, LLC As this web enabled digital age evolves from desktop computers with modems to mobile computing devices and sensors capable
More informationRole of the Investigational Drug Services (IDS) in the Management of Investigational Drugs
Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Charlesworth Rae, BS, PharmD, JD Investigational Drug Pharmacist July 2012 1 Outline of Presentation I. Introduction
More informationRUTGERS LAW RECORD The Internet Journal of Rutgers School of Law Newark www.lawrecord.com
RUTGERS LAW RECORD The Internet Journal of Rutgers School of Law Newark www.lawrecord.com Volume 42 2014-2015 MOBILE MEDICAL APPS: THE NEW MEDICAL DEVICES? ARUNDHATI MOHANKUMAR 1 Overview And Intro Imagine
More informationOn Behalf of: InTouch Health
On Behalf of: InTouch Health White Paper FDA Regulation of Mobile Health Technologies The Current Regulatory Framework as Applied to InTouch Health s Telehealth Solutions June 15, 2012; Updated June 15,
More informationWHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE
WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com
More informationA Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations
A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations Ce3, Inc. and Insight Genetics, Inc. Oncology Forum July 15, 2015 Agenda Introductions Definitions Regulations
More informationMedical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance
Medical Product Development and FDA Regulations IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa Medical Product Development and FDA Regulations Introduction Regulated FDA Overview Medical
More informationGuidance for Industry
Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
More informationHSA Consumer Guide. What is HSA s role in regulating the advertisements of health supplements?
August 2009 Health Supplements: Learn More About Misleading or Exaggerated Claims in Health Supplements Advertisements HSA advises consumers to be cautious of exaggerated and misleading claims in advertisements
More informationEMBRACING NEW TECHNOLOGY: MOBILE HEALTH. Sponsored by: Irving Levin Associates Health Care and Senior Housing M&A Since 1948
EMBRACING NEW TECHNOLOGY: MOBILE HEALTH Sponsored by: Irving Levin Associates Health Care and Senior Housing M&A Since 1948 MOBILE TECHNOLOGY WILL PLAY A KEY ROLE IN MITIGATING FORESEEABLE HEALTHCARE COSTS
More informationWe ask that you allow our office 24-48 hours to respond to telephone messages and callbacks.
NOTICE OF PRIVACY PRACTICE Associated Physicians Group This notice describes how your medical information may be disclosed and how you can get access to this information. Please review these policies carefully.
More informationHow To Integrate Diabetes Manager With Allscripts Ehr
Intégration de la Télémédecine dans le Dossier Médical Hospitalier Joshua L. Cohen, M.D. Professor of Medicine Division of Endocrinology & Metabolism Director, Medical Faculty Associates Diabetes Center
More informationIs it time for a new drug development paradigm?
Is it time for a new drug development paradigm? Robert McDonough, M.D. Senior Director, Clinical Policy Research and Development 1 The Aetna Way Our Cause To make quality health care more affordable and
More informationMedical Device Reporting (MDR) Requirements the New FDA Draft Guidance
Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance February 27, 2014 Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com 1 Essential Requirements n Submit MDR reportable events to FDA
More informationAIS Sports Science/Sports Medicine Best Practice Principles
AIS Sports Science/Sports Medicine Best Practice Principles Introduction For the Australian Sports Commission (ASC) and Australian Institute of Sport (AIS), integrity in sport is paramount. Accordingly,
More informationGuidance for Industry
Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services Food and Drug Administration Center
More informationMarketed Unapproved Drugs: FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice
Marketed Unapproved Drugs: FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice Kurt R. Karst Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, D.C.
More informationSafetyFirst Alert. Errors in Transcribing and Administering Medications
SafetyFirst Alert Massachusetts Coalition for the Prevention of Medical Errors January 2001 This issue of Safety First Alert is a publication of the Massachusetts Coalition for the Prevention of Medical
More informationHow To Know If A Mobile App Is A Medical Device
The Regulation of Medical Device Apps Prepared for West of England Academic Health Science Network and University of Bristol June 2014 June 2014 1 Table of Contents 1 Purpose...3 2 Scope...3 3 The Regulation
More informationMobile Medical Applications (MMAs)
Mobile Medical Applications (MMAs) Prithul Bom, MBA, RAC, CSQE Senior Director, Medical Device & Diagnostics Development Chiltern Elizabeth Brooks, PhD President, Decision Driver Analytics Introduction
More information