mHealth: Regulation and How to Avoid Practicing Medicine on the - PowerPoint PPT Presentation

mHealth: Regulation and How to Avoid Practicing Medicine on the Web Scott A. Edelstein, Esq. Karl M. Nobert, Esq. Partner Of Counsel Squire Sanders Squire Sanders 37 Offices in 18 Countries

mHealth Trends • 81% of physicians have a smartphone 1 • 45% of U.S. adults own smartphones • 52% of smartphone owners have used their phone to look for health information • 19% of smartphone owners have at least one health app on their phone. 2 • 13,000 health, medical and fitness apps 1. 2011 Manhattan Research 2 2. 2012 Pew Research Mobile Health Report

The Medical Device Classification System 3

Medical Device Classification • 3 Classes of Medical Devices • Class I (low risk) • Class II (medium risk) • Class III (high risk and novel devices) • Classes based on control levels 4

Risk Based Classification 1700+ Generic Devices 510(k) Exempt Class I Class II Class III Very low Low (~782) Medium (~799) High (~119) General Controls General Controls General & Special General & Special (may or may not be Controls Controls Premarket GMP exempt) Notification or 510(k) 510(k) submission Premarket Approval Level of Risk & Level of Regulatory Control 5

Examples • Medical Device Classes: – Class I – General Controls – Most exempt from premarket submission » Class II » Special Controls » Premarket Notification [510(k)] – Class III – Require Premarket Approval [PMA] 6

Device Classification CONTINUED Class I – Low Risk Devices - Registration and Listing - Labeling - Good Manufacturing Practices (Quality System Regulation) - Medical Device Reporting 7

What are General Controls? • Basic authorities that - Establishment provide FDA with the registration and device means to regulate medical listing devices. - Premarket notification or 510(k), if not exempt • Applies to all medical devices regardless of - Labeling classification, are subject to premarket and - Misbranding postmarket regulatory controls. - Adulteration - Quality Systems - Records and Reports / - Medical Device Reporting (MDR) 8

Device Classification CONTINUED Class II – Medium Risk Devices General Controls Plus Special Controls • - Performance Standards - Post-Market Surveillance - Patient Registries - Guidelines - Other Appropriate Actions 9

What are Special Controls? • Postmarket Surveillance Study • Patient Registries • General controls alone are insufficient to assure safety and • Guidelines (e.g., Glove effectiveness of Class II devices Manual) • Mandatory • Existing methods are available to Performance Standard provide such assurances. • Recommendations or • Special controls may include Other Actions special labeling requirements, • Special Labeling (e.g., mandatory performance standards and postmarket surveillance. 882.5970, Cranial Orthosis) • A few Class II devices are exempt from the premarket notification. 10

Device Classification CONTINUED Class III – High Risk Devices Life Sustaining - Life Supporting - Implants - Unreasonable Risk Of Injury Or Illness - 11

FDA’s Regulation of Mobile Medical Devices and Smartphone Applications ("apps") 12

Statutory Authority (h) The term "device" … means an instrument, apparatus, implement, machine, contrivance , implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals , or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal 13 intended purposes.

What is an “app”? • A Mobile Application or “app” is:  a software program that runs on smartphones and other mobile communications devices Examples: apps to monitor caloric intake for healthy weight maintenance, to allow doctors to view a patient's X-rays on their mobile device FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or "mobile medical apps." 14

Apps that FDA Intends to Regulate • Only those that meet the statutory definition of a device; and either: • are used as an accessory to a regulated medical device; or • transform a mobile platform into a regulated medical device. 15

FDA’s Proposed Regulatory Approach Mobile Medical Apps Other mobile apps that meet “device” definition Not considered mobile apps 16

FDA’s Proposed Regulatory Approach • Apps that FDA intends to regulate • May be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval) • Other Apps + Enforcement Discretion • The Applicability of the Quality System Regulation 17

App Categories and Classifications 1) Displaying, storing or transmitting patient-specific medical device data in its original format – An MDDS (21 CFR 880.6310) (Class I) 2) Controlling the intended use, function, modes, or energy source of the connected medical device- An Accessory - Required to comply with the controls applicable to that connected device. 3) Transforming or making the mobile platform into a regulated medical device – Radiological Image Display (21 CFR 892.2050) (Class II) 4) Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data – Cardiac Monitoring Software (21 CFR 870.2300) 18

Examples of Regulated Apps Reg. # Medical Device Class # Filing Calculator, Pulmonary Function 868.1900 II 510(k) Interpretation (Diagnostic) Computer, Blood-Pressure 870.1110 II 510(k) Device, Digital Image Storage, 892.2010 1 510(k) Radiological Exempt Electrocardiograph, Ambulatory, 870.2800 II 510(k) With Analysis Algorithm Monitor, Apnea, Home Use 868.2377 II 510(k) Monitor, Ultrasonic, Fetal 884.2660 II 510(k) Over-The-Counter Powered Light 878.4810 II 510(k) Based Laser For Acne Scale, Stand-On, Patient 880.2700 1 510(k) Exempt Stethoscope, Fetal 884.2900 1 510(k) Exempt 19

Examples of Recently FDA Reviewed Mobile Medical Apps 20

FDA Cleared Mobile Medical App ASTRA Picture Archiving Communications Systems (K111694) (Candelis, Inc.) (9/15/11) • Device Description: ASTRA is a web-enabled software app that provides image processing and viewing tools and access to studies and reports from a Local Area Network, Wide Area Network, remote workstation, personal computer, or an iPhone, or iPad via a Virtual Private Network connection. • Intended Use: ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data from imaging modalities (e.g., CR and DR). 21

FDA Cleared Mobile Medical App Carestream PACS (K110919) (Carestream Health, Inc.) (10/20/11) • Device Description / Intended Use: is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems . 22

FDA Cleared Mobile Medical App Mobile MIM PACS (K112930) (MIM Software, Inc.) (12/2/11) • Device Description: In addition to SPECT , PET, CT , MRIf modalities, Mobile MIM can be used for the viewing Mnd/or display for diagnosis of X-ray and Ultrasound medical images. • Intended Use: The Mobile MIM software program is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound. 23

Regulatory Collaboration and Enforcement 24

Regulatory Collaboration Agency Cooperation • • FTC’s Broad Mandate - Publications: • Report: “Mobile Apps for Kids: Current Privacy Disclosures are Dis app ointing” (Feb. 2012) • Guidance Document: “Marketing Your Mobile App: Get It Right from the Start” (Aug 2012) Other Agencies with Potential Involvement • 25

Regulatory Enforcement • Potential FDA Enforcement Action - Untitled and Warning Letters - Failure to comply with the device regulations - Unsupported labeling claims • FTC Enforcement Action - Deceptive Advertising - Unsubstantiated Claims - Financial Forfeiture - Recent mHealth Examples 26

Pursuing Medicare / Medicaid Reimbursement for Medical Devices 27

FDA / CMS Parallel Review Program • A recently created joint-Agency program that • allows for the simultaneous review for FDA medical device clearance and Medicare reimbursement approval • is designed to reduce the time between receiving FDA marketing approval and a Medicare national coverage determination. 28