1. together Mid-Atlantic Telehealth Resource Center (MATRC) 2013 SummitOVERCOMING POLICY CHALLENGES: FDA Regulation of Telehealth:Devices, Networks, and Institutions Anthony T. (Tony) Pavel Partner- Morgan, Lewis & Bockius LLP FDA and Healthcare Practice Group www.morganlewis.com

2. Presenter Anthony T. Pavel Washington, DC tel. 202.739.5612 email. apavel@morganlewis.com Morgan, Lewis & Bockius LLPTony Pavel is a Partner at Morgan Lewis & Bockius, whose practice centers FDA law and medical devices First job in law school Intern with the then Center for Telemedicine Law, 1998 Currently on the Board of Directors, Robert J. Waters Center for Telehealth & e-Health Law Provide counsel to telehealth medical device manufacturers and telehealth networks.2 3. The Food and Drug Administration The Food and Drugs Act of 1906 No Mention of Medical Devices The Federal Food, Drug, and Cosmetic Act of 1938 Defined Devices, Adulteration and Misbranding The Medical Device Amendments of 1976 Three-Tiered Classification System for Devices Notification (510(k)) or Approval (PMA) of Devices for Marketing Quality Control Requirements Several other significant amendments since 76 Morgan, Lewis & Bockius LLP3 4. What is a Medical Device? Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article Intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, or prevention of disease, or intended to affect the structure or function of the body Which does not achieve its principle purposes by chemical action in or on the body of man or by being metabolized (i.e., not a drug). FDCA 201(h), 21 U.S.C. 321(h) VERY Broad definition Morgan, Lewis & Bockius LLP4 5. What is a Medical Device? Intended Use Core concept in FDA law Authority to regulate revolves around the intended use Intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, or prevention of disease, or intended to affect the structure or function of the body Intended use is determined by: Labels and labeling (including websites) Promotional material Oral representations Morgan, Lewis & Bockius LLP5 6. What is a Medical Device? Safe and Effective Class I devices are low risk Class II devices are moderate risk Class III devices are high risk Morgan, Lewis & Bockius LLP6 7. Some Core Telehealth Device Categories Device Type Medical device data systems (MDDS) Medical image storage/communications devices PACS systemsClassification Class INurse call systemsClass IIActive Patient MonitoringClass II or IIIClinical Decision SupportGenerally Class IIMobile Health AppsDepends Morgan, Lewis & Bockius LLPClass IClass II7 8. MDDS MDDS is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: The electronic transfer of medical device data; The electronic storage of medical device data; The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or The electronic display of medical device data Morgan, Lewis & Bockius LLP8 9. MDDS Medical device data is: any electronic data that is available directly from a medical device or that was obtained originally from a medical device. MDDS have limited intended uses (i.e., transmitting, storing, converting according to a preset specification, and displaying data) and do not add value to the data or the devices with which they are used. Conduit. NO active patient monitoring or alarm functions Morgan, Lewis & Bockius LLP9 10. What is Not MDDS? General purpose IT infrastructure used in health care facilities that is not altered or reconfigured outside of its manufactured specifications.Components with the following functions by themselves are NOT considered MDDS if they are used as part of general IT infrastructure even though they may transfer, store, display or convert medical device data, in addition to other information: The electronic transfer of medical device data Network Router Network Hub Wireless access point The electronic storage of medical device data Network Attached Storage (NAS) Storage area network (SAN) The electronic conversion of medical device data from one format to another in accordance with a preset specification Virtualization System (ex. VM Ware) PDF software The electronic display of medical device data Computer Monitor Big screen display Morgan, Lewis & Bockius LLP10 11. The Gray Zone Off the shelf web cam (e.g. Logitech) Walmart/Office Max or consumer camcorder being utilized for clinical telemedicine Intended Use what does the clinical telemed involve General video conferencing / communication? Urgent or Acute Care (Tele-Stroke) ? Diagnosis or communication as part of diagnosis? Camcorders attached to video unit to visualize wounds Note under the Act, an accessory to a medical device is classified the same as the actual device Morgan, Lewis & Bockius LLP11 12. Other Examples Computer to which an FDA-approved electronic telemedicine stethoscope is connected to transmit auscultated sounds The computer probably not MDDS The software probably will be MDDS FDA-approved telemedicine stethoscope with software to record auscultated sounds and forward to a provider (stethoscope/software designed to record and later transmit sounds) Software will be MDDS (if not included in original stethoscope FDA clearance) Morgan, Lewis & Bockius LLP12 13. More Examples Consumer device- iphones, ipad, droid etc. example blood glucose meters connected to these devices, data downloaded to the cloud and pulled by practitioners to make clinical decisions Software that is designed to transmit blood glucose data through consumer devices is MDDS (at a minimum) Audio visual cart with in ports to connect peripherals (e.g. exam camera connected to port by s video cable which connects to the video conferencing unit codec) Everyones favorite. If cart is designed and intended for use with medical devices, FDA considers it a medical device Morgan, Lewis & Bockius LLP13 14. OK When Do You Become a Manufacturer Manufacturing is more than actual manufacture of a device Activities that result in manufacturer responsibilities: Manufacture, preparation, propagation, compounding, assembly, or processing of a medical device Repackaging to change the container, wrapper, or labeling Initial importation Initiation of device specifications Morgan, Lewis & Bockius LLP14 15. Ex: Device Manufacturing MDDS Firms that manufacture MDDS (design the specifications, develop software, etc.) Any user of an MDDS (e.g., any individual, hospital, or corporation) that makes any modifications to the MDDS that are outside the parameters of the original manufacturers specifications for the device, for purposes of the users clinical practice or otherwise for commercial use A user who reconfigures a product into an MDDS device An entity that develops its own software protocols or interfaces that have an intended use consistent with an MDDS An entity that creates a system from multiple components of devices and uses it clinically for functions covered by the MDDS classification, would also be considered to be a device manufacturer Morgan, Lewis & Bockius LLP15 16. Ex: Device Manufacturing MDDS The FDA does not consider the following activities to be manufacturing an MDDS: Purchasing and using general purpose IT equipment/software or infrastructure for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data). Purchasing and using an MDDS marketed by an MDDS manufacturer for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data). Morgan, Lewis & Bockius LLP16 17. Manufacturer Responsibilities Establishment registration and device listing Quality System Regulation Labeling Medical Device Reporting Corrections and Removals Reports Morgan, Lewis & Bockius LLP17 18. Considerations and Actions Assessment of home grown telehealth tech Review Intended use Associated risk compare to FDAs Definitions for Class I,II & III What modifications are being made? One off, replicated, or marketed? Morgan, Lewis & Bockius LLP18 19. Considerations and Actions FDA has limited resources Some of these issues are difficult for the Agency FDA understands how telehealth has evolved FDA has enforcement discretion Other considerations Back to risk level Other liability Morgan, Lewis & Bockius LLP19 20. Questions?Thank you! Morgan, Lewis & Bockius LLP20 21. international presence Almaty Beijing Boston Brussels Chicago Dallas Frankfurt Harrisburg Houston Irvine London Los Angeles Miami Moscow New York Palo Alto Paris Philadelphia Pittsburgh Morgan, Lewis Bockius LLP Princeton &San Francisco Tokyo Washington 21 Wilmington