Loss Control Webinar Series. Mobile Medical Apps: FDA Regulation and Products Liability Implications

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1 Loss Control Webinar Series Mobile Medical Apps: FDA Regulation and Products Liability Implications

2 NEW YORK PENNSYLVANIA CONNECTICUT NEW JERSEY UNITED KINGDOM Mobile Medical Apps: FDA Regulation and Products Liability Implications Michael D. Shalhoub Joseph J. Welter Life Science Matters Blog:

3 Presentation Overview 9/25/13: FDA issues Guidance For Industry and Food and Drug Administration Staff regarding Mobile Medical Applications 9/26/13: Twitter Conference Highpoints of complicated and technical issue Review product liability issues specific to mobile apps and mobile medical apps

4 Statutory Definition Of A Medical Device An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component part which is: Intended in the diagnosis, cure, treatment or prevention of disease in man or other animals, or Intended to affect the structure or function of the body, AND does not achieve primary purpose due to chemical action in the body AND is not dependent on being metabolized

5 Software Meeting That Definition Exploded In Recent Years Medication calculators and treatment planners Imaging viewers Remote cardiac ultrasound, using Facetime Medication adherence apps And so on, and so on Limited only by human ingenuity and technological capability

6 Mobile Apps By Condition In Literature Fiordelli, Maddelana: Mapping mhealth Research: A Decade of Evolution (2013).

7 FDA Guidance: September 2013 FDA disclaimer: Reflects its current thinking Merely recommendations and does not operate to bind FDA FDA recognizes: Variety and potential functions of mobile apps Rapid pace of innovation Potential risks and benefits of the apps FDA will follow public process if it changes its current thinking

8 FDA Guidance: September 2013 Guidance interpretation: Software that runs on any platform including a handheld device may be subject to device regulation if [it] is intended for use in the diagnosis or the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man Extent of regulatory control needed will depend on the risk the device presents to public health

9 Guidance Definitions Mobile Platforms: off-the-shelf handheld computing platforms (e.g. iphone) Mobile App: Software that can run on a mobile platform, or web-based software that runs on a remote server but is tailored to a mobile platform

10 Mobile Medical App Definition A Mobile App that is intended to either Be used as an accessory to a regulated medical device, or To transform a mobile platform into a regulated medical device

11 FDA Guidance: September 2013 FDA s stated intention: Regulate only those mobile apps that are medical devices, AND Those apps whose functionality could pose a risk to patient safety if the app did not function as intended FDA calls these apps mobile medical apps

12 Key Factor: What Is Intended Use? Traditional regulatory indicia: Labeling claims Advertising materials Statements by manufacturers or representatives Example: Light Emitting Diode Illuminating objects generally- not a device Promoted as light source to examine patients- it is a device because it is similar to a ophthalmoscope.

13 What Constitutes an MMA Manufacturer? Mobile Medical App Manufacturer captured in existing definitions under 21 CFR Parts 803, 806, 807 and 820. Anyone who initiates specifications, designs, labels or creates a software system or application for a regulated medical device in whole or in part from multiple software components.

14 MMA Manufacturer Includes: Author of specifications for MMAs Procurer of services to develop MMAs for subsequent commercial distribution Assembler of off-the-shelf software components if marketed to perform as an MMA Creator of MMAs and hardware attachments for a mobile platform Creator of MMAs that permit access to medical device function through website subscription or software as a service.

15 MMA Manufacturer Does Not Include: Distributors not engaging in manufacturing functions Software developers solely responsible for transforming specs into MMA Third parties who solely provide market access to MMAs (Internet and Cloud service providers) Providers of tools, services or infrastructure to create MMAs Licensed practitioners who manufacture or alter MMAs solely for professional purposes Makers of MMAs used solely for research

16 Apple and Google Need Not Worry Definition of mobile medical app manufacturers specifically does not include distributors or online marketplaces such as itunes App Store Also specifically does not include mobile platform manufacturers who do not promote the platform as a medical device

17 Mobile Apps and FDA Mobile Apps not considered to be medical devices Mobile Apps that meet strict definition of mobile medical device are Mobile Medical apps Considered by FDA to be low risk; therefore, FDA will exercise enforcement discretion Regulated mobile medical apps

18 Key Appendices to the Guidance Several important appendices Examples of: Mobile Apps which are not mobile medical apps Mobile apps which by definition are mobile medical apps, but enforcement discretion FDA is not actively enforcing requirements for manufacturers to register and list with the FDA statement by FDA at Twitter meeting 9/26/13 Regulated mobile medical apps Current medical devices specifically regulated

19 Regulated Mobile Medical Apps Traditional classification Class I, II or III For all Mobile Medical Apps, follow Quality System Regulation, including GMPs Institute prompt corrections to prevent user and patient harm Follow regulations pertinent to classification of Mobile Medical Apps (Class I, II or III)

20 Mobile Medical Apps Subject to Regulatory Oversight Mobile apps that connect to medical devices for purpose of controlling the device, or using patient specific medical device data Examples: Remote viewing bedside monitors Control BP cuffs, or insulin delivery Apps to display or store medical device data

21 Mobile Medical Apps Subject to Regulatory Oversight Mobile apps that become a mobile platform by using attachments, display screens or sensors similar to a regulated medical device Examples: ECG or glucose reader Sleep apnea monitor Electronic stethoscope Radiology image viewer

22 Mobile Medical Apps Subject to Regulatory Oversight Mobile medical apps that perform the function of previously cleared or approved devices Examples Radiation dosage or treatment planning calculators Imaging processing software

23 FDA Not To Enforce Requirements For Certain MMAs that: Help in self-managing disease if not specific treatment recommendations Maintain healthy weight or good nutrition and staying fit Alerts for pre-determined medication schedules Health care info tracking and organization for consumers that do not provide recommendations Tools for tracking/trending events/measurements Weight, arthritis, diabetes Tool to provide info to providers Provide easy access to patient health condition or treatment information Best practice guidelines linked to specific patient Drug interaction or allergy lookup tools

24 FDA Not To Enforce Requirements For Certain MMAs that: Assist patients in documenting and communicating conditions to health care providers Videoconference portals Built-in camera to transmit pictures Automate simple tasks for health care providers, including, for example, calculating Body Mass Index Glascow Coma Scale score NIH Stroke Scale Delivery date estimator Enable patients/providers to interact with electronic record systems Access to Personal Health Record or Electronic Health Record System

25 Apps That Are Not Mobile Medical Apps Electronic copies of textbook and other source materials Education tools for providers not intended for diagnosis or treatment of a specific patient Education and source tools for patients general disease info, clinical trial availability, closest medical facilities

26 Miscellaneous Important FDA Statements in the Guidance Comment that the majority of software-related device failures are due to design errors. Specifically mentions failing to validate software Comment that the Guidance does not address the approach for software that performs patientspecific analysis to aid or support clinical decision-making

27 FDA Twitter Meeting 1 hour; September 26, 2013 #FDAApps Highlights of statements by FDA at meeting: We will allow reasonable time for app developers to be in compliance prior to enforcement actions our efforts are focused on education and clarity at this time We r focusing on clarifying areas that need oversight and looking for voluntary compliance Apps that pose little risk to consumers will receive enforcement discretion Depends on risk of the device and patient exposure We will evaluate necessary actions depending on public health risk

28 FDA Twitter Meeting Highlights of statements by FDA at meeting: MobMed that require FDA review will be evaluated according to the same risk-based system the agency applies to other medical devices Will eval Mob Med in a way that balances risks/benefits w/o creating unnecessary burden for app developers UDI rule applies to all devices we oversee including mobmed apps most mobile apps currently on the market do not require FDA review This is a big de-regulatory action

29 Specific Questions About An App? Now that the US government is funded and working again. FDA will field questions about a specific app. to :

30 Mobile App Product Liability Considerations Impact of Guidance? Potential impact if should have obtained FDA clearance or approval but did not Potential preemption protection for PMA mobile medical apps Potential impact if false or misleading information provided to FDA

31 Mobile App Product Liability Considerations Traditional product liability considerations will apply Design appropriate? Instructions warnings appropriate Appropriate for audience? Professionals versus consumers. Appropriate validation and coding?

32 Issues Specific To Mobile Apps Instructions appropriate for intended and/or known users How to communicate instructions and warnings How do you label a software warning? Hackability and stability? Deployment of updates and patches Compatibility and use of other apps Validation?

33 Restatement 3d of Torts: Products Liability, 19 No case on point but identifying commentators who have urged that software should be treated as a product. Under UCC, mass marketed software is a good whereas customized software is a service.

34 Prior Cases Involving Software An electronic medical questionnaire failing to ask pertinent questions held not a product. Appleby v. Miller, 197 Ill. App. 3d 533 (1990) Automated Software controlling trap door not defective because user had control. Bailey v. Disney Worldwide Shared Services, 950 N.Y.S.2d 607 (Sup. Ct., N.Y. Cty. 2012). Software is a product because it is a highly technical tool used to create a graphic representation from technical data. Hou-Tex, Inc. v. Landmark Graphics, 26 S.W.3d 103 (2000).

35 New Case 10/15/13 Alleged defective remote computer monitoring software provided inaccurate information that deprived surgeon of opportunity to take corrective action In medical malpractice context, but highlights the scenario under which a product liability action could arise. Luther v. IOM Company LLC, 2013 La. LEXIS 2234 (October 15, 2013)

36 Other Product Liability Questions Preemption Product liability claims against retailers FDA enforcement of apps manufactured and sold outside of U.S. What about quality of platform, i.e. resolution of images

37 What Does this Mean? Manufacturer must conduct a threshold assessment of its MMA to see whether it is a medical device that the FDA is focused on enforcing. From a litigation perspective, the manufacturer needs to conduct a risk assessment analysis to consider appropriate disclaimers and other strategies for reducing or eliminating potential liability claims. Be ahead of the curve in this emerging frontier of MMAs.

38 NEW YORK PENNSYLVANIA CONNECTICUT NEW JERSEY UNITED KINGDOM Questions/Comments Michael D. Shalhoub Joseph J. Welter Life Science Matters Blog:

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