With the increasing number of medical and health care related apps making their way on smartphones and other portable devices (tablets, media players etc), the US Food and Drug Administration has issued Draft Guidances for bringing certain Mobile Medical Apps into the regulatory regime, seeking feedback from the medical industry and the FDA Staff.
This is a sign of things to come – with an increased focus on mobile health related services in India, undoubtedly, mobile initiatives in India will also come under regulatory scrutiny. Regulators in the country are waking up to the impact of digitization: for example, the insurance regulator IRDA issued draft guidelines regarding web aggregators of insurance services earlier this year. The guidelines from the US FDA for medical mobile apps should be seen as a pointer for something that might happen in India, perhaps a couple of years from today (if not sooner):
What The US FDA Is Seeking To RegulateThe guidelines cover only select apps that are critical to or impact the performance or functionality of currently regulated medical devices, and app developers whose apps qualify as a medical app as per the FDA’s definition, would be under close watch of the authority. App distribution platforms such as app stores are expected to cooperate with app developers in conducting corrections and removals. Although the draft guidance does not establish legally enforceable responsibilities, it does require the manufacturers i.e developers to annually register their establishments with the FDA and provide a list of devices/apps they market, so that it is informed about them.
The FDA believes that this subset of mobile apps poses the same or similar potential risk to the public health as currently regulated devices, if they fail to function as intended.
Apps Considered Mobile Medical Apps
- Mobile apps that are an extension of one or more medical device(s) by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples of displays of patient- specific medical device data include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communication System (PACS) server, or similar display functions that meet the definition of an MDDS. Examples of mobile apps that control medical devices include apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.
- Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Examples include a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or, a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea.
- Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.
Apps Not Considered Medical Apps
- Mobile apps that are electronic “copies” of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received. These types of apps do not contain any patient-specific information, but could show examples for a specific medical specialty. Examples of such medical text books include the electronic Physician’s Desk Reference and similar reference materials that are typically used as part of course instruction and are implemented as electronic books. Exemplary teaching aids and reference materials include: flash cards or quizzes that are used for training purposes or as reference material (e.g., with preloaded medical images, conditions, pictures, graphs, etc.); slideshows of common conditions; lists of medical terminology; and review materials that are to be used by medical students during training. (In contrast, mobile apps that allow the user to input patient-specific information along with reference material to automatically diagnose a disease or condition are considered mobile medical apps).
- Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.
-Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions. Examples include: apps that determine billing codes like ICD-9 (international statistical classification of diseases); medical business accounting functions and aids that track and trend billable hours, procedures, and reminders for scheduled medical appointments or blood donation appointments; apps that automate functions such as collecting patient histories that replace paper-based entry; apps that enable insurance claims data collection and processing; and other apps that are similarly administrative in nature.
- Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication. Examples include apps that use the mobile platform as a magnifying glass (but not specifically for medical purposes),11 recording audio, note- taking, replaying audio with amplification, and other similar functionalities.
- Mobile apps that perform the functionality of an electronic health record system or personal health record system.
The guidelines will also ensure that consumers are not misled and know if the app really does what it promises to do, before buying it. For example, an app called the Sleep Cycle alarm clock, claims to analyze sleep patterns and wake the user up at a time when he feels relaxed. It uses the device’s accelerometer to record the user’s sleep patterns. So, if the FDA finds that it does not do what it claims to do, it will be asked to make necessary changes or simply ask the developer to remove it. This is also in a way an affirmation that mobile apps have been accepted as medical aid tools, and have a huge potential in the field of medicine.
Regulatory Norms To Be Followed
Although the draft guidance does not establish legally enforceable responsibilities, it does require the manufacturers i.e developers to follow some norms:
- Registration & Listing: Annually register their establishments with the FDA and provide a list of devices/apps they market, so that it is informed about who is manufacturing devices/apps, and of the types of devices/apps an establishment is manufacturing.
- Investigational Device Exemption requirements: Allows an investigational device/app to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification submission to FDA. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of non-significant risk must be approved by the IRB only before the study can begin. Mobile medical app manufacturers who are creating mobile apps with novel technologies are encouraged to engage in early collaboration meetings with the FDA to receive clear direction for testing and development of those devices requiring clinical investigations to support marketing.
- Medical device/app manufacturers are required to comply with applicable labeling regulations.
- Mobile medical app manufacturers should identify the current classification covering their mobile medical app. Manufacturers are required to prepare and submit to the FDA an appropriate premarket submission, as required for their device classification.
- Mobile medical app manufacturers are required to comply with the Quality System Regulation or QSR. The QSR does not prescribe in detail how a manufacturer must produce a specific device, but provides a framework for all manufacturers to develop and follow to help ensure that their products consistently meet applicable requirements and specifications. As part of this framework, mobile medical app manufacturers are required to develop requirements for their products that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute their devices. Mobile medical app manufacturers are required to ensure that adequate controls and processes are in place through purchasing controls to ensure safe distribution, installation and operation of the mobile medical app.
- The Medical Device Reporting (MDR) regulation requires manufacturers and importers of medical devices/apps to submit reports to the FDA whenever they receive or otherwise become aware of information, from any source, that reasonably suggests that a device they market may have caused or contributed to a death or serious injury, or has malfunctioned and the device/app or a similar device/app that they market would be likely to cause or contribute to a reportable death or serious injury if the malfunction were to recur.
- A mobile medical app manufacturer may voluntarily take action at any time or may be requested to take action by the FDA to correct problems. Voluntary action is usually taken by device/app manufacturers.
Download the guidelines here
This post first appeared on AppNama – Our sister site that focuses on mobile apps and services.