Zabrze, 28 marca 2015 Kiedy mobilna aplikacja zdrowotna staje się narzędziem medycznym? dr. n. med. Łukasz Kołtowski I Katedra i Klinika Kardiologii Warszawski Uniwersytet Medyczny
NARZĘDZIE MEDYCZNE? WYRÓB MEDYCZNY
WYRÓB MEDYCZNY narzędzie, przyrząd, aparat, sprzęt, materiał lub inny artykuł, stosowany samodzielnie lub w połączeniu, włączając oprogramowanie niezbędne do właściwego stosowania wyrobu, przeznaczone przez wytwórcę do stosowania u ludzi w celu: A. diagnozowania, zapobiegania, monitorowania, leczenia lub łagodzenia przebiegu chorób, B. diagnozowania, monitorowania, leczenia, łagodzenia lub kompensowania urazów lub upośledzeń, C. badania, zastępowania lub modyfikowania budowy anatomicznej lub prowadzenia procesu fizjologicznego, D. regulacji poczęć, który nie osiąga swojego zasadniczego zamierzonego działania w ciele lub na ciele ludzkim środkami farmakologicznymi, immunologicznymi lub metabolicznymi, lecz którego działanie może być przez nie wspomagane; Źródło: ustawa z dnia 20 kwietnia 2004 r. o wyrobach medycznych (Dz.U. Nr 93, poz. 896).
Czy aplikacja mobilna jest wyrobem medycznym? [brak jednoznacznej regulacji w polskim prawodawstwie]
Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, w drodze decyzji administracyjnej, rozstrzyga rozbieżności, które powstają między wytwórcą a jednostką notyfikowaną, w kwestii sklasyfikowania danego wyrobu medycznego. Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych (Dz.U. Nr 107, poz. 679, z późn. zm.) Rozporządzenie Ministra Zdrowia z dnia 5 listopada 2010 r. w sprawie sposobu klasyfikowania wyrobów medycznych(dz.u. Nr 215, poz. 1416) Rozporządzenie Ministra Zdrowia z dnia 12 stycznia 2011 r. w sprawie wymagań zasadniczych oraz procedur oceny zgodności wyrobów medycznych do diagnostyki in vitro(dz.u. z 2013 r. poz. 1127, z późn. zm.)
Czynniki, które bierze się pod uwagę podczas klasyfikacji wyrobu medycznego 1. stopień inwazyjności; 2. czas i rodzaj styczności z pacjentem; 3. sposób zasilania; 4. obecność składników potencjalnie niebezpiecznych dla pacjenta (np. produktów leczniczych, produktów krwiopochodnych, tkanek zwierzęcych).
Lorem Ipsum Dolor Mobile Medical App FDA Guidelines 9 Feb 2015
mobile medical app definition a mobile app that meets the definition of medical device is intended to be used as an accessory to a regulated medical device, or is intended to transform a mobile platform into a regulated medical device.
Mobile Apps that are not medical devices
1) Apps to provide access to electronic copies of medical textbooks or other reference materials*. Medical dictionaries; Electronic copies of medical textbooks or literature articles such as the Physician s Desk Reference or Diagnostic and Statistical Manual of Mental Disorders (DSM); Library of clinical descriptions for diseases and conditions; Encyclopedia of first-aid or emergency care information; Medical abbreviations and definitions; Translations of medical terms across multiple languages. * with generic text search capabilities.
2) Apps for health care providers to use as educational tools for medical training or to reinforce training previously received. Games that simulate various cardiac arrest scenarios to train health professionals in advanced CPR skills.
2) Apps for health care providers to use as educational tools for medical training or to reinforce training previously received. Medical flash cards with medical images, pictures, graphs, etc.;
2) Apps for health care providers to use as educational tools for medical training or to reinforce training previously received. but also: Question/Answer quiz apps; Interactive anatomy diagrams or videos; Surgical training videos; Medical board certification or recertification preparation apps;
3) Intended for general patient education and facilitate patient access to commonly used reference information* Help match patients with potentially appropriate clinical trials and facilitate communication between the patient and clinical trial investigators; * can be patient-specific (i.e., filters information to patient-specific characteristics), but are intended for increased patient awareness, education, and empowerment, and ultimately support patient-centered health care.
3) Intended for general patient education and facilitate patient access to commonly used reference information* Find the closest medical facilities and doctors to the user s location;
4) Apps that automate general office operations in a health care Generate reminders for scheduled medical appointments or everyday health recommendations;
mobile medical app definition a mobile app that meets the definition of medical device is intended to be used to control a regulated medical device, or is intended to transform a mobile platform into a regulated medical device.
Mobile apps that are an extension of a medical device by connecting to such device for purposes of controlling the device.
Examples of mobile apps that control medical devices apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform 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 regulated medical device by: a) using attachments, display screens, or sensors or b) by including functionalities (built-in sensors) similar to those of currently regulated medical devices.
Examples of a mobile apps that transform the mobile platform into a regulated medical device by using attachments or sensors attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter; attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals
Examples of a mobile apps that transform the mobile platform into a regulated medical device by using attachments or sensors attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter;
Examples of a mobile apps that transform the mobile platform into a regulated medical device by using attachments or sensors attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals
Examples of a mobile app that uses the built-in sensors a mobile app that uses accelerometer on a mobile platform to collect motion information for monitoring sleep apnea; a mobile app that uses accelerometer to measure physiological parameters during cardiopulmonary resuscitation (CPR) and give feedback about the quality of CPR being delivered. a mobile app that uses phone microphone for creating electronic stethoscope function a mobile app that uses phone camera and gyroscope to record, view, or analyze eye movements for use in the diagnosis of balance disorders (i.e., nystagmograph).
Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
Mobile apps that become a regulated medical device (software) by performing patientspecific analysis and providing patient-specific diagnosis, or treatment recommendations.
Examples of mobile apps that perform sophisticated analysis or interpret data (electronically collected or manually entered) from another medical device apps that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy; a mobile app that presents donor history questions to a potential blood donor and transmits the responses to determine blood donor eligibility prior to collection of blood or blood components.
Mobile Apps that may meet the definition of a medical device but because they pose a lower risk to the public. FDA will not enforce requirements under the FD&C Act.
Examples of mobile apps that pose a lower risk to the public
1) Mobile apps that provide or facilitate supplemental clinical care improve adhering to pre-determined medication dosing schedules by simple prompting.
2) Provide patients with simple tools to organize and track their health information simple tools for patients with specific conditions or chronic disease (e.g., obesity, anorexia, arthritis, diabetes, heart disease): to log, track, or trend their events or measurements (e.g., blood pressure measurements, drug intake times, diet, daily routine or emotional state) to share this information with their health care provider as part of a disease-management plan.
2) Provide patients with simple tools to organize and track their health information to log, track, or trend their events or measurements (e.g., blood pressure measurements, drug intake times, diet, daily routine or emotional state)
3) Apps that provide easy access to information related to patients health conditions or treatments (beyond providing an electronic copy of a medical reference*) Apps that use a patient s diagnosis to provide a clinician with best practice treatment guidelines for common illnesses or conditions such as influenza; * provide contextually-relevant information to users by matching patient-specific information (e.g., diagnosis, treatments, allergies, signs or symptoms) to reference information routinely used in clinical practice (e.g., practice guidelines) to facilitate a user s assessment of a specific patient.
4) Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions. Apps that serve as videoconferencing portals specifically intended for medical use and to enhance communications between patients, healthcare providers, and caregivers; Apps specifically intended for medical uses that utilize the mobile device s built-in camera or a connected camera for purposes of documenting or transmitting pictures (e.g., photos of a patient s skin lesions or wounds)
5) Mobile apps that perform simple calculations* routinely used in clinical practice Body Mass Index (BMI) Total Body Water / Urea Volume of Distribution Mean arterial pressure Glascow Coma Scale score PGAR score NIH Stroke Scale Delivery date estimator *retain functionality that is similar to simple general purpose tools such as paper charts, spread sheets, timers or generic mathematical calculators
6) Mobile apps that enable individuals to interact with PHR systems or EHR systems provide patients and providers with mobile access to health record systems or enables them to gain electronic access to health information stored within a PHR system or EHR system; generally meant to facilitate general patient health information management and health record-keeping activities.
7) Mobile apps that meet the definition of Medical Device Data Systems intended to transfer, store, convert format, and display medical device data, without controlling or altering the functions or parameters of any connected medical device; a secondary display to a regulated medical device when these apps are not intended to provide primary diagnosis, treatment decisions, or to be used in connection with active patient monitoring.
Low vs High Risk
Wnioski Mobilne aplikacje medyczne, których cechy, funkcjonalność i charakterystyka spełnia definicję wyrobu medycznego podlegają regulacjom ustawy o wyrobach medycznych. Brakuje precyzyjnych wytycznych dot. medycznych aplikacji mobilnych rozwiewających wątpliwości odnośne klasyfikacji oprogramowania w zależności od poziomu ryzyka dla pacjenta (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych).
Dziękuję www.koltowski.com blog o zdrowiu mobilnym