1. No category

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