Telemedicine as a Medical Device

#1
Hello,

In our hospital, a clinician has developed a software described as telemedicine.

It is intended for patients from the hospital to interact with the software when they have any kind of symptoms. Once the patient idenfies the symptoms and opens the software, it directly opens up a questionnaire that addresses those symptoms until they are almost completely described, and then a chat is popped-up allowing the comunication with the clinician (which has received the result from the questionnaire).

The clinician could diagnose or indicate a treatment to alleviate the symptoms through that chat.

In this case the software could be used to communicate symptoms, diagnostic or treatment. In this case, would the software be considered as a medical device?

If the chat is only open to tell the patient: give us your phone number and we will call you, then the software would be also considered medical device?

Should risks as cybersecurity attacks be a reason to consider the software as medical device?

Should risks as missdiagnostic that leads to further invasive or burdensome tests be a reason to consider the software as a medical device?

Thanks in advance
 
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Zero_yield

No cost too great...for Quality
#2
Hello beltrans,

On the FDA website regarding digital health, I found a link to this tool for determining which regulations apply to an app.

So following the questions:
1. Do you create, receive, maintain, or transmit identifiable health information?
-Based on your original response, I'm saying "yes," which takes us to question 2.

2. Are you a health care provider or health plan?
-You said you're part of a hospital, so I'm saying "yes," which takes us to question 5.

5. Is your app intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease?
-Which I think is your question. If you answer "yes," then the software is a medical device.

However, it also has a broken link to something called "Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff", which I believe was superseded by this document. Appendix A and B are examples that are NOT medical devices, and examples that should probably be medical devices.

I am not an expert on this topic, but looking at the examples of each, it looks like the software rides a very fine line.

For example, these two sound similar to what you're describing and are examples of things that are NOT medical devices:

5. Software functions that are generic aids or general-purpose products – This software is not considered a device because it is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Examples include software functions that:
...Allow patients or health care providers to interact through email, web-based platforms, video, or other communication mechanisms (but are not specifically intended for medical purposes);
11. Software functions that are specifically marketed to help patients document, show, or communicate to providers regarding potential medical conditions – These products either pose little or no risk, or are the sole responsibility of the health care providers who have used them in medical applications. Examples include:

o Software that serves as a videoconferencing portal specifically intended for medical use and to enhance communications between patients, health care providers, and caregivers.
However, the second the app starts doing anything to recommend treatment, everything flips. For example, this is one of the items listed as something the FDA intends to exercise enforcement of:

7. Software functions that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider;
So I would be very careful of scope creep when people start suggesting other things they want out of the software.
 

Junn1992

Quite Involved in Discussions
#3
I would say no, because it is not the software that provides diagnosis, and the intended use is simply for patients to communicate with the physician.
 

dgrainger

Trusted Information Resource
#4
MDCG 2019-11 has a section that is applicable:

"d) Communication Systems
The healthcare sector uses communication systems (e.g. email systems, mobile telecommunication systems, video communication systems, paging, etc.) to transfer electronic information. Different types of messages are sent such as prescription, referrals, images, patient records, etc.​
Most of the communication systems handle types of messages other than medical information. This communication system is intended for general purposes, and is used for transferring both medical and non-medical information.​
Communication systems are normally based on software for general purposes, and do not fall within the definition of a medical device.​
Communication system modules might be used with other modules that might be qualified in their own right as medical devices (MDSW).​
A software module generating alarms based on the monitoring and analysis of patient specific physiological parameters is qualified as a medical device (MDSW)."

I don't think it would qualify as a device unless there is some built in decision making algorithm.

These types of products do tend to evolve, so keep an eye on what extra functionality is added over time!
 
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